FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 1 ACI's Maximizing Pharmaceutical Patent Life Cycles Conference PTE-PTA Boot Camp October 3, 2011 Justin J. Oliver Fitzpatrick, Cella, Harper & Scinto 975 F Street NW Washington, D.C

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 2 Introduction  Patent Term Adjustment –Adjustment of term of a patent based on delays by the PTO, which delays may be offset by delays by the applicant –Unlike PTE, PTA is not limited to a patent that covers a particular product and will be granted by the PTO automatically

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 3 Eligibility, Statute & Rules  PTA Eligibility –Applications filed on or after May 29, 2000 –Use PCT filing date for US national stage applications  Statute –35 U.S.C. § 154(b)  Rules –37 C.F.R. §§

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 4 Basics  General Calculation of PTA –(Days of PTO Delay) – (Days of Applicant Delay) = PTA  But Applicant can only have days added (if the calculation results in a number less than zero, then the PTA is zero days)  No limitation on the total number of days that can be added  Calculation is made for each patent  Can be further extended by PTE

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 5 Types of PTO Delays  “A Delay” –PTO fails to respond to applicant submission within set statutory periods (“ ”)  “B Delay” –PTO fails to issue patent within three years of filing  “C Delay” –Miscellaneous delays (e.g., interference)

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 6 A Delay – Statute  35 U.S.C. §154(b)(1)(A) –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- the date on which an application was filed under section 111(a) of this title; or 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.

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 7 A Delay – First Action  USPTO fails to mail a first action within 14 months of: –U.S. filing date –Date national stage application fulfills requirements of § 371  § 371(c) date  First action may include –Written restriction or election of species requirement –Office Action (including Quayle) –Notice of Allowability –Requirement for information under § 1.105

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 8 A Delay – Acting on Applicant Response  USPTO fails to act within 4 months of applicant’s reply or appeal brief –Includes replies to first or subsequent office actions –An applicant reply to a final office action that does not put the claims in condition for allowance does not start the clock (unless RCE filed) –Non-compliant appeal brief or response does not start the clock

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 9 A Delay – Resuming Action After Board or Court Decision  USPTO fails to act within 4 months of decision by Board or Federal court that includes an allowable claim –Appeals, interferences, civil actions

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 10 A Delay – Issuing the Patent  USPTO fails to issue patent within 4 months payment of issue fee –All outstanding requirements must have been satisfied to start clock

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 11 A Delay – Calculation  The period of delay: –Begins on the day after the USPTO deadline (e.g., the day after the 14 month deadline for issuing a first action) –Ends on the day the USPTO issues the delayed paper –Count all days in the period (including beginning and ending dates)

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 12 B Delay – Statute  35 U.S.C. §154(b)(1)(B) –Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application in the United States, not including- (i) any time consumed by continued examination of the application requested by the applicant under section 132(b); (ii) any time consumed by a proceeding under section 135(a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Board of Patent Appeals and Interferences or by a Federal court; or (iii) any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph (3)(C), the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 13 B Delay – Three Year Pendency  Provides for adjustment of term based on failure to issue a patent within 3 years after: – U.S. filing date –date of national phase entry  Excluding –RCE filings – date of filing to issue date –Interferences – same as calculation under C delay –Secrecy Order – same as calculation under C delay –Appellate review (Board or court) – similar to calculation under C delay –Delay requested by applicant – not specifically articulated

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 14 B Delay – National Phase Entry  National phase entry date –§ 371(b)  30-month date, even if application is incomplete –§ 371(f)  Must request § 371(f) start  Application must be complete  Note difference with determination in A Delays –Statute says “actual filing date” in United States for B delay, as opposed to “fulfilled requirements of section 371” for A delay

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 15 B Delay – National Phase Entry  Japan Tobacco –PTO had measured three-year period from the completion of all requirements under § 371(c) (e.g., signed declaration) –This was challenged in Japan Tobacco and led to the PTO correcting the way it calculates B delay  Now the PTO measures it from the national stage commencement under § 371(b) (30-month date) or § 371(f) (express request for early processing)

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 16 C Delays – Statute  35 U.S.C. §154(b)(1)(C) –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.

