Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers THURSDAY, MAY 25, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. Leslie A. McDonell, Partner, Finnegan Henderson Farabow Garrett & Dunner, Boston Margaret J. Sampson, Partner, Baker Botts, Austin, Tex. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 DISCLAIMER These materials have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. and European intellectual property law. These materials reflect only the personal views of the authors and are not individualized legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), and BAKER BOTTS, cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with these authors. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 5

6 DOCTRINE OF DOUBLE PATENTING To prevent the unjustified extension of patent exclusivity beyond the term of a patent. Expectation of public that upon the expiration of the patent it will be free to use the claimed invention and obvious modifications or variants. 6

7 Types: Same-invention. Obviousness-type. DOUBLE PATENTING Prohibition against double patenting applies to pre-aia and AIA patent claims. Grounds for examiner rejection; and Grounds for allegation of invalidity in litigation. Not grounds for AIA Post Grant Proceedings according to PTAB because not a statutory basis for invalidity (See Apple Inc. v. SightSound Techs., CBM , Paper 13, at 25 (Oct. 8, 2013)). Generally, can file a terminal disclaimer to overcome an obviousness-type double-patenting rejection. 7

8 DOUBLE PATENTING FOR PRE-AIA APPLICATIONS Applications with all claims having an effective filing date before March 16, Double patenting rejection authorized where an applicant invokes the provisions of pre-aia 35 U.S.C. 103(c) (joint research agreements), even though there is neither a common inventor nor a common patent owner. [T]he application or patent and the subject matter disqualified under [amended] 35 U.S.C. 103(c) will be treated as commonly owned for purposes of double patenting analysis. This double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 1.321(d). 70 Fed. Reg. 54,261 (Sept. 14, 2005). 8

9 DOUBLE PATENTING FOR AIA AND MIXED APPLICATIONS Applications with all claims having an effective filing date after March 15, 2013, and applications with mixed pre-march 16, 2013, and post-march 15, 2013 effective filing dates. Note: pre-aia 35 U.S.C. 103(c) will not apply because according to AIA SEC. 3(n)(2), only pre-aia 102(g) crosses the line AIA 102(b)(2)(C) and 102(c) now apply to commonly-assigned and joint research inventions. Protection will only shield the prior effectively filed invention from being considered as 102(a)(2) prior art against the later invention, but will, under those limited circumstances, shield the later invention from both novelty and obviousness attack. But that protection may not shield later invention from obviousness double-patenting over earlier. 9

10 EXAMINER REJECTIONS Anticipation type (statutory same-invention double patenting) No requirement that the first patent disclosure qualify as prior art, but requirement for identity of claimed subject matter makes it analogous to anticipation. A species anticipates a genus under 102, but in same-invention double patenting, the species and genus are not the same invention. Non-statutory obviousness-type double patenting Prohibits claims in a second patent or application that are not patentably distinct from claims in a first patent but Gilead opens up date of expiration vs. date of grant. Provisional v. actual rejections Actual ODP rejection - to a pending application in view of a first-issued patent or in view of another pending application. Provisional ODP rejection - in view of a pending application when there are two pending applications by the same inventor or assignee claiming conflicting subject matter. See MPEP 804 (2000). 10

11 11 CASE LAW DEVELOPMENTS

12 A claim to a method of using a compound is not patentably distinct from an earlier claim to the identical compound in a reference patent disclosing the same use. In other words, the specification of the OTDP reference can be consulted to identify a compound s disclosed utility when evaluating OTDP. 12

13 Take home message: without a restriction requirement to provide 121 protection, a method of treatment is not likely to be considered patentably distinct from a compound claim if that method of treatment is disclosed in the compound patent. Despite the fact that the USPTO routinely says compounds and methods of treatment using those compounds are patentably distinct claim groups. 13

14 Sun Pharm. Indus., Ltd. v. Eli Lilly and Co. 611 F.3d 1381 (Fed. Cir. 2010) The Federal Circuit expanded the holding articulated in Geneva to OTDP references that specifically include a utility in the claims - so arguably no review of spec needed. Held - if the specification discloses multiple uses, that disclosure can be used to invalidate a later commonly-owned method patent with claims directed to any of the previously disclosed uses. 14

15 Sun Pharm. Indus., Ltd. v. Eli Lilly and Co. 611 F.3d 1381 (Fed. Cir. 2010) No T.D. Filed Lilly s 614 patent claimed compound gemcitabine and methods of using gemcitabine to treat viral infections. Lilly s 826 patent claimed a methods of using gemcitabine to treat cancer. Original parent app. to 614 claimed only antiviral utility; 614 specification included both antiviral and anticancer utilities. 15

