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  3. 3. HISTORY YEAR DESSCRIPTION/ACT TERM 1790 Congress enacted and President Washington signed “An act to promote the Progress of Useful Arts” Fixed the term of a patent at 14 years from issue Patent act of 1836 Permitted term extension of 7 addition years. A total of 21 years 1861 Congress gave all patents a term of 17 years from issue 17 year term remained the law for more than a century Last 30 years, Congress made Term of a utility patent increasingly complicated in a series of three major changes to the Patent Act 1984 Drug Price Competition and Patent Term Restoration Act 1984 (Hatch-Waxman Act) 1995 Congress implemented the Uruguay Round of the GATT, harmonizing U.S. patent terms with many foreign jurisdictions. GATT included the Agreement on TRIPS treaty Mandated a minimum patent term of 20 years from the application date This change prompted the U.S. Congress to create a system of PTA to compensate patent holders for certain application-processing delays at the USPTO) 1999 American Inventors Protection Act (AIPA) set forth most of the current rules for Patent Term Adjustment Changes to Patent Term Adjustment, both from Congress and Courts
  4. 4. American Inventors Protection Act (AIPA) • Utility and plant applications filed on or after May 29, 2000 • Provides three (3) bases for adjustment under 35 U.S.C. § 154(b)(1): – USPTO failure to take certain actions within specified time frames “A” delay (35 U.S.C. § 154(b)(1)(A)) – USPTO failure to issue a patent within three years of the filing date under 111(a) or commencement date “B” delay(35 U.S.C. § 154(b)(1)(B)) – Delays due to interference, secrecy order, or successful appellate review “C” delay(35 U.S.C. § 154(b)(1)(C)) • Provides day-for-day adjustment for each failure or delay resulting in adjustment
  5. 5. HOW PATENT TERM ADJUSTMENT IS CALCULATED • Patent Term Adjustment is calculated based on examiner and applicant delays during patent prosecution. • A delay = PTO delays in responding (the patent term would be extended 1 day for each day of Patent Office delay) • B delay = Pendency after 3 years (the patent term would be extended 1 day for each day after the 3 year period that the patent is not granted) • C delay = Delay due to interference, appeal, secrecy orders (the patent term would be extended 1 day for each day of the proceeding, order or appeal) • Overlapping delays = Any overlap between A, B, or C delays • Applicant delay = Applicant’s failure to engage in reasonable efforts to conclude examination • PTA = A delay + B delay + C delay - Overlapping delays - Applicant Delay
  6. 6. Failure to take certain actions within specified time frames (14- 4-4-4): • Failure to initially act on the application within fourteen (14) months after filing date/commencement (patents with issue date January 14, 2013 to present). Prior to January 14, 2013, patents that issued from international applications measured the start date from date that 35 USC 371(c) requirements were fulfilled. • Failure to act on a reply or act on an appeal brief within four (4) months after date the reply or appeal brief is filed • Failure to act on an application within four (4) months after a PTAB or court decision if allowable claims remain in the application • Failure to issue the patent within four (4) months of the date the issue fee was paid and all outstanding requirements were satisfied
  7. 7. USPTO failure to issue a patent within three years pendency: • In an international (PCT) application, “date of commencement of the national stage under 371” is start date for the application • In an application filed under 111(a), the filing date is start date for the application • The three-year period does not include time consumed by any of: – Continued examination (RCE) under 35 U.S.C. § 132(b) – Secrecy order, interference, or any appellate review – Applicant-requested delays
  8. 8. • Delays caused by an interference proceeding (35 U.S.C. § 135(a)) • Delays caused by imposition of a secrecy order (35 U.S.C. § 181) • Delays caused by successful appellate review (requires a PTAB/court decision reversing an adverse patentability determination) – all rejections of at least one claim must be reversed – In some instances, a remand shall be considered a decision reversing an adverse patentability determination • These delays are the bases for patent term extension under Public Law 103-465 (URAA)
  9. 9. PATENT TERM FLOWCHART Determine whether pre-GATT term applies, GATT term applies or both terms applies Calculate pre-GATT term (17 years) or GATT terms (20 years) or both Add Patent term adjustment Add any terminal disclaimer Add any Patent term extension Check for premature termination (Maintenance fees, Judgements etc)
  10. 10. “Baseline” Patent Term Pre-GATT or GATT (17 or 20 years) • The baseline term of a utility patent (or plant patent) is either the pre-GATT 17 year term, or the GATT 20 year term. • The determination of which baseline term applies is governed by 35 U.S.C. § 154(c)(1): 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 [i.e., June 8, 1995] shall be the greater of the 20 year term as provided in subsection (a) [i.e., the GATT term], or 17 years from grant, subject to any terminal disclaimers.
