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2701 Patent Term [R-2] | |||
35 U.S.C. 154. Contents and term of patent; provisional | |||
rights. | |||
(a)IN GENERAL.— | |||
(2)TERM.—Subject to the payment of fees under this | (2)TERM.—Subject to the payment of fees under this | ||
title, such grant shall be for a term beginning on the date on which | title, such grant shall be for a term beginning on the date on which | ||
Line 21: | Line 19: | ||
365(b) of this title shall not be taken into account in determining | 365(b) of this title shall not be taken into account in determining | ||
the term of a patent. | the term of a patent. | ||
(c)CONTINUATION.— | (c)CONTINUATION.— | ||
Line 45: | Line 45: | ||
brought under chapter 28 and chapter 29 (other than those provisions | brought under chapter 28 and chapter 29 (other than those provisions | ||
excluded by paragraph (2)) of this title. | excluded by paragraph (2)) of this title. | ||
Line 63: | Line 62: | ||
filed application or applications under 35 U.S.C. 120, | filed application or applications under 35 U.S.C. 120, | ||
121, or 365(c), twenty years from the filing date of the | 121, or 365(c), twenty years from the filing date of the | ||
earliest of such application(s). This patent term provision | earliest of such application(s). This patent term provision | ||
is referred to as the “twenty-year term.” Design | is referred to as the “twenty-year term.” Design | ||
patents have a term of fourteen years from the date of | patents have a term of fourteen years from the date of | ||
patent grant. See 35 U.S.C 173 and MPEP § 1505. | patent grant. See 35 U.S.C 173 and MPEP § | ||
1505. | |||
All patents (other than design patents) that were in | All patents (other than design patents) that were in | ||
Line 124: | Line 131: | ||
more U.S. provisional applications is not considered | more U.S. provisional applications is not considered | ||
in the calculation of the twenty-year term. See | in the calculation of the twenty-year term. See | ||
35 U.S.C. 154(a)(3). | 35 | ||
U.S.C. 154(a)(3). | |||
EXPIRATION DATE OF PATENTS WITH | EXPIRATION DATE OF PATENTS WITH | ||
Line 167: | Line 175: | ||
the expiration date is the date specified. Several decisions | the expiration date is the date specified. Several decisions | ||
related to disclaimers are posted in the Freedom | related to disclaimers are posted in the Freedom | ||
of Information Act (FOIA) section of the USPTO | of Information Act (FOIA) section of the USPTO | ||
Internet site (www.uspto.gov). | Internet site (www.uspto.gov). | ||
PATENT TERM EXTENSIONS OR ADJUSTMENTS | PATENT TERM EXTENSIONS OR ADJUSTMENTS | ||
See MPEP § 2710, et seq., for patent term extensions | See MPEP § 2710, et seq., for patent term extensions | ||
Line 193: | Line 208: | ||
may be extended under 35 U.S.C. 156. | may be extended under 35 U.S.C. 156. | ||
2710Term Extensions or Adjustments | |||
for Delays Within the USPTO | |||
Under 35 U.S.C. 154 [R-2] | |||
Utility and plant patents issuing on applications | Utility and plant patents issuing on applications | ||
Line 203: | Line 220: | ||
are eligible for the patent term adjustment provisions | are eligible for the patent term adjustment provisions | ||
of 35 U.S.C. 154(b)(amended, effective May 29, | of 35 U.S.C. 154(b)(amended, effective May 29, | ||
2000) and 37 CFR 1.702-1.705. See MPEP § 2730. | 2000) and 37 CFR 1.702-1.705. See MPEP § | ||
2730. | |||
Plant and utility patents issuing on applications | Plant and utility patents issuing on applications | ||
Line 217: | Line 236: | ||
no patent term adjustment provisions for design patents. | no patent term adjustment provisions for design patents. | ||
2720Applications Filed Between June 8, | |||
1995, and May 28, 2000 [R-2] | |||
Former 35 U.S.C. 154. Contents and term of patent. | |||
(b)TERM EXTENSION.— | (b)TERM EXTENSION.— | ||
Line 261: | Line 284: | ||
all extensions of a patent under this subsection shall not exceed | all extensions of a patent under this subsection shall not exceed | ||
5 years. | 5 years. | ||
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 | (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 | filed on or after June 8, 1995, is entitled to extension of the patent | ||
Line 281: | Line 307: | ||
reversing an adverse determination of patentability and if the | reversing an adverse determination of patentability and if the | ||
patent is not subject to a terminal disclaimer due to the issuance of | patent is not subject to a terminal disclaimer due to the issuance of | ||
another patent claiming subject matter that is not patentably distinct | another patent claiming subject matter that is not patentably distinct | ||
from that under appellate review. If an application is | from that under appellate review. If an application is | ||
Line 344: | Line 376: | ||
(iv)The number of days, if any, in the period beginning | (iv)The number of days, if any, in the period beginning | ||
on the date of notification under § 5.3(c) and ending on the | on the date of notification under § | ||
5.3(c) and ending on the | |||
date of mailing of the notice of allowance under § 1.311. | date of mailing of the notice of allowance under § 1.311. | ||
Line 363: | Line 397: | ||
occurred before three years from the filing of the first national | occurred before three years from the filing of the first national | ||
application for patent presented for examination; and | application for patent presented for examination; and | ||
(2)Any time during the period of appellate review, as | (2)Any time during the period of appellate review, as | ||
Line 376: | Line 412: | ||
except for design patents, issued on applications filed on or | except for design patents, issued on applications filed on or | ||
after June 8, 1995, and before May 29, 2000. | after June 8, 1995, and before May 29, 2000. | ||
The twenty-year term of a patent issuing from an | The twenty-year term of a patent issuing from an | ||
Line 406: | Line 440: | ||
above, continue to apply to applications filed between | above, continue to apply to applications filed between | ||
and including June 8, 1995 and May 28, 2000. | and including June 8, 1995 and May 28, 2000. | ||
Examiners make no decisions regarding patent term | Examiners make no decisions regarding patent term | ||
Line 420: | Line 459: | ||
If applicant disagrees with the patent term extension | If applicant disagrees with the patent term extension | ||
information printed on the Notice of Allowance | information printed on the Notice of Allowance | ||
and Fee(s) Due, applicant may request | and Fee(s) Due, applicant may request | ||
review by way of a petition under 37 CFR 1.181. To | review by way of a petition under 37 CFR 1.181. To | ||
Line 453: | Line 492: | ||
Virginia 22313-1450. | Virginia 22313-1450. | ||
2730Applications Filed on or After May | |||
29, 2000; Grounds for Adjustment | |||
[R-2] | |||
35 U.S.C. 154. Contents and term of patent; provisional | |||
rights. | |||
(b)ADJUSTMENT OF PATENT TERM.— | (b)ADJUSTMENT OF PATENT TERM.— | ||
Line 519: | Line 563: | ||
(C)GUARANTEE OR ADJUSTMENTS FOR | (C)GUARANTEE OR ADJUSTMENTS FOR | ||
DELAYS DUE TO INTERFERENCES, SECRECY ORDERS, | DELAYS DUE TO INTERFERENCES, SECRECY ORDERS, | ||
AND APPEALS.— Subject to the limitations under paragraph | AND APPEALS.— Subject to the limitations under paragraph | ||
Line 548: | Line 597: | ||
(C)REDUCTION OF PERIOD OF ADJUSTMENT.— | (C)REDUCTION OF PERIOD OF ADJUSTMENT.— | ||
(i)The period of adjustment of the term of a patent | (i)The period of adjustment of the term of a patent | ||
Line 562: | Line 612: | ||
objection, argument, or other request, measuring such 3-month | objection, argument, or other request, measuring such 3-month | ||
period from the date the notice was given or mailed to the applicant. | period from the date the notice was given or mailed to the applicant. | ||
(iii)The Director shall prescribe regulations establishing | (iii)The Director shall prescribe regulations establishing | ||
Line 617: | Line 668: | ||
under this subsection shall not be subject to appeal or challenge by | under this subsection shall not be subject to appeal or challenge by | ||
a third party prior to the grant of the patent. | a third party prior to the grant of the patent. | ||
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 | (a)Failure to take certain actions within specified time | ||
frames. Subject to the provisions of 35 | frames. Subject to the provisions of 35 | ||
Line 660: | Line 714: | ||
the national stage commenced under 35 U.S.C. 371(b) or (f) in an | the national stage commenced under 35 U.S.C. 371(b) or (f) in an | ||
international application, but not including: | international application, but not including: | ||
(1)Any time consumed by continued examination of the | (1)Any time consumed by continued examination of the | ||
Line 685: | Line 744: | ||
patent shall be adjusted if the issuance of the patent was delayed | patent shall be adjusted if the issuance of the patent was delayed | ||
due to the application being placed under a secrecy order under | due to the application being placed under a secrecy order under | ||
35 U.S.C. 181. | 35 | ||
U.S.C. 181. | |||
(e)Delays caused by successful appellate review. Subject | (e)Delays caused by successful appellate review. Subject | ||
Line 714: | Line 774: | ||
design patent, filed on or after May 29, 2000, and patents issued | design patent, filed on or after May 29, 2000, and patents issued | ||
on such applications. | on such applications. | ||
35 U.S.C. 154(b), as amended effective May 29, | 35 U.S.C. 154(b), as amended effective May 29, | ||
Line 779: | Line 837: | ||
on or after May 29, 2000, and before July 14, 2003, | on or after May 29, 2000, and before July 14, 2003, | ||
is entitled to the benefits of the patent term adjustment | 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 | 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 | (RCE) filed under 35 U.S.C. 132(b) and 37 CFR | ||
Line 788: | Line 852: | ||
and 37 CFR 1.702 through 1.705. | and 37 CFR 1.702 through 1.705. | ||
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 | (a)The period of adjustment under § 1.702(a) is the sum of | ||
the following periods: | the following periods: | ||
Line 849: | Line 915: | ||
date the patent was issued; | date the patent was issued; | ||
(2) | (2)(i) The number of days, if any, in the period beginning | ||
(i) The number of days, if any, in the period beginning | |||