16 Sun Pharm. Indus., Ltd. v. Eli Lilly and Co. 611 F.3d 1381 (Fed. Cir. 2010) The specification s disclosure may be used to determine whether a claim to: determine whether a claim merely define[s] an obvious variation of what is earlier claimed learn the meaning of the [claim] terms, and interpret [] the coverage of [a] claim citing, In re Basell, 547 F.3d 1371, 1378 (Fed. Cir. 2008). 16

17 Eli Lilly v Teva Parenteral Medicines, Inc., 689 F.3d 1368 (Fed. Cir. 2012) Claims of an earlier patent alone are to be considered for determining obviousness-type double patenting, except insofar as the disclosure of the earlier patent is necessary to construe the earlier claims, or when the later application claims a use for a composition claimed in an earlier patent wherein the use itself is disclosed but not claimed in the earlier patent. 17

18 Eli Lilly v Teva Parenteral Medicines, Inc., 689 F.3d 1368 (Fed. Cir. 2012) It would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, manufacture and sell it to the public, and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. (Quoting from In re Byck, 48 F.2d 665 (1931)) 18

19 947 App. filed in 1985 with 15 claims RR: Comp groups I-V, Process groups VI-VII, MOT groups VIII-X issued 03/15/88 ELECTED: COMP GROUP II AND MOT GROUP IX DIV-1 App. 086 patent issued 06/27/89 ELECTED: MOT GROUPS VII I-X WITH COMPS OTHER THAN GROUP II 10 way restriction requirement (GROUPS I X) divisional TD filed after 086 patent expired DIV-2 App. filed 10/12/ patent issued 12/12/89 ELECTED: COMP GROUPS I, III, IV, AND V divisional 19

20 Issues on appeal: (1) whether 121 is limited to divisional applications filed before the issuance of the application in which the restriction requirement was entered; and (2) whether the as a result of requirement of 121 applies to the DIV-2 patent and is satisfied here. A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as [an OTDP] reference... 20

21 The most straightforward reading of the statutory text is that the safe harbor of 121 applies even when the PTO issues a restriction requirement that leads to more than two separate [sequential] applications. Moreover, 121 refers broadly to a divisional application, and does not state that the divisional must be a direct divisional of the original application. Had Congress intended to limit the safe harbor only to a divisional of the application in which the restriction requirement was entered, it could have said a divisional application of the original application, rather than simply a divisional application. 21

22 An overlap of claims to independent and distinct inventions within a given divisional application is neither contrary to the restriction requirement nor relevant to the requirements of the third sentence of 121. Rather, what consonance requires is that the claims prosecuted in two or more applications having common lineage in a divisional chain honor, as between applications, the lines of demarcation drawn by the examiner to what he or she considered independent and distinct inventions in the restriction requirement. see St. Jude Medical, Inc. v. Access Closure, Inc., 729 F.3d 1369 (Fed. Cir. 2013) -- where consonance is not maintained, there is no safe harbor protection 22

23 23 Held that 121 safe harbor applies to continuing applications deriving from a divisional application filed as a result of a restriction requirement.

24 121 safe harbor protects patents descending from divisional applications, but not from continuation applications exclusively. Affirmed decision in Symbol Technologies that continuations applications descended from divisionals that were filed as a result of a restriction requirement were protected. A patent need not have issued directly from a divisional application in order to receive 121 protection. Intervening continuation applications do not render a patent ineligible for 121 protection so long as they descended from a divisional application filed as a result of a restriction requirement. 24

25 Amgen s patents issued from continuation applications, which descended from continuations applications exclusively and not from divisional applications. Amgen argued that its patents could have been filed as divisional applications and should be treated as such for purposes of 121. Court disagreed: Because the applications were filed as continuations and not divisional applications - they are not entitled to protections afforded by 121 safe harbor. 25

26 G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) July 12, way restriction requirement (compound, composition, method of-use) Original application filed /160,594 ( the 594 application ) disclosed and claimed compounds, compositions, and methods of use regarding the treatment of pain and inflammation Before restriction requirement in original 594 application! Divisional application on composition claims filed June 1995, issued Oct ,563,165 Compound claims Issued Nov ,466,823 April 1994 CIP 08/223,629 ( the 629 application ) contained all 3 classes of claims Issued as 5,521,207 in May patent invalid for ODP in light of the earlier issued 165 patent; safe harbor protects divisionals; 068 was a CIP. 3-way restriction requirement (compound, composition, method of-use) see Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) PCT application filed Nov PCT/US94/12720 ( the PCT 720 application ), Designated CIP of the 629 application and a CIP of the original 594 application. Contained all three classes of claims U.S. Patent Application No. 08/648,113 ( the 113 application ). Divisional: method-of-use claims 5,760,068 issued June