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 17 C Delay – Interference  Adjustment Calculation for Interference: –The number of days in the period beginning on the date the interference was declared or redeclared to involve the application and ending on the date that the interference was terminated with respect to the application –The number of days in the period beginning on the date prosecution was suspended by the PTO due to an interference proceeding not involving the application and ending on the date of the termination of the suspension

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 18 C Delay – Secrecy Order  Adjustment Calculation for Secrecy Order: –The number of days the application was maintained in a sealed condition under 35 U.S.C. § 181 –The number of days in the period beginning on the date of mailing of an examiner's answer under § in the application under secrecy order and ending on the date the secrecy order was removed –The number of days 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 –The number of days 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 35 U.S.C. § 151

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 19 C Delay – Appellate Review  Adjustment Calculation for Appeals: –The number of days in the period beginning on the date on which a notice of appeal to the Board was filed and ending on the date of a final decision in favor of the applicant by the Board or by a Federal court (appeal or civil action)  Does not count if you file RCE after successful appeal before next action  Slightly different than corresponding B delay calculation B delay refers to decision, action or notice of allowance This allows PTO to exclude time consumed by an appeal that does not result in a decision (e.g., the Examiner decides to withdraw the rejection on appeal)

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 20 Overlap of Delays - Statute  35 U.S.C. §154(b)(2)(A) –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.

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 21 Overlap of Delays – Calculation  What is an “overlap”? –Wyeth v. Dudas  PTO took the position that “overlap” occurred based on the mere existence of A and B delays, even if those delays occurred on different calendar days  Court held that “overlap” occurs when different delays occur on same calendar day

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 22 Overlap of Delays – Calculation Filing Date PTO Deadline PTO Action 3 Year Deadline PTO Deadline PTO Action; Issuance (A) Delay – No overlap(A) Delay – Overlap (B) Delay

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 23 Reduction of PTA – Statute  35 U.S.C. §154(b)(2)(B)-(C) –(B) No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer. –(C) REDUCTION OF PERIOD OF ADJUSTMENT (i) The period of adjustment of the term of a patent under paragraph (1) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. (ii) With respect to adjustments to patent term made under the authority of paragraph (1)(B), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of 3 months that are taken to respond to a notice from the Office making any rejection, objection, argument, or other request, measuring such 3-month period from the date the notice was given or mailed to the applicant. (iii) The Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 24 Reduction of PTA – Rules  37 C.F.R § 1.704(a) – Generally –PTA 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  37 C.F.R. § 1.704(b) – Concerning Replies –Failure to reply to notice/action making any rejection, objection, argument or other request within 3 months of mailing (but option for reinstatement)  Period set for reply in notice/action has no effect on 3-month period  PTO does not yet count the first business day after weekend or holiday as within 3 months (but see Arqule, Inc. v. Kappos)  PTO uses actual date of receipt or express mailing date, not certificate of mailing date or facsimile transmission date  37 C.F.R. § 1.704(c) – Miscellaneous –Specific circumstances that constitute failure of applicant to engage in reasonable efforts

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 25 Reduction of PTA – Specific Circumstances  Applicant requests suspension of action (§ 1.704(c)(1))  Deferral of issuance of patent under § (§ 1.704(c)(2)) –Period ends when patent issues  Abandonment of application or late payment of issue fee (§ 1.704(c)(3)) –Period ends at date decision to revive is mailed, or 4 months after grantable petition is filed  Failure to file a petition to withdraw holding of abandonment or to revive an application within two months of notice (§ 1.704(c)(4)) –Period ends with filing of petition

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 26 Reduction of PTA – Specific Circumstances  Conversion of provisional application into nonprovisional (§ 1.704(c)(5)) –Period is provisional filing date until request for conversion  Submission of preliminary amendment or other preliminary paper (e.g., IDS) less than one month before mailing of (1) office action or (2) notice of allowance, which requires mailing of supplemental action or notice (§ 1.704(c)(6)) –Period is lesser of (1) date of mailing of first action/notice and ending on mailing of supplemental action/notice or (2) 4 months  Submission of reply having an omission (§ 1.704(c)(7)) –Period begins on day after filing of paper and ends on date corrected reply is filed  Submission of supplemental reply or other paper (IDS) (§ 1.704(c)(8)) –Period begins the day after the initial reply and ends with suppl. filing