on the date an interference was declared or redeclared to involve | on the date an interference was declared or redeclared to involve | ||
the application in the interference and ending on the date that the | the application in the interference and ending on the date that the | ||
Line 895: | Line 959: | ||
(c)The period of adjustment under § 1.702(c) is the sum of | (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: | the following periods, to the extent that the periods are not overlapping: | ||
(1)The number of days, if any, in the period beginning on | (1)The number of days, if any, in the period beginning on | ||
Line 909: | Line 974: | ||
(d)The period of adjustment under § 1.702(d) is the sum of | (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: | the following periods, to the extent that the periods are not overlapping: | ||
(1)The number of days, if any, the application was maintained | (1)The number of days, if any, the application was maintained | ||
Line 916: | Line 982: | ||
(2)The number of days, if any, in the period beginning on | (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 | 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 | application under secrecy order and ending on the date the secrecy | ||
order was removed; | order was removed; | ||
Line 952: | Line 1,024: | ||
a specified date, shall be adjusted under § 1.702 and this section | a specified date, shall be adjusted under § 1.702 and this section | ||
beyond the expiration date specified in the disclaimer. | beyond the expiration date specified in the disclaimer. | ||
37 CFR 1.704. Reduction of period of adjustment of patent | |||
term. | |||
(a)The period of adjustment of the term of a patent under | (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 | § | ||
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 | period of time during which the applicant failed to engage in reasonable | ||
efforts to conclude prosecution (processing or examination) | efforts to conclude prosecution (processing or examination) | ||
Line 1,049: | Line 1,123: | ||
reduced by the number of days, if any, beginning on the day after | 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 | the date the reply having an omission was filed and ending on the | ||
date that the reply or other paper correcting the omission was | date that the reply or other paper correcting the omission was | ||
filed; | filed; | ||
Line 1,079: | Line 1,159: | ||
(ii)Four months; | (ii)Four months; | ||
(10) Submission of an amendment under § 1.312 or other | (10) Submission of an amendment under § | ||
1.312 or other | |||
paper after a notice of allowance has been given or mailed, in | 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 | which case the period of adjustment set forth in § 1.703 shall be | ||
Line 1,115: | Line 1,197: | ||
(processing or examination) of the application under | (processing or examination) of the application under | ||
paragraph (c)(10) of this section. | paragraph (c)(10) of this section. | ||
37 CFR 1.705. Patent term adjustment determination | |||
(a)The notice of allowance will include notification of any | (a)The notice of allowance will include notification of any | ||
patent term adjustment under 35 U.S.C. 154(b). | patent term adjustment under 35 U.S.C. 154(b). | ||
Line 1,166: | Line 1,247: | ||
(1)The fee set forth in § 1.18(f); and | (1)The fee set forth in § 1.18(f); and | ||
(2)A showing to the satisfaction of the Director that, in | (2)A showing to the satisfaction of the Director that, in | ||
Line 1,186: | Line 1,269: | ||
issued and must comply with the requirements of paragraphs | issued and must comply with the requirements of paragraphs | ||
(b)(1) and (b)(2) of this section. Any request for reconsideration | (b)(1) and (b)(2) of this section. Any request for reconsideration | ||
(e)The periods set forth in this section are not extendable. | |||
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 | (f)No submission or petition on behalf of a third party concerning | ||
Line 1,198: | Line 1,287: | ||
returned to the third party, or otherwise disposed of, at the convenience | returned to the third party, or otherwise disposed of, at the convenience | ||
of the Office. | of the Office. | ||
2731Period of Adjustment [R-2] | |||
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 | (a) The period of adjustment under § 1.702(a) is the sum of | ||
the following periods: | the following periods: | ||
Line 1,233: | Line 1,324: | ||
of mailing of any of an examiner’s answer under § 1.193, an | 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 | action under 35 U.S.C. 132, or a notice of allowance under | ||
35 U.S.C. 151, whichever occurs first; | 35 | ||
U.S.C. 151, whichever occurs first; | |||
(5)The number of days, if any, in the period beginning on | (5)The number of days, if any, in the period beginning on | ||
Line 1,308: | Line 1,400: | ||
(c)The period of adjustment under § 1.702(c) is the sum of | (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: | the following periods, to the extent that the periods are not overlapping: | ||
(1)The number of days, if any, in the period beginning on | (1)The number of days, if any, in the period beginning on | ||
Line 1,322: | Line 1,415: | ||
(d)The period of adjustment under § 1.702(d) is the sum of | (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: | the following periods, to the extent that the periods are not overlapping: | ||
(1)The number of days, if any, the application was maintained | (1)The number of days, if any, the application was maintained | ||
in a sealed condition under 35 | in a sealed condition under 35 | ||
U.S.C. 181; | U.S.C. 181; | ||
(2)The number of days, if any, in the period beginning on | (2)The number of days, if any, in the period beginning on | ||
Line 1,366: | Line 1,465: | ||
a specified date, shall be adjusted under § 1.702 and this section | a specified date, shall be adjusted under § 1.702 and this section | ||
beyond the expiration date specified in the disclaimer. | beyond the expiration date specified in the disclaimer. | ||
37 CFR 1.703 specifies the period of adjustment if | 37 CFR 1.703 specifies the period of adjustment if | ||
a patent is entitled to patent term adjustment under 35 | 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 | U.S.C. 154(b)(1) and 37 CFR 1.702. When a period is | ||
Line 1,379: | Line 1,476: | ||
length. | length. | ||
35 U.S.C. 154(b)(1)(A) and (B) provide for an | 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 | 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), | period set forth in 35 U.S.C. 154(b)(1)(A)(i), (ii), (iii), | ||
Line 1,396: | Line 1,493: | ||
of the period of adjustment. | of the period of adjustment. | ||
37 CFR 1.703(a) pertains to 35 U.S.C. | 37 CFR 1.703(a) pertains to 35 U.S.C. | ||
154(b)(1)(A) and indicates that the period of adjustment | 154(b)(1)(A) and indicates that the period of adjustment | ||
under 37 CFR 1.702(a) is the sum of the periods | under 37 CFR 1.702(a) is the sum of the periods | ||
Line 1,402: | Line 1,499: | ||
1.703(a)(6). | 1.703(a)(6). | ||
37 CFR 1.703(a)(1) pertains to the provisions of 35 | 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 | 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 number of days, if any, beginning on the date after | ||
Line 1,437: | Line 1,534: | ||
of the relevant PCT Article 22 or Article 39 time | of the relevant PCT Article 22 or Article 39 time | ||
period, but does not request early processing under 35 | period, but does not request early processing under 35 | ||
U.S.C. 371, the requirements of 35 U.S.C. 371 will be | U.S.C. 371, the requirements of 35 U.S.C. 371 will be | ||
met once the applicable time period has expired. | met once the applicable time period has expired. | ||
A written restriction requirement, a written election | A written restriction requirement, a written election | ||
of species requirement, a requirement for information | of species requirement, a requirement for information | ||
under 37 CFR 1.105, an action under Ex parte | under 37 CFR 1.105, an action under Ex parte | ||
Line 1,462: | Line 1,565: | ||
Sequence and/or Amino Acid Sequence Disclosures. | Sequence and/or Amino Acid Sequence Disclosures. | ||
37 CFR 1.703(a)(2) pertains to the provisions of 35 | 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 | 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 number of days, if any, beginning on the day after | ||
Line 1,471: | Line 1,574: | ||
occurs first. | occurs first. | ||
37 CFR 1.703(a)(3) also pertains to the provisions | 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 | 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 | period is the number of days, if any, beginning on the | ||
Line 1,490: | Line 1,593: | ||
with 37 CFR 1.113(c). | with 37 CFR 1.113(c). | ||
37 CFR 1.703(a)(4) also pertains to the provisions | 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 | 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 | period is the number of days, if any, beginning on the | ||
Line 1,508: | Line 1,611: | ||
through (c)(9). | through (c)(9). | ||
37 CFR 1.703(a)(5) pertains to the provisions of 35 | 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 | U.S.C. 154(b)(1)(A)(iii) and specifies that the period | ||
is the number of days, if any, beginning on the day | is the number of days, if any, beginning on the day | ||
Line 1,520: | Line 1,623: | ||
under 35 U.S.C. 151, whichever occurs first. | under 35 U.S.C. 151, whichever occurs first. | ||
The phrase “allowable claims remain in the application” | The phrase “allowable claims remain in the application” | ||
for purposes of 35 U.S.C. 154(b)(1)(A)(iii) | for purposes of 35 U.S.C. 154(b)(1)(A)(iii) | ||
means that after the decision there is at least one | means that after the decision there is at least one | ||
Line 1,539: | Line 1,642: | ||
(A)If claims 1 and 2 (both independent) are | (A)If claims 1 and 2 (both independent) are | ||
pending, the decision affirms the rejection of claim 1, | pending, the decision affirms the rejection of claim 1, | ||
and claim 2 was indicated as allowable prior to the | and claim 2 was indicated as allowable prior to the | ||
appeal, “allowable claims remain in the application” | appeal, “allowable claims remain in the application” | ||
Line 1,561: | Line 1,670: | ||
MPEP § 1214.06, paragraph (I)(B)). | MPEP § 1214.06, paragraph (I)(B)). | ||
37 CFR 1.703(a)(6) pertains to the provisions of | 37 CFR 1.703(a)(6) pertains to the provisions of | ||
