Editing MPEP 2700

{{MPEP Chapter|2600|}}

'''<big>Chapter 2700 Patent Terms and Extensions</big>'''

<div class="noautonum">__TOC__</div>

==2701 Patent Term==

{{Statute|35 U.S.C. 154. Contents and term of patent; provisional rights.}}
(a)IN GENERAL.—
{{Ellipsis}}
(2)TERM.—Subject to the payment of fees under this 
title, such grant shall be for a term beginning on the date on which 
the patent issues and ending 20 years from the date on which the 
application for the patent was filed in the United States or, if the 
application contains a specific reference to an earlier filed application 
or applications under section 120, 121, or 365(c) of this title, 
from the date on which the earliest such application was filed.

(3)PRIORITY.—Priority under section 119, 365(a), or 
365(b) of this title shall not be taken into account in determining 
the term of a patent.

(c)CONTINUATION.—

(1)DETERMINATION.—The term of a patent that is in 
force on or that results from an application filed before the date 
that is 6 months after the date of the enactment of the Uruguay 
Round Agreements Act shall be the greater of the 20-year term as 
provided in subsection (a), or 17 years from grant, subject to any 
terminal disclaimers.

(2)REMEDIES.—The remedies of sections 283, 284, 
and 285 of this title shall not apply to acts which —

(A)were commenced or for which substantial investment 
was made before the date that is 6 months after the date of 
the enactment of the Uruguay Round Agreements Act; and

(B)became infringing by reason of paragraph (1).

(3)REMUNERATION.—The acts referred to in paragraph 
(2) may be continued only upon the payment of an equitable 
remuneration to the patentee that is determined in an action 
brought under chapter 28 and chapter 29 (other than those provisions 
excluded by paragraph (2)) of this title.
{{Ellipsis}}
|}


For applications filed on or after June 8, 1995, Section 
532(a)(1) of the Uruguay Round Agreements Act 
(Pub. L. 103-465, 108 Stat. 4809 (1994)) amended 
35 
U.S.C. 154 to provide that the term of a patent 
(other than a design patent) begins on the date the 
patent issues and ends on the date that is twenty 
years 
from the date on which the application for 
the 
patent was filed in the United States or, if the 
application contains a specific reference to an earlier 
filed application or applications under 35 U.S.C. 120, 
121, or 365(c), twenty years from the filing date of the 
earliest of such application(s). This patent term provision 
is referred to as the “twenty-year term.” Design 
patents have a term of fourteen years from the date of 
patent grant. See 35 U.S.C 173 and MPEP § 1505. 

All patents (other than design patents) that were in 
force on June 8, 1995, or that issued on an application 
that was filed before June 8, 1995, have a term that is 
the greater of the “twenty-year term” or seventeen 
years from the patent grant. See 35 U.S.C. 154(c). A 
patent granted on an international application filed 
before June 8, 1995, and which entered the national 
stage under 35 U.S.C. 371 before, on or after June 8, 
1995, will have a term that is the greater of seventeen 
years from the date of grant or twenty years from the 
international filing date or any earlier filing date 
relied upon under 35 
U.S.C. 120, 121 or 365(c). The 
terms of these patents are subject to reduction by any 
applicable terminal disclaimers (discussed below).

CONTINUING APPLICATIONS

A patent granted on a continuation, divisional, or 
continuation-in-part application that was filed on or 
after June 8, 1995, will have a term which ends 
twenty years from the filing date of earliest application 
for which a benefit is claimed under 35 U.S.C. 
120, 121, or 365(c), regardless of whether the application 
for which a benefit is claimed under 35 U.S.C. 
120, 121, or 365(c) was filed prior to June 8, 1995.

INTERNATIONAL APPLICATIONS

A patent granted on an international application 
filed on or after June 8, 1995 and which enters the 
national stage under 35 U.S.C. 371 will have a term 
which ends twenty years from the filing date of the 
international application. A continuation or a continuation-
in-part application claiming benefit under 
35 
U.S.C. 365(c) of an international application filed 
under 35 U.S.C. 363 designating the United States 
will have a term which ends twenty years from the filing 
date of the parent international application.

FOREIGN PRIORITY

Foreign priority under 35 U.S.C. 119(a)-(d), 365(a), 
or 365(b) is not considered in determining the term of 
a patent. Accordingly, an application claiming priority 
under 35 U.S.C. 365(a) or 365(b) has a term which 
ends twenty years from the filing date of the application 
in the United States and not the prior international 
application.

DOMESTIC PRIORITY UNDER 35 U.S.C. 119(e)

Domestic priority under 35 U.S.C. 119(e) to one or 
more U.S. provisional applications is not considered 
in the calculation of the twenty-year term. See 
35 U.S.C. 154(a)(3).

EXPIRATION DATE OF PATENTS WITH 
TERMINAL DISCLAIMERS

To determine the “original expiration date” of a 
patent subject to a terminal disclaimer, it is generally 
necessary to examine the language of the terminal disclaimer 
in the patent file history. If the disclaimer disclaims 
the terminal portion of the term of the patent 
which would extend beyond the expiration date of an 
earlier issued patent, then the expiration date of the 
earlier issued patent determines the expiration date of 
the patent subject to the terminal disclaimer. Before 
June 8, 1995, the terminal disclaimer date was printed 
on the face of the patent; the date was determined 
from the expected expiration date of the earlier issued 
patent based on a seventeen year term measured from 
grant. When 35 U.S.C. 154 was amended such that all 
patents (other than design patents) that were in force 
on June 8, 1995, or that issued on an application that 
was filed before June 8, 1995, have a term that is the 
greater of the “twenty year term” or seventeen years 
from the patent grant, the terminal disclaimer date as 
printed on many patents became incorrect. If the terminal 
disclaimer of record in the patent file disclaims 
the terminal portion of the patent subsequent to the 
full statutory term of a referenced patent (without 
identifying a specific date), then the date printed on 
the face of the patent is incorrect when the full statutory 
term of the referenced patent is changed as a 
result of 35 U.S.C. 154(c). That is, the referenced 
patent’s “twenty year term” is longer than the seventeen 
year term. In such a case, a patentee may request 
a Certificate of Correction under 37 
CFR 1.323 to 
correct the information printed on the face of the 
patent. However, if the terminal disclaimer of record 
in the patent file disclaims the terminal portion of the 
patent subsequent to a specific date, without reference 
to the full statutory term of a referenced patent, then 
the expiration date is the date specified. Several decisions 
related to disclaimers are posted in the Freedom 
of Information Act (FOIA) section of the USPTO 
Internet site (www.uspto.gov).

PATENT TERM EXTENSIONS OR ADJUSTMENTS

See MPEP § 2710, et seq., for patent term extensions 
or adjustments for delays within the 
USPTO 
under 35 U.S.C. 154 for utility and plant patents 
issuing on applications filed on or after June 8, 
1995. Patents that issue from applications filed before 
June 8, 1995, are not eligible for patent term extension 
or patent term adjustment under 35 
U.S.C. 154.

See MPEP § 2750 et. seq. for patent term extensions 
available under 35 U.S.C. 156 for premarket 
regulatory review. The patent term extension that may 
be available under 35 U.S.C. 156 for premarket regulatory 
review is separate from and will be added to 
any extension that may be available under former and 
current 35 U.S.C. 154. While patents that issue from 
applications filed before June 8, 1995, are not eligible 
for term adjustment under 35 U.S.C. 154, such patents 
may be extended under 35 U.S.C. 156.

==2710 Term Extensions or Adjustments for Delays Within the USPTO Under 35 U.S.C. 154==

Utility and plant patents issuing on applications 
filed on or after June 8, 1995, but before May 29, 
2000, are eligible for the patent term  extension 
provisions of former 35 U.S.C. 154(b) and 37 CFR 
1.701. See MPEP § 2720. Utility and plant patents 
issuing on applications filed on or after May 29, 2000 
are eligible for the patent term adjustment provisions 
of 35 U.S.C. 154(b)(amended, effective May 29, 
2000) and 37 CFR 1.702-1.705. See MPEP § 2730. 

Plant and utility patents issuing on applications 
filed before June 8, 1995 which have a term that is the 
greater of the “twenty-year term” (see MPEP § 2701) 
or seventeen years from patent grant are not eligible 
for term extension or adjustment due to delays in processing 
the patent application by the United States 
Patent and Trademark Office. 

Since the term of a design patent is not affected by 
the length of time prosecution takes place, there are 
no patent term adjustment provisions for design patents.

==2720 Applications Filed Between June 8, 1995, and May 28, 2000==

{{Statute|Former 35 U.S.C. 154. Contents and term of patent.}}
{{Ellipsis}}
(b)TERM EXTENSION.—

(1)INTERFERENCE DELAY OR SECRECY 
ORDERS.—If the issue of an original patent is delayed due to a 
proceeding under section 135(a) of this title, or because the application 
for patent is placed under an order pursuant to section 181 
of this title, the term of the patent shall be extended for the period 
of delay, but in no case more than 5 years.

(2)EXTENSION FOR APPELLATE REVIEW. —If the 
issue of a patent is delayed due to appellate review by the Board 
of Patent Appeals and Interferences or by a Federal court and the 
patent is issued pursuant to a decision in the review reversing an 
adverse determination of patentability, the term of the patent shall 
be extended for a period of time but in no case more than 5 years. 
A patent shall not be eligible for extension under this paragraph if 
it is subject to a terminal disclaimer due to the issue of another 
patent claiming subject matter that is not patentably distinct from 
that under appellate review.

(3)LIMITATIONS.—The period of extension referred to 
in paragraph (2)—

(A)shall include any period beginning on the date on 
which an appeal is filed under section 134 or 141 of this title, or 
on which an action is commenced under section 145 of this title, 
and ending on the date of a final decision in favor of the applicant;

(B)shall be reduced by any time attributable to appellate 
review before the expiration of 3 years from the filing date of 
the application for patent; and

(C)shall be reduced for the period of time during 
which the applicant for patent did not act with due diligence, as 
determined by the Commissioner.

(4)LENGTH OF EXTENSION.—The total duration 
of 
all extensions of a patent under this subsection shall not exceed 
5 years.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.701. Extension of patent term due to examination delay under the Uruguay Round Agreements Act (original applications, other than designs, filed on or after June 8, 1995, and before May 29, 2000).}}
(a)A patent, other than for designs, issued on an application 
filed on or after June 8, 1995, is entitled to extension of the patent 
term if the issuance of the patent was delayed due to:

(1)Interference proceedings under 35 U.S.C. 135(a); and/
or

(2)The application being placed under a secrecy order 
under 35 U.S.C. 181; and/or

(3)Appellate review by the Board of Patent Appeals 
and Interferences or by a Federal court under 35 U.S.C. 141 or 
145, if the patent was issued pursuant to a decision in the review 
reversing an adverse determination of patentability and if the 
patent is not subject to a terminal disclaimer due to the issuance of 
another patent claiming subject matter that is not patentably distinct 
from that under appellate review. If an application is 
remanded by a panel of the Board of Patent Appeals and Interferences 
and the remand is the last action by a panel of the Board of 
Patent Appeals and Interferences prior to the mailing of a notice 
of allowance under 35 U.S.C. 151 in the application, the remand 
shall be considered a decision in the review reversing an adverse 
determination of patentability as that phrase is used in 35 U.S.C. 
154(b)(2) as amended by section 532(a) of the Uruguay Round 
Agreements Act, Public Law 103-465, 108 Stat. 4809, 4983-85 
(1994), and a final decision in favor of the applicant under paragraph 
(c)(3) of this section. A remand by a panel of the Board of 
Patent Appeals and Interferences shall not be considered a decision 
in the review reversing an adverse determination of patentability 
as provided in this paragraph if there is filed a request for 
continued examination under 35 U.S.C. 132(b) that was not first 
preceded by the mailing, after such remand, of at least one of an 
action under 35 U.S.C. 132 or a notice of allowance under 35 
U.S.C. 151.

(b)The term of a patent entitled to extension under paragraph 
(a) of this section shall be extended for the sum of the periods 
of delay calculated under paragraphs (c)(1), (c)(2), (c)(3) and 
(d) of this section, to the extent that these periods are not overlapping, 
up to a maximum of five years. The extension will run from 
the expiration date of the patent.

(c)(1) The period of delay under paragraph (a)(1) of this section 
for an application is the sum of the following periods, to the 
extent that the periods are not overlapping:

(i) With respect to each interference in which the application 
was involved, the number of days, if any, in the period 
beginning on the date the interference was declared or redeclared 
to involve the application in the interference and ending on the 
date that the interference was terminated with respect to the application; 
and

(ii) The number of days, if any, in the period beginning 
on the date prosecution in the application was suspended by the 
Patent and Trademark Office due to interference proceedings 
under 35 
U.S.C. 135(a) not involving the application and ending 
on the date of the termination of the suspension.

(2)The period of delay under paragraph (a)(2) of this section 
for an application is the sum of the following periods, to the 
extent that the periods are not overlapping:

(i)The number of days, if any, the application was 
maintained in a sealed condition under 35 
U.S.C. 181;

(ii)The number of days, if any, in the period beginning 
on the date of mailing of an examiner’s answer under § 1.193in the application under secrecy order and ending on the date the 
secrecy order and any renewal thereof was removed;

(iii)The number of days, if any, in the period beginning 
on the date applicant was notified that an interference would 
be declared but for the secrecy order and ending on the date the 
secrecy order and any renewal thereof was removed; and

(iv)The number of days, if any, in the period beginning 
on the date of notification under § 5.3(c) and ending on the 
date of mailing of the notice of allowance under § 1.311.

(3)The period of delay under paragraph (a)(3) of this section 
is the sum of the number of days, if any, in the period beginning 
on the date on which an appeal to the Board of Patent 
Appeals and Interferences was filed under 35 U.S.C. 134 and ending 
on the date of a final decision in favor of the applicant by the 
Board of Patent Appeals and Interferences or by a Federal court in 
an appeal under 35 
U.S.C. 141 or a civil action under 35 U.S.C. 
145.

(d)The period of delay set forth in paragraph (c)(3) shall be 
reduced by:

(1)Any time during the period of appellate review that 
occurred before three years from the filing of the first national 
application for patent presented for examination; and

(2)Any time during the period of appellate review, as 
determined by the Director, during which the applicant for patent 
did not act with due diligence. In determining the due diligence of 
an applicant, the Director may examine the facts and circumstances 
of the applicant’s actions during the period of appellate 
review to determine whether the applicant exhibited that degree of 
timeliness as may reasonably be expected from, and which is ordinarily 
exercised by, a person during a period of appellate review.

(e)The provisions of this section apply only to original patents, 
except for design patents, issued on applications filed on or 
after June 8, 1995, and before May 29, 2000.
|}


The twenty-year term of a patent issuing from an 
application filed on or after June 8, 1995, and before 
May 29, 2000, may be extended for a maximum of 
five years for delays in the issuance of the patent due 
to interferences, secrecy orders and/or successful 
appeals to the Board of Patent Appeals and Interferences 
(Board) or the Federal courts in accordance 
with 37 
CFR 1.701. See former 35 U.S.C. 154(b), as 
reproduced above. Extensions for successful appeals 
are limited in that the patent must not be subject to a 
terminal disclaimer. Further, the period of extension 
will be reduced by any time attributable to appellate 
review within three years of the filing date of the 
first national application for patent, and the 
period of extension for appellate review will be 
reduced by any time during which the applicant did 
not act with due diligence. The patent term extension 
that may be available under 35 U.S.C. 156 for premarket 
regulatory review is separate from and will be 
added to any extension that may be available under 
former and current 35 U.S.C. 154. See MPEP § 2750et seq. 35 U.S.C. 154(b) was amended, effective May 
29, 2000, to provide for patent term adjustment for 
applications filed on or after May 29, 2000, but the 
provisions of former 35 U.S.C. 154(b), as reproduced 
above, continue to apply to applications filed between 
and including June 8, 1995 and May 28, 2000.

Examiners make no decisions regarding patent term 
extensions. Extensions under former 35 U.S.C. 154will be calculated by PALM and will be printed on the 
Notice of Allowance and Issue Fee Due. Any patent 
term extension granted as a result of administrative 
delay pursuant to 37 CFR 1.701 will also be printed 
on the face of the patent in generally the same location 
as the terminal disclaimer information. The term 
of a patent will be readily discernible from the face of 
the patent (i.e., from the filing date, continuing data, 
issue date and any patent term extensions printed on 
the patent). 

If applicant disagrees with the patent term extension 
information printed on the Notice of Allowance 
and Fee(s) Due, applicant may request 
review by way of a petition under 37 CFR 1.181. To 
avoid loss of patent term, however, any such petitions 
filed during the pendency of the application will not 
be decided until after issuance of the patent. If the 
petition is granted, a Certificate of Correction pursuant 
to 37 CFR 1.322 will be issued. If the patent 
issues with a different patent term extension value 
than that indicated on the Notice of Allowance or 
Office computer records (Patent Application Information 
Retrieval (PAIR)), patentee may seek correction 
of the patent term extension information by filing a 
request for a Certificate of Correction pursuant to 37 
CFR 1.322.

Effective May 24, 2004, 37 CFR 1.701(a)(3) was 
amended to indicate that certain remands by the 
Board shall be considered “a decision in the review 
reversing an adverse determination of patentability” 
for patent term extension purposes. Any request for 
reconsideration of the patent term extension indicated 
on a patent resulting from an application in which the 
notice of allowance was mailed before May 24, 2004 
on the basis of the changes to 37 CFR 1.701 must be 
filed no later than July 21, 2004.

Petitions and Certificates of Correction regarding 
patent term extension under former 35 U.S.C. 154(b)
should be addressed to Mail Stop Patent Ext., 
Commissioner for Patents, P.O. Box 1450, Alexandria, 
Virginia 22313-1450.

==2730 Applications Filed on or After May 29, 2000; Grounds for Adjustment==

{{Statute|35 U.S.C. 154. Contents and term of patent; provisional rights.}}
{{Ellipsis}}
(b)ADJUSTMENT OF PATENT TERM.— 

(1)PATENT TERM GUARANTEES.— 

(A)GUARANTEE OF PROMPT PATENT AND 
TRADEMARK OFFICE RESPONSES.— Subject to the limitations 
under paragraph (2), if the issue of an original patent is 
delayed due to the failure of the Patent and Trademark Office to— 

(i)provide at least one of the notifications under 
section 132 of this title or a notice of allowance under section 151of this title not later than 14 months after— 

(I)the date on which an application was filed 
under section 111(a) of this title; or

(II)the date on which an international application 
fulfilled the requirements of section 371 of this title;

(ii)respond to a reply under section 132, or to an 
appeal taken under section 134, within 4 
months after the date on 
which the reply was filed or the appeal was taken;

(iii)act on an application within 4 
months after the 
date of a decision by the Board of Patent Appeals and Interferences 
under section 134 or 135 or a decision by a Federal court 
under section 141, 145, or 146 in a case in which allowable claims 
remain in the application; or

(iv)issue a patent within 4 months after the date on 
which the issue fee was paid under section 151 and all outstanding 
requirements were satisfied, the term of the patent shall be 
extended 1 day for each day after the end of the period specified in 
clause (i), (ii), (iii), or (iv), as the case may be, until the action 
described in such clause is taken.

(B)GUARANTEE OF NO MORE THAN 3-YEAR 
APPLICATION PENDENCY.— Subject to the limitations under 
paragraph (2), if the issue of an original patent is delayed due to 
the failure of the United States Patent and Trademark Office to 
issue a patent within 3 
years after the actual filing date of the 
application in the United States, not including— 

(i)any time consumed by continued examination 
of the application requested by the applicant under section 132(b);

(ii)any time consumed by a proceeding under section 
135(a), any time consumed by the imposition of an order 
under section 181, or any time consumed by appellate review by 
the Board of Patent Appeals and Interferences or by a Federal 
court; or

(iii)any delay in the processing of the application 
by the United States Patent and Trademark Office requested by 
the applicant except as permitted by paragraph (3)(C), the term of 
the patent shall be extended 1 day for each day after the end of 
that 3-year period until the patent is issued.

(C)GUARANTEE OR ADJUSTMENTS FOR 
DELAYS DUE TO INTERFERENCES, SECRECY ORDERS, 

AND APPEALS.— Subject to the limitations under paragraph 
(2), if the issue of an original patent is delayed due to— 

(i)a proceeding under section 135(a);

(ii)the imposition of an order under section 181; or

(iii)appellate review by the Board of Patent 
Appeals and Interferences or by a Federal court in a case in which 
the patent was issued under a decision in the review reversing an 
adverse determination of patentability, the term of the patent shall 
be extended 1 day for each day of the pendency of the proceeding, 
order, or review, as the case may be.

(2)LIMITATIONS.— 

(A)IN GENERAL.— To the extent that periods of 
delay attributable to grounds specified in paragraph (1) overlap, 
the period of any adjustment granted under this subsection shall 
not exceed the actual number of days the issuance of the patent 
was delayed.

(B)DISCLAIMED TERM.— No patent the term of 
which has been disclaimed beyond a specified date may be 
adjusted under this section beyond the expiration date specified in 
the disclaimer.

(C)REDUCTION OF PERIOD OF ADJUSTMENT.— 

(i)The period of adjustment of the term of a patent 
under paragraph (1) shall be reduced by a period equal to the 
period of time during which the applicant failed to engage in reasonable 
efforts to conclude prosecution of the application.

(ii)With respect to adjustments to patent term 
made under the authority of paragraph (1)(B), an applicant shall 
be deemed to have failed to engage in reasonable efforts to conclude 
processing or examination of an application for the cumulative 
total of any periods of time in excess of 3 months that are 
taken to respond to a notice from the Office making any rejection, 
objection, argument, or other request, measuring such 3-month 
period from the date the notice was given or mailed to the applicant.

(iii)The Director shall prescribe regulations establishing 
the circumstances that constitute a failure of an applicant 
to engage in reasonable efforts to conclude processing or examination 
of an application.

(3)PROCEDURES FOR PATENT TERM ADJUSTMENT 
DETERMINATION.— 

(A)The Director shall prescribe regulations establishing 
procedures for the application for and determination of patent 
term adjustments under this subsection.

(B)Under the procedures established under subparagraph 
(A), the Director shall— 

(i)make a determination of the period of any 
patent term adjustment under this subsection, and shall transmit a 
notice of that determination with the written notice of allowance 
of the application under section 151; and

(ii)provide the applicant one opportunity to 
request reconsideration of any patent term adjustment determination 
made by the Director.

(C)The Director shall reinstate all or part of the cumulative 
period of time of an adjustment under paragraph (2)(C) if 
the applicant, prior to the issuance of the patent, makes a showing 
that, in spite of all due care, the applicant was unable to respond 
within the 3-month period, but in no case shall more than three 
additional months for each such response beyond the original 3-
month period be reinstated.

(D)The Director shall proceed to grant the patent after 
completion of the Director’s determination of a patent term 
adjustment under the procedures established under this subsection, 
notwithstanding any appeal taken by the applicant of such 
determination.

(4)APPEAL OF PATENT TERM ADJUSTMENT 
DETERMINATION.— 

(A)An applicant dissatisfied with a determination 
made by the Director under paragraph (3) shall have remedy by a 
civil action against the Director filed in the United States District 
Court for the District of Columbia within 180 days after the grant 
of the patent. Chapter 7 of title 5, United States Code, shall apply 
to such action. Any final judgment resulting in a change to the 
period of adjustment of the patent term shall be served on the 
Director, and the Director shall thereafter alter the term of the 
patent to reflect such change.

(B)The determination of a patent term adjustment 
under this subsection shall not be subject to appeal or challenge by 
a third party prior to the grant of the patent.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.702. Grounds for adjustment of patent term due to examination delay under the Patent Term Guarantee Act of 1999 (original applications, other than designs, filed on or after May 29, 2000).}}
(a)Failure to take certain actions within specified time 
frames. Subject to the provisions of 35 
U.S.C. 154(b) and this 
subpart, the term of an original patent shall be adjusted if the issuance 
of the patent was delayed due to the failure of the Office to: 

(1)Mail at least one of a notification under 35 U.S.C. 132or a notice of allowance under 35 
U.S.C. 151 not later than fourteen 
months after the date on which the application was filed 
under 35 
U.S.C. 111(a) or fulfilled the requirements of 35 
U.S.C. 
371 in an international application;

(2)Respond to a reply under 35 U.S.C. 132 or to an 
appeal taken under 35 U.S.C. 134 not later than four months after 
the date on which the reply was filed or the appeal was taken; 

(3)Act on an application not later than four months after 
the date of a decision by the Board of Patent Appeals and Interferences 
under 35 U.S.C. 134 or 135 or a decision by a Federal court 
under 35 
U.S.C. 141, 145, or 146 where at least one allowable 
claim remains in the application; or 

(4)Issue a patent not later than four months after the date 
on which the issue fee was paid under 35 U.S.C. 151 and all outstanding 
requirements were satisfied. 

(b)Failure to issue a patent within three years of the actual 
filing date of the application. Subject to the provisions of 35 
U.S.C. 154(b) and this subpart, the term of an original patent shall 
be adjusted if the issuance of the patent was delayed due to the 
failure of the Office to issue a patent within three years after the 
date on which the application was filed under 35 
U.S.C. 111(a) or 
the national stage commenced under 35 U.S.C. 371(b) or (f) in an 
international application, but not including: 

(1)Any time consumed by continued examination of the 
application under 35 U.S.C. 132(b); 

(2)Any time consumed by an interference proceeding 
under 35 U.S.C. 135(a); 

(3)Any time consumed by the imposition of a secrecy 
order under 35 U.S.C. 181;

(4)Any time consumed by review by the Board of Patent 
Appeals and Interferences or a Federal court; or 

(5)Any delay in the processing of the application by the 
Office that was requested by the applicant. 

(c)Delays caused by interference proceedings. Subject to 
the provisions of 35 U.S.C. 154(b) and this subpart, the term of an 
original patent shall be adjusted if the issuance of the patent was 
delayed due to interference proceedings under 35 U.S.C. 135(a). 