  11. 11. WHEN AN APPLICATION FILED BEFORE JUNE 8, 1995, SPENDS LONG PERIODS IN PROSECUTION BEFORE ISSUANCE •Patent Application 06/316,203 was filed on October 29, 1981 •Following a 19 year interference, it issued on March 28, 2006. For GATT 29.10.1981+20 year= 29.10.2001 Pre-GATT 28.03.2006+17 years=28.03.2023 28.03.2023+1109= 10.04.2026 Patent expiration date
  12. 12. EXAMPLE Example 1(facts) • Application filed under 111(a) on 5/1/09 • RCE filed on 3/5/13 • Notice of Allowance mailed on 7/1/13 • Patent issues on 10/1/13 • There were no “A” Delays or “C Delays” • No Applicant delays under 37 CFR 1.704(b) and (c)
  13. 13. Example 1 (Calculation) • Days from filing to issue is (5/1/09 -10/1/13) = 1615 • Days RCE to NOA is (3/5/13 – 7/1/13) = 119 • Days considered as “B” days = 1615-119= 1496 • Overall “B delay” = 1496- 1097 = 399 • Overall PTA = A + B + C- overlap – applicant delay • PTA = 0 + 399 + 0 – 0 – 0 = 399 days
  14. 14. Wyeth and Elan Pharma v. Kappos (as USPTO Director) (Fed. Cir. 2009) The USPTO's view (shown below): The patentee is entitled to three years of PTA. Wyeth's view (shown below): the patentee is entitled to four years of PTA
  15. 15. DECISION • Director had taken an incorrect view of how § 154(b)(2) applies when there is “overlap” between “periods of delay” addressed by the statute. • Affirmed an order by the District Court for the District of Columbia granting summary judgment in favor of Wyeth, in which the lower court found that the USPTO had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of the patent term to which it was entitled.
  16. 16. NOVARTIS v. LEE CASE (2013-1160, -1179), Decided: January 15, 2014 • Facts: Between June 2009 and May 2011, Novartis filed four lawsuits in the District Court for the District of Columbia claiming that, for twenty-three of its patents, the Director had improperly determined the amount of patent term adjustment NOVARTIS •Novartis claimed that the Director’s determinations of the patent term adjustment rested on two mistaken interpretations of § 154(b)(1)(B)(i) as it applies to an applicant’s request for continued examination under 35 U.S.C. § 132(b)—a process, authorized by Congress in 1999, through which an applicant may try to persuade an examiner to allow an application after an otherwise-final rejection. •Novartis also claimed that denial of the statutorily authorized term adjustments constituted a taking of its property in violation of the Fifth Amendment. DIRECTOR 1. Director treated time spent in any continuing examination, no matter when initiated by the applicant, as not counting toward the statute’s allotment to the PTO of three years before adjustment time begins to accrue 2. Director treated as not counting toward the three years both the time from initiation of continued examination to allowance and, in addition, the time from allowance to issuance—even though the latter period is undisputedly counted toward the three years in a case not involving a continued examination.
  17. 17. Decision of DC: November 15, 2012, the district court dismissed Novartis’s claims United States Court of Appeals for the Federal Circuit: PTO was partly correct and partly incorrect in its interpretation. • USPTO on the first point, holding that an RCE limits B delay regardless of when during prosecution it is filed. • Court also agreed with Novartis that the time period from allowance to patent issuance is not part of the "continued examination" process referred to in the statute and may contribute to the B delay. FUTURE FROM THIS CASE: • Patent holders may wish to review their recently issued U.S. patents to identify any patents that took longer than 3 years to issue and in which RCEs were filed during prosecution. • Patent holders may wish to consider whether they are eligible to petition for additional patent term for those patents in light of the Novartis decision. • This holding is significant as it would extend the terms of many future patents, typically by a few days to a few months.