35 U.S.C. 154(b)(1)(A)(iv) and specifies that the | 35 U.S.C. 154(b)(1)(A)(iv) and specifies that the | ||
period is the number of days, if any, beginning on the | period is the number of days, if any, beginning on the | ||
Line 1,585: | Line 1,694: | ||
MPEP § 1308). | MPEP § 1308). | ||
37 CFR 1.703(b) pertains to the provisions of 35 | 37 CFR 1.703(b) pertains to the provisions of 35 | ||
U.S.C. 154(b)(1)(B) and indicates that the period of | U.S.C. 154(b)(1)(B) and indicates that the period of | ||
adjustment under 37 CFR 1.702(b) is the number of | adjustment under 37 CFR 1.702(b) is the number of | ||
Line 1,620: | Line 1,729: | ||
application. | application. | ||
37 CFR 1.703(c) pertains to the provisions of 35 | 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 | 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 | adjustment under 37 CFR 1.702(c) is the sum of the | ||
Line 1,636: | Line 1,745: | ||
of the suspension. | of the suspension. | ||
37 CFR 1.703(d) pertains to the provisions of 35 | 37 CFR 1.703(d) pertains to the provisions of 35 | ||
U.S.C. 154(b)(1)(C)(ii) and indicates that the period | 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 | of adjustment under 37 CFR 1.702(d) is the sum of | ||
Line 1,646: | Line 1,755: | ||
examiner’s answer under 37 CFR 1.193 in the application | examiner’s answer under 37 CFR 1.193 in the application | ||
under secrecy order and ending on the date the | under secrecy order and ending on the date the | ||
secrecy order was removed; (3) the number of days, if | secrecy order was removed; (3) the number of days, if | ||
any, in the period beginning on the date applicant was | any, in the period beginning on the date applicant was | ||
Line 1,655: | Line 1,770: | ||
of the notice of allowance under 35 U.S.C. 151and 37 CFR 1.311. | 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 | 37 CFR 1.703(e) pertains to the provisions of 35 | ||
U.S.C. 154(b)(1)(C)(iii) and indicates that the period | 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 | of adjustment under 37 CFR 1.702(e) is the sum of the | ||
Line 1,682: | Line 1,797: | ||
calculated under 37 CFR 1.704. | calculated under 37 CFR 1.704. | ||
Moreover, 37 CFR 1.703(f) provides that the date | Moreover, 37 CFR 1.703(f) provides that the date | ||
indicated on any certificate of mailing or transmission | indicated on any certificate of mailing or transmission | ||
under 37 CFR 1.8 shall not be taken into account in | under 37 CFR 1.8 shall not be taken into account in | ||
Line 1,719: | Line 1,834: | ||
patent term reinstated. | patent term reinstated. | ||
Finally, 37 CFR 1.703(g) indicates that no patent, | Finally, 37 CFR 1.703(g) indicates that no patent, | ||
the term of which has been disclaimed beyond a specified | the term of which has been disclaimed beyond a specified | ||
date, shall be adjusted under 37 CFR 1.702 and | date, shall be adjusted under 37 CFR 1.702 and | ||
Line 1,725: | Line 1,840: | ||
(35 U.S.C. 154(b)(2)(B)). | (35 U.S.C. 154(b)(2)(B)). | ||
2732Reduction of Period of Adjustment | |||
of Patent Term [R-2] | |||
37 CFR 1.704. Reduction of period of adjustment of patent | |||
term. | |||
(a)The period of adjustment of the term of a patent under § | (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 | 1.703(a) through (e) shall be reduced by a period equal to the | ||
Line 1,747: | Line 1,867: | ||
that is three months after the date of mailing or transmission of the | that is three months after the date of mailing or transmission of the | ||
Office communication notifying the applicant of the rejection, | 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. | |||
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 | (c) Circumstances that constitute a failure of the applicant | ||
Line 1,764: | Line 1,890: | ||
ending on the date of the termination of the suspension; | ending on the date of the termination of the suspension; | ||
(2)Deferral of issuance of a patent under § 1.314, in | (2)Deferral of issuance of a patent under § | ||
1.314, in | |||
which case the period of adjustment set forth in § 1.703 shall be | 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 | reduced by the number of days, if any, beginning on the date a | ||
Line 1,849: | Line 1,977: | ||
(ii)Four months; | (ii)Four months; | ||
(10)Submission of an amendment under § 1.312 or other | (10)Submission of an amendment under § | ||
1.312 or other | |||
paper after a notice of allowance has been given or mailed, in | 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 | which case the period of adjustment set forth in § 1.703 shall be | ||
Line 1,878: | Line 2,008: | ||
information disclosure statement. This thirty-day period is not | information disclosure statement. This thirty-day period is not | ||
extendable. | extendable. | ||
(e)Submission of an application for patent term adjustment | (e)Submission of an application for patent term adjustment | ||
Line 1,885: | Line 2,020: | ||
(processing or examination) of the application under | (processing or examination) of the application under | ||
paragraph (c)(10) of this section. | paragraph (c)(10) of this section. | ||
37 CFR 1.704 implements the provisions of 35 | 37 CFR 1.704 implements the provisions of 35 | ||
U.S.C. 154(b)(2)(C) which provides that the period of | U.S.C. 154(b)(2)(C) which provides that the period of | ||
patent term adjustment under 35 U.S.C. 154(b)(1) | patent term adjustment under 35 U.S.C. 154(b)(1) | ||
Line 1,982: | Line 2,115: | ||
reduction of patent term adjustment under 35 U.S.C. | reduction of patent term adjustment under 35 U.S.C. | ||
154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an | 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 | Office action sets a six-month period for reply, as is | ||
commonly set in applications subject to secrecy | commonly set in applications subject to secrecy | ||
Line 2,083: | Line 2,222: | ||
application or late payment of the issue fee as a circumstance | application or late payment of the issue fee as a circumstance | ||
that constitutes a failure of an applicant to | that constitutes a failure of an applicant to | ||
engage in reasonable efforts to conclude processing or | engage in reasonable efforts to conclude processing or | ||
examination of an application. Obviously, if the application | examination of an application. Obviously, if the application | ||
Line 2,129: | Line 2,274: | ||
of abandonment or to revive the application was filed. | of abandonment or to revive the application was filed. | ||
If a petition to withdraw the holding of abandonment | If a petition to withdraw the holding of abandonment | ||
is granted, the Office’s PALM system records | is granted, the Office’s PALM system records | ||
should be checked to ensure that the correct term | should be checked to ensure that the correct term | ||
Line 2,157: | Line 2,302: | ||
nonprovisional application under 35 U.S.C. 111(a) | nonprovisional application under 35 U.S.C. 111(a) | ||
(pursuant to 35 U.S.C. 111(b)(5); (see MPEP | (pursuant to 35 U.S.C. 111(b)(5); (see MPEP | ||
§ 201.04(b)) as a circumstance that constitutes a failure | § | ||
201.04(b)) as a circumstance that constitutes a failure | |||
of an applicant to engage in reasonable efforts to | of an applicant to engage in reasonable efforts to | ||
conclude processing or examination of an application. | conclude processing or examination of an application. | ||
Line 2,183: | Line 2,330: | ||
to engage in reasonable efforts to conclude processing | to engage in reasonable efforts to conclude processing | ||
or examination of an application. If the submission of | or examination of an application. If the submission of | ||
a preliminary amendment or other paper requires the | a preliminary amendment or other paper requires the | ||
Office to issue a supplemental Office action or notice | Office to issue a supplemental Office action or notice | ||
Line 2,201: | Line 2,354: | ||
of allowance. | of allowance. | ||
37 CFR 1.704(c)(7) establishes submission of a | 37 CFR 1.704(c)(7) establishes submission of a | ||
reply having an omission (37 CFR 1.135(c)) as a circumstance | reply having an omission (37 CFR 1.135(c)) as a circumstance | ||
that constitutes a failure of an applicant to | that constitutes a failure of an applicant to | ||
Line 2,256: | Line 2,409: | ||
supplemental reply or such other paper was filed. | supplemental reply or such other paper was filed. | ||
37 CFR 1.704(c)(9) establishes submission of an | 37 CFR 1.704(c)(9) establishes submission of an | ||
amendment or other paper in an application containing | amendment or other paper in an application containing | ||
allowed claims after a decision by the Board of | allowed claims after a decision by the Board of | ||
Line 2,282: | Line 2,435: | ||
date of the supplemental Office action or notice of | date of the supplemental Office action or notice of | ||
allowance or four months. The phrase “lesser of…or | allowance or four months. The phrase “lesser of…or | ||
[f]our months” is to provide a four-month cap for a | [f]our months” is to provide a four-month cap for a | ||
reduction under 37 CFR 1.704(c)(9) if the Office | reduction under 37 CFR 1.704(c)(9) if the Office | ||
Line 2,339: | Line 2,498: | ||
37 CFR 1.312 or other paper. | 37 CFR 1.312 or other paper. | ||
37 CFR 1.704(c)(11) establishes further prosecution | 37 CFR 1.704(c)(11) establishes further prosecution | ||
via a continuing application as a circumstance | via a continuing application as a circumstance | ||
that constitutes a failure of an applicant to engage in | that constitutes a failure of an applicant to engage in | ||
Line 2,380: | Line 2,539: | ||
application (including a CPA), the period of adjustment | application (including a CPA), the period of adjustment | ||
set forth in 37 CFR 1.703 (if any) will not | 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. | |||
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 | A CPA under 37 CFR 1.53(d) filed on or after May | ||
Line 2,465: | Line 2,630: | ||
CFR 1.704(c)(10). | CFR 1.704(c)(10). | ||
2733Patent Term Adjustment | |||
Determination [R-2] | |||
37 CFR 1.705. Patent term adjustment determination. | |||
(a)The notice of allowance will include notification of any | (a)The notice of allowance will include notification of any | ||
patent term adjustment under 35 U.S.C. 154(b). | patent term adjustment under 35 U.S.C. 154(b). | ||
Line 2,480: | Line 2,649: | ||
determinations required by 35 U.S.C. 154(b)(3)(B)(i) | determinations required by 35 U.S.C. 154(b)(3)(B)(i) | ||