(d)Delays caused by secrecy order. Subject to the provisions 
of 35 U.S.C. 154(b) and this subpart, the term of an original 
patent shall be adjusted if the issuance of the patent was delayed 
due to the application being placed under a secrecy order under 
35 U.S.C. 181. 

(e)Delays caused by successful appellate review. Subject 
to the provisions of 35 U.S.C. 154(b) and this subpart, the 
term of an original patent shall be adjusted if the issuance of the 
patent was delayed due to review by the Board of Patent Appeals 
and Interferences under 35 U.S.C. 134 or by a Federal court under 
35 U.S.C. 141 or 145, if the patent was issued under a decision in 
the review reversing an adverse determination of patentability. If 
an application is remanded by a panel of the Board of Patent 
Appeals and Interferences and the remand is the last action by a 
panel of the Board of Patent Appeals and Interferences prior to the 
mailing of a notice of allowance under 35 U.S.C. 151 in the application, 
the remand shall be considered a decision by the Board of 
Patent Appeals and Interferences as that phrase is used in 35 
U.S.C. 154(b)(1)(A)(iii), a decision in the review reversing an 
adverse determination of patentability as that phrase is used in 35 
U.S.C. 154(b)(1)(C)(iii), and a final decision in favor of the applicant 
under § 1.703(e). A remand by a panel of the Board of Patent 
Appeals and Interferences shall not be considered a decision in the 
review reversing an adverse determination of patentability as provided 
in this paragraph if there is filed a request for continued 
examination under 35 U.S.C. 132(b) that was not first preceded by 
the mailing, after such remand, of at least one of an action under 
35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151. 

(f)The provisions of this section and §§1.703 through 1.705apply only to original applications, except applications for a 
design patent, filed on or after May 29, 2000, and patents issued 
on such applications. 
|}


35 U.S.C. 154(b), as amended effective May 29, 
2000, and 37 CFR 1.702-1.705 apply to utility and 
plant patent applications filed on or after May 29, 
2000. All references to 35 U.S.C. 154(b) hereinafter 
are to 35 U.S.C. 154(b), as amended effective May 
29, 2000.

37 CFR 1.702 sets forth the bases for patent term 
adjustment under 35 U.S.C. 154(b)(1).

37 CFR 1.702(a) indicates that a patent is entitled 
to patent term adjustment if the Office fails to perform 
certain acts of examination within specified time 
frames (35 U.S.C. 154(b)(1)(A)). 

37 CFR 1.702(b) indicates that a patent is entitled 
to patent term adjustment if, subject to a number of 
limitations, the Office fails to issue a patent within 
three years of the actual filing date of the application 
(35 U.S.C. 154(b)(1)(B)). In the case of an international 
application, the phrase “actual filing date of the 
application in the United States” means the date the 
national stage commenced under 35 U.S.C. 371(b) or 
(f). See Changes to Implement Patent Term Adjustment 
Under Twenty-Year Patent Term, 65 FR 56366, 
56382-84, (Sept. 18, 2000), 1239 Off. Gaz. Pat. Office14, 28-30 (Oct. 3, 2000). 

37 CFR 1.702(c) indicates that a patent is entitled 
to patent term adjustment if the issuance of the patent 
was delayed by an interference proceeding (35 U.S.C. 
154(b)(1)(C)(i)). 37 CFR 1.702(d) indicates that a 
patent is entitled to patent term adjustment if the issuance 
of the patent was delayed by the application 
being placed under a secrecy order under 35 U.S.C. 
181 (35 U.S.C. 154(b)(1)(C)(ii)). 37 CFR 1.702(e)
indicates that a patent is entitled to patent term adjustment 
if the issuance of the patent was delayed by successful 
appellate review under 35 U.S.C. 134, 141, or 
145 (35 U.S.C. 154(b)(1)(C)(iii)).

Effective May 24, 2004, 37 CFR 1.702(e) was 
amended to indicate that certain remands by the 
Board of Patent Appeals and Interferences shall be 
considered “a decision in the review reversing an 
adverse determination of patentability” for patent 
term adjustment purposes. Any request for reconsideration 
of the patent term adjustment indicated on a 
patent resulting from an application in which the 
notice of allowance was mailed before May 24, 2004 
on the basis of the changes to 37 CFR 1.702 must be 
filed no later than July 21, 2004.

37 CFR 1.702(f) provides that the provisions of 
37 
CFR 1.702 through 1.705 apply only to original 
(i.e., non-reissue) applications, except applications for 
a design patent, filed on or after May 29, 2000, and 
patents issued on such applications. Since a continued 
prosecution application (CPA) filed under 37 CFR 
1.53(d) is a new (continuing) application, a CPA filed 
on or after May 29, 2000, and before July 14, 2003,
is entitled to the benefits of the patent term adjustment 
provisions of 35 U.S.C. 154(b) and 37 CFR 1.702through 1.705. Since a request for continued examination 
(RCE) filed under 35 U.S.C. 132(b) and 37 CFR 
1.114 is not a new application (it is a submission in a 
previously filed application), filing an RCE in an 
application filed before May 29, 2000, does not cause 
that application to be entitled to the benefits of the 
patent term adjustment provisions of 35 U.S.C. 154(b)
and 37 CFR 1.702 through 1.705.

{{Statute|37 CFR 1.703. Period of adjustment of patent term due to examination delay.}}
(a)The period of adjustment under § 1.702(a) is the sum of 
the following periods: 

(1)The number of days, if any, in the period beginning on 
the day after the date that is fourteen months after the date on 
which the application was filed under 35 U.S.C. 111(a) or fulfilled 
the requirements of 35 U.S.C. 371 and ending on the date of mailing 
of either an action under 35 U.S.C. 132, or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first; 

(2)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date a reply 
under § 1.111 was filed and ending on the date of mailing of either 
an action under 35 U.S.C. 132, or a notice of allowance under 
35 
U.S.C. 151, whichever occurs first; 

(3)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date a reply in 
compliance with § 1.113(c) was filed and ending on the date of 
mailing of either an action under 35 U.S.C. 132, or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first; 

(4)The number of days, if any, in the period beginning on 
the day after the date that is four months 
after the date an appeal 
brief in compliance with § 1.192 was filed and ending on the date 
of mailing of any of an examiner’s answer under § 1.193, an 
action under 35 U.S.C. 132, or a notice of allowance under 
35 
U.S.C. 151, whichever occurs first; 

(5)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date of a final 
decision by the Board of Patent Appeals and Interferences or by a 
Federal court in an appeal under 35 U.S.C. 141 or a civil action 
under 35 U.S.C. 145 or 146 where at least one allowable claim 
remains in the application and ending on the date of mailing of 
either an action under 35 U.S.C. 132 or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first; and 

(6)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date the issue 
fee was paid and all outstanding requirements were satisfied and 
ending on the date a patent was issued. 

(b)The period of adjustment under § 1.702(b) is the number 
of days, if any, in the period beginning on the day after the date 
that is three years after the date on which the application was filed 
under 35 U.S.C. 111(a) or the national stage commenced under 
35 
U.S.C. 371(b) or (f) in an international application and ending 
on the date a patent was issued, but not including the sum of the 
following periods: 

(1)The number of days, if any, in the period beginning on 
the date on which a request for continued examination of the 
application under 35 U.S.C. 132(b) was filed and ending on the 
date the patent was issued; 

(2)

(i) The number of days, if any, in the period beginning 
on the date an interference was declared or redeclared to involve 
the application in the interference and ending on the date that the 
interference was terminated with respect to the application; and

(ii)The number of days, if any, in the 
period beginning 
on the date prosecution in the application was suspended by 
the Office due to interference proceedings under 35 U.S.C. 135(a)
not involving the application and ending on the date of the termination 
of the suspension; 

(3)(i) The number of days, if any, the application was 
maintained in a sealed condition under 35 
U.S.C. 181;

(ii)The number of days, if any, in the period beginning 
on the date of mailing of an examiner's answer under § 1.193in the application under secrecy order and ending on the date the 
secrecy order was removed; 

(iii)The number of days, if any, in the period beginning 
on the date applicant was notified that an interference would 
be declared but for the secrecy order and ending on the date the 
secrecy order was removed; and 

(iv)The number of days, if any, in the period beginning 
on the date of notification under § 5.3(c) of this chapter and 
ending on the date of mailing of the notice of allowance under 35 
U.S.C. 151; and, 

(4)The number of days, if any, in the period beginning on 
the date on which a notice of appeal to the Board of Patent 
Appeals and Interferences was filed under 35 U.S.C. 134 and §
1.191 and ending on the date of the last decision by the Board of 
Patent Appeals and Interferences or by a Federal court in an 
appeal under 35 U.S.C. 141 or a civil action under 35 
U.S.C. 145, 
or on the date of mailing of either an action under 35 U.S.C. 132, 
or a notice of allowance under 35 U.S.C. 151, whichever occurs 
first, if the appeal did not result in a decision by the Board of 
Patent Appeals and Interferences. 

(c)The period of adjustment under § 1.702(c) is the sum of 
the following periods, to the extent that the periods are not overlapping: 

(1)The number of days, if any, in the period beginning on 
the date an interference was declared or redeclared to involve the 
application in the interference and ending on the date that the 
interference was terminated with respect to the application; and 

(2)The number of days, if any, in the period beginning on 
the date prosecution in the application was suspended by the 
Office due to interference proceedings under 35 U.S.C. 135(a) not 
involving the application and ending on the date of the termination 
of the suspension. 

(d)The period of adjustment under § 1.702(d) is the sum of 
the following periods, to the extent that the periods are not overlapping: 

(1)The number of days, if any, the application was maintained 
in a sealed condition under 35 
U.S.C. 181; 

(2)The number of days, if any, in the period beginning on 
the date of mailing of an examiner’s answer under § 1.193 in the 
application under secrecy order and ending on the date the secrecy 
order was removed; 

(3)The number of days, if any, in the period beginning on 
the date applicant was notified that an interference would be 
declared but for the secrecy order and ending on the date the 
secrecy order was removed; and 

(4)The number of days, if any, in the period beginning on 
the date of notification under § 5.3(c) of this chapter and ending 
on the date of mailing of the notice of allowance under 35 U.S.C. 
151. 

(e)The period of adjustment under § 1.702(e) is the sum of 
the number of days, if any, in the period beginning on the date on 
which a notice of appeal to the Board of Patent Appeals and Interferences 
was filed under 35 U.S.C. 134 and § 1.191 and ending on 
the date of a final decision in favor of the applicant by the Board 
of Patent Appeals and Interferences or by a Federal court in an 
appeal under 35 U.S.C. 141 or a civil action under 35 U.S.C. 145. 

(f)The adjustment will run from the expiration date of 
the patent as set forth in 35 U.S.C. 154(a)(2). To the extent that 
periods of delay attributable to the grounds specified in §1.702overlap, the period of adjustment granted under this section shall 
not exceed the actual number of days the issuance of the patent 
was delayed. The term of a patent entitled to adjustment under §
1.702 and this section shall be adjusted for the sum of the periods 
calculated under paragraphs (a) through (e) of this section, to the 
extent that such periods are not overlapping, less the sum of the 
periods calculated under § 1.704. The date indicated on any certificate 
of mailing or transmission under § 1.8 shall not be taken into 
account in this calculation.

(g)No patent, the term of which has been disclaimed beyond 
a specified date, shall be adjusted under § 1.702 and this section 
beyond the expiration date specified in the disclaimer. 
|}


{{Statute|37 CFR 1.704. Reduction of period of adjustment of patent term.}}
(a)The period of adjustment of the term of a patent under 
§ 1.703(a) through (e) shall be reduced by a period equal to the 
period of time during which the applicant failed to engage in reasonable 
efforts to conclude prosecution (processing or examination) 
of the application. 

(b)With respect to the grounds for adjustment set forth in §§
1.702(a) through (e), and in particular the ground of adjustment 
set forth in § 1.702(b), an applicant shall be deemed to have failed 
to engage in reasonable efforts to conclude processing or examination 
of an application for the cumulative total of any periods of 
time in excess of three months that are taken to reply to any notice 
or action by the Office making any rejection, objection, argument, 
or other request, measuring such three-month period from the date 
the notice or action was mailed or given to the applicant, in which 
case the period of adjustment set forth in § 1.703 shall be reduced 
by the number of days, if any, beginning on the day after the date 
that is three months after the date of mailing or transmission of the 
Office communication notifying the applicant of the rejection, 
objection, argument, or other request and ending on the date the 
reply was filed. The period, or shortened statutory period, for 
reply that is set in the Office action or notice has no effect on the 
three-month period set forth in this paragraph. 

(c)Circumstances that constitute a failure of the applicant to 
engage in reasonable efforts to conclude processing or examination 
of an application also include the following circumstances, 
which will result in the following reduction of the period of 
adjustment set forth in § 1.703 to the extent that the periods are 
not overlapping: 

(1)Suspension of action under § 1.103 at the applicant’s 
request, in which case the period of adjustment set forth in § 1.703shall be reduced by the number of days, if any, beginning on the 
date a request for suspension of action under § 1.103 was filed and 
ending on the date of the termination of the suspension; 

(2)Deferral of issuance of a patent under § 1.314, in 
which case the period of adjustment set forth in § 1.703 shall be 
reduced by the number of days, if any, beginning on the date a 
request for deferral of issuance of a patent under § 1.314 was filed 
and ending on the date the patent was issued; 

(3)Abandonment of the application or late payment of 
the issue fee, in which case the period of adjustment set forth in 
§1.703 shall be reduced by the number of days, if any, beginning 
on the date of abandonment or the date after the date the issue fee 
was due and ending on the earlier of: 

(i)The date of mailing of the decision reviving the 
application or accepting late payment of the issue fee; or

(ii)The date that is four months after the date the 
grantable petition to revive the application or accept late payment 
of the issue fee was filed;

(4)Failure to file a petition to withdraw the holding of 
abandonment or to revive an application within two months from 
the mailing date of a notice of abandonment, in which case the 
period of adjustment set forth in § 1.703 shall be reduced by the 
number of days, if any, beginning on the day after the date two 
months from the mailing date of a notice of abandonment and 
ending on the date a petition to withdraw the holding of abandonment 
or to revive the application was filed; 

(5)Conversion of a provisional application under 
35 
U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 
111(a) pursuant to 35 U.S.C. 111(b)(5), in which case the period 
of adjustment set forth in § 1.703 shall be reduced by the number 
of days, if any, beginning on the date the application was filed 
under 35 U.S.C. 111(b) and ending on the date a request in compliance 
with §1.53(c)(3) to convert the provisional application 
into a nonprovisional application was filed; 

(6)Submission of a preliminary amendment or other preliminary 
paper less than one month before the mailing of an 
Office action under 35 U.S.C. 132 or notice of allowance under 
35 
U.S.C. 151 that requires the mailing of a supplemental Office 
action or notice of allowance, in which case the period of adjustment 
set forth in § 1.703 shall be reduced by the lesser of: 

(i)The number of days, if any, beginning on the day 
after the mailing date of the original Office action or notice of 
allowance and ending on the date of mailing of the supplemental 
Office action or notice of allowance; or 

(ii)Four months;

(7)Submission of a reply having an omission (§1.135(c)), 
in which case the period of adjustment set forth in § 1.703 shall be 
reduced by the number of days, if any, beginning on the day after 
the date the reply having an omission was filed and ending on the 
date that the reply or other paper correcting the omission was 
filed; 

(8)Submission of a supplemental reply or other paper, 
other than a supplemental reply or other paper expressly requested 
by the examiner, after a reply has been filed, in which case the 
period of adjustment set forth in § 1.703 shall be reduced by the 
number of days, if any, beginning on the day after the date the initial 
reply was filed and ending on the date that the supplemental 
reply or other such paper was filed; 

(9)Submission of an amendment or other paper after a 
decision by the Board of Patent Appeals and Interferences, other 
than a decision designated as containing a new ground of rejection 
under § 1.196(b) or statement under § 1.196(c), or a decision by a 
Federal court, less than one month before the mailing of an Office 
action under 35 U.S.C. 132 or notice of allowance under 
35 
U.S.C. 151 that requires the mailing of a supplemental Office 
action or supplemental notice of allowance, in which case the 
period of adjustment set forth in § 1.703 shall be reduced by the 
lesser of: 

(i)The number of days, if any, beginning on the day 
after the mailing date of the original Office action or notice of 
allowance and ending on the mailing date of the supplemental 
Office action or notice of allowance; or

(ii)Four months;

(10) Submission of an amendment under § 1.312 or other 
paper after a notice of allowance has been given or mailed, in 
which case the period of adjustment set forth in § 1.703 shall be 
reduced by the lesser of: 

(i)The number of days, if any, beginning on the date 
the amendment under § 1.312 or other paper was filed and ending 
on the mailing date of the Office action or notice in response to 
the amendment under § 1.312 or such other paper; or

(ii)Four months; and

(11) Further prosecution via a continuing application, in 
which case the period of adjustment set forth in § 1.703 shall not 
include any period that is prior to the actual filing date of the 
application that resulted in the patent. 

(d)A paper containing only an information disclosure 
statement in compliance with §§ 1.97 and 1.98 will not be considered 
a failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under 
paragraphs (c)(6), (c)(8), (c)(9), or (c)(10) of this section if it is 
accompanied by a statement that each item of information contained 
in the information disclosure statement was first cited in 
any communication from a foreign patent office in a counterpart 
application and that this communication was not received by any 
individual designated in § 1.56(c) more than thirty days prior to 
the filing of the information disclosure statement. This thirty-day 
period is not extendable. 

(e)Submission of an application for patent term adjustment 
under § 1.705(b) (with or without request under § 1.705(c) for 
reinstatement of reduced patent term adjustment) will not be considered 
a failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under 
paragraph (c)(10) of this section. 
|}


{{Statute|37 CFR 1.705. Patent term adjustment determination}}
(a)The notice of allowance will include notification of any 
patent term adjustment under 35 U.S.C. 154(b). 

(b)Any request for reconsideration of the patent term adjustment 
indicated in the notice of allowance, except as provided in 
paragraph (d) of this section, and any request for reinstatement of 
all or part of the term reduced pursuant to § 1.704(b) must be by 
way of an application for patent term adjustment. An application 
for patent term adjustment under this section must be filed no later 
than the payment of the issue fee but may not be filed earlier than 
the date of mailing of the notice of allowance. An application for 
patent term adjustment under this section must be accompanied 
by: 

(1)The fee set forth in § 1.18(e); and 

(2)A statement of the facts involved, specifying: 

(i)The correct patent term adjustment and the basis 
or bases under § 1.702 for the adjustment; 

(ii)The relevant dates as specified in §§ 1.703(a) 
through (e) for which an adjustment is sought and the adjustment 
as specified in § 1.703(f) to which the patent is entitled; 

(iii)Whether the patent is subject to a terminal disclaimer 
and any expiration date specified in the terminal disclaimer; 
and 

(iv)(A)Any circumstances during the prosecution of 
the application resulting in the patent that constitute a failure to 
engage in reasonable efforts to conclude processing or examination 
of such application as set forth in § 1.704; or

(B)That there were no circumstances constituting a 
failure to engage in reasonable efforts to conclude processing or 
examination of such application as set forth in § 1.704. 

(c)Any application for patent term adjustment under this 
section that requests reinstatement of all or part of the period of 
adjustment reduced pursuant to § 1.704(b) for failing to reply to a 
rejection, objection, argument, or other request within three 
months of the date of mailing of the Office communication notifying 
the applicant of the rejection, objection, argument, or other 
request must also be accompanied by: 

(1)The fee set forth in § 1.18(f); and 

(2)A showing to the satisfaction of the Director that, in 
spite of all due care, the applicant was unable to reply to the rejection, 
objection, argument, or other request within three months of 
the date of mailing of the Office communication notifying the 
applicant of the rejection, objection, argument, or other request. 
The Office shall not grant any request for reinstatement for more 
than three additional months for each reply beyond three months 
from the date of mailing of the Office communication notifying 
the applicant of the rejection, objection, argument, or other 
request. 

(d)If there is a revision to the patent term adjustment indicated 
in the notice of allowance, the patent will indicate the 
revised patent term adjustment. If the patent indicates or should 
have indicated a revised patent term adjustment, any request for 
reconsideration of the patent term adjustment indicated in the 
patent must be filed within two months of the date the patent 
issued and must comply with the requirements of paragraphs 
(b)(1) and (b)(2) of this section. Any request for reconsideration 
under this section that raises issues that were raised, or could have 
been raised, in an application for patent term adjustment under 
paragraph (b) of this section shall be dismissed as untimely as to 
those issues. 

(e)The periods set forth in this section are not extendable. 

(f)No submission or petition on behalf of a third party concerning 
patent term adjustment under 35 U.S.C. 154(b) will be 
considered by the Office. Any such submission or petition will be 
returned to the third party, or otherwise disposed of, at the convenience 
of the Office. 
|}


==2731 Period of Adjustment==

{{Statute|37 CFR 1.703. Period of adjustment of patent term due to examination delay.}}
(a) The period of adjustment under § 1.702(a) is the sum of 
the following periods: 

(1)The number of days, if any, in the period beginning on 
the day after the date that is fourteen months after the date on 
which the application was filed under 35 U.S.C. 111(a) or fulfilled 
the requirements of 35 U.S.C. 371 and ending on the date of 
mailing of either an action under 35 U.S.C. 132, or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first;

(2)The number of days, if any, in the period beginning on 
the day after the date that is fourteen months after the date on 
which the application was filed under 35 U.S.C. 111(a) or fulfilled 
the requirements of 35 U.S.C. 371 and ending on the date of 
mailing of either an action under 35 U.S.C. 132, or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first;

(3)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date a reply in 
compliance with § 1.113(c) was filed and ending on the date of 
mailing of either an action under 35 U.S.C. 132, or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first;

(4)The number of days, if any, in the period beginning on 
the day after the date that is four months 
after the date an appeal 
brief in compliance with § 1.192 was filed and ending on the date 
of mailing of any of an examiner’s answer under § 1.193, an 
action under 35 U.S.C. 132, or a notice of allowance under 
35 U.S.C. 151, whichever occurs first;

(5)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date of a final 
decision by the Board of Patent Appeals and Interferences or by a 
Federal court in an appeal under 35 U.S.C. 141 or a civil action 
under 35 U.S.C. 145 or 146 where at least one allowable claim 
remains in the application and ending on the date of mailing of 
either an action under 35 U.S.C. 132 or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first; and

(6)The number of days, if any, in the period beginning on 
the day after the date that is four months after the date the issue 
fee was paid and all outstanding requirements were satisfied and 
ending on the date a patent was issued.

(b) The period of adjustment under § 1.702(b) is the number 
of days, if any, in the period beginning on the day after the date 
that is three years after the date on which the application was filed 
under 35 
U.S.C. 111(a) or the national stage commenced under 
35 
U.S.C. 371(b) or (f) in an international application and ending 
on the date a patent was issued, but not including the sum of the 
following periods:

(1) The number of days, if any, in the period beginning 
on the date on which a request for continued examination of the 
application under 35 U.S.C. 132(b) was filed and ending on the 
date the patent was issued;

(2)(i)The number of days, if any, in the period beginning 
on the date an interference was declared or redeclared to involve 
the application in the interference and ending on the date that the 
interference was terminated with respect to the application; and

(ii)The number of days, if any, in the 
period beginning 
on the date prosecution in the application was suspended by 
the Office due to interference proceedings under 35 U.S.C. 135(a)
not involving the application and ending on the date of the termination 
of the suspension; 

(3)(i)The number of days, if any, the application was 
maintained in a sealed condition under 35 
U.S.C. 181;

(ii)The number of days, if any, in the period beginning 
on the date of mailing of an examiner's answer under § 1.193in the application under secrecy order and ending on the date the 
secrecy order was removed;

(iii)The number of days, if any, in the period beginning 
on the date applicant was notified that an interference would 
be declared but for the secrecy order and ending on the date the 
secrecy order was removed; and

(iv)The number of days, if any, in the period beginning 
on the date of notification under § 5.3(c) of this chapter and 
ending on the date of mailing of the notice of allowance under 35 
U.S.C. 151; and, 

(4)The number of days, if any, in the period beginning on 
the date on which a notice of appeal to the Board of Patent 
Appeals and Interferences was filed under 35 U.S.C. 134 and §
1.191 and ending on the date of the last decision by the Board of 
Patent Appeals and Interferences or by a Federal court in an 
appeal under 35 U.S.C. 141 or a civil action under 35 
U.S.C. 145, 
or on the date of mailing of either an action under 35 U.S.C. 132, 
or a notice of allowance under 35 U.S.C. 151, whichever occurs 
first, if the appeal did not result in a decision by the Board of 
Patent Appeals and Interferences.

(c)The period of adjustment under § 1.702(c) is the sum of 
the following periods, to the extent that the periods are not overlapping:

(1)The number of days, if any, in the period beginning on 
the date an interference was declared or redeclared to involve the 
application in the interference and ending on the date that the 
interference was terminated with respect to the application; and 

(2)The number of days, if any, in the period beginning on 
the date prosecution in the application was suspended by the 
Office due to interference proceedings under 35 U.S.C. 135(a) not 
involving the application and ending on the date of the termination 
of the suspension.

(d)The period of adjustment under § 1.702(d) is the sum of 
the following periods, to the extent that the periods are not overlapping: 

(1)The number of days, if any, the application was maintained 
in a sealed condition under 35 
U.S.C. 181; 

(2)The number of days, if any, in the period beginning on 
the date of mailing of an examiner’s answer under § 1.193 in the 
application under secrecy order and ending on the date the secrecy 
order was removed; 

(3)The number of days, if any, in the period beginning on 
the date applicant was notified that an interference would be 
declared but for the secrecy order and ending on the date the 
secrecy order was removed; and

(4)The number of days, if any, in the period beginning on 
the date of notification under § 5.3(c) of this chapter and ending 
on the date of mailing of the notice of allowance under 35 U.S.C. 
151.

