This chapter discusses the intricacies involved with patent terms including how a term may be adjusted or extended. It is a fairly new chapter in the MPEP, therefore all the laws and rules have been included.

In all likelihood, at least a couple of questions will be asked on patent terms and extensions. The PTO loves to test over new and obscure information and this chapter covers quite a bit.

2701 Patent Term

35 U.S.C. 154 Contents and term of patent; provisional rights.
(a) IN GENERAL.
(1) CONTENTS.Every patent shall contain a short title of the invention and a grant to the patentee, his heirs or assigns, of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States, and, if the invention is a process, of the right to exclude others from using, offering for sale or selling throughout the United States, or importing into the United States, products made by that process, referring to the specification for the particulars thereof.
(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.
(4) SPECIFICATION AND DRAWING.A copy of the specification and drawing shall be annexed to the patent and be a part of such patent.

35 U.S.C. 154 Contents and term of patent; provisional rights.
(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 20year 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.

2710 Term extensions or adjustments for delays within the USPTOunder 35 U.S.C. 154
for applications filed on or after June 8, 1995, the term of a utility or plant patent begins on the date the patent issues and ends on the date that is 20 years from the date on which the application for the patent was filed in the U.S.

if the application contains a specific reference to an earlier filed application, the term of a utility or plant patent begins on the date the patent issues and ends on the date that is 20 years from the filing date of the earliest of such application

design patents have a term of 14 years from the date of patent grant

patents in force on June 8, 1995, or that issued from an application that was filed before June 8, 1995, have a term that is the greater of the 20 year term or 17 years from the patent grant

continuing applications:
a patent granted on a continuation, divisional, or continuationinpart application that was filed on or after June 8, 1995, will have a term which ends 20 years from the filing date of the earliest application

international applications:
a patent granted on an international application filed on or after June 8, 1995 and which enters the national stage will have a term which ends 20 years from the filing date of the international application

foreign priority:
is not considered in determining the term of a patent
an application claiming priority has a term which ends 20 years from the filing date of the application in the U.S. and not the prior international application

domestic priority:
is not considered in the calculation of the 20 year term

patents with terminal disclaimers:
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

2720 Applications filed between June 8, 1995, and May 28, 2000

§ 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 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.
(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 wasdeclared 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 § 1.193 in 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 Commissioner, during which the applicant for patent did not act with due diligence. In determining the due diligence of an applicant, the Commissioner 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 20 year term for patents issued between June 8, 1995 and May 28, 2000 may be extended for a maximum of 5 years for delays in the issuance of the patent

delays may be due to:
interferences
secrecy orders

appeals
if the patent issues with a different patent term extension value than that indicated on the Notice of Allowance or Office computer records, the patentee may seek correction of the information by filing a request for a Certificate of Correction

if the applicant disagrees with the PTO's determination of whether to extend the patent, he or she may request review by petitioning under 37 C.F.R. 1.181

2730 Applications filed on or after May 29, 2000; Grounds for adjustment
the following rules discuss patent term adjustments (PTA)

the amendments made to both are effective May 29, 2000 for both plant and utility patents

35 U.S.C. 154 Contents and term of patent; provisional rights.
(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 151 of 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 3YEAR 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 3year 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 3month 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 3month period, but in no case shall more than three additional months for each such response beyond the original 3month 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.

§ 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, 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. 132 or 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
(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 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 pursuant to a decision reversing an adverse determination of patentability.
(f) The provisions of this section and §§1.703 through 1.705 apply only to original applications, except applications for a design patent, filed on or after May 29, 2000, and patents issued on such applications.

1.702(a):
a patent is entitled to Patent Term Adjustments (PTA) if the Office fails to perform certain acts of examination within specified time periods

1.702(b):
a patent is entitled to PTA if the Office fails to issue a patent within 3 years of the actual filing date of the application for international applications, the actual filing date is the date national stage commences

1.702(c):
a patent is entitled to PTA if the patent is delayed by an interference

1.702(d):
a patent is entitled to PTA if the patent is delayed by a secrecy order

1.702(e):
a patent is entitled to PTA if the patent is delayed by an appeal

furthermore, as noted in 1.702(f), these new PTA rules apply only to original applications (except those claiming designs) filed on or after May 29, 2000 and patents issued on these applications
the rules will not apply to requests for continuing examination (RCE)
the rules will apply to CIP's because there is new material in a CIP application

no submission or petition on behalf of a third party concerning a PTA under 35 U.S.C. 154(b) will be considered by the Office

§ 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 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 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 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 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 under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (I) 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 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 § 1.193 in 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 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 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.
(I) 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 adjustment 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 § 1.702 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.

§ 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 threemonth 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 § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for suspension of action under § 1.103 was 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 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 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 § 1.56(c) more than thirty days prior to the filing of the information disclosure statement. This thirtyday 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.

2750 Patent term extension for delays at other agencies under 35 U.S.C. 156
The right to a patent term extension may be based upon regulatory agency review (such as FDA approval). This was a problem in the past; inventors would conceive of and reduce an idea to practice, apply for a patent, finally be granted a patent, but would not be able to sell or make any profit from their invention until FDA approval was granted. Sometimes, gaining approval from the FDA or another regulatory committee would take so long that a large portion of the patent term was already gone.

