Patent Term Adjustment

Transcription

1 AIPLA Spring Meeting May 16, 2014 Philadelphia, Pa. Robert Ashbrook 2014 Dechert LLP

2 Patent Term History 1790: 14 years 1836: 14 years plus 7 year extension 1861: 17 years 1984: Hatch Waxman (patent term extension) 1995: GATT (20 years from application) 1999: AIPA (patent term adjustment) 2010: Wyeth v. Kappos 2012: Regulatory change for B delay pending BPAI appeals 2013: America Invents Act Final rule adopted May 15, : AIA Technical Corrections Act 2014: Novartis v. Lee 2014?: Goodlatte bill? 2

3 Beginning of a Patent s Term for a term beginning on the date on which the patent issues. 35 U.S.C. 154(a)(2) Every Tuesday Term begins just after 12:00 a.m., eastern time. Encore Wire Corp. v. Southwire Corp. No. 3:10-cv-86, 2011 U.S. Dist. LEXIS 22073, 2011 WL (N.D. Ga. Mar. 4, 2011) Provisional rights. 35 U.S.C. 154(d) 3

4 Patent Term Flowchart 4

5 Baseline Patent Term Pre-GATT or GATT (17 or 20 years) June 8, 1995, is the key date Expired before June 8, 1995? Pre-GATT term (17 years). 35 U.S.C. 154(c)(1). Pending or in force on June 8, 1995? Longer of pre-gatt or GATT term. 35 U.S.C. 154(c)(1) Filed on or after June 8, 1995? GATT term (20 years). 35 U.S.C. 154(a)(2) 5

6 Baseline Patent Term Pre-GATT or GATT (17 or 20 years) US 5,475,064 Pending on June 8, 1995 Greater of the pre-gatt or GATT term 6

7 Pre-GATT Patent Term Issue date plus 17 years December 12, 1995, plus 17 years = December 12,

8 GATT Patent Term Specific reference plus 20 years December 21, 1994, plus 20 years = December 21, 2014 Longer of the two terms is December 21,

9 GATT Patent Term Specific reference plus 20 years Same phrase used in 35 U.S.C. 120 Only one of several requirements for 120 priority Where to find a specific reference Priority under 119, 365(a), 365(b), 386(a), or 386(b) is not considered Provisionals Foreign national applications International applications 9

10 Pre-GATT Patent Term Surprising results when applications filed before June 8, 1995, spend long periods in prosecution US 7,018,407 filed in 1981 Longer of pre-gatt or GATT 19 year long interference Issued March 28, 2006 Pre-GATT term expires in years after filing! 10

11 GATT Patent Term Surprising results when applications filed on or after June 8, 1995, claim early priority dates US 7,604,811 filed in 1996 GATT term applies Specific reference to 1984 Expires years before issuance! What client would waste money prosecuting this patent?!? Shout-out: 1201Tuesday.com 11

12 Last Day of a Patent s Term Hypothetical: Application filed Jan. 1, 1995 and patent issues Jan. 1, Pre-GATT term is 17 years from grant GATT term ends 20 years from the date on which the application for the patent was filed What is the last day the patent can be enforced? January 1, 2015? Term length is 20 years and 1 day December 31, 2014? Term length is 20 years exactly The answer is unclear 12

13 PTA focuses on the duration of the term, not the issue and expiration dates GATT term is the same as pre-gatt term if prosecution takes 3 years (for an original app.) GATT term is longer if prosecution is faster 13

14 GATT term is shorter if prosecution is slower PTA adjusts for some delays in prosecution Adjustment is to the expiration date 14

15 PTA implemented by the American Inventors Protection Act. 35 U.S.C. 154(b); 37 C.F.R Applies to utility applications filed on or after May 29, 2000 Guarantees against three kinds of prosecution delay A delay. 35 U.S.C. 154(b)(1)(A) B delay. 35 U.S.C. 154(b)(1)(B) C delay. 35 U.S.C. 154(b)(1)(C) Deduction for overlapping delay Deduction for applicant delay 15

16 A Delay A delay guarantees against four specific PTO response delays 1. An initial office action within 14 months of the filing date. 35 U.S.C. 154(b)(1)(A)(i) The priority date is irrelevant (i.e., for divisionals, cons, CIPs, etc.) For international applications, time is measured from entry into the US national stage AIA Technical Corrections Act for patents issued after Jan. 14, 2013 USPTO will begin to implement on May 20, 2014 Restrictions do count as a response A notice to file missing parts does not count as a response 16