(e)The period of adjustment under § 1.702(e) is the sum of 
the number of days, if any, in the period beginning on the date on 
which a notice of appeal to the Board of Patent Appeals and Interferences 
was filed under 35 U.S.C. 134 and § 1.191 and ending 
on the date of a final decision in favor of the applicant by the 
Board of Patent Appeals and Interferences or by a Federal court in 
an appeal under 35 U.S.C. 141 or a civil action under 35 U.S.C. 
145. 

(f)The adjustment will run from the expiration date of the 
patent as set forth in 35 U.S.C. 154(a)(2). To the extent that periods 
of delay attributable to the grounds specified in §1.702 overlap, 
the period of adjustment granted under this section shall not 
exceed the actual number of days the issuance of the patent was 
delayed. The term of a patent entitled to adjustment under § 1.702and this section shall be adjusted for the sum of the periods calculated 
under paragraphs (a) through (e) of this section, to the extent 
that such periods are not overlapping, less the sum of the periods 
calculated under § 1.704. The date indicated on any certificate of 
mailing or transmission under § 1.8 shall not be taken into account 
in this calculation.

(g)No patent, the term of which has been disclaimed beyond 
a specified date, shall be adjusted under § 1.702 and this section 
beyond the expiration date specified in the disclaimer.
|}


37 CFR 1.703 specifies the period of adjustment if 
a patent is entitled to patent term adjustment under 35 
U.S.C. 154(b)(1) and 37 CFR 1.702. When a period is 
indicated (in 37 CFR 1.703 or 1.704) as “beginning” 
on a particular day, that day is included in the period, 
in that such day is “day one” of the period and not 
“day zero.” For example, a period beginning on April 
1 and ending on April 10 is ten (and not nine) days in 
length.

35 U.S.C. 154(b)(1)(A) and (B) provide for an 
adjustment of one day for each day after the end of the 
period set forth in 35 U.S.C. 154(b)(1)(A)(i), (ii), (iii), 
(iv), and (B) until the prescribed action is taken, 
whereas 35 U.S.C. 154(b)(1)(C) provides for an 
adjustment of one day for each day of the pendency of 
the proceeding, order, or review prescribed in 35 
U.S.C. 154(b)(1)(C)(i) through (iii). Therefore, the 
end of the period set forth in 37 CFR 1.703(a) and 
1.703(b) (which correspond to 35 U.S.C. 
154(b)(1)(A) and (B)) is “day zero” (not “day one”) 
as to the period of adjustment, whereas the first day of 
the proceeding, order, or review set forth in 37 CFR 
1.703(c), 1.703(d), and 1.703(e) (which correspond to 
35 U.S.C. 154(b)(1)(C)(i) through (iii)) is “day one” 
of the period of adjustment.

37 CFR 1.703(a) pertains to 35 U.S.C. 
154(b)(1)(A) and indicates that the period of adjustment 
under 37 CFR 1.702(a) is the sum of the periods 
specified in 37 CFR 1.703(a)(1) through 37 CFR 
1.703(a)(6).

37 CFR 1.703(a)(1) pertains to the provisions of 35 
U.S.C. 154(b)(1)(A)(i) and specifies that the period is 
the number of days, if any, beginning on the date after 
the day that is fourteen months after the date on which 
the application was filed under 35 U.S.C. 111(a) or 
fulfilled the requirements of 35 U.S.C. 371 in an international 
application and ending on the mailing date of 
either an action under 35 U.S.C. 132, or a notice of 
allowance under 35 U.S.C. 151, whichever occurs 
first. For purposes of 35 U.S.C. 154(b)(1)(A)(i)(II), an 
international application fulfills the requirements of 
35 U.S.C. 371 on the date of commencement of the 
national stage under 35 U.S.C. 371(b) or (f), or the 
date the application fulfills the requirements of 35 
U.S.C. 371(c) if that date is later than the date of commencement 
of the national stage under 35 U.S.C. 
371(b) or (f). In other words, the requirements of 35 
U.S.C. 371 are met when applicant has met all of the 
requirements of 35 U.S.C. 371(c) and, unless applicant 
requests early processing under 35 U.S.C. 371(f), 
the time limit set forth in the applicable one of PCT 
Articles 22 and 39 has expired. Accordingly, the 
requirements of 35 U.S.C. 371 are met when the 
Office can begin examination of the patent application. 
If, for example, an applicant files the required 
oath or declaration (35 U.S.C. 115) and any necessary 
English translation after the expiration of the time 
limit set forth in Article 22 of the PCT or the time 
limit under Article 39 of the PCT, the date the requirements 
of 35 U.S.C. 371 are met is the date the requirements 
of 35 U.S.C. 371(c) are met. If, however, an 
applicant files the required declaration, filing fee, and 
any required English translation before the expiration 
of the relevant PCT Article 22 or Article 39 time 
period, but does not request early processing under 35 
U.S.C. 371, the requirements of 35 U.S.C. 371 will be 
met once the applicable time period has expired.

A written restriction requirement, a written election 
of species requirement, a requirement for information 
under 37 CFR 1.105, an action under Ex parte 
Quayle, 1935 Comm’r Dec. 11 (1935), and a notice of 
allowability (PTOL-37) are each an action issued as a 
result of the examination conducted pursuant to 35 
U.S.C. 131. As such, each of these Office actions is a 
notification under 35 U.S.C. 132. Office notices and 
letters issued as part of the pre-examination processing 
of an application are not notices issued as a result 
of an examination conducted pursuant to 35 U.S.C. 
131, and thus are not notifications under 35 U.S.C. 
132. Examples of such pre-examination processing 
notices are: a Notice of Incomplete Nonprovisional 
Application, a Notice of Omitted Item(s) in a Nonprovisional 
Application, a Notice to File Missing Parts of 
Application, a Notice of Informal Application, a 
Notice to File Corrected Application Papers Filing 
Date Granted, or a Notice to Comply with Requirements 
for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures. 

37 CFR 1.703(a)(2) pertains to the provisions of 35 
U.S.C. 154(b)(1)(A)(ii) and specifies that the period is 
the number of days, if any, beginning on the day after 
the date that is four months after the date a reply 
under 37 CFR 1.111 was filed and ending on the mailing 
date of either an action under 35 U.S.C. 132, or a 
notice of allowance under 35 U.S.C. 151, whichever 
occurs first.

37 CFR 1.703(a)(3) also pertains to the provisions 
of 35 U.S.C. 154(b)(1)(A)(ii) and specifies that the 
period is the number of days, if any, beginning on the 
day after the date that is four months after the date a 
reply in compliance with 37 CFR 1.113(c) was filed 
and ending on the date of mailing of either an action 
under 35 U.S.C. 132, or a notice of allowance under 
35 U.S.C. 151, whichever occurs first. A reply under 
37 CFR 1.113 is a reply to a final Office action, and a 
reply in compliance with 37 CFR 1.113 is a reply that 
cancels all of the rejected claims and removes all outstanding 
objections and requirements or otherwise 
places the application in condition for allowance. Any 
amendment after final that does not cancel all of the 
rejected claims and remove all outstanding objections 
and requirements or otherwise place the application in 
condition for allowance is not a reply in compliance 
with 37 CFR 1.113(c).

37 CFR 1.703(a)(4) also pertains to the provisions 
of 35 U.S.C. 154(b)(1)(A)(ii) and specifies that the 
period is the number of days, if any, beginning on the 
day after the date that is four months after the date an 
appeal brief in compliance with 37 CFR 1.192 was 
filed and ending on the mailing date of any of an 
examiner’s answer under 37 CFR 1.193, an action 
under 35 U.S.C. 132, or a notice of allowance under 
35 U.S.C. 151, whichever occurs first. As discussed 
below, the phrase “the date on which” an “appeal was 
taken” in 35 U.S.C. 154(b)(1)(A)(ii) means the date 
on which an appeal brief (and not a notice of appeal) 
was filed. The phrase “appeal brief in compliance 
with 37 CFR 1.192” requires that: (1) the appeal brief 
fee (37 CFR 1.17(c)) be paid (37 CFR 1.192(a)); and 
(2) the appeal brief complies with 37 CFR 1.192(c)(1) 
through (c)(9).

37 CFR 1.703(a)(5) pertains to the provisions of 35 
U.S.C. 154(b)(1)(A)(iii) and specifies that the period 
is the number of days, if any, beginning on the day 
after the date that is four months after the date of a 
final decision by the Board of Patent Appeals and 
Interferences or by a Federal court in an appeal under 
35 U.S.C. 141 or a civil action under 35 U.S.C. 145 or 
146, where at least one allowable claim remains in the 
application and ending on the mailing date of either 
an action under 35 U.S.C. 132, or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first. 

The phrase “allowable claims remain in the application” 
for purposes of 35 U.S.C. 154(b)(1)(A)(iii) 
means that after the decision there is at least one 
pending claim (for purposes of statutory construction, 
“words importing the plural include the singular” (1 
U.S.C. 1)) that is not withdrawn from consideration 
and is not subject to a rejection, objection, or other 
requirement. This applies in the following situations: 
(1) at least one claim is allowable (not merely 
objected to) at the time the examiner’s answer is 
mailed and is not canceled before, or made subject to 
a rejection as a result of, the appellate review; or (2) 
when all of the rejections applied to at least one claim 
are reversed, and such claim is not made subject to a 
rejection, as a result of the appellate review. For 
example: 

(A)If claims 1 and 2 (both independent) are 
pending, the decision affirms the rejection of claim 1, 
and claim 2 was indicated as allowable prior to the 
appeal, “allowable claims remain in the application” 
for purposes of 35 U.S.C. 154(b)(1)(A)(iii). 

(B)If claims 1 and 2 are pending, the decision 
affirms the rejection of claim 1, and claim 2 was 
objected to by the examiner prior to the appeal as 
being allowable except for its dependency from claim 
1, “allowable claims” do not “remain in the application” 
for purposes of 35 U.S.C. 154(b)(1)(A)(iii) 
(claim 2 is not allowable because there is an outstanding 
objection to it). 

(C)If claims 1 and 2 are pending, and the decision 
affirms the rejection of claim 1 and reverses the 
rejection of claim 2, “allowable claims remain in the 
application” for purposes of 35 U.S.C. 
154(b)(1)(A)(iii) (claim 2 is “allowable” within the 
meaning of 37 CFR 1.703(a)(5) because there is no 
outstanding objection or requirement as to it (see 
MPEP § 1214.06, paragraph (I)(B)).

37 CFR 1.703(a)(6) pertains to the provisions of 
35 U.S.C. 154(b)(1)(A)(iv) and specifies that the 
period is the number of days, if any, beginning on the 
day after the date that is four months after the date the 
issue fee was paid and all outstanding requirements 
were satisfied and ending on the date the patent was 
issued. The date the issue fee was paid and all outstanding 
requirements were satisfied is the later of the 
date the issue fee was paid or the date all outstanding 
requirements were satisfied. Note that the filing of a 
priority document (and processing fee) is not considered 
an outstanding requirement under 35 U.S.C. 
154(b)(1)(A)(iv) and 37 CFR 1.703(a)(6) because if 
the priority document is not filed the patent simply 
issues without the priority claim (the application is 
not abandoned) and since no petition is required to 
add a priority claim after payment of the issue fee. If 
prosecution in an application is reopened after allowance 
(see MPEP § 1308), all outstanding requirements 
are not satisfied until the application is again in condition 
for allowance as indicated by the issuance of a 
new notice of allowance under 35 U.S.C. 151 (see 
MPEP § 1308).

37 CFR 1.703(b) pertains to the provisions of 35 
U.S.C. 154(b)(1)(B) and indicates that the period of 
adjustment under 37 CFR 1.702(b) is the number of 
days, if any, in the period beginning on the day after 
the date that is three years after the actual filing date 
of the application and ending on the date a patent was 
issued. 37 CFR 1.703(b) also sets forth the limitations 
on patent term adjustment specified in 35 U.S.C. 
154(b)(1)(B)(i) and (ii). Specifically, 37 CFR 
1.703(b) provides that the period of adjustment of the 
term of a patent shall not include the period equal 
to 
the sum of the following periods: (1) The period 
of 
pendency consumed by continued examination 
of 
the application under 35 U.S.C. 132(b) (35 
U.S.C.
 
154(b)(1)(B)(i)); (2) the period of pendency 
consumed by interference proceedings (35 U.S.C. 
154(b)(1)(B)(ii)); (3) the period of pendency consumed 
by imposition of a secrecy order (35 U.S.C. 
154(b)(1)(B)(ii)); and (4) the period of pendency consumed 
by appellate review under 35 U.S.C. 134, 141, 
145, whether successful or unsuccessful (35 U.S.C. 
154(b)(1)(B)(ii)). The provisions of 35 U.S.C. 
154(b)(1)(B)(iii) concerning the period of pendency 
consumed by delays in the processing of the application 
requested by the applicant are treated in 37 CFR 
1.704 as such delays are also circumstances constituting 
a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination of an 
application. 

37 CFR 1.703(c) pertains to the provisions of 35 
U.S.C. 154(b)(1)(C)(i) and indicates that the period of 
adjustment under 37 CFR 1.702(c) is the sum of the 
following periods (to the extent that such periods are 
not overlapping): (1) the number of days, if any, in the 
period beginning on the date an interference was 
declared or redeclared to involve the application in 
the interference and ending on the date that the interference 
was terminated with respect to the application; 
and (2) the number of days, if any, in the period 
beginning on the date prosecution in the application 
was suspended by the Office due to interference proceedings 
under 35 U.S.C. 135(a) not involving the 
application and ending on the date of the termination 
of the suspension.

37 CFR 1.703(d) pertains to the provisions of 35 
U.S.C. 154(b)(1)(C)(ii) and indicates that the period 
of adjustment under 37 CFR 1.702(d) is the sum of 
the following periods (to the extent that such periods 
are not overlapping): (1) the number of days, if any, 
the application was maintained in a sealed condition 
under 35 U.S.C. 181; (2) the number of days, if any, in 
the period beginning on the date of mailing of an 
examiner’s answer under 37 CFR 1.193 in the application 
under secrecy order and ending on the date the 
secrecy order was removed; (3) the number of days, if 
any, in the period beginning on the date applicant was 
notified that an interference would be declared but for 
the secrecy order and ending on the date the secrecy 
order was removed; and (4) the number of days, if 
any, in the period beginning on the date of notification 
under 37 CFR 5.3(c) and ending on the date of mailing 
of the notice of allowance under 35 U.S.C. 151and 37 CFR 1.311.

37 CFR 1.703(e) pertains to the provisions of 35 
U.S.C. 154(b)(1)(C)(iii) and indicates that the period 
of adjustment under 37 CFR 1.702(e) is the sum of the 
number of days, if any, in the period beginning on the 
date on which a notice of appeal to the Board of 
Patent Appeals and Interferences was filed under 35 
U.S.C. 134 and 37 CFR 1.191 and ending on the date 
of a final decision in favor of the applicant by the 
Board of Patent Appeals and Interferences or by a 
Federal court in an appeal under 35 U.S.C. 141 or a 
civil action under 35 U.S.C. 145.

37 CFR 1.703(f) indicates that the adjustment will 
run from the expiration date of the patent as set forth 
in 35 U.S.C. 154(a)(2) and also indicates that to the 
extent that periods of delay attributable to the 
grounds specified in 37 CFR 1.702 overlap, the period 
of adjustment will not exceed the actual number of 
days the issuance of the patent was delayed (35 
U.S.C. 154(b)(2)(A)). 37 CFR 1.703(f) also specifically 
indicates that the term of a patent entitled to 
adjustment under 37 CFR 1.702 and 1.703 shall be 
adjusted for the sum of the periods calculated under 
37 CFR 1.703(a) through (e), to the extent that such 
periods are not overlapping, less the sum of the periods 
calculated under 37 CFR 1.704. 

Moreover, 37 CFR 1.703(f) provides that the date 
indicated on any certificate of mailing or transmission 
under 37 CFR 1.8 shall not be taken into account in 
this calculation. The date indicated on a certificate of 
mailing is used only to determine whether the correspondence 
is timely (including whether any extension 
of the time and fee are required) so as to avoid abandonment 
of the application or termination or dismissal 
of proceedings. The actual date of receipt of the correspondence 
in the Office is used for all other purposes. 
See 37 CFR 1.8(a). Thus, while the date indicated on 
any certificate of mailing or transmission under 37 
CFR 1.8 will continue to be taken into account in 
determining timeliness, the date of filing (37 CFR 
1.6) will be the date used in a patent term adjustment 
calculation. Applicant may wish to consider the use of 
the “Express Mail Post Office to Addressee” service 
of the United States Postal Service (37 CFR 1.10) or 
facsimile transmission (37 CFR 1.6(d)) for replies to 
be accorded the earliest possible filing date for patent 
term adjustment calculations. Alternatively, applicant 
may choose to mail correspondence with sufficient 
time to ensure that the correspondence is received in 
the Office (and stamped with a date of receipt) before 
the expiration of the three-month period. Applicants 
are encouraged to check PAIR to verify the date of 
deposit entered in PALM for the correspondence. 
Applicants should contact the Office for correction of 
any such entries prior to the mailing of the notice of 
allowance. At the time of the mailing of the notice of 
allowance, the patent term adjustment calculation will 
be made with the dates in PALM. Thereafter, a patent 
term adjustment application (37 CFR 1.705(b) or (c)), 
accompanied by the requisite fee and statement or 
showing, will be necessary to have any reduction of 
patent term reinstated.

Finally, 37 CFR 1.703(g) indicates that no patent, 
the term of which has been disclaimed beyond a specified 
date, shall be adjusted under 37 CFR 1.702 and 
1.703 beyond the expiration date specified in the disclaimer 
(35 U.S.C. 154(b)(2)(B)).

==2732 Reduction of Period of Adjustment of Patent Term==

{{Statute|37 CFR 1.704. Reduction of period of adjustment of patent term.}}
(a)The period of adjustment of the term of a patent under §
1.703(a) through (e) shall be reduced by a period equal to the 
period of time during which the applicant failed to engage in reasonable 
efforts to conclude prosecution (processing or examination) 
of the application. 

(b)With respect to the grounds for adjustment set forth in §§
1.702(a) through (e), and in particular the ground of adjustment 
set forth in § 1.702(b), an applicant shall be deemed to have failed 
to engage in reasonable efforts to conclude processing or examination 
of an application for the cumulative total of any periods of 
time in excess of three months that are taken to reply to any notice 
or action by the Office making any rejection, objection, argument, 
or other request, measuring such three-month period from the date 
the notice or action was mailed or given to the applicant, in which 
case the period of adjustment set forth in § 1.703 shall be reduced 
by the number of days, if any, beginning on the day after the date 
that is three months after the date of mailing or transmission of the 
Office communication notifying the applicant of the rejection, 
objection, argument, or other request and ending on the date the 
reply was filed. The period, or shortened statutory period, for 
reply that is set in the Office action or notice has no effect on the 
three-month period set forth in this paragraph.

(c) Circumstances that constitute a failure of the applicant 
to engage in reasonable efforts to conclude processing or examination 
of an application also include the following circumstances, 
which will result in the following reduction of the period of 
adjustment set forth in § 1.703 to the extent that the periods are 
not overlapping: 

(1)Suspension of action under § 1.103 at the applicant’s 
request, in which case the period of adjustment set forth in § 1.703shall be reduced by the number of days, if any, beginning on the 
date a request for suspension of action under § 1.103 was filed and 
ending on the date of the termination of the suspension; 

(2)Deferral of issuance of a patent under § 1.314, in 
which case the period of adjustment set forth in § 1.703 shall be 
reduced by the number of days, if any, beginning on the date a 
request for deferral of issuance of a patent under § 1.314 was filed 
and ending on the date the patent was issued;

(3)Abandonment of the application or late payment of 
the issue fee, in which case the period of adjustment set forth in 
§1.703 shall be reduced by the number of days, if any, beginning 
on the date of abandonment or the date after the date the issue fee 
was due and ending on the earlier of: 

(i)The date of mailing of the decision reviving the 
application or accepting late payment of the issue fee; or

(ii)The date that is four months after the date the 
grantable petition to revive the application or accept late payment 
of the issue fee was filed;

(4)Failure to file a petition to withdraw the holding of 
abandonment or to revive an application within two months from 
the mailing date of a notice of abandonment, in which case the 
period of adjustment set forth in § 1.703 shall be reduced by the 
number of days, if any, beginning on the day after the date 
two 
months from the mailing date of a notice of abandonment and 
ending on the date a petition to withdraw the holding of abandonment 
or to revive the application was filed; 

(5)Conversion of a provisional application under 35 
U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 
111(a) pursuant to 35 U.S.C. 111(b)(5), in which case the period 
of adjustment set forth in § 1.703 shall be reduced by the number 
of days, if any, beginning on the date the application was filed 
under 35 U.S.C. 111(b) and ending on the date a request in compliance 
with §1.53(c)(3) to convert the provisional application 
into a nonprovisional application was filed;

(6)Submission of a preliminary amendment or other preliminary 
paper less than one month before the mailing of an 
Office action under 35 U.S.C. 132 or notice of allowance under 35 
U.S.C. 151 that requires the mailing of a supplemental Office 
action or notice of allowance, in which case the period of adjustment 
set forth in § 1.703 shall be reduced by the lesser of:

(i)The number of days, if any, beginning on the day 
after the mailing date of the original Office action or notice of 
allowance and ending on the date of mailing of the supplemental 
Office action or notice of allowance; or 

(ii)Four months;

(7)Submission of a reply having an omission (§1.135(c)), 
in which case the period of adjustment set forth in § 1.703 shall be 
reduced by the number of days, if any, beginning on the day after 
the date the reply having an omission was filed and ending on the 
date that the reply or other paper correcting the omission was 
filed;

(8)Submission of a supplemental reply or other paper, 
other than a supplemental reply or other paper expressly requested 
by the examiner, after a reply has been filed, in which case the 
period of adjustment set forth in § 1.703 shall be reduced by the 
number of days, if any, beginning on the day after the date the initial 
reply was filed and ending on the date that the supplemental 
reply or other such paper was filed;

(9)Submission of an amendment or other paper after a 
decision by the Board of Patent Appeals and Interferences, other 
than a decision designated as containing a new ground of rejection 
under § 1.196(b) or statement under § 1.196(c), or a decision by a 
Federal court, less than one month before the mailing of an Office 
action under 35 U.S.C. 132 or notice of allowance under 35 
U.S.C. 151 that requires the mailing of a supplemental Office 
action or supplemental notice of allowance, in which case the 
period of adjustment set forth in § 1.703 shall be reduced by the 
lesser of: 

(i)The number of days, if any, beginning on the day 
after the mailing date of the original Office action or notice of 
allowance and ending on the mailing date of the supplemental 
Office action or notice of allowance; or

(ii)Four months;

(10)Submission of an amendment under § 1.312 or other 
paper after a notice of allowance has been given or mailed, in 
which case the period of adjustment set forth in § 1.703 shall be 
reduced by the lesser of: 

(i)The number of days, if any, beginning on the date 
the amendment under § 1.312 or other paper was filed and ending 
on the mailing date of the Office action or notice in response to 
the amendment under § 1.312 or such other paper; or

(ii)Four months; and

(11)Further prosecution via a continuing application, in 
which case the period of adjustment set forth in § 1.703 shall not 
include any period that is prior to the actual filing date of the 
application that resulted in the patent.

(d)A paper containing only an information disclosure statement 
in compliance with §§ 1.97 and 1.98 will not be considered a 
failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under paragraphs 
(c)(6), (c)(8), (c)(9), or (c)(10) of this section if it is accompanied 
by a statement that each item of information contained in the 
information disclosure statement was first cited in any communication 
from a foreign patent office in a counterpart application and 
that this communication was not received by any individual designated 
in § 1.56(c) more than thirty days prior to the filing of the 
information disclosure statement. This thirty-day period is not 
extendable.

(e)Submission of an application for patent term adjustment 
under § 1.705(b) (with or without request under § 1.705(c) for 
reinstatement of reduced patent term adjustment) will not be considered 
a failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under 
paragraph (c)(10) of this section.
|}


37 CFR 1.704 implements the provisions of 35 
U.S.C. 154(b)(2)(C) which provides that the period of 
patent term adjustment under 35 U.S.C. 154(b)(1) 
“shall be reduced by a period equal to the period of 
time during which the applicant failed to engage in 
reasonable efforts to conclude prosecution of the 
application,” and specifies certain circumstances as 
constituting a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination 
of an application. Further, 35 U.S.C. 154(b)(2)(C)(iii) 
gives the Office the authority to prescribe regulations 
establishing circumstances that constitute “a failure of 
an applicant to engage in reasonable efforts to conclude 
processing or examination of an application.” 
35 U.S.C. 154(b)(2)(C) does not require the applicant’s 
action or inaction (that amounts to a failure to 
engage in reasonable efforts to conclude prosecution 
of the application) to have caused or contributed to 
patent term adjustment for the period of adjustment to 
be reduced due to such action or inaction. The patent 
term adjustment provisions of 35 U.S.C. 154(b) create 
a balanced system allowing for patent term adjustment 
due to Office delays for a reasonably diligent 
applicant. Since the public has an interest in the technology 
disclosed and covered by a patent being available 
to the public at the earliest possible date, 35 
U.S.C. 154(b)(2)(C)(i) provides that patent term 
adjustment is reduced by any period of time during 
which applicant failed to engage in reasonable efforts 
to conclude prosecution of the application, regardless 
of whether the applicant’s actions or inactions caused 
or contributed to patent term adjustment.

37 CFR 1.704(a) implements the provisions of 35 
U.S.C. 154(b)(2)(C)(i) and sets forth that the period of 
adjustment shall be reduced by a period equal to the 
period of time during which the applicant failed to 
engage in reasonable efforts to conclude prosecution 
(i.e., processing or examination) of an application.