are made by a computer program that uses the infor | are made by a computer program that uses the infor | ||
mation (dates of receipt and nature of applicant correspondence | mation (dates of receipt and nature of applicant correspondence | ||
and of the dates of mailing and nature of | and of the dates of mailing and nature of | ||
Line 2,490: | Line 2,666: | ||
the third page of the form. | the third page of the form. | ||
37 CFR 1.705(b) provides that any request for | 37 CFR 1.705(b) provides that any request for | ||
review or reconsideration of the patent term adjustment | review or reconsideration of the patent term adjustment | ||
indicated in the notice of allowance (except as | indicated in the notice of allowance (except as | ||
Line 2,521: | Line 2,697: | ||
until the patent issues, and if the patent issues with a | until the patent issues, and if the patent issues with a | ||
value that is incorrect, request a certificate of correction. | value that is incorrect, request a certificate of correction. | ||
Information as to how the patent term adjustment | Information as to how the patent term adjustment | ||
Line 2,554: | Line 2,731: | ||
that the duplicate was received in the USPTO. | that the duplicate was received in the USPTO. | ||
2734Application for Patent Term | |||
Adjustment; Due Care Showing [R- | |||
2] | |||
37 CFR 1.705. Patent term adjustment determination. | |||
(b)Any request for reconsideration of the patent term adjustment | (b)Any request for reconsideration of the patent term adjustment | ||
indicated in the notice of allowance, except as provided in | indicated in the notice of allowance, except as provided in | ||
Line 2,583: | Line 2,766: | ||
and any expiration date specified in the terminal disclaimer; | and any expiration date specified in the terminal disclaimer; | ||
and | and | ||
(iv)(A)Any circumstances during the prosecution of | (iv)(A)Any circumstances during the prosecution of | ||
Line 2,613: | Line 2,801: | ||
the applicant of the rejection, objection, argument, or other | the applicant of the rejection, objection, argument, or other | ||
request. | request. | ||
Line 2,655: | Line 2,843: | ||
DUE CARE SHOWING | DUE CARE SHOWING | ||
37 CFR 1.705(c) implements the provisions of 35 | 37 CFR 1.705(c) implements the provisions of 35 | ||
U.S.C. 154(b)(3)(C) and specifically provides that a | U.S.C. 154(b)(3)(C) and specifically provides that a | ||
request for reinstatement of all or part of the period of | request for reinstatement of all or part of the period of | ||
Line 2,693: | Line 2,881: | ||
prudent person standard has been applied in deciding | prudent person standard has been applied in deciding | ||
petitions under the “unavoidable delay” standard of | petitions under the “unavoidable delay” standard of | ||
35 U.S.C. 133. See In re Mattullath, 38 App. D.C. | 35 U.S.C. 133. See In re Mattullath, 38 App. D.C. | ||
497, 514-15 (1912) (“the word ‘unavoidable’ … is | 497, 514-15 (1912) (“the word ‘unavoidable’ … is | ||
Line 2,765: | Line 2,959: | ||
with other matters (e.g., an inter partes lawsuit or | with other matters (e.g., an inter partes lawsuit or | ||
interference) that is given priority over the application; | interference) that is given priority over the application; | ||
(B)illness or death of the practitioner in charge of | (B)illness or death of the practitioner in charge of | ||
Line 2,777: | Line 2,972: | ||
United States or chooses to communicate with the | United States or chooses to communicate with the | ||
United States representative via a foreign representative; | United States representative via a foreign representative; | ||
(D)vacation or other non-attention to an application | (D)vacation or other non-attention to an application | ||
Line 2,799: | Line 2,995: | ||
working on an interference or taking a vacation is | working on an interference or taking a vacation is | ||
generally aware of that fact before the event and | generally aware of that fact before the event and | ||
should make plans for another to take over his or her | should make plans for another to take over his or her | ||
work so that it is completed and filed in the Office | work so that it is completed and filed in the Office | ||
Line 2,810: | Line 3,012: | ||
spite of all due care” under 35 U.S.C. 154(b)(3)(C). | spite of all due care” under 35 U.S.C. 154(b)(3)(C). | ||
2735Request for Reconsideration of | |||
Patent Term Adjustment | |||
Determination [R-2] | |||
37 CFR 1.705. Patent term adjustment determination. | |||
(d)If there is a revision to the patent term adjustment indicated | (d)If there is a revision to the patent term adjustment indicated | ||
in the notice of allowance, the patent will indicate the | in the notice of allowance, the patent will indicate the | ||
Line 2,828: | Line 3,036: | ||
(e) The periods set forth in this section are not extendable. | (e) The periods set forth in this section are not extendable. | ||
Line 2,866: | Line 3,073: | ||
as untimely as to those issues. | as untimely as to those issues. | ||
2736Third Party Papers [R-2] | |||
37 CFR 1.705. Patent term adjustment determination. | |||
(f)No submission or petition on behalf of a third party concerning | (f)No submission or petition on behalf of a third party concerning | ||
patent term adjustment under 35 U.S.C. 154(b) will be | patent term adjustment under 35 U.S.C. 154(b) will be | ||
Line 2,875: | Line 3,086: | ||
returned to the third party, or otherwise disposed of, at the convenience | returned to the third party, or otherwise disposed of, at the convenience | ||
of the Office. | of the Office. | ||
Line 2,887: | Line 3,097: | ||
disposed of, at the convenience of the Office. | disposed of, at the convenience of the Office. | ||
2750Patent Term Extension for Delays | |||
at other Agencies under 35 U.S.C. | |||
156 [R-2] | |||
The right to a patent term extension based upon | The right to a patent term extension based upon | ||
Line 2,893: | Line 3,105: | ||
and Patent Term Restoration Act of 1984, | and Patent Term Restoration Act of 1984, | ||
Pub. L. No. 98-417, 98 Stat. 1585 (codified at | Pub. L. No. 98-417, 98 Stat. 1585 (codified at | ||
21 U.S.C. 355(b), (j), (l); 35 U.S.C. 156, 271, | 21 | ||
U.S.C. 355(b), (j), (l); 35 U.S.C. 156, 271, | |||
282)(Hatch-Waxman Act). The act sought to eliminate | 282)(Hatch-Waxman Act). The act sought to eliminate | ||
two distortions to the normal “patent term produced | two distortions to the normal “patent term produced | ||
Line 2,899: | Line 3,112: | ||
receive premarket regulatory approval.” Eli Lilly & | receive premarket regulatory approval.” Eli Lilly & | ||
Co. v. Medtronic Inc., 496 U.S. 661, 669, 15 USPQ2d | Co. v. Medtronic Inc., 496 U.S. 661, 669, 15 USPQ2d | ||
1121, 1126 (1990). The first distortion was that the | 1121, 1126 (1990). The first distortion was that the | ||
patent owner loses patent term during the early years | patent owner loses patent term during the early years | ||
Line 2,928: | Line 3,147: | ||
date of the patent. | date of the patent. | ||
In exchange for extension of the term of the patent, | In exchange for extension of the term of the patent, | ||
Congress legislatively overruled Roche Products v. | Congress legislatively overruled Roche Products v. | ||
Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 | Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 | ||
Line 3,002: | Line 3,221: | ||
not addressed herein. | not addressed herein. | ||
2751Eligibility Requirements [R-2] | |||
35 U.S.C. 156. Extension of patent term | |||
(a)The term of a patent which claims a product, a method of | (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 | using a product, or a method of manufacturing a product shall be | ||
Line 3,057: | Line 3,281: | ||
The product referred to in paragraphs (4) and (5) is | The product referred to in paragraphs (4) and (5) is | ||
hereinafter in this section referred to as the “approved product.” | hereinafter in this section referred to as the “approved product.” | ||
(f)For purposes of this section: | (f)For purposes of this section: | ||
Line 3,117: | Line 3,343: | ||
Patent Term Restoration Act for an animal drug or a veterinary | Patent Term Restoration Act for an animal drug or a veterinary | ||
biological product. | biological product. | ||
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 | (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, | patent claims a product as defined in paragraph (b) of this section, | ||
Line 3,132: | Line 3,359: | ||
(b)The term product referred to in paragraph (a) of this section | (b)The term product referred to in paragraph (a) of this section | ||
means — | means — | ||
(l)The active ingredient of a new human drug, antibiotic | (l)The active ingredient of a new human drug, antibiotic | ||
Line 3,144: | Line 3,372: | ||
that is not primarily manufactured using recombinant DNA, | that is not primarily manufactured using recombinant DNA, | ||
recombinant RNA, hybridoma technology, or other processes | recombinant RNA, hybridoma technology, or other processes | ||
including site specific genetic manipulation techniques, including | including site specific genetic manipulation techniques, including | ||
any salt or ester of the active ingredient, as a single entity or in | any salt or ester of the active ingredient, as a single entity or in | ||
Line 3,151: | Line 3,385: | ||
subject to regulation under the Federal Food, Drug, and Cosmetic | subject to regulation under the Federal Food, Drug, and Cosmetic | ||
Act. | Act. | ||
37 CFR 1.720. Conditions for extension of patent term | |||
The term of a patent may be extended if: | The term of a patent may be extended if: | ||
(a)The patent claims a product or a method of using or manufacturing | (a)The patent claims a product or a method of using or manufacturing | ||
a product as defined in § 1.710; | a product as defined in § | ||
1.710; | |||
(b)The term of the patent has never been previously | (b)The term of the patent has never been previously | ||
Line 3,224: | Line 3,459: | ||
(h)No other patent term has been extended for the same regulatory | (h)No other patent term has been extended for the same regulatory | ||
review period for the product. | review period for the product. | ||
35 U.S.C. 156(a) sets forth what patents can be | 35 U.S.C. 156(a) sets forth what patents can be | ||
Line 3,250: | Line 3,483: | ||
(2)the patent has never been extended under | (2)the patent has never been extended under | ||
35 U.S.C. 156(e)(1); | 35 | ||
U.S.C. 156(e)(1); | |||