17 A Delay A delay guarantees against four specific PTO response delays 2. Response within 4 months to a reply to an office action Vacated and re-issued response may count. U. Mass. v. Kappos 3. Response within 4 months after a PTAB decision 4. Issuance within 4 months after payment of the issue fee Day-for-day adjustment of the expiration date for every day that a PTO response is delayed 17

18 B Delay B delay is a backstop guarantee against prosecution lasting more than three years Diligent applicants should get at least the pre-gatt term Day-for-day adjustment of the expiration date for every day beyond three years it takes the patent to issue Three years measured from the filing date The priority date is irrelevant (i.e., for divisionals and cons) For international applications, time is measured from entry into the US national stage 18

19 B Delay Three exceptions to B delay: 1. Time consumed by continued examination pursuant to a request for continued examination. 35 U.S.C. 154(b)(1)(B)(i) 2. Time consumed by interferences, derivation proceedings, secrecy orders, PTAB appeals, and civil actions. 35 U.S.C. 154(b)(1)(B)(ii) For applications where a notice of allowance is mailed on or after September 17, 2012, the time consumed by a PTAB appeal changed from when a notice of appeal was filed to when a brief is filed 3. Delays requested by the applicant. 35 U.S.C. 154(b)(1)(B)(iii) 19

20 B Delay 35 U.S.C. 154(b)(1)(B) Novartis: exceptions are exceptions to the trigger USPTO: exceptions are exceptions to the remedy Trigger Exceptions Remedy 20

21 B Delay The RCE exception was litigated in Novartis v. Lee, 740 F.3d 593 (Fed. Cir. 2014) PTO: all time from filing an RCE until issuance is consumed by continued examination pursuant to an RCE Held, the time after a notice of allowance is not consumed by continued examination Federal Circuit formula: time from filing until issuance, minus time from RCE to allowance, minus three years, equals B delay Hundreds of cases currently backlogged 21

22 C Delay C delay is a guarantee against delays for: Interference or derivation proceeding Secrecy order Successful PTAB appeal ( success is narrowly construed) Successful civil action B and C delay work in tandem for appeals and civil actions No B delay allowed, but C delay allowed if successful 22

23 Overlap Patentee cannot benefit from an overlap of A, B, or C delay. 35 U.S.C. 154(b)(2)(A) USPTO: Any A delay necessarily contributes to B delay, so patentees get whichever is greater, not both Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010): Overlap means two delays occurring on the same calendar day 23

24 Applicant Delay Deduction for the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution. 35 U.S.C. 154(c) Statutory applicant delay: when the applicant takes more than 3 months to respond to any rejection, etc. Any shortened statutory reply date is irrelevant USPTO has substantive rulemaking authority to define other instances of applicant delay 24

25 Applicant Delay Regulatory applicant delays: Applicant requests for delay. 37 C.F.R (c)(1) & (2) Abandonment. 37 C.F.R (c)(3) & (4) Conversion of a provisional app. 37 C.F.R (c)(5) Amendment requiring a supplemental office action. 37 C.F.R (c)(6) & (9) Preliminary amendment or amendment after a PTAB decision, up to one month before an office action, resulting in a supplemental office action 25

26 Applicant Delay Regulatory applicant delays: Reply with an omission and supplemental reply. 37 C.F.R (c)(7) & (8) An IDS filed after a reply is the most common source of delay Supplemental amendments, terminal disclaimers, etc. But preliminary amendments nor interview summaries Any paper filed after a notice of allowance, unless filed with the issue fee. 37 C.F.R (c)(10) Rule 312 amendments, status request, etc. 26

27 Applicant Delay Regulatory applicant delays: Extension for an appeal briefs. 37 C.F.R (c)(11) PTO closed this loophole for applications allowed on or after September 17, 2012 Continuation applications. 37 C.F.R (c)(12) No carryover of PTA from before the filing date How and how much applicant delay is assessed varies by subsection 27

28 Applicant Delay Regulatory applicant delays: Extension for an appeal briefs. 37 C.F.R (c)(11) PTO closed this loophole for applications allowed on or after September 17, 2012 Continuation applications. 37 C.F.R (c)(12) No carryover of PTA from before the filing date. 28

29 Applicant Delay The pernicious effect of applicant delay: Delays issuance Accelerates expiration Effect upon clients? Effect upon your practice? 29