37 CFR 1.704(b) provides that with respect to the 
ground for adjustments set forth in 37 CFR 1.702(a) 
through (e), and in particular 37 CFR 1.702(b), an 
applicant shall be deemed to have failed to engage in 
reasonable efforts to conclude prosecution for the 
cumulative total of any periods of time in excess of 
three months that are taken to reply to any notice or 
action by the Office making any rejection, objection, 
argument, or other request, measuring such three-
month period from the date the notice or action was 
mailed or given to the applicant. A Notice of Omitted 
Items in a Nonprovisional Application, however, is 
not a notice or action by the Office making a rejection, 
objection, argument, or other request within the 
meaning of 35 U.S.C. 154(b)(2)(C)(ii) or 37 CFR 
1.704(b), since the Office does not require a reply to 
that notice to continue the processing and examination 
of an application. 37 CFR 1.704(b) indicates that 
the period of adjustment set forth in 37 CFR 1.703shall be reduced by the number of days, if any, beginning 
on the day after the date that is three months after 
the date of mailing or transmission of the Office communication 
notifying the applicant of the rejection, 
objection, argument, or other request and ending on 
the date the reply was filed. As discussed above, a 
reply is considered filed on the date of its actual 
receipt in the Office as defined by 37 CFR 1.6, and the 
date indicated on any certificate of mailing or transmission 
under 37 CFR 1.8 will not be taken into 
account for patent term adjustment purposes.

The three-month period in 37 CFR 1.704(b) applies 
to the Office notices and letters issued as part of the 
pre-examination processing of an application (except 
a Notice of Omitted Items in a Nonprovisional Application 
as discussed above). These notices include: (1) 
a Notice of Incomplete Nonprovisional Application 
(except as to any period prior to the filing date ultimately 
accorded to the application); (2) a Notice to 
File Missing Parts of Non-Provisional Application; 
(3) a Notice of Informal Application; (4) a Notice to 
File Corrected Application Papers Filing Date 
Granted; or (5) a Notice to Comply with Requirements 
for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures.

In addition, the three-month period in 35 U.S.C. 
154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless 
of the period for reply set in the Office action or 
notice. For example, if an Office action sets a one-
month period for reply (restriction requirement), the 
applicant may obtain a two-month extension of time 
under 37 CFR 1.136(a) before being subject to a 
reduction of patent term adjustment under 35 U.S.C. 
154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an 
Office action sets a six-month period for reply, as is 
commonly set in applications subject to secrecy 
orders (see MPEP §130), the applicant is subject to a 
reduction of patent term adjustment under 35 U.S.C. 
154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant 
does not reply to the Office action within three 
months, notwithstanding that a reply may be timely 
filed six months after the mailing date of the Office 
action.

37 CFR 1.704(c) establishes further circumstances 
that constitute a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination 
of an application. 37 CFR 1.704(c)(1) through 
(c)(11) set forth actions or inactions by an applicant 
that interfere with the Office’s ability to process or 
examine an application (and thus circumstances that 
constitute a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination 
of an application), as well as the period by which a 
period of adjustment set forth in 37 CFR 1.703 shall 
be reduced if an applicant engages in any of the enumerated 
actions or inactions. 37 CFR 1.704(c) 
requires that an applicant refrain from engaging in 
actions or inactions that prevent or interfere with the 
Office’s ability to process or examine an application. 
An applicant who is engaging in actions or inactions 
that prevent or interfere with the Office’s ability to 
process or examine an application cannot reasonably 
be characterized as “engag[ing] in reasonable efforts 
to conclude processing or examination of an application” 
(35 U.S.C. 154(b)(2)(C)(i)).

37 CFR 1.704(c)(1) through 1.704(c)(11) address 
situations that occur with sufficient frequency to warrant 
being specifically provided for in the rules of 
practice. These situations do not represent an exhaustive 
listing of actions or inactions that interfere with 
the Office’s ability to process or examine an application, 
since there are a myriad of actions or inactions 
that occur infrequently but will interfere with the 
Office’s ability to process or examine an application 
(e.g., applicant files and persists in requesting reconsideration 
of a meritless petition under 37 CFR 1.10; 
parties to an interference obtain an extension for purposes 
of settlement negotiations which do not result in 
settlement of the interference; and when the scope of 
the broadest claim in the application at the time an 
application is placed in condition for allowance is 
substantially the same as suggested or allowed by the 
examiner more than six months earlier than the date 
the application was placed in condition for allowance). 
Thus, the actions or inactions set forth in 37 
CFR 1.704154(c) are exemplary circumstances that 
constitute a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination 
of an application. The Office may also reduce a period 
of adjustment provided in 37 CFR 1.703 on the basis 
of conduct that interferes with the Office’s ability to 
process or examine an application under the authority 
provided in 35 U.S.C. (b)(2)(C)(iii), even if such conduct 
is not specifically addressed in 37 CFR 1.704(c).

37 CFR 1.704(c)(1) establishes suspension of 
action under 37 CFR 1.103 at the applicant’s request 
as a circumstance that constitutes a failure of an applicant 
to engage in reasonable efforts to conclude processing 
or examination of an application. Obviously, 
if action is suspended at the applicant’s request, the 
Office is precluded from processing or examining the 
application as a result of an action by the applicant. 37 
CFR 1.704(c)(1) also provides that in such a case the 
period of adjustment set forth in 37 CFR 1.703 shall 
be reduced by the number of days, if any, beginning 
on the date a request for suspension of action under 37 
CFR 1.103 was filed and ending on the date of the termination 
of the suspension.

37 CFR 1.704(c)(2) establishes deferral of issuance 
of a patent under 37 CFR 1.314 as a circumstance that 
constitutes a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination 
of an application. Obviously, if issuance of the patent 
is deferred under 37 CFR 1.314, the Office is precluded 
from issuing the application as a result of an 
action by the applicant. When a petition under 37 
CFR 1.314 is granted, the petition decision generally 
states that the application will be held for a period of a 
month to await the filing of a paper. At the end of the 
period, the application is returned to the issue process 
without a further communication from the Office to 
the applicant. 37 CFR 1.704(c)(2) also provides that 
in such a case the period of adjustment set forth in 37 
CFR 1.703 shall be reduced by the number of days, if 
any, beginning on the date a request for deferral of 
issuance of a patent under 37 CFR 1.314 was filed and 
ending on the issue date of the patent.

37 CFR 1.704(c)(3) establishes abandonment of the 
application or late payment of the issue fee as a circumstance 
that constitutes a failure of an applicant to 
engage in reasonable efforts to conclude processing or 
examination of an application. Obviously, if the application 
is abandoned (either by failure to prosecute or 
late payment of the issue fee), the Office is precluded 
from processing or examining the application as a 
result of an action or inaction by the applicant. 37 
CFR 1.704(c)(3) also provides that in such a case the 
period of adjustment set forth in 37 CFR 1.703 shall 
be reduced by the number of days, if any, beginning 
on the date of abandonment or the date after the day 
the issue fee was due, and ending on the earlier of: (1) 
the date of mailing of the decision reviving the application 
or accepting late payment of the issue fee; or 
(2) the date that is four months after the date the 
grantable petition to revive the application or accept 
late payment of the issue fee was filed. The phrase 
“earlier of…[t]he date that is four months after the 
date the grantable petition to revive the application or 
accept late payment of the issue fee was filed” is to 
place a cap (measured from the filing date of the 
grantable petition) on the reduction if the Office does 
not act on (grant) the grantable petition to revive 
within four months of the date it was filed.

37 CFR 1.704(c)(4) establishes failure to file a petition 
to withdraw a holding of abandonment or to 
revive an application within two months from the 
mailing date of a notice of abandonment as a circumstance 
that constitutes a failure of an applicant to 
engage in reasonable efforts to conclude processing or 
examination of an application. Any applicant who 
considers an application to have been improperly held 
abandoned (the reduction in 37 CFR 1.704(c)(3) is 
applicable to the revival of an application properly 
held abandoned) is expected to file a petition to withdraw 
the holding of abandonment (or to revive the 
application) within two months from the mailing date 
of a notice of abandonment. See MPEP § 711.03(c), 
paragraph (I). 37 CFR 1.704(c)(4) also provides that 
in such a case the period of adjustment set forth in 37 
CFR 1.703 shall be reduced by the number of days, if 
any, beginning on the day after the date two months 
from the mailing date of a notice of abandonment and 
ending on the date a petition to withdraw the holding 
of abandonment or to revive the application was filed.

If a petition to withdraw the holding of abandonment 
is granted, the Office’s PALM system records 
should be checked to ensure that the correct term 
adjustment determination is made. Applicants are 
encouraged to check the Office’s PALM system 
records for their applications through PAIR (see 
MPEP § 2733). For example, if applicant shows that a 
reply was filed in the Office on March 2, but the 
March 2 reply was never matched with the file, when 
the petition to withdraw the holding of abandonment 
is granted, the receipt of a paper on March 2 should be 
recorded on the Office’s PALM system records. If the 
papers or dates are recorded incorrectly, applicant 
should contact the examiner, the examiner’s supervisor 
or the Technology Center customer service representative 
to have the entry corrected. If an applicant 
receives a Notice of Abandonment and does not 
request that the holding of abandonment be withdrawn 
within two months of the mailing date of the 
notice, the applicant has failed to engage in reasonable 
efforts to conclude prosecution and any patent 
term adjustment will be reduced pursuant to 37 CFR 
1.704(c)(4).

37 CFR 1.704(c)(5) establishes conversion of a 
provisional application under 35 U.S.C. 111(b) to a 
nonprovisional application under 35 U.S.C. 111(a) 
(pursuant to 35 U.S.C. 111(b)(5); (see MPEP 
§ 201.04(b)) as a circumstance that constitutes a failure 
of an applicant to engage in reasonable efforts to 
conclude processing or examination of an application. 
Conversion of a provisional application to a nonprovisional 
application will require the Office to reprocess 
the application (as a nonprovisional application) up to 
one year after the filing date that will be accorded to 
such nonprovisional application as a result of an 
action by the applicant. 37 CFR 1.704(c)(5) also provides 
that in such a case the period of adjustment set 
forth in 37 CFR 1.703 shall be reduced by the number 
of days, if any, beginning on the date the application 
was filed under 35 U.S.C. 111(b) and ending on the 
date a request in compliance with 37 CFR 1.53(c)(3) 
to convert the provisional application into a nonprovisional 
application was filed.

37 CFR 1.704(c)(6) establishes submission of a 
preliminary amendment or other preliminary paper 
less than one month before the mailing of an Office 
action under 35 U.S.C. 132 or a notice of allowance 
under 35 U.S.C. 151 that requires the mailing of a 
supplemental Office action or notice of allowance as a 
circumstance that constitutes a failure of an applicant 
to engage in reasonable efforts to conclude processing 
or examination of an application. If the submission of 
a preliminary amendment or other paper requires the 
Office to issue a supplemental Office action or notice 
of allowance, the submission of that preliminary 
amendment or other paper has interfered with the processing 
and examination of an application. 37 CFR 
1.704(c)(6) also provides that in such a case the 
period of adjustment set forth in 37 CFR 1.703 shall 
be reduced by the lesser of the number of days, if any, 
beginning on the day after the mailing date of the 
original Office action or notice of allowance and ending 
on the date of mailing of the supplemental Office 
action or notice of allowance or four months. The 
phrase “lesser of… or [f]our months” is to provide a 
four-month cap for a reduction under 37 CFR 
1.704(c)(6) if the Office takes longer than four 
months to issue a supplemental Office action or notice 
of allowance.

37 CFR 1.704(c)(7) establishes submission of a 
reply having an omission (37 CFR 1.135(c)) as a circumstance 
that constitutes a failure of an applicant to 
engage in reasonable efforts to conclude processing or 
examination of an application. Submitting a reply 
having an omission requires the Office to issue an 
action under 37 CFR 1.135(c) and await and process 
the applicant’s reply to the action under 37 CFR 
1.135(c) before the initial reply (as corrected) can be 
treated on its merits. In addition, 37 CFR 1.704(c)(7) 
provides that in such a case the period of adjustment 
set forth in 37 CFR 1.703 shall be reduced by the 
number of days, if any, beginning on the day after the 
date the reply having an omission was filed and ending 
on the date that the reply or other paper correcting 
the omission was filed. The reference to 37 CFR 
1.135(c) is parenthetical because 37 CFR 1.704(c)(7) 
is not limited to Office actions under 37 CFR 1.135(c) 
but applies when the Office issues any action or notice 
indicating that a reply has an omission which must be 
corrected: e.g., (1) a decision on a petition under 37 
CFR 1.47 dismissing the petition as lacking an item 
necessary to grant the petition; or (2) a notice indicating 
that the computer readable format sequence listing 
filed in reply to a Notice to Comply with Requirements 
for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures 
(PTO-1661) does not comply with 37 CFR 1.821 et 
seq.

37 CFR 1.704(c)(8) establishes submission of a 
supplemental reply or other paper after a reply has 
been filed as a circumstance that constitutes a failure 
of an applicant to engage in reasonable efforts to conclude 
processing or examination of an application. 
The submission of a supplemental reply or other 
paper (e.g., an information disclosure statement (IDS) 
or petition) after an initial reply was filed requires the 
Office to restart consideration of the initial reply in 
view of the supplemental reply or other paper, which 
will result in a delay in the Office’s response to the 
initial reply. 37 CFR 1.704(c)(8) does not apply to a 
supplemental reply or other paper that was expressly 
requested by the examiner. If an amendment is 
requested by an examiner, the examiner will have the 
paper processed so that it is included as part of an 
interview summary or examiner’s amendment and not 
a separate paper for PALM to flag in the patent term 
adjustment calculation. 37 CFR 1.704(c)(8) also provides 
that in such a case the period of adjustment set 
forth in 37 CFR 1.703 shall be reduced by the number 
of days, if any, beginning on the day after the date the 
initial reply was filed and ending on the date that the 
supplemental reply or such other paper was filed.

37 CFR 1.704(c)(9) establishes submission of an 
amendment or other paper in an application containing 
allowed claims after a decision by the Board of 
Patent Appeals and Interferences (other than a decision 
containing a rejection under 37 CFR 1.196(b)) or 
a Federal court less than one month before the mailing 
of an Office action under 35 U.S.C. 132 or notice of 
allowance under 35 U.S.C. 151, that requires the 
mailing of a supplemental Office action or supplemental 
notice of allowance as a circumstance that 
constitutes a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination 
of an application. The submission of an amendment or 
other paper (e.g., IDS or petition) in an application 
after a Board of Patent Appeals and Interferences or 
court decision requires the Office to restart consideration 
of the application in view of the amendment or 
other paper, which will result in a delay in the Office’s 
taking action on the application. 37 CFR 1.704(c)(9) 
also provides that in such a case the period of adjustment 
set forth in 37 CFR 1.703 shall be reduced by 
the lesser of the number of days, if any, beginning on 
the day after the mailing date of the original Office 
action or notice of allowance and ending on the mailing 
date of the supplemental Office action or notice of 
allowance or four months. The phrase “lesser of…or 
[f]our months” is to provide a four-month cap for a 
reduction under 37 CFR 1.704(c)(9) if the Office 
takes longer than four months to issue a supplemental 
Office action or notice of allowance. If the amendment 
is requested by an examiner, the examiner will 
have the paper processed so that it is included as part 
of an interview summary or examiner’s amendment 
and not a separate paper for PALM to flag in the 
patent term adjustment calculation. 

37 CFR 1.704(c)(10) establishes submission of an 
amendment under 37 CFR 1.312 or other paper after a 
notice of allowance has been given or mailed as a circumstance 
that constitutes a failure of an applicant to 
engage in reasonable efforts to conclude processing or 
examination of an application. The submission of 
amendments (or other papers) after an application is 
allowed may cause substantial interference with the 
patent issue process. Certain papers filed after allowance 
are not considered to be a failure to engage in 
reasonable efforts to conclude processing or examination 
of an application. See Clarification of 37 CFR 
1.704(c)(10) – Reduction of Patent Term Adjustment 
for Certain Types of Papers Filed After a Notice of 
Allowance has been Mailed, 1247 Off. Gaz. Pat. 
Office 111 (June 26, 2001). The submission of the following 
papers after a “Notice of Allowance” is notconsidered a failure to engage in reasonable efforts to 
conclude processing or examination of an application: 
(1) Fee(s) Transmittal (PTOL-85B); (2) Power of 
Attorney; (3) Power to Inspect; (4) Change of 
Address; (5) Change of Status (small/not small entity 
status); (6) a response to the examiner’s reasons for 
allowance or a request to correct an error or omission 
in the “Notice of Allowance” or “Notice of 
Allowability;” and (7) letters related to government 
interests (e.g., those between NASA and the Office). 
Papers that will be considered a failure to engage in 
reasonable efforts to conclude processing or examination 
of an application include: (1) a request for a 
refund; (2) a status letter; (3) amendments under 37 
CFR 1.312; (4) late priority claims; (5) a certified 
copy of a priority document; (6) drawings; (7) letters 
related to biologic deposits; and (8) oaths or declarations. 
37 CFR 1.704(c)(10) provides that in such a 
case the period of adjustment set forth in 37 CFR 
1.703 shall be reduced by the lesser of: (1) the number 
of days, if any, beginning on the date the amendment 
under 37 CFR 1.312 was filed and ending on the mailing 
date of the Office action or notice in response to 
the amendment under 37 CFR 1.312 or such other 
paper; or (2) four months. The phrase “lesser of …or 
[f]our months” is to provide a four-month cap for a 
reduction under 37 CFR 1.704(c)(10) if the Office 
takes longer than four months to issue an Office 
action or notice in response to the amendment under 
37 CFR 1.312 or other paper.

37 CFR 1.704(c)(11) establishes further prosecution 
via a continuing application as a circumstance 
that constitutes a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination 
of an application. Currently, a continuing application 
may be used to: (1) obtain further examination of 
an invention disclosed and claimed in the 
prior 
application (continuation application); (2) obtain 
examination (for the first time) of an invention disclosed 
but not claimed or not elected for examination 
in the prior application (divisional application); or (3) 
obtain examination of an invention neither disclosed 
nor claimed in the prior application (continuation-in-
part application). The provisions of 35 U.S.C. 132(b) 
and 37 CFR 1.114 permit an applicant to obtain further 
or continued examination of an invention disclosed 
and claimed in an application, which renders it 
unnecessary for an applicant whose application is eligible 
for patent term adjustment under 35 U.S.C. 
154(b) to file a continuing application to obtain further 
examination of an invention disclosed and 
claimed in an application. If an applicant is filing a 
continuing application to obtain examination (for the 
first time) of an invention disclosed but not claimed or 
not elected for examination in the prior application or 
an invention neither disclosed nor claimed in the prior 
application, it is not appropriate for that applicant to 
obtain any benefit in the continuing application for 
examination delays that might have occurred in the 
prior application. Thus, the Office has established further 
prosecution via a continuing application as a circumstance 
that constitutes a failure of an applicant to 
engage in reasonable efforts to conclude processing or 
examination of an application, in that the period of 
adjustment set forth in 37 CFR 1.703 shall not include 
any period that is prior to the actual filing date of the 
application that resulted in the patent. Thus, if the 
application that resulted in the patent is a continuing 
application (including a CPA), the period of adjustment 
set forth in 37 CFR 1.703 (if any) will not 
include any period that is prior to the actual filing date 
of the application (in the case of a CPA, the filing date 
of the request for a CPA) that resulted in the patent.

A CPA under 37 CFR 1.53(d) filed on or after May 
29, 2000 and before July 14, 2003 is entitled to the 
patent term adjustment provisions of 35 U.S.C. 154(b) 
as amended by § 4402 of the American Inventors Protection 
Act of 1999 (CPAs can only be filed in design 
patent applications on or after July 14, 2003, and 
design applications are not entitled to PTA). The 
period of patent term adjustment set forth in 37 CFR 
1.703 (if any), however, will not include any period 
that is prior to the filing date of the request for that 
CPA.

Delays before the filing date of an application are 
not relevant to whether an application is entitled to 
patent term adjustment. Patent term adjustment will 
not be reduced by applicant actions or inactions (that 
amount to a failure to engage in reasonable efforts to 
conclude processing or examination of the application) 
occurring in a prior (or other) application.

37 CFR 1.704(d) provides that a paper containing 
only an information disclosure statement in compliance 
with 37 CFR 1.97 and 1.98 will not be considered 
(result in a reduction) under 37 CFR 1.704(c)(6), 
1.704(c)(8), 1.704(c)(9), or 1.704(c)(10) if it is 
accompanied by a statement that each item of information 
contained in the information disclosure statement 
was first cited in a communication from a 
foreign patent office in a counterpart application and 
that this communication was not received by any individual 
designated in 37 CFR 1.56(c) more than thirty 
days prior to the filing of the information disclosure 
statement. This provision will permit applicants to 
submit information first cited in a communication 
from a foreign patent office in a counterpart application 
to the Office without a reduction in patent term 
adjustment if an information disclosure statement is 
promptly (within thirty days of receipt of the first
communication) submitted to the Office. Compliance 
with the statement requirement of 37 CFR 1.704(d) 
does not substitute for compliance with any relevant 
requirement of 37 CFR 1.97 or 1.98. 37 CFR 1.704(d) 
also provides that this thirty-day period is not extendable.


37 CFR 1.704(e) provides that submission of an 
application for patent term adjustment under 37 CFR 
1.705(b) (with or without request under 37 CFR 
1.705(c) for reinstatement of reduced patent term 
adjustment) will not be considered a failure to engage 
in reasonable efforts to conclude prosecution (processing 
or examination) of the application under 37 
CFR 1.704(c)(10). Due to the time constraints on the 
Office under 35 U.S.C. 154(b)(1)(A)(iv) and (B) to 
complete its patent term adjustment determination and 
issue the patent, the Office must require applicants to 
follow the specific procedure set forth in 37 CFR 
1.705 for requesting reconsideration of the Office’s 
initial patent term adjustment determination and for 
requesting reinstatement of patent term adjustment 
reduced under 37 CFR 1.704(b). Thus, while submission 
of an application for patent term adjustment 
under 37 CFR 1.705(b) (regardless of whether it contains 
a request under 37 CFR 1.705(c) for reinstatement 
of reduced patent term adjustment) will interfere 
with the patent printing process, submission of the 
application will not be considered a failure to engage 
in reasonable efforts to conclude prosecution (processing 
or examination) of the application under 37 
CFR 1.704(c)(10). Other papers concerning patent 
term adjustment (e.g., status letters, untimely applications 
for patent term adjustment, requests for reconsideration 
of the Office’s decisions on applications for 
patent term adjustment, petitions under 37 CFR 1.181, 
1.182, or 1.183 concerning patent term adjustment, or 
miscellaneous letters concerning patent term adjustment), 
however, will be considered a failure to engage 
in reasonable efforts to conclude prosecution (processing 
or examination) of the application under 37 
CFR 1.704(c)(10).

==2733 Patent Term Adjustment Determination==

{{Statute|37 CFR 1.705. Patent term adjustment determination.}}
(a)The notice of allowance will include notification of any 
patent term adjustment under 35 U.S.C. 154(b). 
|}


37 CFR 1.705 implements the provisions of 35 
U.S.C. 154(b)(3) and (b)(4)(B) and indicates that the 
notice of allowance will include notification of any 
patent term adjustment under 35 U.S.C. 154(b) (35 
U.S.C. 154(b)(3)(B)(i)). The patent term adjustment 
determinations required by 35 U.S.C. 154(b)(3)(B)(i) 
are made by a computer program that uses the infor
mation (dates of receipt and nature of applicant correspondence 
and of the dates of mailing and nature of 
Office actions or notices) recorded in the PALM system. 
The Office currently issues a notice of allowance 
using a form entitled, Notice of Allowance and Fee(s) 
Due (PTOL-85). Since November 13, 2001, the 
Notice of Allowance and Fee(s) Due (PTOL-85) 
includes the patent term adjustment information on 
the third page of the form.

37 CFR 1.705(b) provides that any request for 
review or reconsideration of the patent term adjustment 
indicated in the notice of allowance (except as 
provided in 37 CFR 1.705(d)) and any request for 
reinstatement of all or part of the term reduced pursuant 
to 37 CFR 1.704(a) must be filed no later than the 
payment of the issue fee but may not be filed earlier 
than the date of mailing of the notice of allowance. 
See MPEP § 2734 for a discussion of the requirements 
of any such request.

If a registered practitioner receives a notice of 
allowance with a patent term adjustment that is longer 
than expected, the practitioner should disclose the 
error to the Office in compliance with the practitioner’s 
duty of candor and good faith in practice before 
the Office. Where the correct patent term adjustment 
is thought to be less than indicated by the Office, an 
application for term adjustment under 37 CFR 
1.705(b) need not be filed. Instead, a letter could be 
filed with the issue fee payment, indicating that the 
term adjustment is thought to be longer than appropriate. 
The Office does not require the practitioner to 
determine whether the Office’s patent term adjustment 
determination is correct. Alternatively, if a 
notice of allowance indicates a patent term adjustment 
that is longer than expected, since the Office frequently 
corrects the error after mailing the notice of 
allowance, the practitioner (or applicant) may wait 
until the patent issues, and if the patent issues with a 
value that is incorrect, request a certificate of correction.