(3)the application for extension is submitted by | (3)the application for extension is submitted by | ||
Line 3,273: | Line 3,507: | ||
35 | 35 | ||
U.S.C. 156(a)(5)(C) apply. | U.S.C. 156(a)(5)(C) apply. | ||
35 U.S.C. 156(c)(4) also requires that no other | 35 U.S.C. 156(c)(4) also requires that no other | ||
Line 3,302: | Line 3,541: | ||
MEANING OF “PRODUCT” AS DEFINED IN 35 U.S.C. 156(f) | MEANING OF “PRODUCT” AS DEFINED IN | ||
35 | |||
U.S.C. 156(f) | |||
As required by 35 U.S.C. 156(a), patents eligible | As required by 35 U.S.C. 156(a), patents eligible | ||
Line 3,378: | Line 3,619: | ||
the ester form which is used for oral administration is | the ester form which is used for oral administration is | ||
a different drug product from the same active moiety | a different drug product from the same active moiety | ||
in a salt form which is administered by injection, even | in a salt form which is administered by injection, even | ||
though both the salt and the ester are used to treat the | though both the salt and the ester are used to treat the | ||
Line 3,405: | Line 3,652: | ||
(1991) (The court rejected the approach of Glaxo in | (1991) (The court rejected the approach of Glaxo in | ||
considering whether Abbott was entitled to exclusivity). | considering whether Abbott was entitled to exclusivity). | ||
A patent is considered to claim the product at least | A patent is considered to claim the product at least | ||
Line 3,420: | Line 3,668: | ||
term of the patent has never been previously | term of the patent has never been previously | ||
extended, except for extensions issued pursuant to | extended, except for extensions issued pursuant to | ||
37 CFR 1.701, 1.760, or 1.790. An extension issued | 37 | ||
CFR 1.701, 1.760, or 1.790. An extension issued | |||
pursuant to 37 CFR 1.701 is an extension of the patent | pursuant to 37 CFR 1.701 is an extension of the patent | ||
due to administrative delay within the Office. Note | due to administrative delay within the Office. Note | ||
Line 3,443: | Line 3,692: | ||
Pat. & Tm. 1990). See also Baxter Diagnostics v. AVL | Pat. & Tm. 1990). See also Baxter Diagnostics v. AVL | ||
Scientific Corp. 798 F. Supp. 612, 619-620; | Scientific Corp. 798 F. Supp. 612, 619-620; | ||
25 USPQ2d 1428,1434 (CD CA 1992)(Congress | 25 | ||
USPQ2d 1428,1434 (CD CA 1992)(Congress | |||
intended only Class III medical devices to be eligible | intended only Class III medical devices to be eligible | ||
for patent term extension). | for patent term extension). | ||
Line 3,467: | Line 3,717: | ||
as explained below. See In re Patent Term Extension | as explained below. See In re Patent Term Extension | ||
Application, U.S. Patent No. 3,849,549, | Application, U.S. Patent No. 3,849,549, | ||
226 USPQ 283, 284 (Pat. & Tm. Office 1985). If the | 226 | ||
USPQ 283, 284 (Pat. & Tm. Office 1985). If the | |||
product is a human drug product, then the approval of | product is a human drug product, then the approval of | ||
the active ingredient must be the first permitted commercial | the active ingredient must be the first permitted commercial | ||
Line 3,480: | Line 3,731: | ||
of patent term provided the patent claims that ingredient. | of patent term provided the patent claims that ingredient. | ||
See In re Alcon Laboratories Inc., 13 USPQ2d | See In re Alcon Laboratories Inc., 13 USPQ2d | ||
1115, 1121 (Comm’r Pat. & Tm. 1989) for examples | 1115, 1121 (Comm’r Pat. & Tm. 1989) for examples | ||
of products having different combinations of active | of products having different combinations of active | ||
Line 3,521: | Line 3,778: | ||
animals. | animals. | ||
2752Patent Term Extension Applicant | |||
35 U.S.C. 156. Extension of patent term | |||
(d)(1) To obtain an extension of the term of a patent under | (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 | this section, the owner of record of the patent or its agent shall | ||
Line 3,554: | Line 3,813: | ||
(E)such patent or other information as the Director may | (E)such patent or other information as the Director may | ||
require. | require. | ||
37 CFR 1.730. Applicant for extension of patent term; | |||
signature requirements. | |||
(a)Any application for extension of a patent term must be | (a)Any application for extension of a patent term must be | ||
submitted by the owner of record of the patent or its agent and | submitted by the owner of record of the patent or its agent and | ||
Line 3,581: | Line 3,841: | ||
the Office may require proof that the practitioner is authorized to | the Office may require proof that the practitioner is authorized to | ||
act on behalf of the patent owner or agent of the patent owner. | act on behalf of the patent owner or agent of the patent owner. | ||
35 U.S.C. 156(d)(1) requires that the application | 35 U.S.C. 156(d)(1) requires that the application | ||
Line 3,603: | Line 3,861: | ||
marketing applicant before the Food and Drug | marketing applicant before the Food and Drug | ||
Administration or the Department of Agriculture, it is | Administration or the Department of Agriculture, it is | ||
advisable for the applicant for patent term extension | advisable for the applicant for patent term extension | ||
to obtain a letter from the marketing applicant specifically | to obtain a letter from the marketing applicant specifically | ||
authorizing such reliance. | authorizing such reliance. | ||
2753Application Contents [R-2] | |||
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 | (a)An application for extension of patent term must be | ||
made in writing to the Director. A formal application for the | made in writing to the Director. A formal application for the | ||
Line 3,750: | Line 4,018: | ||
approved product and the significant dates applicable to such | approved product and the significant dates applicable to such | ||
activities; | activities; | ||
(12) A statement beginning on a new page that in the | (12) A statement beginning on a new page that in the | ||
Line 3,755: | Line 4,028: | ||
a statement as to the length of extension claimed, including how | a statement as to the length of extension claimed, including how | ||
the length of extension was determined; | the length of extension was determined; | ||
(13) A statement that applicant acknowledges a duty to | (13) A statement that applicant acknowledges a duty to | ||
Line 3,761: | Line 4,036: | ||
Secretary of Agriculture any information which is material to the | Secretary of Agriculture any information which is material to the | ||
determination of entitlement to the extension sought (see | determination of entitlement to the extension sought (see | ||
§ 1.765); | § | ||
1.765); | |||
(14) The prescribed fee for receiving and acting upon the | (14) The prescribed fee for receiving and acting upon the | ||
Line 3,780: | Line 4,057: | ||
Unless the notice indicates otherwise, this time period may be | Unless the notice indicates otherwise, this time period may be | ||
extended under the provisions of § 1.136. | extended under the provisions of § 1.136. | ||
37 CFR 1.740 sets forth the requirements for a formal | 37 CFR 1.740 sets forth the requirements for a formal | ||
Line 3,787: | Line 4,062: | ||
MPEP § 2752 for a discussion of who may apply for a | MPEP § 2752 for a discussion of who may apply for a | ||
patent term extension. See 37 CFR 1.741 and MPEP | patent term extension. See 37 CFR 1.741 and MPEP | ||
§ 2754 for a description of the information that must | § | ||
2754 for a description of the information that must | |||
be submitted in the patent term extension application | be submitted in the patent term extension application | ||
in order to be accorded a filing date. | in order to be accorded a filing date. | ||
Line 3,826: | Line 4,103: | ||
the approval date is generally the effective date stated | the approval date is generally the effective date stated | ||
in the regulation and the date the regulation is published. | in the regulation and the date the regulation is published. | ||
37 CFR 1.740(a)(4) provides that for drug products, | 37 CFR 1.740(a)(4) provides that for drug products, | ||
Line 3,862: | Line 4,140: | ||
the law (35 U.S.C. 154) at the time of filing of the | the law (35 U.S.C. 154) at the time of filing of the | ||
application for patent term extension, and should | application for patent term extension, and should | ||
include any patent term adjustment under 35 U.S.C. | include any patent term adjustment under 35 U.S.C. | ||
154(b). | 154(b). | ||
Line 3,965: | Line 4,249: | ||
to also be changed. | to also be changed. | ||
In order to change the address of all correspondence, | |||
In order to change the address of all correspondence, | |||
including maintenance fee reminders, a change | including maintenance fee reminders, a change | ||
of address should also be filed. A change of address | of address should also be filed. A change of address | ||
Line 3,990: | Line 4,279: | ||
fifth copy is used by the Legal Advisor. | fifth copy is used by the Legal Advisor. | ||
2754Filing Date [R-2] | |||
37 CFR 1.741. Complete application given a filing date; | |||
petition procedure. | |||
(a)The filing date of an application for extension of a patent | (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 | term is the date on which a complete application is received in the | ||
Line 4,009: | Line 4,300: | ||
claims the approved product or a method of using or manufacturing | claims the approved product or a method of using or manufacturing | ||
the approved product; | the approved product; | ||
(5)Sufficient information to enable the Director to determine | (5)Sufficient information to enable the Director to determine | ||
Line 4,032: | Line 4,325: | ||
the notice indicates otherwise, this time period may be extended | the notice indicates otherwise, this time period may be extended | ||
under the provisions of § 1.136. | under the provisions of § 1.136. | ||
FILING DATE ACCORDED | FILING DATE ACCORDED | ||
An application for patent term extension under | An application for patent term extension under | ||
Line 4,047: | Line 4,338: | ||
As set forth in 37 CFR 1.741(a), the filing date | As set forth in 37 CFR 1.741(a), the filing date | ||
of an application for patent term extension is the | of | ||
date on which a complete application is received | an application for patent term extension is the | ||
in the USPTO or filed pursuant to the certificate | date | ||
of mailing provisions of 37 CFR 1.8 (see MPEP § 512for suggested formats for a certificate of mailing) | on which a complete application is received | ||