35 U.S.C. 156 was designed to create new incentives for the research and development of certain products subject to premarket government approval by a regulatory agency
the statute enables owners of patents to add to the patent term if they lost time awaiting premarket government approval from a regulatory agency
an application for an extension of a patent term under 35 U.S.C. 156 must be submitted by the recorded owner or its agent within the 60 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

2751 Eligibility requirements
the PTO has added three laws to discuss the lovely details of patent term extensions for delays at other agencies (an overview was discussed in MPEP 2750, the previous section) the three laws are:
35 U.S.C. 156:
which describes exactly what types of patents may be extended and the extension conditions
37 C.F.R. 1.710:
which describes the patents that may be extended
37 C.F.R. 1.720:
which describes the conditions for the extension

35 U.S.C. 156 Extension of patent term.
(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 nonfoodproducing animals and in foodproducing animals, and
(ii) was not extended on the basis of the regulatory review period for use in nonfoodproducing animals, the permission for the commercial marketing or use of the drug or product after the regulatory review period for use in foodproducing animals is the first permitted commercial marketing or use of the drug or product for administration to a foodproducing animal. The product referred to in paragraphs (4) and (5) is hereinafter in this section referred to as the "approved product."
(b) Except as provided in subsection (d)(5)(F), the rights derived from any patent the term of which is extended under this section shall during the period during which the term of the patent is extended
(1) in the case of a patent which claims a product, be limited to any use approved for the
product
(A) before the expiration of the term of the patent
(i) under the provision of law under which the applicable regulatory review occurred, or
(ii) under the provision of law under which any regulatory review
described in paragraph (1), (4), or (5) of subsection (g) occurred, and
(B) on or after the expiration of the regulatory review period upon which the extension of the patent was based;
(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the product
(A) before the expiration of the term of the patent
(i) under any provision of law under which an applicable regulatory review occurred, and
(ii) under the provision of law under which any regulatory review
described in paragraph (1), (4), or (5) of subsection (g) occurred, and
(B) on or after the expiration of the regulatory review period upon which the extension of the patent was based; and
(3) 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
(A) the approved product, or
(B) the product if it has been subject to a regulatory review period described in paragraphs (1), (4), or (5) of subsection (g). As used in this subsection, the term "product" includes an approved product.
(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 onehalf 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. (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 sixtyday 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.
(2) (A) Within 60 days of the submittal of an application for extension of the term of a patent under paragraph (1), the Director shall notify
(i) the Secretary of Agriculture if the patent claims a drug product or a method of using or manufacturing a drug product and the drug product is subject to the VirusSerumToxin Act, and
(ii) the Secretary of Health and Human Services if the patent claims any other drug product, a medical device, or a food additive or color additive or a method of using or manufacturing such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug and Cosmetic Act, of the extension application and shall submit to the Secretary who is so notified a copy of the application. Not later than 30 days after the receipt of an application from the Director, the Secretary reviewing the application shall review the dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Director of the determination, and shall publish in the Federal Register a notice of such determination.
(B) (i) If a petition is submitted to the Secretary making the determination under subparagraph (A), not later than 180 days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period, the Secretary making the determination shall, in accordance with regulations promulgated by the Secretary, determine if the applicant acted with due diligence during the applicable regulatory review period. The Secretary making the determination shall make such determination not later than 90 days after the receipt of such a petition. For a drug product, device, or additive subject to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, the Secretary may not delegate the authority to make the determination prescribed by this clause to an office below the Office of the Commissioner of Food and Drugs. For a product subject to the VirusSerumToxin Act, the Secretary of Agriculture may not delegate the authority to make the determination prescribed by this clause to an office below the office of the Assistant Secretary for Marketing and Inspection Services.
(ii) The Secretary making a determination under clause (i) shall notify the Director of the determination and shall publish in the Federal Register a notice of such determination together with the factual and legal basis for such determination. Any interested person may request, within the 60day period beginning on the publication of a determination, the Secretary making the determination to hold an informal hearing on the
determination. If such a request is made within such period, such Secretary shall hold such hearing not later than 30 days after the date of the request, or at the request of the person making the request, not later than 60 days after such date. The Secretary who is holding the hearing shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportunity to participate in the hearing. Within 30 days after the completion of the hearing, such Secretary shall affirm or revise the determination which was the subject of the hearing and notify the Director of any revision of the determination and shall publish any such revision in the Federal Register.
(3) For the purposes of paragraph (2)(B), the term "due diligence" means 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.
(4) An application for the extension of the term of a patent is subject to the disclosure requirements prescribed by the Director.
(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. (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 60day period beginning on the day on which the product involved receives permission for commercial marketing or use, except that, if within that 60day 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.
(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.
(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.
(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 VirusSerum 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 VirusSerum 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.
(g) For purposes of this section, the term "regulatory review period" has the following meanings:
(1) (A) In the case of a product which is a new drug, antibiotic drug, or human biological product, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a new drug, antibiotic drug, or human biological product is the sum of
(i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 became effective for the approved product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507, and
(ii) the period beginning on the date the application was initially submitted for the approved product under section 351, subsection (b) of section 505, or section 507 and ending on the date such application was approved under such section.
(2) (A) In the case of a product which is a food additive or color additive, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a food or color additive is the sum of
(i) the period beginning on the date a major health or environmental effects test on the additive was initiated and ending on the date a petition was initially submitted with respect to the product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and
(ii) the period beginning on the date a petition was initially submitted with respect to the product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and ending on the date such regulation became effective or, if objections were filed to such regulation, ending on the date such objections were resolved and commercial marketing was permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, ending on the date such proceedings were finally resolved and commercial marketing was permitted.
(3) (A) In the case of a product which is a medical device, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a medical device is the sum of
(i) the period beginning on the date a clinical investigation on humans involving the device was begun and ending on the date an application was initially submitted with respect to the device under section 515, and
(ii) the period beginning on the date an application was initially submitted with respect to the device under section 515 and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of a product development protocol was initially submitted under section 515(1)(5) and ending on the date the protocol was declared completed under section 515(1)(6).
(4) (A) In the case of a product which is a new animal drug, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(B) The regulatory review period for a new animal drug product is the sum of
(i) the period beginning on the earlier of the date a major health or environmental effects test on the drug was initiated or the date an exemption under subsection (j) of section 512 became effective for the approved new animal drug product and ending on the date an application was initially submitted for such animal drug product under section 512, and
(ii) the period beginning on the date the application was initially submitted for the approved animal drug product under subsection (b) of section 512 and ending on the date such application was approved under such section.
(5) (A) In the case of a product which is a veterinary biological product, the term
means the period described in subparagraph (B) to which the limitation described
in paragraph (6) applies.
(B) The regulatory period for a veterinary biological product is the sum of
(i) the period beginning on the date the authority to prepare an experimental biological product under the Virus SerumToxin Act became effective and ending on the date an application for a license was submitted under the VirusSerumToxin Act, and
(ii) the period beginning on the date an application for a license was initially submitted for approval under the VirusSerumToxin Act and ending on the date such license was issued.
(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 VirusSerumToxin Act), three years.
(h) The Director may establish such fees as the Director determines appropriate to cover the costs to the Office of receiving and acting upon applications under this section.