Information as to how the patent term adjustment 
calculation has been made will be available through 
Patent Application Information Retrieval (PAIR) at 
http://pair.uspto.gov. This system is available to all 
patent applicants who have a customer number as the 
correspondence address for the application. Applicants 
should routinely use PAIR to check the accuracy 
of the data entered in the PALM system for their 
applications (i.e., the type of the paper and date of 
receipt in the Office) throughout prosecution. If any 
errors are detected, they should be brought to the 
Office’s attention (e.g., the examiner or the Technology 
Center’s customer service representative) as soon 
as possible to ensure that they are corrected before 
allowance of the application and the initial determination 
of the patent term adjustment. In checking Office 
records, applicants should keep in mind that the date 
that should be recorded in the Office computer 
records is the date of receipt of the paper, not the date 
that it was mailed under 37 CFR 1.8. In addition, if an 
original paper is misplaced by the Office and a duplicate 
is filed with a post card receipt showing the date 
of receipt of the original paper, the date shown on the 
post-card receipt for the original paper is the date that 
should be shown in the Office computer records. If 
Express Mail service was used, then the date shown as 
the “date in” on the Express Mail label will be entered 
into the Office computer records. Otherwise, the date 
reflected in the Office computer records for a duplicate 
copy of correspondence will normally be the date 
that the duplicate was received in the USPTO.

==2734 Application for Patent Term Adjustment; Due Care Showing==

{{Statute|37 CFR 1.705. Patent term adjustment determination.}}
{{Ellipsis}}
(b)Any request for reconsideration of the patent term adjustment 
indicated in the notice of allowance, except as provided in 
paragraph (d) of this section, and any request for reinstatement of 
all or part of the term reduced pursuant to § 1.704(b) must be by 
way of an application for patent term adjustment. An application 
for patent term adjustment under this section must be filed no later 
than the payment of the issue fee but may not be filed earlier than 
the date of mailing of the notice of allowance. An application for 
patent term adjustment under this section must be accompanied 
by: 

(1)The fee set forth in § 1.18(e); and 

(2)A statement of the facts involved, specifying: 

(i)The correct patent term adjustment and the basis 
or bases under § 1.702 for the adjustment; 

(ii)The relevant dates as specified in §§ 1.703(a) 
through (e) for which an adjustment is sought and the adjustment 
as specified in § 1.703(f) to which the patent is entitled; 

(iii)Whether the patent is subject to a terminal disclaimer 
and any expiration date specified in the terminal disclaimer; 
and 

(iv)(A)Any circumstances during the prosecution of 
the application resulting in the patent that constitute a failure to 
engage in reasonable efforts to conclude processing or examination 
of such application as set forth in § 1.704; or

(B)That there were no circumstances constituting a 
failure to engage in reasonable efforts to conclude processing or 
examination of such application as set forth in § 1.704. 

(c)Any application for patent term adjustment under this 
section that requests reinstatement of all or part of the period of 
adjustment reduced pursuant to § 1.704(b) for failing to reply to a 
rejection, objection, argument, or other request within three 
months of the date of mailing of the Office communication notifying 
the applicant of the rejection, objection, argument, or other 
request must also be accompanied by: 

(1)The fee set forth in § 1.18(f); and 

(2)A showing to the satisfaction of the Director that, in 
spite of all due care, the applicant was unable to reply to the rejection, 
objection, argument, or other request within three months of 
the date of mailing of the Office communication notifying the 
applicant of the rejection, objection, argument, or other request. 
The Office shall not grant any request for reinstatement for more 
than three additional months for each reply beyond three months 
from the date of mailing of the Office communication notifying 
the applicant of the rejection, objection, argument, or other 
request. 
|}


37 CFR 1.705(b) provides that any request for 
review or reconsideration of the patent term adjustment 
indicated in the notice of allowance (except as 
provided in 37 CFR 1.705(d)) and any request for 
reinstatement of all or part of the term reduced pursuant 
to 37 CFR 1.704(a) must be filed no later than the 
payment of the issue fee but may not be filed earlier 
than the date of mailing of the notice of allowance. 37 
CFR 1.705(b) provides that any such request must be 
by way of an application for patent term adjustment 
accompanied by the fee set forth in 37 CFR 1.18(e) 
and a statement of the facts involved. 37 CFR 
1.705(b) also provides that such statement of facts 
must specify: (1) the basis or bases under 37 CFR 
1.702 for the adjustment; (2) the relevant dates as 
specified in 37 CFR 1.703(a) through (e) for which an 
adjustment is sought and the adjustment as specified 
in 37 CFR 1.703(f) to which the patent is entitled; (3) 
whether the patent is subject to a terminal disclaimer 
and any expiration date specified in the terminal disclaimer; 
and (4) any circumstances during the prosecution 
of the application resulting in the patent that 
constitute a failure to engage in reasonable efforts to 
conclude processing or examination of such application 
as set forth in 37 CFR 1.704 (or a statement that 
there were no such circumstances). Since the Office 
must complete its determination of patent term adjustment 
before proceeding to issue the patent (35 U.S.C. 
154(b)(3)(D)), the Office must require that such application 
for patent term adjustment be filed within a 
non-extendable time period and set forth with particularity 
why the Office’s patent term adjustment determination 
is not correct. In the absence of these 
requirements, the issuance of the patent will be further 
delayed by a protracted patent term adjustment determination 
proceeding.

DUE CARE SHOWING

37 CFR 1.705(c) implements the provisions of 35 
U.S.C. 154(b)(3)(C) and specifically provides that a 
request for reinstatement of all or part of the period of 
adjustment reduced pursuant to 37 CFR 1.704(b) for 
failing to reply to a rejection, objection, argument, or 
other request within three months of the date of mailing 
of the Office communication notifying the applicant 
of the rejection, objection, argument, or other 
request must include: (1) the fee set forth in 37 
CFR 
1.18(f); and (2) a showing to the satisfaction 
of 
the Director that, in spite of all due care, the applicant 
was unable to reply to the rejection, objection, 
argument, or other request within three months of the 
date of mailing of the Office communication notifying 
the applicant of the rejection, objection, argument, or 
other request. 37 CFR 1.705(c) also provides that the 
Office shall not grant any request for reinstatement for 
more than three additional months for each reply 
beyond three months of the date of mailing of the 
Office communication notifying the applicant of the 
rejection, objection, argument, or other request (35 
U.S.C. 154(b)(3)(C)).

Filing a reply outside of three months after an 
Office action is per se a failure to engage in reasonable 
efforts to conclude prosecution under 35 U.S.C. 
154(b)(2)(C)(ii) unless applicant can establish that the 
delay was “in spite of all due care.” The Office “shall 
reinstate all or part of the cumulative period of time of 
an adjustment reduced under [35 U.S.C. 
154(b)(2)(C)] if the applicant… makes a showing 
that, in spite of all due care, the applicant was unable 
to respond within the 3-month period….” See 35 
U.S.C. 154(b)(3)(C). The “due care” of a reasonably 
prudent person standard has been applied in deciding 
petitions under the “unavoidable delay” standard of 
35 U.S.C. 133. See In re Mattullath, 38 App. D.C. 
497, 514-15 (1912) (“the word ‘unavoidable’ … is 
applicable to ordinary human affairs, and requires no 
more or greater care or diligence than is generally 
used and observed by prudent and careful men in relation 
to their most important business”) (quoting and 
adopting Ex parte Pratt, 1887 Dec. Comm’r Pat. 31, 
32-33); see also Ray v. Lehman, 55 F.3d 606, 609, 34 
USPQ2d 1786, 1787 (Fed. Cir. 1995) (“in determining 
whether a delay…was unavoidable, one looks to 
whether the party…exercised the due care of a reasonably 
prudent person”). While the legislative history of 
the American Inventors Protection Act of 1999 is 
silent as to the meaning of the phrase “in spite of all 
due care,” the phrases “all due care” and “unable to 
respond” invoke a higher degree of care than the ordinary 
due care standard of 35 U.S.C. 133, as well as 
the “reasonable efforts to conclude processing or 
examination [or prosecution] of an application” standard 
of 35 U.S.C. 154(b)(2)(C)(i) and (iii). Therefore, 
applicants should not rely upon decisions relating to 
the “unavoidable delay” standard of 35 U.S.C. 133 as 
controlling in a request to reinstate reduced patent 
term adjustment on the basis of a showing that the 
applicant was unable to respond within the three-
month period in spite of all due care. 

Examples

Examples of showings that may establish that the 
applicant was unable to respond within the three-
month period in spite of all due care are as follows:

(A)a showing that the original three-month 
period was insufficient to obtain the test data necessary 
for an affidavit or declaration under 37 CFR 
1.132 that was submitted with a reply filed outside the 
original three-month period; 

(B)a showing that the applicant was unable to 
reply within the original three-month period due to a 
natural disaster; 

(C)a showing that applicant was unable to reply 
within the original three-month period because testing 
was required to reply to an Office action, and the testing 
necessarily took longer than three months; or 

(D)a showing that the applicant was unable to 
reply within the original three-month period due to illness 
or death of a sole practitioner of record who was 
responsible for prosecuting the application.

The patent term adjustment term reinstated would be 
limited to the period in which the showing establishes 
that applicant was acting with all due care to reply to 
the Office notice or action, but circumstances (outside 
applicant’s control) made applicant unable to reply in 
spite of such due care. An applicant will not be able to 
show that he or she was unable to respond within the 
three-month period “in spite of all due care” if the 
reply was not filed within the three-month period due 
to reasons within the control of applicant or agencies 
within the applicant’s control. 

Examples of circumstances that would NOT establish 
that the applicant was unable to respond within 
the three-month period in spite of all due care are:

(A)an applicant’s or representative’s preoccupation 
with other matters (e.g., an inter partes lawsuit or 
interference) that is given priority over the application;

(B)illness or death of the practitioner in charge of 
the application if the practitioner is associated (in a 
law firm) with other practitioners (since the other 
practitioners could have taken action to reply within 
the three-month period);

(C)time consumed with communications 
between the applicant and his or her representative, 
regardless of whether the applicant resides in the 
United States or chooses to communicate with the 
United States representative via a foreign representative;

(D)vacation or other non-attention to an application 
that results in a failure to reply within the three-
month period;

(E)applicant filing a reply on or near the last day 
of the three-month period using first class mail with a 
certificate of mailing under 37 CFR 1.8, rather than 
by Express Mail under 37 CFR 1.10 or facsimile (if 
permitted), and the reply is not received (filed) in the 
Office until after the three-month period; or

(F)failure of clerical employees of applicant or 
applicant’s representative to properly docket the 
Office action or notice for reply or perform other tasks 
necessary for reply within the three-month period.

Rarely is the power of attorney given to a single attorney 
and often many attorneys are given power of 
attorney in an application. An attorney in litigation, 
working on an interference or taking a vacation is 
generally aware of that fact before the event and 
should make plans for another to take over his or her 
work so that it is completed and filed in the Office 
within the three-month period. Thus, failure to reply 
within the three-month period in 35 U.S.C. 
154(b)(2)(C)(ii) due to preoccupation with other matters 
(e.g., an inter partes lawsuit or interference) 
given priority over the application, or vacation or 
other non-attention to an application, cannot be relied 
upon to show that applicant was unable to reply “in 
spite of all due care” under 35 U.S.C. 154(b)(3)(C).

==2735 Request for Reconsideration of Patent Term Adjustment Determination==

{{Statute|37 CFR 1.705. Patent term adjustment determination.}}
{{Ellipsis}}
(d)If there is a revision to the patent term adjustment indicated 
in the notice of allowance, the patent will indicate the 
revised patent term adjustment. If the patent indicates or should 
have indicated a revised patent term adjustment, any request for 
reconsideration of the patent term adjustment indicated in the 
patent must be filed within two months of the date the patent 
issued and must comply with the requirements of paragraphs 
(b)(1) and (b)(2) of this section. Any request for reconsideration 
under this section that raises issues that were raised, or could have 
been raised, in an application for patent term adjustment under 
paragraph (b) of this section shall be dismissed as untimely as to 
those issues.

(e) The periods set forth in this section are not extendable.
{{Ellipsis}}
|}


Since the Office is obligated to provide a determination 
of patent term adjustment under 35 U.S.C. 
154(b) in the notice of allowance (i.e., before the 
actual patent issue date), the Office must project (or 
estimate) the actual patent issue date and base its 
patent term adjustment determination on that projection. 
Additionally, there are a number of papers which 
if submitted by an applicant after the mailing of the 
notice of allowance will result in a reduction of any 
patent term adjustment, and there may be Office 
delays occurring after mailing the notice of allowance 
resulting in an increase in the amount of patent term 
adjustment. Thus, 37 CFR 1.705(d) provides for a 
revision of the patent term adjustment when revision 
is necessitated by events occurring after the mailing 
of the notice of allowance. 37 CFR 1.705(d) specifically 
provides that if there is a revision to the patent 
term adjustment indicated in the notice of allowance, 
the patent will indicate the revised patent term adjustment. 
37 CFR 1.705(d) also provides that if the patent 
indicates or should have indicated a revised patent 
term adjustment, any request for reconsideration of 
the patent term adjustment indicated in the patent 
must be filed within two months of the date the patent 
issued and must comply with the requirements of 37 
CFR 1.705(b). The two month period is not extendable. 
37 CFR 1.705(e).

Any request for reconsideration under 37 CFR 
1.705(d) that raises issues that were raised, or could 
have been raised, in an application for patent term 
adjustment under 37 CFR 1.705(b) shall be dismissed 
as untimely as to those issues.

==2736 Third Party Papers==

{{Statute|37 CFR 1.705. Patent term adjustment determination.}}
{{Ellipsis}}
(f)No submission or petition on behalf of a third party concerning 
patent term adjustment under 35 U.S.C. 154(b) will be 
considered by the Office. Any such submission or petition will be 
returned to the third party, or otherwise disposed of, at the convenience 
of the Office.
{{Ellipsis}}
|}


37 CFR 1.705(f) implements the provisions of 35 
U.S.C. 154(b)(4)(B) and provides that no submission 
or petition on behalf of a third party concerning patent 
term adjustment under 35 U.S.C. 154(b) will be considered 
by the Office, and that any such submission or 
petition will be returned to the third party, or otherwise 
disposed of, at the convenience of the Office.

==2750 Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156==

The right to a patent term extension based upon 
regulatory review is the result of the Drug Price Competition 
and Patent Term Restoration Act of 1984, 
Pub. L. No. 98-417, 98 Stat. 1585 (codified at 
21 U.S.C. 355(b), (j), (l); 35 U.S.C. 156, 271, 
282)(Hatch-Waxman Act). The act sought to eliminate 
two distortions to the normal “patent term produced 
by the requirement that certain products must 
receive premarket regulatory approval.” Eli Lilly & 
Co. v. Medtronic Inc., 496 U.S. 661, 669, 15 USPQ2d 
1121, 1126 (1990). The first distortion was that the 
patent owner loses patent term during the early years 
of the patent because the product cannot be commercially 
marketed without approval from a regulatory 
agency. The second distortion occurred after the end 
of the patent term because competitors could not 
immediately enter the market upon expiration of the 
patent because they were not allowed to begin testing 
and other activities necessary to receive FDA 
approval before patent expiration.

The part of the act codified as 35 U.S.C. 156 was 
designed to create new incentives for research and 
development of certain products subject to premarket 
government approval by a regulatory agency. The 
statute enables the owners of patents on certain 
human drugs, food or color additives, medical 
devices, animal drugs, and veterinary biological products 
to restore to the terms of those patents some of 
the time lost while awaiting premarket government 
approval from a regulatory agency. The rights derived 
from extension of the patent term are limited to the 
approved product (as defined in 35 U.S.C. 156(a)(4)
and (a)(5)). See 35 U.S.C. 156(b). Accordingly, if the 
patent claims other products in addition to the 
approved product, the exclusive patent rights to the 
additional products expire with the original expiration 
date of the patent. 

In exchange for extension of the term of the patent, 
Congress legislatively overruled Roche Products v. 
Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 
(Fed. Cir. 1984) as to products covered by 35 U.S.C. 
271(e) and provided that it shall not be an act of 
infringement, for example, to make and test a patented 
drug solely for the purpose of developing and 
submitting information for an Abbreviated New Drug 
Application (ANDA). 35 U.S.C. 271(e)(1). See 
Donald O. Beers, Generic and Innovator Drugs: A 
Guide to FDA Approval Requirements, Fifth Edition, 
Aspen Law & Business, 1999, 4.3[2] for a discussion 
of the Hatch-Waxman Act and infringement litigation. 
Furthermore, Congress provided that an ANDA cannot 
be filed until five years after the approval date of 
the product if the active ingredient or a salt or ester of 
the active ingredient had not been previously 
approved under section 505(b) of the Federal Food, 
Drug and Cosmetic Act. 21 U.S.C. 355(j)(4)(D)(ii). 
See also Lourie, Patent Term Restoration: History, 
Summary, and Appraisal, 40 Food, Drug and Cosmetic 
L. J. 351, 353-60 (1985). See also Lourie, 
Patent Term Restoration, 66 J. Pat. Off. Soc’y 526 
(1984). 

On November 16, 1988, 35 U.S.C. 156 was 
amended by Public Law 100-670, essentially to add 
animal drugs and veterinary biologics to the list of 
products that can form the basis of patent term extension. 
Animal drug products which are primarily manufactured 
through biotechnology are excluded from 
the provisions of patent term extension. 

On December 3, 1993, 35 U.S.C. 156 was further 
amended to provide for interim extension of a patent 
where a product claimed by the patent was expected 
to be approved, but not until after the original expiration 
date of the patent. Public Law 103-179, Section 
5.

An application for the extension of the term of a 
patent under 35 U.S.C. 156 must be submitted by the 
owner of record of the patent or its agent within the 
sixty-day period beginning on the date the product 
received permission for commercial marketing or use 
under the provision of law under which the applicable 
regulatory review period occurred for commercial 
marketing or use. See 35 U.S.C. 156(d)(1). The 
USPTO initially determines whether the application is 
formally complete and whether the patent is eligible 
for extension. The statute requires the Director of 
the United States Patent and Trademark Office to 
notify the Secretary of Agriculture or the Secretary of 
Health and Human Services of the submission of an 
application for extension of patent term which complies 
with 35 
U.S.C. 156 within sixty days and to submit 
to the Secretary a copy of the application. Not 
later than thirty days after receipt of the application 
from the Director, the Secretary will determine 
the length of the applicable regulatory review period 
and notify the Director of the determination. If the 
Director determines that the patent is eligible for 
extension, the Director calculates the length of 
extension for which the patent is eligible under the 
appropriate statutory provision and issues an appropriate 
Certificate of Extension.

Patent term extensions provided by private relief 
legislation, public laws other than as enacted by 
35 
U.S.C. 156, such as 35 U.S.C. 155 and 155A, are 
not addressed herein.

==2751 Eligibility Requirements==

{{Statute|35 U.S.C. 156. Extension of patent term}}
{{Ellipsis}}
(a)The term of a patent which claims a product, a method of 
using a product, or a method of manufacturing a product shall be 
extended in accordance with this section from the original expiration 
date of the patent, which shall include any patent term adjustment 
granted under section 154(b) if —

(1)the term of the patent has not expired before an application 
is submitted under subsection (d)(1) for its extension;

(2)the term of the patent has never been extended under 
subsection (e)(1) of this section;

(3)an application for extension is submitted by the owner 
of record of the patent or its agent and in accordance with the 
requirements of paragraphs (1) through (4) of subsection (d);

(4)the product has been subject to a regulatory review 
period before its commercial marketing or use;

(5)(A) except as provided in subparagraph (B) or (C), the 
permission for the commercial marketing or use of the product 
after such regulatory review period is the first permitted commercial 
marketing or use of the product under the provision of law 
under which such regulatory review period occurred;

(B)in the case of a patent which claims a method of 
manufacturing the product which primarily uses recombinant 
DNA technology in the manufacture of the product, the permission 
for the commercial marketing or use of the product after such 
regulatory period is the first permitted commercial marketing or 
use of a product manufactured under the process claimed in the 
patent; or

(C)for purposes of subparagraph (A), in the case of a 
patent which —

(i)claims a new animal drug or a veterinary biological 
product which (I) is not covered by the claims in any other 
patent which has been extended, and (II) has received permission 
for the commercial marketing or use in non-food-producing animals 
and in food-producing animals, and

(ii)was not extended on the basis of the regulatory 
review period for use in non-food-producing animals, the permission 
for the commercial marketing or use of the drug or product 
after the regulatory review period for use in food-producing animals 
is the first permitted commercial marketing or use of the 
drug or product for administration to a food-producing animal.

The product referred to in paragraphs (4) and (5) is 
hereinafter in this section referred to as the “approved product.”
{{Ellipsis}}
(f)For purposes of this section:

(1)The term “product” means:

(A)A drug product.

(B)Any medical device, food additive, or color additive 
subject to regulation under the Federal Food, Drug, and Cosmetic 
Act.

(2)The term “drug product” means the active ingredient 
of—

(A)a new drug, antibiotic drug, or human biological 
product (as those terms are used in the Federal Food, Drug, and 
Cosmetic Act and the Public Health Service Act) or

(B)a new animal drug or veterinary biological product 
(as those terms are used in the Federal Food, Drug, and Cosmetic 
Act and the Virus-Serum-Toxin Act) which is not primarily manufactured 
using recombinant DNA, recombinant RNA, hybridoma 
technology, or other processes involving site specific genetic 
manipulation techniques, including any salt or ester of the active 
ingredient, as a single entity or in combination with another active 
ingredient.

(3)The term “major health or environmental effects test” 
means a test which is reasonably related to the evaluation of the 
health or environmental effects of a product, which requires at 
least six months to conduct, and the data from which is submitted 
to receive permission for commercial marketing or use. Periods of 
analysis or evaluation of test results are not to be included in 
determining if the conduct of a test required at least six months.

(4)(A)Any reference to section 351 is a reference to section 
351 of the Public Health Service Act.

(B)Any reference to section 503, 505, 512, or 515 is a 
reference to section 503, 505, 512, or 515 of the Federal Food, 
Drug and Cosmetic Act.

(C)Any reference to the Virus-Serum-Toxin Act is a 
reference to the Act of March 4, 1913 (21 U.S.C. 151 - 158).

(5)The term “informal hearing” has the meaning prescribed 
for such term by section 201(y) of the Federal Food, Drug 
and Cosmetic Act.

(6)The term “patent” means a patent issued by the 
United States Patent and Trademark Office.

(7)The term “date of enactment” as used in this section 
means September 24, 1984, for human drug product, a medical 
device, food additive, or color additive.

(8)The term “date of enactment” as used in this section 
means the date of enactment of the Generic Animal Drug and 
Patent Term Restoration Act for an animal drug or a veterinary 
biological product.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.710. Patents subject to extension of the patent term}}
(a)A patent is eligible for extension of the patent term if the 
patent claims a product as defined in paragraph (b) of this section, 
either alone or in combination with other ingredients that read on 
a composition that received permission for commercial marketing 
or use, or a method of using such a product, or a method of manufacturing 
such a product, and meets all other conditions and 
requirements of this subpart.

(b)The term product referred to in paragraph (a) of this section 
means — 

(l)The active ingredient of a new human drug, antibiotic 
drug, or human biological product (as those terms are used in the 
Federal Food, Drug, and Cosmetic Act and the Public Health Service 
Act) including any salt or ester of the active ingredient, as a 
single entity or in combination with another active ingredient; or

(2)The active ingredient of a new animal drug or veterinary 
biological product (as those terms are used in the Federal 
Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) 
that is not primarily manufactured using recombinant DNA, 
recombinant RNA, hybridoma technology, or other processes 
including site specific genetic manipulation techniques, including 
any salt or ester of the active ingredient, as a single entity or in 
combination with another active ingredient; or

(3)Any medical device, food additive, or color additive 
subject to regulation under the Federal Food, Drug, and Cosmetic 
Act.
|}


{{Statute|37 CFR 1.720. Conditions for extension of patent term}}
The term of a patent may be extended if:

(a)The patent claims a product or a method of using or manufacturing 
a product as defined in § 1.710;

(b)The term of the patent has never been previously 
extended, except for extensions issued pursuant to §§ 1.701, 
1.760, or 1.790; 

(c)An application for extension is submitted in compliance 
with § 1.740;

(d)The product has been subject to a regulatory review 
period as defined in 35 U.S.C. 156(g) before its commercial marketing 
or use;

(e)The product has received permission for commercial 
marketing or use and —

(1)The permission for the commercial marketing or use 
of the product is the first received permission for commercial marketing 
or use under the provision of law under which the applicable 
regulatory review occurred, or

(2)In the case of a patent other than one directed to subject 
matter within § 1.710(b)(2) claiming a method of manufacturing 
the product that primarily uses recombinant DNA technology 
in the manufacture of the product, the permission for the commercial 
marketing or use is the first received permission for the commercial 
marketing or use of a product manufactured under the 
process claimed in the patent, or

(3)In the case of a patent claiming a new animal drug or 
a veterinary biological product that is not covered by the claims in 
any other patent that has been extended, and has received permission 
for the commercial marketing or use in non-food-producing 
animals and in food-producing animals, and was not extended on 
the basis of the regulatory review period for use in non-food-producing 
animals, the permission for the commercial marketing or 
use of the drug or product after the regulatory review period for 
use in food-producing animals is the first permitted commercial 
marketing or use of the drug or product for administration to a 
food-producing animal.