or the Express Mail provisions of 37 CFR 1.10. | in | ||
Patent term extension applications should not be filed | 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 | by facsimile, however correspondence setting forth a | ||
change of address and other papers relating to a patent | change of address and other papers relating to a patent | ||
Line 4,061: | Line 4,358: | ||
The term “complete application” is defined in | The term “complete application” is defined in | ||
37 CFR 1.741(a) and is an application meeting the | 37 | ||
CFR 1.741(a) and is an application meeting the | |||
requirements set forth in 35 U.S.C. 156(d)(1). For the | requirements set forth in 35 U.S.C. 156(d)(1). For the | ||
establishment of a filing date, the distinction between | establishment of a filing date, the distinction between | ||
Line 4,068: | Line 4,366: | ||
requirements of 37 CFR 1.740 may be satisfied outside | requirements of 37 CFR 1.740 may be satisfied outside | ||
the 60 day filing period, the requirements of | the 60 day filing period, the requirements of | ||
37 CFR 1.741 are mandated by 35 U.S.C. 156 and | 37 | ||
CFR 1.741 are mandated by 35 U.S.C. 156 and | |||
must be satisfied within the 60 day filing period for | must be satisfied within the 60 day filing period for | ||
the establishment of the filing date. The Office will | the establishment of the filing date. The Office will | ||
Line 4,078: | Line 4,377: | ||
before a final determination of eligibility and length | before a final determination of eligibility and length | ||
of patent term extension is made. | of patent term extension is made. | ||
INFORMAL APPLICATION | INFORMAL APPLICATION | ||
37 CFR 1.740. Formal requirements for application for | |||
extension of patent term; correction of informalities. | |||
(c)If an application for extension of patent term is informal | (c)If an application for extension of patent term is informal | ||
under this section, the Office will so notify the applicant. The | under this section, the Office will so notify the applicant. The | ||
Line 4,089: | Line 4,396: | ||
Unless the notice indicates otherwise, this time period may be | Unless the notice indicates otherwise, this time period may be | ||
extended under the provisions of § 1.136. | extended under the provisions of § 1.136. | ||
Line 4,106: | Line 4,412: | ||
held to be informal under 37 CFR 1.740. | held to be informal under 37 CFR 1.740. | ||
2754.01Deadline for Filing an Application | |||
Under 35 U.S.C. 156(d)(1) | |||
An application for patent term extension under | An application for patent term extension under | ||
Line 4,144: | Line 4,451: | ||
marketing applicant. | marketing applicant. | ||
2754.02Filing Window for an Application | |||
Under 35 U.S.C. 156(d)(5) | |||
A first application for interim extension under | A first application for interim extension under | ||
Line 4,182: | Line 4,490: | ||
under 35 U.S.C. 156(d)(5). | under 35 U.S.C. 156(d)(5). | ||
2754.03Filing 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. | A request for an interim extension under 35 U.S.C. | ||
Line 4,192: | Line 4,506: | ||
under 35 U.S.C. 156(e)(2). | under 35 U.S.C. 156(e)(2). | ||
2755Eligibility Determination [R-2] | |||
37 CFR 1.750. Determination of eligibility for extension of | |||
patent term | |||
A determination as to whether a patent is eligible for extension | A determination as to whether a patent is eligible for extension | ||
may be made by the Director solely on the basis of the representations | may be made by the Director solely on the basis of the representations | ||
Line 4,215: | Line 4,533: | ||
from the date of the final determination. The time periods set forth | from the date of the final determination. The time periods set forth | ||
herein are subject to the provisions of § 1.136. | herein are subject to the provisions of § 1.136. | ||
The determination as to whether a patent is eligible | The determination as to whether a patent is eligible | ||
Line 4,239: | Line 4,555: | ||
requested may result in an adverse final determination. | requested may result in an adverse final determination. | ||
A final determination may be made at any time | |||
A final determination may be made at any time | |||
after an application is filed. A single request for | after an application is filed. A single request for | ||
reconsideration of a final determination may be filed | reconsideration of a final determination may be filed | ||
Line 4,254: | Line 4,571: | ||
See MPEP § 2758. | See MPEP § 2758. | ||
2755.01Interim Extension of Patent | |||
Term During the Processing of | |||
the Application [R-2] | |||
35 U.S.C. 156. Extension of patent term. | |||
(e)(2) If the term of a patent for which an application has | (e)(2) If the term of a patent for which an application has | ||
been submitted under subsection (d)(1) would expire before a certificate | been submitted under subsection (d)(1) would expire before a certificate | ||
Line 4,264: | Line 4,585: | ||
determination is made, the term of the patent for periods of up to | 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. | one year if he determines that the patent is eligible for extension. | ||
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 | An applicant who has filed a formal application for extension | ||
in compliance with § 1.740 may request one or more interim | in compliance with § 1.740 may request one or more interim | ||
Line 4,282: | Line 4,607: | ||
recorded in the official file of the patent and will be considered as | 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 | part of the original patent. In no event will the interim extensions | ||
granted under this section be longer than the maximum period for | granted under this section be longer than the maximum period for | ||
extension to which the applicant would be eligible. | extension to which the applicant would be eligible. | ||
If the original term of the patent for which extension | If the original term of the patent for which extension | ||
Line 4,309: | Line 4,638: | ||
eligible for patent term extension, an interim extension | eligible for patent term extension, an interim extension | ||
of the patent term is not warranted under | of the patent term is not warranted under | ||
35 U.S.C. 156(e)(2). See In re Alcon Laboratories | 35 | ||
U.S.C. 156(e)(2). See In re Alcon Laboratories | |||
Inc., 13 USPQ2d 1115, 1123 (Comm’r. Pat.& Tm. | Inc., 13 USPQ2d 1115, 1123 (Comm’r. Pat.& Tm. | ||
1989). | 1989). | ||
Line 4,319: | Line 4,649: | ||
156(e)(2). See In re Reckitt, 230 USPQ at 370. | 156(e)(2). See In re Reckitt, 230 USPQ at 370. | ||
While 37 CFR 1.760 provides that a request for an | While 37 CFR 1.760 provides that a request for an | ||
interim extension by the applicant “should” be filed | interim extension by the applicant “should” be filed | ||
three months prior to the expiration of the patent, this | three months prior to the expiration of the patent, this | ||
Line 4,341: | Line 4,671: | ||
and Trademark Office. | and Trademark Office. | ||
2755.02Interim Extension of Patent | |||
Term Before Product Approval | |||
35 U.S.C. 156. Extension of patent term. | |||
(d)(5)(A) If the owner of record of the patent or its agent reasonably | (d)(5)(A) If the owner of record of the patent or its agent reasonably | ||
expects that the applicable regulatory review period | expects that the applicable regulatory review period | ||
Line 4,357: | Line 4,690: | ||
(i) the identity of the product subject to regulating | (i) the identity of the product subject to regulating | ||
review and the Federal statute under which such review is occurring; | review and the Federal statute under which such review is occurring; | ||
(ii) the identity of the patent for which interim extension | (ii) the identity of the patent for which interim extension | ||
Line 4,365: | Line 4,699: | ||
(iii) information to enable the Director to determine under | (iii) information to enable the Director to determine under | ||
subsection (a)(1), (2), and (3) the eligibility of a patent for extension; | subsection (a)(1), (2), and (3) the eligibility of a patent for extension; | ||
(iv) a brief description of the activities undertaken by the | (iv) a brief description of the activities undertaken by the | ||
Line 4,392: | Line 4,727: | ||
during the period beginning 60 days before, and ending 30 days | during the period beginning 60 days before, and ending 30 days | ||
before, the expiration of the preceding interim extension. | before, the expiration of the preceding interim extension. | ||
(D)Each certificate of interim extension under this | (D)Each certificate of interim extension under this | ||
Line 4,428: | Line 4,768: | ||
manufacturing a product, be limited to the method of manufacturing | manufacturing a product, be limited to the method of manufacturing | ||
as used to make the product then under regulatory review. | as used to make the product then under regulatory review. | ||
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 | (a)An owner of record of a patent or its agent who reasonably | ||
expects that the applicable regulatory review period | expects that the applicable regulatory review period | ||
Line 4,453: | Line 4,795: | ||
(b)A complete application for interim extension under this | (b)A complete application for interim extension under this | ||
section shall include all of the information required for a formal | 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 | 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 | undergoing regulatory review. Sections (a)(3) and (a)(5) of | ||
§ 1.740 are not applicable to an application for interim extension | § 1.740 are not applicable to an application for interim extension | ||
Line 4,464: | Line 4,814: | ||
required under §§ 1.740 and 1.741 that are not present in the preceding | required under §§ 1.740 and 1.741 that are not present in the preceding | ||
interim extension application. | interim extension application. | ||
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 | 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 | at the end of the 60-day period beginning on the date on | ||
Line 4,474: | Line 4,825: | ||
its agent files an application for extension under §§ 1.740 and | its agent files an application for extension under §§ 1.740 and | ||
1.741 including any additional information required under | 1.741 including any additional information required under | ||
35 U.S.C. 156(d)(1) not contained in the application for interim | 35 | ||