30 Calculation of PTA: add A delay plus B delay plus C delay minus overlap minus applicant delay equals total patent term adjustment Total PTA is added to the baseline term 30

31 Example Date Event A delay B delay Overlap Ap. delay Comments Provisional filed Provisional has no effect on PTA Utility app. Filed Baseline term expires Restriction 306 days month A delay Election days Statutory applicant delay Non-final OA 0 days PTO gets 4 months to act Amendment - 59 days - 90 days B delay begins to accrue Final OA 31 days 153 days 31 days - 4-month A delay, overlapping days RCE - 92 days - - B delay stops accruing IDS days 1.704(c)(8) applicant delay Allowance 0 days Rule 312 amend days - - Novartis would restart B delay amend. entry - 30 days - 30 days 1.704(c)(10). Novartis B delay? Issue fee paid - 31 days - 0 days Issue date 31 days 153 days 31 days - 4-month A delay; overlapping days TOTAL for each column: days days - 62 days days = 705 days of PTA Jan. 1, days = Dec. 6,

32 Process Preliminary calculation with notice of allowance B delay will not be included Opportunity to petition for unavoidable statutory applicant delay. 35 U.S.C. 154(b)(3)(C) Final calculation on the face of the patent USPTO computer program calculates thousands each week. It does not account for every circumstance! 32

33 Process 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). 37 C.F.R (b) Changes made via a certificate of correction After a decision, a patentee has 180 days to file a civil action in the E.D. Va. 35 U.S.C. 154(b)(4) Otherwise, the PTO determination stands. Novartis v. Lee, 740 F.3d 593 (Fed. Cir. 2014) 33

34 Odds and Ends The PTO has 4 months to respond, but applicants have only 3 months to respond Certificates of mailing do not count for applicant delay Applicants can use the weekend and holiday rule There is a duty of candor in post-allowance PTA petition practice Petitions must include the correct PTA. 37 C.F.R (b)(2)(i) 34

35 Strategy Does the client want postpone expiration, instead of obtaining a patent ASAP? File a provisional Wait 3 months to respond to any office action to maximize B delay Pay the issue fee quickly (unless B delay is accruing) Avoid applicant delay! Applicant delay postpones issue AND accelerates expiration Appeal instead of filing an RCE if you are confident of success 35

36 Strategy After a restriction, quickly file a divisional Avoid terminal disclaimers if possible Possible to consolidate claims in the application with more PTA? Abandon claims with ODP rejections? Abandon the prior application if it has less PTA? File contemporaneously to avoid divisionals? Competing considerations for patent term and protection against ODP rejections under 35 U.S.C. 121 Following a restriction, file a divisional ASAP 36

37 Terminal Disclaimers Terminal disclaimers are applied after PTA. 35 U.S.C. 154(b)(2)(b) Terminal disclaimers still matter after GATT PTA can differ between patents in a family Co-ownership requirement Usually found on the face of the patent But printing mistakes get made check the wrapper! 37

38 Terminal Disclaimers What is being disclaimed? Not all disclaimers use the USPTO form Iterative process to determine the prior patent s expiration date 38

39 Terminal Disclaimers Terminal disclaimers work identically for design, utility and plant patents Apple s D677 issued June 29, 2010 and expires June 29, 2024 Apple sues Samsung Apple files a T.D. during litigation! TD over D593,087 D087 issued May 26, 2009 D087 expires May 26, 2023 D677 expires May 26,

40 Patent Term Extension Hatch-Waxman PTE GATT implementation PTE Available from June 8, 1995, to May 28, 2000 Superseded by patent term adjustment Akin to PTA C delay 40

41 Premature Termination Premature terminations appear on PAIR Maintenance fees Expiration at the end of the grace period at 4, 8, or 12 years Beware zombie patents that come back from the dead Revival available for 2 years for unintentional delay Revival available at any time for unavoidable delay 41

42 Premature Termination Disclaimers can be filed at any time The Re-s Reissues Reexaminations (and supplemental examination) Reviews (inter partes, covered business method, post-grant) Judgments 42

43 For further information, visit our website at dechert.com. Right click on chart to edit data Robert Ashbrook Dechert practices as a limited liability partnership or limited liability company other than in Almaty, Dublin, Hong Kong, Luxembourg and Tbilisi. Ut Malesuada Praesent Dictum Eros Sit Amet Varius Sollicitudin Rhoncus 2014 Robert Ashbrook