(f)The application is submitted within the sixty-day period 
beginning on the date the product first received permission for 
commercial marketing or use under the provisions of law under 
which the applicable regulatory review period occurred; or in the 
case of a patent claiming a method of manufacturing the product 
which primarily uses recombinant DNA technology in the manufacture 
of the product, the application for extension is submitted 
within the sixty-day period beginning on the date of the first permitted 
commercial marketing or use of a product manufactured 
under the process claimed in the patent; or in the case of a patent 
that claims a new animal drug or a veterinary biological product 
that is not covered by the claims in any other patent that has been 
extended, and said drug or product has received permission for the 
commercial marketing or use in non-food-producing animals, the 
application for extension is submitted within the sixty-day period 
beginning on the date of the first permitted commercial marketing 
or use of the drug or product for administration to a food-producing 
animal;

(g)The term of the patent, including any interim extension 
issued pursuant to § 1.790, has not expired before the submission 
of an application in compliance with § 1.741; and

(h)No other patent term has been extended for the same regulatory 
review period for the product.
|}


35 U.S.C. 156(a) sets forth what patents can be 
extended and the conditions under which they may be 
extended. 37 CFR 1.710 also addresses the patents 
that may be extended, and 37 CFR 1.720 describes the 
conditions under which a patent may be extended. As 
set forth in 35 U.S.C. 156 and 37 CFR 1.710, a patent 
which claims a human drug product, medical device, 
food or color additive first approved for marketing or 
use after September 24, 1984, or an animal drug or 
veterinary biological product (which was not primarily 
manufactured through biotechnology) first 
approved for marketing or use after November 16, 
1988, may qualify for patent term extension. Furthermore, 
35 U.S.C. 156(a)(1) - (5) require that the applicant 
establish that:

(1)the patent has not expired before an application 
under 35 U.S.C. 156(d) was filed (this may be an 
application for patent term extension under subsection 
(d)(1) or an application for interim extension under 
subsection (d)(5));

(2)the patent has never been extended under 
35 U.S.C. 156(e)(1); 

(3)the application for extension is submitted by 
the owner of record of the patent or its agent to the 
Office within 60 days of regulatory agency approval 
of the commercial marketing application and the 
application includes details relating to the patent, the 
approved product, and the regulatory review time 
spent in securing regulatory agency approval;

(4)the product has been subject to a regulatory 
review period within the meaning of 35 U.S.C. 156(g)
before its commercial marketing or use;

(5)the approval is the first permitted commercial 
marketing or use of the product (35 U.S.C. 
156(a)(5)(A)), except in the case of human drug products 
manufactured using recombinant DNA technology 
where the provisions of 35 U.S.C. 156(a)(5)(B)
apply, or in the case of a new animal drug or a veterinary 
biological product where the provisions of 
35 
U.S.C. 156(a)(5)(C) apply.

35 U.S.C. 156(c)(4) also requires that no other 
patent term has been extended for the same regulatory 
review period for the product. See MPEP § 2761. 

TERMINALLY DISCLAIMED PATENTS ARE 
ELIGIBLE

A patent may be extended under 35 U.S.C. 156, 
even though it has been terminally disclaimed. A 
patent term extension under 35 U.S.C. 156 is a limited 
extension of the patent rights associated with the 
approved product that is attached onto the original 
term of the patent. See 35 U.S.C. 156(b). Only one 
patent may be extended for a regulatory review period 
for any product, and 35 U.S.C. 156 sets the expiration 
date of a patent term extension. Although 35 U.S.C. 
154(b)(2)(June 8, 1995) precludes a patent from being 
extended under 35 U.S.C. 154(b) if the patent has 
been terminally disclaimed due to an obviousness-
type double patenting rejection (see MPEP § 2720), 
there is no such exclusion in 35 U.S.C. 156. Additionally, 
35 U.S.C. 154(b)(2)(B)(May 29, 2000) provides 
that a patent cannot be adjusted beyond the date set by 
the disclaimer (see MPEP § 2730), but there is no 
similar provision in 35 U.S.C. 156. Thus patents may 
receive a patent term extension under 35 U.S.C. 156beyond an expiration date set by a terminal disclaimer.


MEANING OF “PRODUCT” AS DEFINED IN 35 U.S.C. 156(f)

As required by 35 U.S.C. 156(a), patents eligible 
for extension of patent term are those which: 

(A)claim a “product” as defined in 35 U.S.C. 
156(f)(1), either alone or in combination with other 
ingredients, wherein the product reads on a composition 
(product) that received permission for commercial 
marketing or use, or a method of using such a 
product, or a method of manufacturing such a product, 
and 

(B)meet all other conditions and requirements of 
the statute. 

The term “claims a product” is not synonymous 
with “infringed by a product.” A patent which claims 
a metabolite of an approved drug does not claim the 
approved drug. Hoechst-Roussel Pharmaceuticals 
Inc. v. Lehman, 109 F.3d 756, 759, 42 USPQ2d 1220, 
1223 (Fed. Cir. 1997).

The term “product” means:

(A)The active ingredient of a new human drug, 
antibiotic drug, or human biological product (as those 
terms are used in the Federal Food, Drug, and Cosmetic 
Act and the Public Health Service Act) including 
any salt or ester of the active ingredient, as a 
single entity or in combination with another active 
ingredient; or

(B)The active ingredient of a new animal drug or 
veterinary biological product (as those terms are used 
in the Federal Food, Drug, and Cosmetic Act and the 
Virus-Serum-Toxin Act) that is not primarily manufactured 
using recombinant DNA, recombinant RNA, 
hybridoma technology, or other processes including 
site specific genetic manipulation techniques, including 
any salt or ester of the active ingredient, as a single 
entity or in combination with another active 
ingredient; or

(C)Any medical device, food additive, or color 
additive subject to regulation under the Federal Food, 
Drug, and Cosmetic Act. 

See 21 CFR 60.3(b) for definitions of terms such as 
active ingredient, color additive, food additive, human 
drug product, and medical device.

Essentially, a “product” is a “drug product,” medical 
device, food additive, or color additive requiring 
Food and Drug Administration or Department of 
Agriculture (Plant and Animal Inspection Service) 
approval of an order or regulation prior to commercial 
marketing or use. “Drug product” is the active ingredient 
of a human drug, animal drug (excluding those 
primarily manufactured using recombinant DNA, 
recombinant RNA, hybridoma technology, or other 
processes including site specific genetic manipulation 
techniques), or biological product (as defined by the 
Federal Food, Drug and Cosmetics Act and the Public 
Health Service Act) including any salt or ester of the 
active ingredient, as a single entity or in combination 
with another active ingredient. Animal biological 
products are approved by the Plant and Animal 
Inspection Service of the Department of Agriculture.

A “drug product” means the active ingredient found 
in the final dosage form prior to administration of the 
product to the patient, not the resultant form the drug 
may take after administration. In this regard, a drug in 
the ester form which is used for oral administration is 
a different drug product from the same active moiety 
in a salt form which is administered by injection, even 
though both the salt and the ester are used to treat the 
same disease condition. The ester form is a different 
active ingredient from the salt form. Both the ester 
and the salt active ingredient may each support an 
extension of patent term of different patents provided 
the acid itself has not previously been approved. See 
Glaxo Operations UK Ltd. v. Quigg, 706 F.Supp. 
1224, 1232-33, 10 USPQ2d 1100, 1107 (E.D. Va. 
1989); aff’d., 894 F.2d 392, 13 USPQ2d 1628 (Fed. 
Cir. 1990).

Furthermore, a “drug product” is the active ingredient 
of a particular new drug, rather than the entire 
composition of the drug product approved by the 
Food and Drug Administration. See Fisons plc v. 
Quigg, 1988 U.S. Dist. LEXIS 10935; 8 USPQ2d 
1491, 1495 (D.D.C. 1988); aff’d., 876 F2d 99, 110; 10 
USPQ2d 1869, 1870 (Fed. Cir. 1989). An active 
ingredient of a drug is the ingredient in the drug product 
that becomes therapeutically active when administered. 
Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 
392, 393, 13 USPQ2d 1628, 1629 (Fed. Cir. 1990); 
but c.f., Abbott Laboratories v. Young, 920 F.2d 984, 
989 n.7 (D.C. Cir. 1990), cert denied, 112 S. Ct. 76 
(1991) (The court rejected the approach of Glaxo in 
considering whether Abbott was entitled to exclusivity). 

A patent is considered to claim the product at least 
in those situations where the patent claims the active 
ingredient per se, or claims a composition or formulation 
which contains the active ingredient(s) and reads 
on the composition or formulation approved for commercial 
marketing or use.

NO PREVIOUS EXTENSIONS (WITH LIMITED 
EXCEPTIONS)

37 CFR 1.720(b) explains that patent term extension 
pursuant to 35 U.S.C. 156 is available only if the 
term of the patent has never been previously 
extended, except for extensions issued pursuant to 
37 CFR 1.701, 1.760, or 1.790. An extension issued 
pursuant to 37 CFR 1.701 is an extension of the patent 
due to administrative delay within the Office. Note 
that the term of a patent is “adjusted,” not extended, 
pursuant to 37 CFR 1.702-1.705. An extension issued 
pursuant to 37 CFR 1.760 is an interim extension 
under 35 U.S.C. 156(e)(2). An extension issued pursuant 
to 37 CFR 1.790 is an interim extension under 
35 U.S.C. 156(d)(5).

REGULATORY REVIEW PERIOD

37 CFR 1.720(d) restates the statutory requirement 
set forth in 35 U.S.C. 156(a)(4). The regulatory 
review period must have been a regulatory review 
period defined by the statute. A regulatory review 
period under section 510(k) of the Federal Food, Drug 
and Cosmetic Act is not a regulatory review period 
which gives rise to eligibility for patent term extension 
under 35 U.S.C. 156. In re Nitinol Medical Technologies 
Inc., 17 USPQ2d 1492, 1492-1493 (Comm’r 
Pat. & Tm. 1990). See also Baxter Diagnostics v. AVL 
Scientific Corp. 798 F. Supp. 612, 619-620; 
25 USPQ2d 1428,1434 (CD CA 1992)(Congress 
intended only Class III medical devices to be eligible 
for patent term extension).

If the product is alleged to be a medical device, 
then regulatory review must have occurred under section 
515, and not section 505, of the Federal Food, 
Drug and Cosmetic Act. Drug products are not 
reviewed under section 515.

If more than one application for patent term extension 
is filed based upon a single regulatory review 
period, election will be required of a single patent. 
See MPEP § 2761. 

FIRST PERMITTED MARKETING OR USE

37 CFR 1.720(e) follows 35 U.S.C. 156(a)(5), and 
sets forth that the approval under the relevant provision 
of law must have been the first permitted marketing 
or use of the product under the provision of law, 
unless the product is for use in food producing animals 
as explained below. See In re Patent Term Extension 
Application, U.S. Patent No. 3,849,549, 
226 USPQ 283, 284 (Pat. & Tm. Office 1985). If the 
product is a human drug product, then the approval of 
the active ingredient must be the first permitted commercial 
marketing or use of the active ingredient as a 
single entity or in combination with another active 
ingredient under the provision of law under which 
regulatory review occurred.

Where a product contains multiple active ingredients, 
if any one active ingredient has not been previously 
approved, it can form the basis of an extension 
of patent term provided the patent claims that ingredient. 
See In re Alcon Laboratories Inc., 13 USPQ2d 
1115, 1121 (Comm’r Pat. & Tm. 1989) for examples 
of products having different combinations of active 
ingredients. A different ratio of hormones is not a different 
active ingredient for purposes of 35 U.S.C. 156. 
Furthermore, an approved product having two active 
ingredients, which are not shown to have a synergistic 
effect or have pharmacological interaction, will not be 
considered to have a single active ingredient made of 
the two active ingredients.

As to 35 U.S.C. 156(a)(5)(C), which is addressed in 
37 CFR 1.720(e)(3), the term of a patent directed to a 
new animal drug or veterinary biological product may 
be extended based on a second or subsequent 
approval of the active ingredient provided all the following 
conditions exist:

(A)the patent claims the drug or product;

(B)the drug or product is not covered by the 
claims in any other patent that has been extended;

(C)the patent term was not extended on the basis 
of the regulatory review period for use in non-food 
producing animals; and

(D)the second or subsequent approval was the 
first permitted commercial marketing or use of the 
drug or product for administration to a food-producing 
animal. In this case, the application must be filed 
within sixty days of the first approval for administration 
to a food-producing animal.

For animal drugs or products, prior approval for use 
in a non-food producing animal will not make a patent 
ineligible for patent term extension based upon a later 
approval of the drug or product for use in food producing 
animals, if the later approval is the first 
approval of the drug or product for use in food producing 
animals. 

==2752 Patent Term Extension Applicant==

{{Statute|35 U.S.C. 156. Extension of patent term}}
{{Ellipsis}}
(d)(1) To obtain an extension of the term of a patent under 
this section, the owner of record of the patent or its agent shall 
submit an application to the Director. Except as provided in paragraph 
(5), such an application may only be submitted within the 
sixty-day period beginning on the date the product received permission 
under the provision of law under which the applicable 
regulatory review period occurred for commercial marketing or 
use. The application shall contain —

(A)the identity of the approved product and the Federal 
statute under which regulatory review occurred;

(B)the identity of the patent for which an extension is 
being sought and the identity of each claim of such patent;

(C)information to enable the Director to determine under 
subsections (a) and (b) the eligibility of a patent for extension and 
the rights that will be derived from the extension and information 
to enable the Director and the Secretary of Health and Human Services 
or the Secretary of Agriculture to determine the period of the 
extension under subsection (g);

(D)a brief description of the activities undertaken by the 
applicant during the applicable regulatory review period with 
respect to the approved product and the significant dates applicable 
to such activities; and

(E)such patent or other information as the Director may 
require.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.730. Applicant for extension of patent term; signature requirements.}}
(a)Any application for extension of a patent term must be 
submitted by the owner of record of the patent or its agent and 
must comply with the requirements of § 1.740.

(b)If the application is submitted by the patent owner, the 
application must be signed either by:

(1)The patent owner in compliance with § 3.73(b) of this 
chapter; or

(2)A registered practitioner on behalf of the patent 
owner.

(c)If the application is submitted on behalf of the patent 
owner by an agent of the patent owner (e.g., a licensee of the 
patent owner), the application must be signed by a registered practitioner 
on behalf of the agent. The Office may require proof that 
the agent is authorized to act on behalf of the patent owner.

(d)If the application is signed by a registered practitioner, 
the Office may require proof that the practitioner is authorized to 
act on behalf of the patent owner or agent of the patent owner.
|}


35 U.S.C. 156(d)(1) requires that the application 
for extension of the patent term must be submitted by 
the owner of record of the patent or its agent. If the 
application is filed by an assignee, the application 
papers should refer to the reel and frame number of 
the recorded assignment. A power of attorney from 
the patent owner to any patent attorney or agent submitting 
the patent term extension application papers 
should be filed, if the attorney or agent is not already 
of record in the patent (see 37 CFR 1.34(b)).

If the applicant for patent term extension was not 
the marketing applicant before the regulatory agency, 
then there must be an agency relationship between the 
patent owner and the marketing applicant during the 
regulatory review period. To show that such an applicant 
is authorized to rely upon the activities of the 
marketing applicant before the Food and Drug 
Administration or the Department of Agriculture, it is 
advisable for the applicant for patent term extension 
to obtain a letter from the marketing applicant specifically 
authorizing such reliance.

==2753 Application Contents==

{{Statute|37 CFR 1.740. Formal requirements for application for extension of patent term; correction of informalities.}}
(a)An application for extension of patent term must be 
made in writing to the Director. A formal application for the 
extension of patent term must include:

(1)A complete identification of the approved product as 
by appropriate chemical and generic name, physical structure or 
characteristics;

(2)A complete identification of the Federal statute 
including the applicable provision of law under which the regulatory 
review occurred;

(3)An identification of the date on which the product 
received permission for commercial marketing or use under the 
provision of law under which the applicable regulatory review 
period occurred;

(4)In the case of a drug product, an identification of each 
active ingredient in the product and as to each active ingredient, a 
statement that it has not been previously approved for commercial 
marketing or use under the Federal Food, Drug, and Cosmetic 
Act, the Public Health Service Act, or the Virus-Serum-Toxin Act, 
or a statement of when the active ingredient was approved for 
commercial marketing or use (either alone or in combination with 
other active ingredients), the use for which it was approved, and 
the provision of law under which it was approved.

(5)A statement that the application is being submitted 
within the sixty day period permitted for submission pursuant to § 
l.720(f) and an identification of the date of the last day on which 
the application could be submitted;

(6)A complete identification of the patent for which an 
extension is being sought by the name of the inventor, the patent 
number, the date of issue, and the date of expiration;

(7)A copy of the patent for which an extension is being 
sought, including the entire specification (including claims) and 
drawings;

(8)A copy of any disclaimer, certificate of correction, 
receipt of maintenance fee payment, or reexamination certificate 
issued in the patent;

(9)A statement that the patent claims the approved product, 
or a method of using or manufacturing the approved product, 
and a showing which lists each applicable patent claim and demonstrates 
the manner in which at least one such patent claim reads 
on:

(i)The approved product, if the listed claims include 
any claim to the approved product;

(ii)The method of using the approved product, if the 
listed claims include any claim to the method of using the 
approved product; and

(iii)The method of manufacturing the approved product, 
if the listed claims include any claim to the method of manufacturing 
the approved product;

(10) A statement beginning on a new page of the relevant 
dates and information pursuant to 35 
U.S.C. 156(g) in order to 
enable the Secretary of Health and Human Services or the Secretary 
of Agriculture, as appropriate, to determine the applicable 
regulatory review period as follows:

(i)For a patent claiming a human drug, antibiotic, or 
human biological product:

(A)The effective date of the investigational new 
drug (IND) application and the IND number;

(B)The date on which a new drug application 
(NDA) or a Product License Application (PLA) was initially submitted 
and the NDA or PLA number; and

(C)The date on which the NDA was approved or 
the Product License issued;

(ii)For a patent claiming a new animal drug:

(A)The date a major health or environmental 
effects test on the drug was initiated, and any available substantiation 
of that date, or the date of an exemption under subsection (j) 
of Section 512 of the Federal Food, Drug, and Cosmetic Act 
became effective for such animal drug;

(B)The date on which a new animal drug application 
(NADA) was initially submitted and the NADA number; and

(C)The date on which the NADA was approved;

(iii)For a patent claiming a veterinary biological product:


(A)The date the authority to prepare an experimental 
biological product under the Virus-Serum-Toxin Act became 
effective;

(B)The date an application for a license was submitted 
under the Virus-Serum-Toxin Act; and

(C)The date the license issued;

(iv)For a patent claiming a food or color additive:

(A)The date a major health or environmental 
effects test on the additive was initiated and any available substantiation 
of that date;

(B)The date on which a petition for product 
approval under the Federal Food, Drug and Cosmetic Act was initially 
submitted and the petition number; and

(C)The date on which the FDA published a Federal 
Register notice listing the additive for use;

(v)For a patent claiming a medical device:

(A)The effective date of the investigational device 
exemption (IDE) and the IDE number, if applicable, or the date on 
which the applicant began the first clinical investigation involving 
the device, if no IDE was submitted, and any available substantiation 
of that date;

(B)The date on which the application for product 
approval or notice of completion of a product development protocol 
under Section 515 of the Federal Food, Drug and Cosmetic 
Act was initially submitted and the number of the application; and

(C)The date on which the application was 
approved or the protocol declared to be completed;

(11) A brief description beginning on a new page of the 
significant activities undertaken by the marketing applicant during 
the applicable regulatory review period with respect to the 
approved product and the significant dates applicable to such 
activities;

(12) A statement beginning on a new page that in the 
opinion of the applicant the patent is eligible for the extension and 
a statement as to the length of extension claimed, including how 
the length of extension was determined;

(13) A statement that applicant acknowledges a duty to 
disclose to the Director of the United States Patent and Trademark 
Office and the Secretary of Health and Human Services or the 
Secretary of Agriculture any information which is material to the 
determination of entitlement to the extension sought (see
§ 1.765);

(14) The prescribed fee for receiving and acting upon the 
application for extension (see § 1.20(j)); and

(15) The name, address, and telephone number of the person 
to whom inquiries and correspondence relating to the application 
for patent term extension are to be directed.

(b)The application under this section must be accompanied 
by two additional copies of such application (for a total of three 
copies).

(c)If an application for extension of patent term is informal 
under this section, the Office will so notify the applicant. The 
applicant has two months from the mail date of the notice, or such 
time as is set in the notice, within which to correct the informality. 
Unless the notice indicates otherwise, this time period may be 
extended under the provisions of § 1.136.
|}


37 CFR 1.740 sets forth the requirements for a formal 
application for extension of patent term. See 
MPEP § 2752 for a discussion of who may apply for a 
patent term extension. See 37 CFR 1.741 and MPEP 
§ 2754 for a description of the information that must 
be submitted in the patent term extension application 
in order to be accorded a filing date. 

37 CFR 1.740(a)(1) requires a complete identification 
of the approved product as by appropriate chemical 
and generic name, physical structure or 
characteristics so as to enable the Director to 
make a determination of whether the patent claims the 
approved product, or a method of using or manufacturing 
the approved product.

37 CFR 1.740(a)(2) requires a complete identification 
of the federal statute including the applicable provision 
of law under which the regulatory review 
occurred. When the regulatory review of the product 
took place under more than one Federal statute, each 
appropriate statute should be listed. This could apply 
to a situation where a human biological product is 
tested under an investigational new drug (IND) application 
pursuant to the Federal Food, Drug, and Cosmetic 
Act, but is approved under the Public Health 
Service Act; or to a situation where approval is sought 
for use of a particular medical device with a specific 
drug product which may require approval under more 
than a single provision of law. The product that forms 
the basis of an application for patent term extension 
must be either a medical device or a drug product; it 
cannot be a combination of those separate products. 
See the file history of U.S. Patent No. 4,428,744 for 
an example of the application of this principle.

The date that a product receives permission for 
commercial marketing or use (which must be identified 
pursuant to 37 CFR 1.740(a)(3)) is generally the 
mailing date of the letter from the regulatory agency 
indicating regulatory approval. For a food additive, 
the approval date is generally the effective date stated 
in the regulation and the date the regulation is published.

37 CFR 1.740(a)(4) provides that for drug products, 
each active ingredient must be identified and there 
must be an indication of the use for which the product 
was approved. For each active ingredient, a statement 
must be made that either the active ingredient was not 
previously approved for commercial marketing or use 
under the Federal Food, Drug and Cosmetic Act, or 
that the active ingredient was approved for commercial 
marketing or use (either alone or in combination 
with other active ingredients) and the provision of law 
under which it was approved. The information is 
especially necessary for a determination of eligibility 
where, for example, the application is based on a second 
or subsequent approval of an active ingredient, 
but the first approval for administration to a food-producing 
animal.

In accordance with 37 CFR 1.740(a)(5), the application 
must be submitted within the sixty day period 
permitted for submission pursuant to 37 CFR 
1.720(f). If the sixty day period ends on a Saturday, 
Sunday or Federal holiday, then the last day on which 
the application could be submitted will be considered 
to be the next business day following the Saturday, 
Sunday or Federal holiday. See 37 CFR 1.7. However, 
applicants are cautioned to avoid filing an application 
for patent term extension on the last day for filing to 
avoid the application being denied because the filing 
deadline was inadvertently missed. 

The expiration date of the patent for which an 
extension is sought as identified pursuant to 37 CFR 
1.740(a)(6) should be the expiration date according to 
the law (35 U.S.C. 154) at the time of filing of the 
application for patent term extension, and should 
include any patent term adjustment under 35 U.S.C. 
154(b). 

Pursuant to 37 CFR 1.740(a)(9), the application for 
patent term extension need only explain how one 
product claim of the patent claims the approved product, 
if there is a claim to the product. In addition, the 
application need only explain how one method of use 
claim of the patent claims the method of use of the 
approved product, if there is a claim to the method of 
use of the product. Lastly, the application need only 
explain how one claim of the patent claims the 
method of manufacturing the approved product, if 
there is a claim to the method of manufacturing the 
approved product. At most, a showing explaining 
three claims is required. However, each claim that 
claims the approved product, the method of use of the 
approved product, or the method of manufacturing the 
approved product must be listed. See 35 U.S.C. 
156(d)(1)(B). 

The showing should clearly explain how each listed 
claim reads on the approved product. For example, 
where a generic chemical structure is used in the 
claim to define the claimed invention, a listing of variables 
and substituents which correspond to the 
approved product is appropriate. Where a claim uses 
the “means for” language permitted by 35 U.S.C. 112, 
paragraph 6, reference to the column and line number 
of the patent text and any drawing reference numbers, 
as well as a description of any relevant equivalents, is 
also appropriate.

Pursuant to 37 CFR 1.740(a)(10), the patent term 
extension applicant must provide a statement to 
enable the Secretary of Health and Human Services or 
the Secretary of Agriculture, as appropriate, to determine 
the applicable regulatory period. In cases where 
there is no regulatory event to reflect the commencement 
of the testing or approval phase of the regulatory 
review period, applicants should include in the application 
the dates that they claim initiate either the 
approval or the testing phases and an explanation of 
their reasonable bases for why they conclude that 
these dates are the relevant dates. For instance, when 
the clinical trials are conducted outside of the United 
States, the testing phase for a medical device begins 
on the date the clinical investigation involving the 
device began. An applicant should include an explanation 
as to why the date claimed is the date on which 
such clinical investigations had commenced. If the 
applicant has any means of substantiating that date, 
that information should be included in the application.

37 CFR 1.740(a)(11) requires a brief description of 
the activities of the marketing applicant before the 
regulatory agency. This description should include an 
identification of significant communications of substance 
with the regulatory agency and the dates 
related to such communications. For example, these 
activities would include the dates of the submissions 
of new data to the FDA, communications between 
FDA and the applicant with respect to the appropriate 
protocols for testing the product, and communications 
between FDA and the applicant that are attempts to 
define the particular requirements for premarketing 
approval for this particular product. The applicant is 
not required to establish the existence of due diligence 
during the regulatory review period in order to have a 
complete application.

As stated above, the marketing applicant must have 
been an agent of the patent owner, if not the same 
entity as the patent owner. Accordingly, the Office 
will not assist the patent owner in obtaining information 
required in an application for patent term extension 
from the marketing applicant. It is sufficient that 
the description of the activities briefly identify those 
significant activities undertaken by the marketing 
applicant directed toward regulatory approval, and a 
submission of insignificant details or identification of 
non-substantive communications is not required.

37 CFR 1.740(a)(12) requires that the extension 
applicant state the length of extension claimed and 
show how the length of extension was calculated, 
including whether the 14-year limit of 35 U.S.C. 
156(c)(3) or the two or three limit of 35 U.S.C. 
156(g)(6)(C) applies.