U.S.C. 156(d)(1) not contained in the application for interim | |||
extension, the patent shall be further extended in accordance with | extension, the patent shall be further extended in accordance with | ||
the provisions of 35 U.S.C. 156. | the provisions of 35 U.S.C. 156. | ||
If a patent that claims a product which is undergoing | If a patent that claims a product which is undergoing | ||
Line 4,511: | Line 4,861: | ||
that a patent is eligible for extension under | that a patent is eligible for extension under | ||
35 U.S.C. 156, but for regulatory approval, is published | 35 U.S.C. 156, but for regulatory approval, is published | ||
in the Federal Register. | in the Federal Register. A sample order granting | ||
a second interim extension follows: | |||
UNITED STATES PATENT AND TRADEMARK OFFICEBEFORE THE COMMISSIONER OF PATENTS AND | |||
TRADEMARKS | |||
In re___ | |||
Request for Patent Term Extension ORDER GRANTING | |||
U.S. Patent No.___ INTERIM EXTENSION | |||
On __, patent owner __, filed an application under 35 U.S.C. | |||
156(d)(5) for interim extension of the term of U.S. Patent No. __. | |||
The patent claims the active ingredient __ in the human drug | |||
product “___.” The application indicates that the product is currently | |||
undergoing a regulatory review before the Food and Drug | |||
Administration for permission to market or use the product commercially. | |||
The original term of the patent expired on ___ On ___, | |||
the patent was granted an first interim extension under 35 U.S.C. | |||
156(d)(5) for a period of one year. | |||
Review of the application indicates that except for receipt of permission | |||
to market or use the product commercially, the subject | |||
patent would be eligible for an extension of the patent term under | |||
35 U.S.C. 156. Since it is apparent that the regulatory review | |||
period may extend beyond the date of expiration of the patent, as | |||
extended by the first interim extension, a second interim extension | |||
of the patent term under 35 U.S.C. 156(d)(5) is appropriate. | |||
An interim extension under 35 U.S.C. 156(d)(5) of the term of | |||
U.S. Patent No. __ is granted for a period of one year from the | |||
extended expiration date of the patent. | |||
As seen from the example given, a series of one- | |||
year interim extensions may be granted if requested in | year interim extensions may be granted if requested in | ||
a timely manner (in the window of time between | a timely manner (in the window of time between | ||
Line 4,529: | Line 4,915: | ||
U.S.C. 156(d)(5)(E). | U.S.C. 156(d)(5)(E). | ||
2756Correspondence Between the | |||
USPTO and the Regulatory Agency[R-2] | |||
It is the Director’s responsibility to decide | It is the Director’s responsibility to decide | ||
Line 4,565: | Line 4,952: | ||
The patent term extension applicant receives a copy | The patent term extension applicant receives a copy | ||
of all correspondence between the Office and the regulatory | of all correspondence between the Office and the regulatory | ||
agency. | agency. | ||
The Animal and Health Inspection Service of the | The Animal and Health Inspection Service of the | ||
Department of Agriculture is responsible for assisting | Department of Agriculture is responsible for assisting | ||
the Office in determining the eligibility of patent | the Office in determining the eligibility of patent | ||
Line 4,588: | Line 4,975: | ||
notified of any informalities and it is anticipated that | notified of any informalities and it is anticipated that | ||
the informalities will be corrected or explained, a first | the informalities will be corrected or explained, a first | ||
letter is sent to the regulatory agency requesting | letter is sent to the regulatory agency requesting infor | ||
mation regarding eligibility. The letter is accompanied | |||
by a copy of the patent term extension application. | by a copy of the patent term extension application. | ||
This letter does not request the determination of the | This letter does not request the determination of the | ||
Line 4,619: | Line 5,014: | ||
extension. | extension. | ||
While the Office has primary responsibility for the | While the Office has primary responsibility for the | ||
eligibility determination, the regulatory agency often | eligibility determination, the regulatory agency often | ||
possesses information which is not readily available | possesses information which is not readily available | ||
Line 4,665: | Line 5,060: | ||
of the applicable regulatory review period. | of the applicable regulatory review period. | ||
2757Regulatory Agency Determination | |||
of the Length of the Regulatory | |||
Review Period | |||
Under 35 U.S.C. 156, the regulatory agency is | Under 35 U.S.C. 156, the regulatory agency is | ||
Line 4,693: | Line 5,090: | ||
testing phase and the final approval phase. This provides | testing phase and the final approval phase. This provides | ||
the Office with the information necessary to | the Office with the information necessary to | ||
determine the actual length of extension for which the | determine the actual length of extension for which the | ||
patent may be eligible. The Federal Register Notice | patent may be eligible. The Federal Register Notice | ||
Line 4,713: | Line 5,116: | ||
warranted under 35 U.S.C. 156(d)(5) and (e)(2). | warranted under 35 U.S.C. 156(d)(5) and (e)(2). | ||
2757.01Due Diligence Determination | |||
If a due diligence petition is filed during the 180- | If a due diligence petition is filed during the 180- | ||
Line 4,740: | Line 5,143: | ||
21 CFR Ch. 1, Subparts D and E. | 21 CFR Ch. 1, Subparts D and E. | ||
2758Notice of Final Determination - | |||
Calculation of Patent Term Extension | |||
[R-2] | |||
35 U.S.C. 156. Extension of patent term. | |||
(c)The term of a patent eligible for extension under subsection | (c)The term of a patent eligible for extension under subsection | ||
(a) shall be extended by the time equal to the regulatory | (a) shall be extended by the time equal to the regulatory | ||
Line 4,770: | Line 5,177: | ||
under subsection (e)(i) for the same regulatory review period for | under subsection (e)(i) for the same regulatory review period for | ||
any product. | any product. | ||
(6)A period determined under any of the preceding paragraphs | (6)A period determined under any of the preceding paragraphs | ||
is subject to the following limitations: | is subject to the following limitations: | ||
Line 4,790: | Line 5,199: | ||
for a regulation or application for registration described in | for a regulation or application for registration described in | ||
such paragraph was submitted, or | such paragraph was submitted, or | ||
(iii)no clinical investigation described in paragraph | (iii)no clinical investigation described in paragraph | ||
Line 4,801: | Line 5,212: | ||
the enactment of this section and if an action described in subparagraph | the enactment of this section and if an action described in subparagraph | ||
(B) was taken before the date of enactment of this section | (B) was taken before the date of enactment of this section | ||
with respect to the approved product and the commercial marketing | with respect to the approved product and the commercial marketing | ||
or use of the product has not been approved before such date, | or use of the product has not been approved before such date, | ||
Line 4,809: | Line 5,226: | ||
used in the Federal Food, Drug, and Cosmetic Act or the Virus- | used in the Federal Food, Drug, and Cosmetic Act or the Virus- | ||
Serum-Toxin Act), three years. | Serum-Toxin Act), three years. | ||
Line 4,840: | Line 5,256: | ||
denial. The applicant is given a period, usually one | denial. The applicant is given a period, usually one | ||
month, in which to seek reconsideration of the determination. | month, in which to seek reconsideration of the determination. | ||
If the patent is found to be eligible for extension, | |||
the Notice of Final Determination may include text | |||
similar to the following: | |||
A determination has been made that U.S. Patent No. ___, | |||
which claims the human drug ___, is eligible for patent term | |||
extension under 35 U.S.C. 156. The period of extension has | |||
been determined to be ___. | |||
A single request for reconsideration of this final determination | |||
as to the length of extension of the term of the patent | |||
may be made if filed within one month of the date of this | |||
notice. Extensions of time under 37 CFR 1.136(a) are not | |||
applicable to this time period. In the absence of such request | |||
for reconsideration, the Director will issue a certificate | |||
of extension, under seal, for a period of ___ days. | |||
The period of extension has been calculated using the FDA | |||
determination of the length of the regulatory review period | |||
published in the Federal Register of ___. Under 35 U.S.C. | |||
156(c). | |||
Period of Extension = 1/2 (Testing Phase) + Approval | |||
Phase | |||
= 1/2 (___ -___) + ___ | |||
= ___ days | |||
Since the regulatory review period began __, before the | |||
patent issued ___, only that portion of the regulatory review | |||
period occurring after the date the patent issued has been | |||
considered in the above determination of the length of the | |||
extension period 35 | |||
U.S.C. 156(c). (From __ to ___) is___ | |||
days; this period is subtracted for the number of days occurring | |||
in the testing phase according to the FDA determination | |||
of the length of the regulatory review period.) No | |||
determination of a lack of due diligence under 35 U.S.C. | |||
156(c)(1) was made. | |||
The 14 year exception of 35 U.S.C. 156(c)(3) operates to | |||
limit the term of the extension in the present situation | |||
because it provides that the period remaining in the term of | |||
the patent measured from the date of approval of the | |||
approved product (___) when added to the period of extension | |||
calculated above (___ days) cannot exceed fourteen | |||
years. The period of extension is thus limited to ___, by | |||
operation of 35 U.S.C. 156(c)(3). Since the patent term (35 | |||
U.S.C. 154) would expire on ___, the period of extension is | |||
the number of days to extend the term of the patent from its | |||
expiration date to and including ___, or ___ days. | |||
The limitations of 35 U.S.C. 156(g)(6) do not operate to further | |||
reduce the period of extension determined above. | |||
See MPEP § 2759 for further information pertaining | See MPEP § 2759 for further information pertaining | ||