§ 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
(I) 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 VirusSerumToxin 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.

§ 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 nonfoodproducing animals and in foodproducing animals, and was not extended on the basis of the regulatory review period for use in nonfoodproducing animals, the permission for the commercial marketing or use of the drug or product after the regulatory review period for use in foodproducing animals is the first permitted commercial marketing or use of the drug or product for administration to a foodproducing animal.
(f) The application is submitted within the sixtyday 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 sixtyday 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 nonfoodproducing animals, the application for extension is submitted within the sixtyday period beginning on the date of the first permitted commercial marketing or use of the drug or product for administration to a foodproducing 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.

patents claiming the following types of inventions may qualify for an extension:
a human drug product
medical devices
food or color additive first approved for marketing or use after Sept. 24, 1984
animal drug
veterinary biological product first approved for marketing or use after Nov 16, 1988

the applicant must establish that:
the patent has not expired
the patent has never been extended under 35 U.S.C. 156 before
the owner of record or its agent submitted the extension application within 60 days of regulatory agency approval
the product has been subject to a regulatory review period before its commercial marketing or use
the approval is the first permitted commercial marketing or use of the product 2752 Patent term extension applicant

the application for extension must be submitted by the owner of record or its agent

if filed by assignee, there must be a reference to the recorded assignment 2753 Application contents

§ 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 Commissioner. 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 SerumToxin 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 § 1.720(I) 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 SerumToxin Act became effective;
(B) The date an application for a license was submitted under the VirusSerumToxin 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 Commissioner of Patents and Trademarks 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 C.F.R. 1.740 sets forth the formal requirements for the application for extension of patent term in detail

note that 5 copies of the application for patent term extension are required

2754 Filing date

§ 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 Commissioner 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 Commissioner 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.

the filing date for an application for patent term extension is the date the complete
application is received in the USPTO or filed pursuant to certification of mailing provisions or Express Mail provisions
it may not be filed by facsimile
if the application does not meet the formal requirements of 37 C.F.R. 1.740(a), then the applicant will have to correct the informality within the time period set forth in the notice
if the application meets the requirements of 37 C.F.R. 1.741, the application filing date will be established even if the application is held to be informal under 37 C.F.R. 1.740

2755 Eligibility determination

§ 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 Commissioner 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 Commissioner 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.

§ 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 Commissioner 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.

the Commissioner may issue an interim extension for the patent term for up to one year pending a final decision on the application for extension
if the original term of the patent will expire before a final decision to issue, a certificate of extension can be made

§ 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.

§ 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 60day period beginning on the date on which the product involved receives permission for commercial marketing or use. If within that 60day 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.

2762 Duty of disclosure in patent term extension proceedings

§ 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.
(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.

2764 Express withdrawal of application for extension of patent term

§ 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.