37 CFR 1.740(a)(15) requires the patent term 
extension applicant to provide a correspondence 
address. A fax number should also be provided. Normally 
only communications regarding the application 
for patent term extension will be sent to the address 
specified in the patent term extension application. If 
the address is changed after filing the application for 
patent term extension, the change of address should 
be sent to Mail Stop Patent Extension, since 
changing the address for the patent file will not cause 
the address for the patent term extension application 
to also be changed.

In order to change the address of all correspondence, 
including maintenance fee reminders, a change 
of address should also be filed. A change of address 
must be signed by the patent applicant, the assignee of 
the entire interest, or an attorney or agent of record. 
37 CFR 1.33(a). Accordingly, if the patent term extension 
application is signed by the marketing applicant, 
as an agent of the patent owner, a power of attorney 
from the patent owner to any attorney for the marketing 
applicant would be necessary for the attorney for 
the marketing applicant to be able to sign a change of 
address for the patent file. 

Pursuant to 37 CFR 1.740(b), two additional copies 
of the application for patent term extension must be 
filed with the application. In addition, applicants are 
requested to file an additional two copies of the application, 
for a total of five copies. The original copy is 
placed into the patent application file after the Notice 
of Final Determination is mailed. Two copies of the 
application are forwarded to the regulatory agency, 
one copy is made available for public inspection in 
the Office of Patent Legal Administration, and the 
fifth copy is used by the Legal Advisor.

==2754 Filing Date==

{{Statute|37 CFR 1.741. Complete application given a filing date; petition procedure.}}
(a)The filing date of an application for extension of a patent 
term is the date on which a complete application is received in the 
Office or filed pursuant to the procedures set forth in §1.8 or §
1.10. A complete application must include:

(1)An identification of the approved product;

(2)An identification of each Federal statute under which 
regulatory review occurred;

(3)An identification of the patent for which an extension 
is being sought;

(4)An identification of each claim of the patent which 
claims the approved product or a method of using or manufacturing 
the approved product;

(5)Sufficient information to enable the Director to determine 
under subsections (a) and (b) of 35 U.S.C. 156 the eligibility 
of a patent for extension, and the rights that will be derived from 
the extension, and information to enable the Director and the Secretary 
of Health and Human Services or the Secretary of Agriculture 
to determine the length of the regulatory review period; and

(6)A brief description of the activities undertaken by the 
marketing applicant during the applicable regulatory review 
period with respect to the approved product and the significant 
dates applicable to such activities.

(b)If an application for extension of patent term is incomplete 
under this section, the Office will so notify the applicant. If 
applicant requests review of a notice that an application is incomplete, 
or review of the filing date accorded an application under 
this section, applicant must file a petition pursuant to this paragraph 
accompanied by the fee set forth in § 1.17(h) within two 
months of the mail date of the notice that the application is incomplete, 
or the notice according the filing date complained of. Unless 
the notice indicates otherwise, this time period may be extended 
under the provisions of § 1.136.
|}


FILING DATE ACCORDED

An application for patent term extension under 
35 
U.S.C. 156 may be filed by mail addressed to 
Mail Stop Patent Ext., Commissioner for Patents, 
P.O. Box 1450, Alexandria, Virginia 22313-1450 or 
may be hand carried to the Office of Patent Legal 
Administration. Applicants are encouraged to use the 
post card receipt practice described in MPEP § 502.

As set forth in 37 CFR 1.741(a), the filing date 
of an application for patent term extension is the 
date on which a complete application is received 
in the USPTO or filed pursuant to the certificate 
of mailing provisions of 37 CFR 1.8 (see MPEP § 512for suggested formats for a certificate of mailing) 
or the Express Mail provisions of 37 CFR 1.10. 
Patent term extension applications should not be filed 
by facsimile, however correspondence setting forth a 
change of address and other papers relating to a patent 
term extension may be sent by facsimile to the Office 
of Patent Legal Administration. 

COMPLETE APPLICATION

The term “complete application” is defined in 
37 CFR 1.741(a) and is an application meeting the 
requirements set forth in 35 U.S.C. 156(d)(1). For the 
establishment of a filing date, the distinction between 
the requirements of 37 CFR 1.740 and the requirements 
of 37 CFR 1.741 are important. While the 
requirements of 37 CFR 1.740 may be satisfied outside 
the 60 day filing period, the requirements of 
37 CFR 1.741 are mandated by 35 U.S.C. 156 and 
must be satisfied within the 60 day filing period for 
the establishment of the filing date. The Office will 
consider each of these statutory requirements to be 
satisfied in an application which provides sufficient 
information, directed to each requirement, to act on 
the application, even though further information may 
be desired by the USPTO or the regulatory agency 
before a final determination of eligibility and length 
of patent term extension is made.

INFORMAL APPLICATION

{{Statute|37 CFR 1.740. Formal requirements for application for extension of patent term; correction of informalities.}}
{{Ellipsis}}
(c)If an application for extension of patent term is informal 
under this section, the Office will so notify the applicant. The 
applicant has two months from the mail date of the notice, or such 
time as is set in the notice, within which to correct the informality. 
Unless the notice indicates otherwise, this time period may be 
extended under the provisions of § 1.136.
{{Ellipsis}}
|}


If the application does not meet all the formal 
requirements of 37 CFR 1.740(a) (see MPEP § 2753), 
the applicant will be notified of the informalities and 
may seek to have that holding reviewed under 37 CFR 
1.740(c) or to correct the informality. The time periods 
set forth therein are subject to the provisions of 37 
CFR 1.136, unless otherwise stated in the notice.

Note that if the application satisfies the requirements 
of 37 CFR 1.741, the application filing date 
will have been established even if the application is 
held to be informal under 37 CFR 1.740.

===2754.01 Deadline for Filing an Application Under 35 U.S.C. 156(d)(1)===

An application for patent term extension under 
35 
U.S.C. 156(d)(1) may only be filed within the 
sixty-day period beginning on the date the product 
received permission under the provision of law under 
which the applicable regulatory review period 
occurred for commercial marketing or use. The statutory 
time period is not extendable and cannot be 
waived or excused. See U.S. Patent No. 4,486,425 
(application for patent term extension filed after the 
end of the 60-day period and was therefore denied). 
The sixty-day period begins on the regulatory agency 
approval date which marks the end of the regulatory 
review period. The statute takes into account only the 
regulatory review carried out by the Food and Drug 
Administration or the Department of Agriculture and 
no other government obstacles to marketing or use. 
See Unimed, Inc. v. Quigg, 888 F2d 826, 828; 
12 
USPQ2d 1644, 1646 (Fed. Cir. 1989). For drug 
products the approval date is the date of a letter by the 
Food and Drug Administration indicating that the 
application has been approved, even if the letter 
requires further action before the drug can be marketed. 
Mead Johnson Pharmaceutical Group v. 
Bowen, 838 F2d 1332, 1336; 6 USPQ2d 1565, 1568 
(D.C. Cir. 1988). For food or color additives, the relevant 
date is the effective date of the regulation or 
order, which is set forth in the regulation or order, and 
which is generally the date that the regulation or order 
is published, e.g., in the Federal Register. See 
21 
U.S.C. 348(e). This date will generally be later 
than the date the approval is communicated to the 
marketing applicant. 

===2754.02 Filing Window for an Application Under 35 U.S.C. 156(d)(5)===

A first application for interim extension under 
35 
U.S.C. 156(d)(5) (to extend the patent term before 
product approval) must be filed within the period 
beginning six months and ending fifteen days before 
the patent is due to expire. Each subsequent application 
for interim extension must be filed during the 
period beginning sixty days before and ending thirty 
days before the expiration of the preceding interim 
extension. 35 U.S.C. 156(d)(5)(C). An interim extension 
granted under 35 U.S.C. 156(d)(5) terminates 
sixty days after permission for commercial marketing 
or use of the product is granted, except, if within the 
sixty-day period any additional information needed 
for an application for patent term extension under 
35 
U.S.C. 156(d)(1) is submitted, the patent may be 
further extended. 35 U.S.C. 156(d)(5)(E). The additional 
information required to be submitted includes 
the fee for an application for patent term extension 
under 35 U.S.C. 156(d)(1) and identification of the 
date the product received permission for commercial 
marketing or use and a statement that the application 
is being submitted within sixty days of such date and 
identification of the last date that the application 
could be submitted. See 37 CFR 1.740(a)(3) and (5). 
However, if the product is not approved within the 
period of interim extension, a new request for interim 
extension must be filed and another interim extension 
granted to keep the patent in force. An applicant is 
generally limited to four one-year interim extensions.

See MPEP § 2755.02 for additional information 
pertaining to the interim extension of patent term 
under 35 U.S.C. 156(d)(5).

===2754.03 Filing of a Request for an Extension Under 35 U.S.C. 156(e)(2)===

A request for an interim extension under 35 U.S.C. 
156(e)(2) (to extend the patent term during the processing 
of the patent term extension application) 
should be made at least three months before the patent 
is due to expire. See MPEP § 2755.01 for information 
pertaining to the interim extension of patent term 
under 35 U.S.C. 156(e)(2).

==2755 Eligibility Determination==

{{Statute|37 CFR 1.750. Determination of eligibility for extension of patent term}}
A determination as to whether a patent is eligible for extension 
may be made by the Director solely on the basis of the representations 
contained in the application for extension filed in compliance 
with § 1.740 or § 1.790. This determination may be 
delegated to appropriate Patent and Trademark Office officials 
and may be made at any time before the certificate of extension is 
issued. The Director or other appropriate officials may require 
from applicant further information or make such independent 
inquiries as desired before a final determination is made on 
whether a patent is eligible for extension. In an application for 
extension filed in compliance with § 1.740, a notice will be mailed 
to applicant containing the determination as to the eligibility of 
the patent for extension and the period of time of the extension, if 
any. This notice shall constitute the final determination as to the 
eligibility and any period of extension of the patent. A single 
request for reconsideration of a final determination may be made 
if filed by the applicant within such time as may be set in the 
notice of final determination or, if no time is set, within one month 
from the date of the final determination. The time periods set forth 
herein are subject to the provisions of § 1.136.
|}


The determination as to whether a patent is eligible 
for an extension will normally be made solely from 
the representations contained in the application for 
patent term extension. However, further information 
may be required or inquiry made of applicant before a 
final determination is made on whether a patent is eligible 
for extension. In circumstances where further 
information is required by the Office, the applicant 
will be given a time period within which to respond. 
The failure to provide a response within the time 
period provided may result in a final determination 
adverse to the granting of an extension of patent term 
unless the response period is extended. An extension 
of time to respond may be requested under the provisions 
of 37 CFR 1.136. Under appropriate circumstances, 
e.g., if time is of the essence for a particular 
reason, a request for information may contain a statement 
that the provisions of 37 CFR 1.136(a) are not 
available. The intentional failure to provide the information 
requested may result in an adverse final determination.

A final determination may be made at any time 
after an application is filed. A single request for 
reconsideration of a final determination may be filed 
within one month or within such other time period set 
in the final determination. A notice will be mailed to 
applicant containing the determination as to eligibility 
of the patent for extension and the period of time of 
the extension of the term, if any. This notice shall constitute 
the final determination as to eligibility and any 
period of extension of the patent term. If no request 
for reconsideration is filed within the time period set 
in the notice of final determination, the certificate of 
patent term extension will be issued in due course. 
See MPEP § 2758.

===2755.01 Interim Extension of Patent Term During the Processing of the Application===

{{Statute|35 U.S.C. 156. Extension of patent term.}}
{{Ellipsis}}
(e)(2) If the term of a patent for which an application has 
been submitted under subsection (d)(1) would expire before a certificate 
of extension is issued or denied under paragraph (1) 
respecting the application, the Director shall extend, until such 
determination is made, the term of the patent for periods of up to 
one year if he determines that the patent is eligible for extension.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.760. Interim extension of patent term under 35 U.S.C. 156(e)(2).}}
An applicant who has filed a formal application for extension 
in compliance with § 1.740 may request one or more interim 
extensions for periods of up to one year each pending a final 
determination on the application pursuant to § 1.750. Any such 
request should be filed at least three months prior to the expiration 
date of the patent. The Director may issue interim extensions, 
without a request by the applicant, for periods of up to one year 
each until a final determination is made. The patent owner or 
agent will be notified when an interim extension is granted and 
notice of the extension will be published in the Official Gazette of 
the United States Patent and Trademark Office. The notice will be 
recorded in the official file of the patent and will be considered as 
part of the original patent. In no event will the interim extensions 
granted under this section be longer than the maximum period for 
extension to which the applicant would be eligible.
|}


If the original term of the patent for which extension 
is sought will expire before a final decision to 
issue a certificate of extension can be made, and a 
determination is made that the patent is eligible for 
extension, 35 U.S.C. 156 provides that the Director 
may issue an interim extension of the patent term 
for up to one year pending a final decision on the 
application for extension. Should additional time be 
necessary, additional interim extensions of up to one 
year may be granted by the Director. The length 
of any interim extension is discretionary with the 
Director so long as it is for one year or less. Its 
length should be set to provide time for completion of 
any outstanding requirements. See In re Reckitt & 
Colman Products Ltd., 230 USPQ 369, 372 (Comm’r 
Pat. & Tm. 1986). The Director may issue an 
interim extension under 35 U.S.C. 156(e)(2) with or 
without a request from the applicant.

Where a determination is made that the patent is not 
eligible for patent term extension, an interim extension 
of the patent term is not warranted under 
35 U.S.C. 156(e)(2). See In re Alcon Laboratories 
Inc., 13 USPQ2d 1115, 1123 (Comm’r. Pat.& Tm. 
1989).

Where an interim extension has been granted and it 
is subsequently determined that the patent is not eligible 
for patent term extension, the interim extension 
may be vacated ab initio as ineligible under 35 U.S.C. 
156(e)(2). See In re Reckitt, 230 USPQ at 370. 

While 37 CFR 1.760 provides that a request for an 
interim extension by the applicant “should” be filed 
three months prior to the expiration of the patent, this 
time frame is not mandatory. Any request filed within 
a shorter period of time will be considered, upon a 
proper showing, where it is not possible to make an 
earlier request. However, for an interim extension to 
be granted, the application for extension, in compliance 
with 37 CFR 1.741, must have been filed prior to 
the expiration date of the patent. In no event will an 
interim extension be granted for a period of patent 
term extension longer than the period of extension to 
which the patent would be eligible.

A notice of each interim extension granted will be 
issued to the applicant for patent term extension. The 
notice will be recorded in the official file of the patent 
and will be considered as part of the original patent. 
Notification of the issuance of the interim extension 
will be published in the Official Gazette of the Patent 
and Trademark Office.

===2755.02 Interim Extension of Patent Term Before Product Approval===

{{Statute|35 U.S.C. 156. Extension of patent term.}}
{{Ellipsis}}
(d)(5)(A) If the owner of record of the patent or its agent reasonably 
expects that the applicable regulatory review period 
described in paragraphs (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), 
or (5)(B)(ii) of subsection (g) that began for a product that is the 
subject of such patent may extend beyond the expiration of the 
patent term in effect, the owner or its agent may submit an application 
to the Director for an interim extension during the period 
beginning 6 months, and ending 15 days before such term is due 
to expire. The application shall contain—

(i) the identity of the product subject to regulating 
review and the Federal statute under which such review is occurring;

(ii) the identity of the patent for which interim extension 
is being sought and the identity of each claim of such patent which 
claims the product under regulatory review or a method of using 
or manufacturing the product;

(iii) information to enable the Director to determine under 
subsection (a)(1), (2), and (3) the eligibility of a patent for extension;

(iv) a brief description of the activities undertaken by the 
applicant during the applicable regulatory review period to date 
with respect to the product under review and the significant dates 
applicable to such activities; and

(v) such patent or other information as the Director may 
require.

(5)(B)If the Director determines that, except for permission 
to market or use the product commercially, the patent would 
be eligible for an extension of the patent term under this section, 
the Director shall publish in the Federal Register a notice of such 
determination, including the identity of the product under regulatory 
review, and shall issue to the applicant a certificate of interim 
extension for a period of not more than 1 year.

(C)The owner of record of a patent, or its agent, for 
which an interim extension has been granted under subparagraph 
(B), may apply for not more than 4 
subsequent interim extensions 
under this paragraph, except that, in the case of a patent subject to 
subsection (g)(6)(C), the owner of record of the patent, or its 
agent, may apply for only 1 subsequent interim extension under 
this paragraph. Each such subsequent application shall be made 
during the period beginning 60 days before, and ending 30 days 
before, the expiration of the preceding interim extension.

(D)Each certificate of interim extension under this 
paragraph shall be recorded in the official file of the patent and 
shall be considered part of the original patent.

(E)Any interim extension granted under this paragraph 
shall terminate at the end of the 60-day period beginning on 
the day on which the product involved receives permission for 
commercial marketing or use, except that, if within that 60-day 
period, the applicant notifies the Director of such permission and 
submits any additional information under paragraph (1) of this 
subsection not previously contained in the application for interim 
extension, the patent shall be further extended, in accordance with 
the provisions of this section—

(i)for not to exceed 5 years from the date of expiration 
of the original patent term; or

(ii)if the patent is subject to subsection (g)(6)(C), 
from the date on which the product involved receives approval for 
commercial marketing or use.

(F)The rights derived from any patent the term of 
which is extended under this paragraph shall, during the period of 
interim extension—

(i)in the case of a patent which claims a product, 
be limited to any use then under regulatory review;

(ii)in the case of a patent which claims a method of 
using a product, be limited to any use claimed by the patent then 
under regulatory review; and

(iii)in the case of a patent which claims a method of 
manufacturing a product, be limited to the method of manufacturing 
as used to make the product then under regulatory review.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.790. Interim extension of patent term under 35 U.S.C. 156(d)(5).}}
(a)An owner of record of a patent or its agent who reasonably 
expects that the applicable regulatory review period 
described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), 
or (5)(B)(ii) of subsection (g) that began for a product that is the 
subject of such patent may extend beyond the expiration of the 
patent term in effect may submit one or more applications for 
interim extensions for periods of up to one year each. The initial 
application for interim extension must be filed during the period 
beginning 6 months and ending 15 days before the patent term is 
due to expire. Each subsequent application for interim extension 
must be filed during the period beginning 60 days before and ending 
30 days before the expiration of the preceding interim extension. 
In no event will the interim extensions granted under this 
section be longer than the maximum period of extension to 
which 
the applicant would be entitled under 35 
U.S.C. 156(c).

(b)A complete application for interim extension under this 
section shall include all of the information required for a formal 
application under § 1.740 and a complete application under § 1.741. Sections (a)(1), (a)(2), (a)(4), and (a)(6) - (a)(17) of § 1.740 and § 1.741 shall be read in the context of a product currently 
undergoing regulatory review. Sections (a)(3) and (a)(5) of 
§ 1.740 are not applicable to an application for interim extension 
under this section.

(c)The content of each subsequent interim extension application 
may be limited to a request for a subsequent interim extension 
along with a statement that the regulatory review period has 
not been completed along with any materials or information 
required under §§ 1.740 and 1.741 that are not present in the preceding 
interim extension application.
|}


{{Statute|37 CFR 1.791. Termination of interim extension granted prior to regulatory approval of a product for commercial 
marketing or use.}}
Any interim extension granted under 35 U.S.C. 156(d)(5) terminates 
at the end of the 60-day period beginning on the date on 
which the product involved receives permission for commercial 
marketing or use. If within that 60-day period the patent owner or 
its agent files an application for extension under §§ 1.740 and 
1.741 including any additional information required under 
35 U.S.C. 156(d)(1) not contained in the application for interim 
extension, the patent shall be further extended in accordance with 
the provisions of 35 U.S.C. 156.
|}


If a patent that claims a product which is undergoing 
the approval phase of regulatory review as defined 
by 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), 
(4)(B)(ii), and (5)(B)(ii) is expected to expire before 
approval is granted, interim patent term extension is 
available under 35 U.S.C. 156(d)(5). The application 
for patent term extension that must be submitted is 
generally the same as would be filed had the product 
been approved, except that the approval date is not 
required to be set forth. Once the product is approved, 
the application must be converted to an application 
for patent term extension under 35 U.S.C. 156(d)(1) 
to obtain patent term extension under that subsection.

Processing of an application for interim patent term 
extension under 35 U.S.C. 156(d)(5) is performed in 
the Office of Patent Legal Administration and is similar 
to other applications for patent term extension, 
except that the Office is not required to seek the 
advice of the relevant regulatory agency. The relevant 
agency, however, is normally consulted before an 
interim extension is granted or before the application 
is denied. The fee for an application for patent term 
extension under 35 U.S.C. 156(d)(5) is set forth in 37 
CFR 1.20(j)(2), and the fee for a subsequent application 
is set forth in 37 CFR 1.20(j)(3). Copies of an 
application for interim extension are maintained in the 
same manner as applications for patent term extension. 
As required by 35 U.S.C. 156(d)(5)(B), a determination 
that a patent is eligible for extension under 
35 U.S.C. 156, but for regulatory approval, is published 
in the Federal Register.

A series of one-
year interim extensions may be granted if requested in 
a timely manner (in the window of time between 
thirty and sixty days before the extended expiration 
date).

An interim extension granted under 35 U.S.C. 
156(d)(5) terminates sixty days after permission for 
commercial marketing or use of the product is 
granted, except, if within the sixty day period any 
additional information needed for an application for 
patent term extension under 35 U.S.C. 156(d)(1) is 
submitted, the patent may be further extended. 
35 
U.S.C. 156(d)(5)(E).

==2756 Correspondence Between the USPTO and the Regulatory Agency==

It is the Director’s responsibility to decide 
whether an applicant has satisfied the requirements of 
the statute and whether the patent qualifies for patent 
term extension. The regulatory agency possesses 
expertise and records regarding some of the statutory 
requirements and has certain direct responsibilities 
under 35 U.S.C. 156 for determining the length of the 
regulatory review period. Consequently, to facilitate 
eligibility decisions and permit the regulatory agency 
and the Office to carry out their responsibilities under 
35 U.S.C. 156, both the Food and Drug Administration 
and the Department of Agriculture have entered 
into an “agreement” of cooperation with the Office. 
Memorandum of Understanding Between the Patent 
and Trademark Office and the Food and Drug Administration, 
52 Fed. Reg. 17830 (May 12, 1987); Memorandum 
of Understanding Between the Patent 
and 
Trademark Office and the Animal and Plant 
Health Inspection Service, 54 Fed. Reg. 26399 
(June 
23, 1989); 1104 OG 18 (July 11, 1989). The 
agreements establish the procedures whereby the regulatory 
agency assists the Office in determining 
a 
patent’s eligibility for patent term restoration under 
35 U.S.C. 156. It also establishes procedures for 
exchanging information between the regulatory 
agency and the 
Office regarding regulatory review 
period determinations, due diligence petitions and 
informal regulatory agency hearings under the law. 
The patent term extension applicant receives a copy 
of all correspondence between the Office and the regulatory 
agency.

The Animal and Health Inspection Service of the 
Department of Agriculture is responsible for assisting 
the Office in determining the eligibility of patent 
claiming a veterinary biological product that has been 
subject to the Virus-Serum-Toxin Act (21 U.S.C. 151-
59) and for determining the regulatory review period 
of the veterinary biological product. The Secretary of 
Health and Human Services of the Food and Drug 
Administration is responsible for assisting the Office 
in determining the eligibility of patents claiming any 
other product for which regulatory review gives rise 
to eligibility for patent term extension. 21 CFR 60.10.

INFORMATION REGARDING ELIGIBILITY 
FOR EXTENSION

If the Office has no clear reason to deny eligibility 
for patent term extension (even if there are questions 
concerning eligibility), or if the applicant has been 
notified of any informalities and it is anticipated that 
the informalities will be corrected or explained, a first 
letter is sent to the regulatory agency requesting information regarding eligibility. The letter is accompanied 
by a copy of the patent term extension application. 
This letter does not request the determination of the 
applicable regulatory review period.

The regulatory agency reply is usually in the form 
of a written response:

(A)verifying whether the product has undergone 
a regulatory review period within the meaning of 
35 
U.S.C. 156(g) prior to commercial marketing or 
use; 

(B)stating whether the marketing permission was 
for the first permitted commercial marketing or use of 
that product, or, in the case of recombinant DNA technology, 
whether such commercial marketing or use 
was the first permitted under the process claimed in 
the patent; 

(C)informing the Office whether the patent term 
extension application was submitted within sixty days 
after the product was approved for marketing or use; 
and 

(D)providing the Office with any other information 
relevant to the Office determination of whether a 
patent related to a product is eligible for patent term 
extension.

While the Office has primary responsibility for the 
eligibility determination, the regulatory agency often 
possesses information which is not readily available 
to the Office. The assistance on the part of the regulatory 
agency enables both the Office and the agency to 
process applications efficiently and to conserve 
resources. 

PRELIMINARY ELIGIBILITY DECISION

Upon receipt of a reply from the regulatory agency 
to the first letter from the Office requesting assistance 
on determining eligibility, a preliminary eligibility 
decision (not the final decision) is made as to whether 
the patent is eligible for an extension of its term. As 
noted above, the reply from the regulatory agency will 
usually inform the Office as to whether the permission 
for commercial marketing and use of the product on 
which the application for patent term extension is 
based is the first such approval for that product. Furthermore, 
the regulatory agency usually provides 
information regarding the date of product approval to 
permit a determination as to whether the application 
was filed within the sixty-day statutory period. The 
information provided by the regulatory agency is 
then 
compared with the related information from the 
application. If no major discrepancies are found and 
the patent is determined to be eligible for patent term 
extension, a second letter requesting a determination 
of the length of the regulatory review period of the 
product is mailed to the regulatory agency not later 
than sixty (60) days after the Office receipt date of the 
reply from the regulatory agency. In the interest of 
efficiency, if the patent is determined to be ineligible 
for patent term extension, the Office will dismiss the 
application rather than request a determination of the 
regulatory review period. In re Allen & Hansbury, 
Ltd., 227 USPQ 955, 960 n. 9 (Comm’r Pat. & Tm. 
1985). A certified copy of the application for patent 
term extension is sent to the regulatory agency along 
with the second letter. The second letter states that, 
subject to final review, the patent is considered eligible 
for patent term extension and requests a determination 
of the applicable regulatory review period.