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 27 Reduction of PTA – Specific Circumstances  Submission of Amendment or other paper after a decision by the Board (except new ground of rejection), or Federal court less than 1 month before Office Action or allowance that requires supplement action or paper (§ 1.704(c)(9)) –Period is lesser of (1) day after mailing of action/notice and ending on date of mailing of new supplemental action/notice, or (2) 4 months  Submission of 312 amendment or other paper (e.g., IDS) after notice of allowance was given or mailed (§ 1.704(c)(10)) –Period is lesser of (1) day of filing of 312 amendment/other paper through mailing of notice in response to such paper, or (2) 4 months  Filing of a continuing application (§ 1.704(c)(11)) –Wipes out calculation and starts fresh

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 28 Reduction of PTA – Specific Circumstances  Information Disclosure Statement –Will not be considered failure to engage in reasonable efforts to conclude prosecution if:  Accompanied by statement that each item of information was first cited in any communication from a foreign patent office in a counterpart application; and  The communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS 56(c) includes applicants, attorneys, and “every other person who is substantively involved in the preparation and prosecution …”

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 29 Correction of PTA – During Prosecution  Applicant cannot request correction of PTA until the first calculation provided with Notice of Allowance  However, the entries in PAIR made throughout prosecution will be used by the PTO to make the PTA calculation –To avoid problems, during prosecution an applicant should ensure that the entries in PAIR are correct –Errors in PAIR can be corrected before the PTA calculation by calling the Examiner or Tech Center

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 30 Correction of PTA – At Allowance  Correcting PTA Calculation provided with Notice of Allowance –File a request for reconsideration no later than payment of issue fee (A and C delays)  Request should include: Statement of facts »Correct term and basis for adjustment »Relevant dates »Whether a Terminal Disclaimer is involved »Any circumstances constituting failure to engage in reasonable efforts to conclude prosecution (or statement that there were no such circumstances) fee

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 31 Correction of PTA – Reinstatement  Under 37 C.F.R. § 1.705(c), an applicant may apply for reinstatement of all or part of reductions in PTA due to a failure to respond to a PTO rejection, objection, argument, or other request within 3 months –Requirements:  Showing that, in spite of all due care, applicant was unable to respond within 3 months  Fee –Example – Time for scientific testing to rebut rejection

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 32 Correction of PTA – At Issuance  Correcting PTA Calculation listed on issued patent –File a request for reconsideration no later than 2 months after issue date  Applies to errors that could not have been corrected at allowance  Requirements for the request are similar to those at allowance

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 33 Correction of PTA – In Court  Correcting PTA through an action in District Court –Now Eastern District of Virginia (America Invents Act) –File civil action no later than 180 days after patent grant –Option available after administrative remedies have been exhausted (i.e., file request in PTO first) –180 days measure regardless of whether applicant has yet received a response to any request filed with PTO

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 34 Correction of PTA – In Court  Bristol-Myers Squibb Co. v. Kappos –Is 180 day rule absolute?  Argues that the 180-day clock should not run until agency action is resolved, not when patent is issued See ICC v. Brotherhood of Locomotive Engineers, 482 U.S. 270 (1987) (a statutory period for seeking judicial review of an administrative decision does not begin to run until after any timely requests for administrative reconsideration have been resolved)  Since most motions for reconsideration of PTA filed by Applicants are not resolved by the PTO until many months after they are filed, BMS argues that the 180-day clock should be tolled until final agency action is received from the PTO

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 35 Correction of PTA – In Court  Novartis v. Kappos –Based on the Wyeth decision, the PTO implemented interim procedures to correct Wyeth-type errors for patents that issued after September 1, 2009 –Novartis is challenging the interim procedures and arguing that it should be permitted to correct Wyeth-type mistakes for cases that issued on or before September 1, 2009 –Awaiting decision on summary judgment motions

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 36 Practice Tips  Reply to all actions within 3 months –File response on the business day prior to weekend or holiday (for now) –If you need to take an extension, do not wait until next due date to file  File any preliminary amendments or replacement drawings as early as possible  Ask foreign associates to provide search reports within 30 days (Rule 56(c) person?)  Don’t convert provisional applications

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 37 Practice Tips  File all responses at 3 month date? –Restrictions? –Quayle actions?  Request restriction requirements in writing? (A vs. B delay)  Failure to engage in reasonable efforts to conclude prosecution?

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 38 Practice Tips  What if your calculation indicates that the PTO error was in favor of the applicant? –Prior practice – letter or Cert. of Correction  No longer proper –Current practice  Not required to request correction  But, if you want it corrected, you must use normal procedure (with the fee) Disclaim improper term

FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 39 

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