  18. 18. PRE AND POST AIA (AIA Technical Corrections Act) PRE AIA • Applicants could petition to correct the preliminary calculation, then petition after issuance, then file a civil action POST AIA • Patentees must petition for a correction (within 2 months after issue, extendable). • Fourteen (14) month PTA period and the three (3) year PTA period are measured from the same date: the date on which an application was filed under 35 U.S.C. § 111(a) in an application under 35 U.S.C. § 111; or the date of commencement of the national stage under 35 U.S.C. § 371 in an international application. On May 15, 2014, the USPTO published rules to implement the patent term adjustment (PTA) provisions of the Leahy-Smith America Invents Act (AIA) and the AIA Technical Corrections Act
  19. 19. EXAMPLE FOR DELAY • January 1, 2008: Foreign national application filing date • January 1, 2009: International filing date • July 1, 2011: Declaration filed and 35 U.S.C. § 371(c) met • November 1, 2012: Restriction • December 1, 2012: Election • May 1, 2013: Allowance • June 1, 2013: Issue fee paid • November 5, 2013: Issuance
  20. 20. • As application was filed on or after June 8, 1995, the 20 year GATT term applies. • Baseline term expires on January 1, 2029. • This patent is also eligible for PTA because the application was filed after May 29, 2000. • The current A delay rules apply because the patent issued after the AIA Technical Corrections Act became effective on January 14, 2013. • There is no B delay, C delay, overlap, or applicant delay in this scenario. • Application entered the U.S. national stage 30 months after its international filing date, on July 1, 2011. • Triggered a 14 month guarantee for the Patent Office to reply (i.e., by September 1, 2012. • A restriction qualifies as a response for purposes of 14 month A delay, the restriction on November 1, 2012, was delayed by 61 days beyond the 14 month guarantee. • Applicant‟s election on December 1, 2012 triggered a 4 month guarantee for a reply by the Patent Office (i.e., by April 1, 2012. • Allowance from the Patent Office on May 1 was delayed by 30 days beyond the guarantee . • Payment of the issue fee on June 1, 2013, triggered a guarantee of issuance in 4 months (i.e., by October 1, 2013). • The actual issuance on Tuesday, November 5 was delayed by 35 days beyond the 4 month guarantee. SOLUTION
  21. 21. • delay is 61 days, plus 30 days, plus 35 days, or 126 days. • Assuming no other effects, the expiration of this patent is 126 days after the baseline expiration date, or May 7, 2029. • 01.01.2009+20 years+126 days= 07.05.2029
  22. 22. PFIZER, INC. v. MICHELLE K. LEE (2015-1265); Decided: January 22, 2016 • FACTS: On May 2, 2003, Wyeth filed Patent Application No. 10/428,894 (“’894 application”) entitled “Calicheamicin Derivative-Carrier Conjugates,” which generally claimed a pharmacological method utilized in the treatment of cancer. • The ’894 application eventually issued as the ’768 patent on April 10, 2012. At the time of filing, pursuant to 37 C.F.R. § 1.136(a)(3), Wyeth filed an authorization for the PTO to charge all required fees necessary for it to qualify automatically for all authorized extensions of time during the pendency of the ’894 application. • On July 28, 2003, the PTO mailed a Notice to File Missing Parts of Non- provisional Application. • Wyeth filed the missing parts of its application on December 8, 2003. • The statutory deadline for the PTO to issue its first office action expired on July 2, 2004, fourteen (14) months from the date the application was filed. • On August 5, 2005, having received no office action, Wyeth sent a letter to the PTO asking when an office action on the merits might be expected.
  23. 23. • On August 10, 2005, 404 days after the July 2, 2004 deadline, the PTO mailed a restriction requirement. A restriction requirement informs the applicant that “two or more independent and distinct inventions are claimed in one application,” and that the applicant is required to elect one of the inventions if the applicant wishes to continue prosecuting the application. • The deadline for Wyeth to reply to the restriction requirement was extended automatically for up to six months based on Wyeth’s previously filed authorization for extension of time. • Accordingly, the deadline for Wyeth to respond was February 10, 2006. On February 6, 2006, Wyeth participated in a telephone interview with the Examiner and explained that the restriction requirement had omitted claims 75, 76, and 103- 106 from its categorization of the various claims in the application. • During the interview, the Examiner acknowledged that the restriction requirement was not complete; he agreed to withdraw it and issue a corrected restriction requirement. • The PTO issued a corrected restriction requirement on February 23, 2006, 601 days after the July 2, 2004 deadline. Appellants were given a new deadline to respond to the corrected restriction requirement, which was also extended automatically to six months. • On May 22, 2006, Wyeth filed its response.
  24. 24. • PTO delayed the mailing of a separate office action with respect to the applicants’ Request for Continued Examination (“RCE”). • The PTO’s delay with respect to the RCE amounted to 280 days of additional A Delay. • The propriety of that calculation is not at issue in this appeal. Prosecution of the ’894 application continued until October 11, 2011, when the PTO issued a Notice of Allowance. • On April 10, 2012, the ’894 application issued as the ’768 patent, reflecting a total PTA award of 1291 days, of which 684 days were attributed to A Delay. • The PTO calculated this A Delay based upon: (1) the issuance of the examiner’s first restriction requirement on August 10, 2005, 404 days beyond fourteen months from the date on which Wyeth filed the ’894 application, and (2) the issuance of the response to Wyeth’s RCE on April 22, 2011, 280 days beyond four months from the date on which the RCE was filed. • The PTO did not award A Delay for the 197 days that elapsed between the issuance of the first restriction requirement and the mailing of the corrected restriction requirement. • It is that 197 days which are at issue.
  25. 25. CAFC DECISION • 37 CFR § 1.704 provides that an applicant submitting a deficient paper to the USPTO reduces available PTA until the deficiency is corrected. Conversely, the court decided in Pfizer that the USPTO mailing a deficient paper to the applicant does not accrue PTA (as long as the paper satisfies the § 132 notice requirement). The court did not acknowledge this discrepancy between deficient applicant action that accrues delay versus deficient USPTO action that does not accrue delay. • For now, in order to help maximize PTA, applicants may be wise to double check filing papers for any omissions before their submission to the USPTO and to double check in a timely fashion USPTO actions for any deficiencies in order to bring them to the USPTO’s attention for correction as soon as possible.
  26. 26. THANKS