==2757 Regulatory Agency Determination of the Length of the Regulatory Review Period==

Under 35 U.S.C. 156, the regulatory agency is 
responsible for the determination of the length of the 
regulatory review period for the approved product on 
which the application for patent term extension is 
based. The determination by the regulatory agency is 
made based on the application as well as the official 
regulatory agency records for the approved product. 
See, e.g., 21 CFR Ch. 1, Subpart C. The determination 
of the length of the regulatory review period is solely 
the responsibility of the regulatory agency. Aktiebolaget 
Astra v. Lehman, 71 F.3d 1578, 1580-81, 
37 
USPQ2d 1212, 1214-15 (Fed. Cir. 1995); U.S. 
Patent No. 4,215,113.

Once the determination has been made, the regulatory 
agency publishes the information in the Federal 
Register and forwards a letter to the Office with the 
same information. Included in both the Federal Register 
Notice and the letter to the Office are the total 
length of the regulatory review period and the relevant 
dates on which the determination is based. Both 
the letter to the Office and the Federal Register Notice 
separate the total regulatory period into the initial or 
testing phase and the final approval phase. This provides 
the Office with the information necessary to 
determine the actual length of extension for which the 
patent may be eligible. The Federal Register Notice 
also sets a date, 180 days after publication of the 
notice, as a deadline for filing written comments concerning 
any of the information set forth in the notice 
or a petition for a determination regarding whether the 
marketing applicant has acted with due diligence during 
the regulatory review period. The letter to the 
Office makes clear that the determination does not 
take into account the issue date of the patent nor does 
it exclude one-half of the testing phase.

The regulatory review period determination is not 
final until due diligence petitions and informal hearings, 
if any, have been resolved. A certificate for 
extension of the term of a patent may not issue from 
the Office until the regulatory review period determination 
is final unless an interim extension appears 
warranted under 35 U.S.C. 156(d)(5) and (e)(2). 

===2757.01 Due Diligence Determination===

If a due diligence petition is filed during the 180-
day period following publication of the regulatory 
agency determination of the regulatory review period, 
the regulatory agency (e.g., FDA) makes the determination 
under 35 U.S.C. 156(d)(2)(B) whether the 
applicant for patent term extension acted with due diligence 
during the regulatory review proceedings. The 
term “due diligence” is defined in 35 U.S.C. 156(d)(3)
as “that degree of attention, continuous directed 
effort, and timeliness as may reasonably be expected 
from, and are ordinarily exercised by, a person during 
a regulatory review period.” After affirming or revising 
the determination of the regulatory review period, 
the regulatory agency notifies the Office and publishes 
the results in the Federal Register. If no comment 
or petition is filed in the time period provided, 
the regulatory agency notifies the Office that the 
period for filing a due diligence petition pursuant to 
the notice has expired and that the regulatory agency 
therefore considers its determination of the regulatory 
review period for the product to be final. Following 
notification from the regulatory agency, the Office 
proceeds with the final eligibility determination. See 
21 CFR Ch. 1, Subparts D and E.

==2758 Notice of Final Determination - Calculation of Patent Term Extension==

{{Statute|35 U.S.C. 156. Extension of patent term.}}
{{Ellipsis}}
(c)The term of a patent eligible for extension under subsection 
(a) shall be extended by the time equal to the regulatory 
review period for the approved product which period occurs after 
the date the patent is issued, except that—

(1)each period of the regulatory review period shall be 
reduced by any period determined under subsection (d)(2)(B) during 
which the applicant for the patent extension did not act with 
due diligence during such period of the regulatory review period;

(2)after any reduction required by paragraph (1), the 
period of extension shall include only one-half of the time remaining 
in the periods described in paragraphs (1)(B)(i), (2)(B)(i), 
(3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g);

(3)if the period remaining in the term of a patent after the 
date of the approval of the approved product under the provision 
of law under which such regulatory review occurred when added 
to the regulatory review period as revised under paragraphs (1) 
and (2) exceeds fourteen years, the period of extension shall be 
reduced so that the total of both such periods does not exceed 
fourteen years, and

(4)in no event shall more than one patent be extended 
under subsection (e)(i) for the same regulatory review period for 
any product.
{{Ellipsis}}
(6)A period determined under any of the preceding paragraphs 
is subject to the following limitations:

(A)If the patent involved was issued after the date of 
the enactment of this section, the period of extension determined 
on the basis of the regulatory review period determined under any 
such paragraph may not exceed five years.

(B)If the patent involved was issued before the date of 
the enactment of this section and —

(i)no request for an exemption described in paragraph 
(1)(B) or (4)(B) was submitted and no request for the 
authority described in paragraph (5)(B) was submitted,

(ii)no major health or environment effects test 
described in paragraph (2)(B) or (4)(B) was initiated and no petition 
for a regulation or application for registration described in 
such paragraph was submitted, or

(iii)no clinical investigation described in paragraph 
(3) was begun or product development protocol described in such 
paragraph was submitted, before such date for the approved product 
the period of extension determined on the basis of the regulatory 
review period determined under any such paragraph may not 
exceed five years.

(C)If the patent involved was issued before the date of 
the enactment of this section and if an action described in subparagraph 
(B) was taken before the date of enactment of this section 
with respect to the approved product and the commercial marketing 
or use of the product has not been approved before such date, 
the period of extension determined on the basis of the regulatory 
review period determined under such paragraph may not exceed 
two years or in the case of an approved product which is a new 
animal drug or veterinary biological product (as those terms are 
used in the Federal Food, Drug, and Cosmetic Act or the Virus-
Serum-Toxin Act), three years.
{{Ellipsis}}
|}


After reviewing the information provided by the 
regulatory agency, if the Office determines the patent 
to be eligible for extension, the calculation is made of 
the length of extension for which the patent is eligible 
under the appropriate statutory provisions (35 U.S.C. 
156(c); 37 CFR 1.750). The length of extension is 
subject to the limitations of 35 U.S.C. 156(c)(3) and 
35 U.S.C. 156(g)(6). A Notice of Final Determination 
is mailed to applicant which states the length of extension 
for which the application has been determined to 
be eligible and the calculations used to determine the 
length of extension. Recently mailed Notices of Final 
Determination are posted in the Freedom of Information 
(FOIA) section of the USPTO web site 
(www.uspto.gov) with other Decisions of the 
Director. The notice provides a period, usually 
one month, in which the applicant can request reconsideration 
of any aspect of the Office determination as 
to eligibility or the length of extension for which the 
application has been found eligible.

If the application has been determined to be ineligible 
for patent term extension, an appropriate Notice of 
Final Determination is mailed to applicant which 
denies the application and sets forth the basis for the 
denial. The applicant is given a period, usually one 
month, in which to seek reconsideration of the determination.

See MPEP § 2759 for further information pertaining 
to the issuance of a certificate of extension. 

A patent term extension generally extends the 
patent from its “original expiration date,” as defined 
by 35 U.S.C. 154 to include extension under 
35 
U.S.C. 154(b). Patents “in force on June 8, 
1995 
only because of a Hatch-Waxman extension are 
not entitled to re-apply a restoration extension to a 20-
year from filing term.” Merck & Co. v. Kessler, 
80 
F.3d 1543, 1553, 38 USPQ2d 1347, 1354 (Fed. 
Cir. 1996). However, if the patent received an interim 
extension under 35 U.S.C. 156(d)(5) and the patent is 
eligible for either a two- or a three-year extension, the 
extension would run from the approval date of the 
product, not the original expiration date of the patent. 
See 35 
U.S.C. 156(d)(5)(E)(ii).

No certificate or extension will be issued if the term 
of a patent cannot be extended, even though the patent 
is otherwise determined to be eligible for extension. 
In such situations the final determination would issue 
indicating that no certificate will issue.

CALCULATION OF PATENT TERM EXTENSION

The procedure for calculating the length of the 
patent term extension is set forth for human drugs, 
antibiotic drugs, and human biological products in 
37 
FR 1.775; for food or color additives in 37 CFR 
1.776; for medical devices in 37 CFR 1.777; for animal 
drug products in 37 CFR 1.778; and for veterinary 
biological products in 37 CFR 1.779. The length 
of patent term extension is the length of the regulatory 
review period as determined by the Secretary of 
Health and Human Services or the Secretary of Agriculture, 
but reduced, where appropriate, by the time 
periods provided in 37 CFR 1.775 - 1.779. The Office 
will rely on the Secretary’s determination of the 
length of the regulatory review period when calculating 
the length of the extension period under 37 CFR 
1.775 - 1.779.

Any part of the regulatory review period which 
occurs before the patent was granted will not be 
counted toward patent term extension. Any period in 
which the marketing applicant failed to exercise due 
diligence, thereby unnecessarily adding to the length 
of the regulatory review period after the patent issued, 
will not be considered in determining the length of the 
extension period. In making the calculation of the 
extension period, half days will be ignored and thus 
will not be subtracted from the regulatory review 
period.

For products other than animal drug or veterinary 
biological products, the calculated extension period 
cannot exceed any of the following statutory maximum 
periods of extension:

(A)If the period remaining in the term of the 
patent after the date of approval of the approved product 
when added to the calculated regulatory review 
period exceeds fourteen years, the period of extension 
shall be reduced so that the total of both such periods 
does not exceed fourteen years;

(B)If the patent involved was issued after September 
24, 1984, (the date of enactment of the statute), 
the calculated period of extension may not 
exceed five years;

(C)If the patent involved was issued before September 
24, 1984, (the date of enactment of the statute), 
and the regulatory review period proceeding 
started after this date, the calculated period of extension 
may not exceed five years; and 

(D)If the patent involved was issued before September 
24, 1984, (the date of enactment of the statute), 
and the regulatory review period proceeding 
started before this date, and the commercial marketing 
or use of the product has been approved after such 
date, the calculated period of extension may not 
exceed two years.

For animal drug or veterinary biological products, 
the calculated extension period cannot exceed any of 
the following statutory maximum periods of extension:

(A)If the period remaining in the term of 
the 
patent after the date of approval of the approved 
product when added to the calculated regulatory 
review period exceeds fourteen years, the period of 
extension shall be reduced so that the total of both 
such periods does not exceed fourteen years;

(B)If the patent involved was issued afterNovember 16, 1988, the calculated period of extension 
may not exceed five years;

(C)If the patent involved was issued beforeNovember 16, 1988, and the regulatory review period 
proceeding started after this date, the calculated 
period of extension may not exceed five years; and

(D)If the patent involved was issued beforeNovember 16, 1988, and the regulatory review period 
proceeding started before this date, and the commercial 
marketing or use of the product has been 
approved after such date, the calculated period of 
extension may not exceed three years.

The patent term extension of a patent that issued 
before September 24, 1984, where the regulatory 
review period began and ended before September 24, 
1984, would only be a function of the regulatory 
review period and the fourteen-year limit, and may be 
extended for more than five years. Hoechst Aktiengesellschaft 
v. Quigg, 916 F2d 522, 525, 16 USPQ2d 
1549, 1551 (Fed. Cir. 1990).

==2759 Certificate of Extension of Patent Term==

{{Statute|35 U.S.C. 156. Extension of patent term.}}
{{Ellipsis}}
(e)(1) A determination that a patent is eligible for extension 
may be made by the Director solely on the basis of the representations 
contained in the application for the extension. If the Director 
determines that a patent is eligible for extension under subsection 
(a) and that the requirements of paragraphs (1) through (4) of subsection 
(d) have been complied with, the Director shall issue to 
the applicant for the extension of the term of the patent a certificate 
of extension, under seal, for the period prescribed by subsection 
(c). Such certificate shall be recorded in the official file of the 
patent and shall be considered as part of the original patent.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.780. Certificate or order of extension of patent term.}}
If a determination is made pursuant to § 1.750 that a patent is 
eligible for extension and that the term of the patent is to be 
extended, a certificate of extension, under seal, or an order granting 
interim extension under 35 U.S.C. 156(d)(5), will be issued to 
the applicant for the extension of the patent term. Such certificate 
or order will be recorded in the official file of the patent and will 
be considered as part of the original patent. Notification of the 
issuance of the certificate or order of extension will be published 
in the Official Gazette of the United States Patent and Trademark 
Office. Notification of the issuance of the order granting an 
interim extension under 35 U.S.C. 156(d)(5), including the identity 
of the product currently under regulatory review, will be published 
in the Official Gazette of the United States Patent and 
Trademark Office and in the Federal Register. No certificate of, 
or order granting, an extension will be issued if the term of the 
patent cannot be extended, even though the patent is otherwise 
determined to be eligible for extension. In such situations, the 
final determination made pursuant to § 1.750 will indicate that no 
certificate or order will issue.
|}


Once a determination is made pursuant to 37 CFR 
1.750 that a patent is eligible for extension of its term, 
a certificate of extension, under seal, will be issued to 
the patent owner at the correspondence address specified 
in the application for patent term extension. Following 
the one-month period provided in the Notice 
of Final Determination, and where an extension is 
appropriate, the Certificate of Extension is signed by 
the Director. The original certificate is mailed or 
delivered to the applicant and a copy is sent to the regulatory 
agency. A copy of the certificate is placed in 
the two files (official file/patent file and public file) 
maintained for the patent term extension application.

Upon issuance of the certificate of extension, a 
notice is published in the Official Gazette.

All original papers from the application for patent 
term extension in the official file are transferred to the 
official patent file of the subject patent and become a 
part of the permanent record. A copy of the certificate 
of extension of patent term is added to the patent electronic 
database as part of the patent record in the 
same 
manner as is a certificate of correction or a terminal 
disclaimer. The patent is also added to the list of 
patents extended under 35 U.S.C. 156, a copy 
of 
which is posted on the USPTO web site 
(www.uspto.gov) and which is also available in the 
Reading Room of the Public Search Room and from 
the Office of Patent Legal Administration. The public 
file for the application for patent term extension is 
stored in the Office of Patent Legal Administration.

==2760 Trade Secret, Confidential, and Protective Order Material==

There is no provision in the statute or the rules for 
withholding from the public any information that is 
submitted to the Office or the regulatory agency relating 
to an application for patent term extension. While 
one submitting such materials to the Office in relation 
to a pending application for patent term extension 
must generally assume that such materials will be 
made of record in the file and be made public, the 
Office is not unmindful of the difficulties this sometimes 
imposes. Proprietary or trade secret information 
should be submitted generally in accordance with the 
procedures set forth in MPEP § 724.02. Identification 
of the propriety or trade secret material should be 
made by page, line, and word, as necessary. The 
Office will not in the first instance undertake the task 
of determining the precise material in the application 
which is proprietary or trade secret information. Only 
the applicant is in a position to make this determination. 
See In re Schering-Plough Corp., 1 USPQ2d 
1926, 1926 (Comm’r Pat. & Tm. 1986).

The information will not be made public as part of 
the patent file before a certificate of patent extension 
is issued. Should the Office receive a Freedom of 
Information Act (FOIA) request for the material, the 
applicant will be provided notice and an opportunity 
to substantiate its claim that the material is proprietary 
before the Office determines whether disclosure of the 
material is required under the FOIA. If such information 
was material to a determination of eligibility or 
any other Office responsibility under 35 U.S.C. 156, it 
will be made public at the time the certificate of 
extension is issued. Otherwise, if a suitable petition to 
expunge is filed before the issuance of the certificate, 
the trade secret or confidential information will be 
expunged from the file and returned to the patent term 
extension applicant. If a petition to expunge is not 
filed prior to the issuance of the certificate, all of the 
information will be open to public inspection.

==2761 Multiple Applications for Extension of Term of the Same Patent or of Different Patents for the Same Regulatory Review Period for a Product==

{{Statute|35 U.S.C. 156. Extension of patent term.}}
{{Ellipsis}}
(c)(4) in no event shall more than one patent be extended 
under subsection (e)(i) for the same regulatory review period for 
any product.
{{Ellipsis}}
|}


{{Statute|37 CFR 1.785. Multiple applications for extension of term of the same patent or of different patents for the same regulatory review period for a product.}}
(a)Only one patent may be extended for a regulatory review 
period for any product § 1.720 (h). If more than one application 
for extension of the same patent is filed, the certificate of extension 
of patent term, if appropriate, will be issued based upon the 
first filed application for extension.

(b)If more than one application for extension is filed by a 
single applicant which seeks the extension of the term of two or 
more patents based upon the same regulatory review period, and 
the patents are otherwise eligible for extension pursuant to the 
requirements of this subpart, in the absence of an election by the 
applicant, the certificate of extension of patent term, if appropriate, 
will be issued upon the application for extension of the patent 
term having the earliest date of issuance of those patents for which 
extension is sought.

(c)If an application for extension is filed which seeks the 
extension of the term of a patent based upon the same regulatory 
review period as that relied upon in one or more applications for 
extension pursuant to the requirements of this subpart, the certificate 
of extension of patent term will be issued on the application 
only if the patent owner or its agent is the holder of the regulatory 
approval granted with respect to the regulatory review period.

(d)An application for extension shall be considered complete 
and formal regardless of whether it contains the identification 
of the holder of the regulatory approval granted with respect 
to the regulatory review period. When an application contains 
such information, or is amended to contain such information, it 
will be considered in determining whether an application is eligible 
for an extension under this section. A request may be made of 
any applicant to supply such information within a non-extendable 
period of not less than one month whenever multiple applications 
for extension of more than one patent are received and rely upon 
the same regulatory review period. Failure to provide such information 
within the period for reply set shall be regarded as conclusively 
establishing that the applicant is not the holder of the 
regulatory approval.

(e)Determinations made under this section shall be included 
in the notice of final determination of eligibility for extension of 
the patent term pursuant to § 1.750 and shall be regarded as part of 
that determination.
|}


Only one patent may be extended for a regulatory 
review period for any product. If more than one application 
for extension is filed for a single patent by different 
applicants, the certificate of extension of the 
term of the patent, if appropriate, would be issued 
based upon the first filed application for extension of 
patent term. If a single applicant files more than one 
application for patent term extension for a single 
patent based upon the regulatory review period of different 
products, then the final determination under 
37 CFR 1.750 will provide a period of time (usually 
one month) for the patent owner to elect the product 
for which extension is desired. An express withdrawal 
of the applications for extension of the nonelected 
products should accompany the election. The final 
determination will indicate that if the patent owner 
fails to elect a single product within the set time 
period, the Office will issue a certificate of extension 
for the patent for a specified one of the products.

If more than one application for extension is filed 
by a single applicant for the extension of the terms of 
different patents based upon the same regulatory 
review period for a product, the certificate of extension 
will be issued on the application for extension of 
the patent having the earliest date of issuance of those 
for which extension is sought unless all but one application 
for extension is voluntarily withdrawn by the 
applicant. When plural patents are found to be eligible 
for patent term extension based on the same regulatory 
review of a product, the final determination under 
37 CFR 1.750 will provide a period of time (usually 
one month) for the patent owner to elect the patent for 
which extension is desired. An express withdrawal of 
the application(s) for extension of the nonelected 
patent(s) should accompany the election. A failure to 
elect within the set time period will result in issuance 
of a certificate of extension for the patent having the 
earliest date of issue.

If applications for extension are filed by different 
applicants for the extension of the terms of different 
patents based upon the same regulatory review period 
of a product, the certificate of extension will be issued 
on the application of the holder of the regulatory 
approval (marketing applicant). If the marketing 
applicant is not an applicant for extension, the certificate 
of extension will issue to the applicant for extension 
which holds an express authorization from the 
marketing applicant to rely upon the regulatory 
review period as the basis for the application for 
extension. See also 37 CFR 1.785(d).

==2762 Duty of Disclosure in Patent Term Extension Proceedings==

{{Statute|37 CFR 1.765. Duty of disclosure in patent term extension proceedings.}}
(a)A duty of candor and good faith toward the Patent and 
Trademark Office and the Secretary of Health and Human Services 
or the Secretary of Agriculture rests on the patent owner or 
its agent, on each attorney or agent who represents the patent 
owner and on every other individual who is substantively 
involved on behalf of the patent owner in a patent term extension 
proceeding. All such individuals who are aware, or become aware, 
of material information adverse to a determination of entitlement 
to the extension sought, which has not been previously made of 
record in the patent term extension proceeding must bring such 
information to the attention of the Office or the Secretary, as 
appropriate, in accordance with paragraph (b) of this section, as 
soon as it is practical to do so after the individual becomes aware 
of the information. Information is material where there is a substantial 
likelihood that the Office or the Secretary would consider 
it important in determinations to be made in the patent term extension 
proceeding.

(b)Disclosures pursuant to this section must be accompanied 
by a copy of each written document which is being disclosed. 
The disclosure must be made to the Office or the Secretary, as 
appropriate, unless the disclosure is material to determinations to 
be made by both the Office and the Secretary, in which case duplicate 
copies, certified as such, must be filed in the Office and with 
the Secretary. Disclosures pursuant to this section may be made to 
the Office or the Secretary, as appropriate, through an attorney or 
agent having responsibility on behalf of the patent owner or its 
agent for the patent term extension proceeding or through a patent 
owner acting on his or her own behalf. Disclosure to such an attorney, 
agent or patent owner shall satisfy the duty of any other individual. 
Such an attorney, agent or patent owner has no duty to 
transmit information which is not material to the determination of 
entitlement to the extension sought.

(c)No patent will be determined eligible for extension and 
no extension will be issued if it is determined that fraud on the 
Office or the Secretary was practiced or attempted or the duty of 
disclosure was violated through bad faith or gross negligence in 
connection with the patent term extension proceeding. If it is 
established by clear and convincing evidence that any fraud was 
practiced or attempted on the Office or the Secretary in connection 
with the patent term extension proceeding or that there was 
any violation of the duty of disclosure through bad faith or gross 
negligence in connection with the patent term extension proceeding, 
a final determination will be made pursuant to § 1.750 that the 
patent is not eligible for extension.
{{Ellipsis}}
|}


A duty of candor and good faith toward the 
USPTO, the Secretary of Health and Human Services, 
and the Secretary of Agriculture rests on the patent 
owner or its agent, on each attorney or agent who represents 
the patent owner, and on every other individual 
who is substantively involved on behalf of the 
patent owner in a patent term extension proceeding. 
All such individuals who are aware, or become aware, 
of material information adverse to a determination of 
entitlement to the extension sought, which has not 
been previously made of record in the patent term 
extension proceeding, must bring such information to 
the attention of the Office or the Secretary, as appropriate, 
as soon as it is practicable to do so after the 
individual becomes aware of the information. Information 
is “material” when there is a substantial likelihood 
that the Office or the Secretary would consider it 
important in determinations to be made in the patent 
term extension proceeding. Any such material information 
should be submitted to the Director of the 
United States Patent and Trademark Office, the Secretary 
of Health and Human Services, or the Secretary 
of Agriculture, as appropriate, accompanied by a copy 
of each written document being disclosed. The information 
may be submitted through a patent attorney or 
agent.

A determination of eligibility for an extension or 
the issuance of a certificate will not be made if clear 
and convincing evidence of fraud or attempted fraud 
on the Office or a Secretary is determined to be 
present, or the duty of disclosure is determined to 
have been violated through bad faith or gross negligence 
in connection with the patent term extension 
proceeding. Since the determination as to whether a 
patent is eligible for extension may be made solely on 
the basis of the representations made in the application 
for extension, a final determination to refuse a 
patent term extension because of fraud or a violation 
of the duty of disclosure is expected to be rare. See 
MPEP § 2010.

==2763 Limitation of Third Party Participation==

{{Statute|37 CFR 1.765. Duty of disclosure in patent term extension proceedings.}}
{{Ellipsis}}
(d)The duty of disclosure pursuant to this section rests on 
the individuals identified in paragraph (a) of this section and no 
submission on behalf of third parties, in the form of protests or 
otherwise, will be considered by the Office. Any such submissions 
by third parties to the Office will be returned to the party 
making the submission, or otherwise disposed of, without consideration 
by the Office.
{{Ellipsis}}
|}


Although the statute specifically provides for public 
input into the determination of the regulatory 
review period, i.e., the filing of a due diligence petition 
before the regulatory agency, no such provision 
was made for proceedings before the Office. Since 
applicant already has a duty of disclosure to both the 
Office and the regulatory agency, and Congress 
expected that it would be an administratively simple 
proceeding, no input from third parties is permitted. 
Absent an invitation from the Director, any such 
submission would be inappropriate. Accordingly, 37 
CFR 1.765(d) precludes submissions to the Office by 
or on behalf of third parties, thereby making patent 
term extension proceedings in the Office an ex partematter between the patent owner or its agent and 
the Office. Submissions by third parties not requested by 
the Office will be returned, or otherwise disposed of, 
without consideration. See In re Dubno, 12 USPQ2d 1153, 1154 (Comm’r Pat. & Tm. 1989).

==2764 Express Withdrawal of Application for Extension of Patent Term==

{{Statute|37 CFR 1.770. Express withdrawal of application for extension of patent term.}}
An application for extension of patent term may be expressly 
withdrawn before a determination is made pursuant to § 1.750 by 
filing in the Office, in duplicate, a written declaration of withdrawal 
signed by the owner of record of the patent or its agent. An 
application may not be expressly withdrawn after the date permitted 
for reply to the final determination on the application. An 
express withdrawal pursuant to this section is effective when 
acknowledged in writing by the Office. The filing of an express 
withdrawal pursuant to this section and its acceptance by the 
Office does not entitle applicant to a refund of the filing fee 
(§ 1.20(j)) or any portion thereof.
|}


Any request for withdrawal of an application for 
extension of patent term after a determination has 
been made pursuant to 37 CFR 1.750 must be submitted 
on or before the date permitted for reply to the 
final determination, and be accompanied by a petition 
under 37 CFR 1.182 with the appropriate petition filing 
fee.

{{MPEP Chapter|2600|}}