Line 4,862: | Line 5,335: | ||
See 35 | See 35 | ||
U.S.C. 156(d)(5)(E)(ii). | U.S.C. 156(d)(5)(E)(ii). | ||
No certificate or extension will be issued if the term | No certificate or extension will be issued if the term | ||
Line 4,870: | Line 5,348: | ||
CALCULATION OF PATENT TERM EXTENSION | CALCULATION OF PATENT TERM EXTENSION | ||
The procedure for calculating the length of the | The procedure for calculating the length of the | ||
Line 4,935: | Line 5,414: | ||
the calculated extension period cannot exceed any of | the calculated extension period cannot exceed any of | ||
the following statutory maximum periods of extension: | the following statutory maximum periods of extension: | ||
(A)If the period remaining in the term of | (A)If the period remaining in the term of | ||
Line 4,966: | Line 5,446: | ||
1549, 1551 (Fed. Cir. 1990). | 1549, 1551 (Fed. Cir. 1990). | ||
2759Certificate of Extension of Patent | |||
Term [R-2] | |||
35 U.S.C. 156. Extension of patent term. | |||
(e)(1) A determination that a patent is eligible for extension | (e)(1) A determination that a patent is eligible for extension | ||
may be made by the Director solely on the basis of the representations | may be made by the Director solely on the basis of the representations | ||
Line 4,980: | Line 5,468: | ||
(c). Such certificate shall be recorded in the official file of the | (c). Such certificate shall be recorded in the official file of the | ||
patent and shall be considered as part of the original patent. | patent and shall be considered as part of the original patent. | ||
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 | 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 | eligible for extension and that the term of the patent is to be | ||
Line 5,004: | Line 5,493: | ||
final determination made pursuant to § 1.750 will indicate that no | final determination made pursuant to § 1.750 will indicate that no | ||
certificate or order will issue. | certificate or order will issue. | ||
Once a determination is made pursuant to 37 CFR | Once a determination is made pursuant to 37 CFR | ||
Line 5,022: | Line 5,509: | ||
Upon issuance of the certificate of extension, a | Upon issuance of the certificate of extension, a | ||
notice is published in the Official Gazette. | notice is published in the Official Gazette. A sample | ||
Official Gazette Notice Follows: | |||
PATENT TERM EXTENDED UNDER 35 U.S.C. 156 | |||
A Certificate extending the term of the following patent was | |||
issued on __. | |||
U.S. Patent No.: __ Granted: __; Applicant: __; Owner of Record: | |||
__; Title: ___; Classification: __ Product Trade Name: __; Original | |||
Expiration Date: __; Term Extended: ____; Extended Expiration | |||
Date: __. | |||
All original papers from the application for patent | All original papers from the application for patent | ||
Line 5,042: | Line 5,540: | ||
stored in the Office of Patent Legal Administration. | stored in the Office of Patent Legal Administration. | ||
2760Trade Secret, Confidential, and | |||
Protective Order Material | |||
There is no provision in the statute or the rules for | There is no provision in the statute or the rules for | ||
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of determining the precise material in the application | of determining the precise material in the application | ||
which is proprietary or trade secret information. Only | which is proprietary or trade secret information. Only | ||
the applicant is in a position to make this determination. | the applicant is in a position to make this determination. | ||
See In re Schering-Plough Corp., 1 USPQ2d | See In re Schering-Plough Corp., 1 USPQ2d | ||
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information will be open to public inspection. | information will be open to public inspection. | ||
2761Multiple Applications for Extension | |||
of Term of the Same Patent or | |||
of Different Patents for the Same | |||
Regulatory Review Period for a | |||
Product | |||
35 U.S.C. 156. Extension of patent term. | |||
(c)(4) in no event shall more than one patent be extended | (c)(4) in no event shall more than one patent be extended | ||
under subsection (e)(i) for the same regulatory review period for | under subsection (e)(i) for the same regulatory review period for | ||
any product. | any product. | ||
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 | (a)Only one patent may be extended for a regulatory review | ||
period for any product § 1.720 (h). If more than one application | period for any product § 1.720 (h). If more than one application | ||
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the patent term pursuant to § 1.750 and shall be regarded as part of | the patent term pursuant to § 1.750 and shall be regarded as part of | ||
that determination. | that determination. | ||
Only one patent may be extended for a regulatory | Only one patent may be extended for a regulatory | ||
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patent based upon the regulatory review period of different | patent based upon the regulatory review period of different | ||
products, then the final determination under | products, then the final determination under | ||
37 CFR 1.750 will provide a period of time (usually | 37 | ||
CFR 1.750 will provide a period of time (usually | |||
one month) for the patent owner to elect the product | one month) for the patent owner to elect the product | ||
for which extension is desired. An express withdrawal | for which extension is desired. An express withdrawal | ||
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for the patent for a specified one of the products. | for the patent for a specified one of the products. | ||
If more than one application for extension is filed | If more than one application for extension is filed | ||
by a single applicant for the extension of the terms of | by a single applicant for the extension of the terms of | ||
different patents based upon the same regulatory | different patents based upon the same regulatory | ||
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will be issued on the application for extension of | will be issued on the application for extension of | ||
the patent having the earliest date of issuance of those | the patent having the earliest date of issuance of those | ||
for which extension is sought unless all but one application | for which extension is sought unless all but one application | ||
for extension is voluntarily withdrawn by the | for extension is voluntarily withdrawn by the | ||
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extension. See also 37 CFR 1.785(d). | extension. See also 37 CFR 1.785(d). | ||
2762Duty of Disclosure in Patent Term | |||
Extension Proceedings [R-2] | |||
37 CFR 1.765. Duty of disclosure in patent term extension | |||
proceedings. | |||
(a)A duty of candor and good faith toward the Patent and | (a)A duty of candor and good faith toward the Patent and | ||
Trademark Office and the Secretary of Health and Human Services | Trademark Office and the Secretary of Health and Human Services | ||
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a final determination will be made pursuant to § 1.750 that the | a final determination will be made pursuant to § 1.750 that the | ||
patent is not eligible for extension. | patent is not eligible for extension. | ||
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agent. | agent. | ||
A determination of eligibility for an extension or | |||
A determination of eligibility for an extension or | |||
the issuance of a certificate will not be made if clear | the issuance of a certificate will not be made if clear | ||
and convincing evidence of fraud or attempted fraud | and convincing evidence of fraud or attempted fraud | ||
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MPEP § 2010. | MPEP § 2010. | ||
2763Limitation of Third Party Participation | |||
[R-2] | |||
37 CFR 1.765. Duty of disclosure in patent term extension | |||
proceedings. | |||
(d)The duty of disclosure pursuant to this section rests on | (d)The duty of disclosure pursuant to this section rests on | ||
the individuals identified in paragraph (a) of this section and no | the individuals identified in paragraph (a) of this section and no | ||
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making the submission, or otherwise disposed of, without consideration | making the submission, or otherwise disposed of, without consideration | ||
by the Office. | by the Office. | ||
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or on behalf of third parties, thereby making patent | 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 | 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. Submissions by third parties not requested by | |||
the Office will be returned, or otherwise disposed of, | the Office will be returned, or otherwise disposed of, | ||
without consideration. See In re Dubno, 12 USPQ2d 1153, 1154 (Comm’r Pat. & Tm. 1989). | without consideration. See In re Dubno, | ||
12 | |||
USPQ2d | |||
1153, 1154 (Comm’r Pat. & Tm. 1989). | |||
2764Express Withdrawal of Application | |||
for Extension of Patent Term | |||
37 CFR 1.770. Express withdrawal of application for | |||
extension of patent term. | |||
An application for extension of patent term may be expressly | An application for extension of patent term may be expressly | ||
withdrawn before a determination is made pursuant to § 1. | withdrawn before a determination is made pursuant to § | ||
1.750by | |||
filing in the Office, in duplicate, a written declaration of withdrawal | filing in the Office, in duplicate, a written declaration of withdrawal | ||
signed by the owner of record of the patent or its agent. An | signed by the owner of record of the patent or its agent. An | ||
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withdrawal pursuant to this section and its acceptance by the | withdrawal pursuant to this section and its acceptance by the | ||
Office does not entitle applicant to a refund of the filing fee | Office does not entitle applicant to a refund of the filing fee | ||
(§ 1.20(j)) or any portion thereof. | (§ | ||
1.20(j)) or any portion thereof. | |||
Any request for withdrawal of an application for | Any request for withdrawal of an application for | ||
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under 37 CFR 1.182 with the appropriate petition filing | under 37 CFR 1.182 with the appropriate petition filing | ||
fee. | fee. | ||