27 G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) In Pfizer v Teva, Fed. Cir. had held that the 121 did not apply to CIP s - protection for applications filed as a result of a restriction requirement is limited to divisional applications Pfizer filed for reissue of the 068 patent alleging err in prosecuting the application leading up to the 068 patent as a continuation-in-part, rather than as a divisional application. after initially rejecting the reexam petition saying that the error was not correctable in reissue, PTO eventually allowed the claims as RE 44,048 on March 5,

28 G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) Holding: REISSUE invalid for OTDP Not entitled to safe harbor protection because it s not a divisional or a descendant of a divisional. Simply deleting that new matter from the reissue patent does not retroactively alter the nature of the 113 application. Section 121 is inapplicable to the RE 048 patent for a second reason as well: The RE 048 patent (the challenged patent) and the 165 patent (the reference patent) are not derived from the same restriction requirement. 28

29 Ex Parte Sauerberg, Appeal (Jan. 12, 2017) RR: (1) compounds and : (2) methods of use compounds elected 613 patent issued CON-1 to compounds 016 patent issued CON-2 to compounds 993 patent issued patent issued DIV to methods of use OTDP rejection appealed 29

30 Ex Parte Sauerberg, Appeal (Jan. 12, 2017) 121 Safe Harbor provisions to not apply -- the 993 application was not filed as a result of the restriction requirement because it was not filed during the pendency of the restricted application. The safe harbor provision expressly states that it only applies if the divisional application is filed before the issuance of the patent on the other application. Citing G.D. Searle v. Lupin: We apply a strict test for application of section 121, [g]iven the potential windfall [a] patent term extension could provide to a patentee. 30

31 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) OTDP issue on appeal: whether a patent that issues after but expires before another commonly-owned patent qualify as a double patenting reference for the other patent. Pre-Gilead landscape: Cases measured double patenting based on which patent issued first, and invalidated only the laterissued patent. 31

32 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) T.D. Filed over 483 Gilead s 483 and 375 patents were unrelated and did not claim priority to any common patent. Patents claimed Tamiflu (oseltamivir), its metabolite, its formulation, and its method of use to treat the flu. Federal Circuit assumed for purposes of appeal that 483 claims were a mere obvious variant of the 375 claims. 32

33 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) District court granted summary judgment of infringement to Gilead, concluding that a later-issued but earlier-expiring patent can never be a double patenting reference. The Federal Circuit reversed in a split decision. Holding: a patent that issues after but expires before another patent can qualify as a double patenting reference for the other patent. 33

34 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) Take home message -- expiration date (rather than issue date) should be considered when determining which patent is the earlier patent for OTDP analysis. Court s Reasoning: The court gave little import to the fact that the 483 patent issued first. Prior cases looked to issue dates because they previously served as a reliable stand-in for the date that really mattered patent expiration. [T]hose [prior] cases dealt with patents to which the URAA did not apply and, critical to a double patenting analysis, to patents for which the expiration date was inextricably intertwined with the issuance date. 34

35 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) Focusing on the date of issue could lead to gamesmanship during prosecution (i.e., by arranging for app. with latest filing date to issue first). [U]sing the expiration date as a benchmark in post-uraa cases of [OTDP] preserves the ability of inventors to use a terminal disclaimer of later-expiring patents to create one expiration date for their term of exclusivity over their inventions

36 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) [W]hen a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention. This principle is violated when a patent expires and the public is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention. 36

37 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) Dissent (Rader): The majority s expansion of OTDP is unwarranted... Doctrine was used to curtail [the] practice of patentees filing successive continuations to obtain additional patent terms for obvious modifications where earlier patents and applications did not qualify as prior art. After the URAA, successive continuations generally do not result in any additional patent term and thus a primary motivation behind the doctrine... is largely no longer applicable. 37

38 Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014) Dissent (cont d): This case does not raise the policy concern regarding subsequent extensions of patent term and does not involve the potential for harassment by multiple assignees because of TD. Interplay between OTDP doctrine and AIA s firstinventor-to-file provision may produce unwarranted and unforeseen consequences

39 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) OTDP issue on appeal: For applications filed after the 1995 URA Act, can an applicant choose to file separate applications for overlapping subject matter and claim different priority dates without running afoul of OTDP? 39

40 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) Background: No T.D. Filed (~4 years + ~2 years PTA) Kennedy s 442 and 766 patents were related but claimed different priority dates. District court held asserted claims of 442 patent invalid over the 766 patent claims for OTDP and entered partial final judgment under Rule 54(b) in favor of AbbVie. 40

41 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) Genus: 766 patent claims a method of treating RA by co-administering anti-tnfα antibody and MTX. Species: 442 patent claims a method of treating an individual suffering from RA whose active disease is incompletely controlled despite already receiving MTX (i.e., particularly sick patients). Kennedy s claim of nonobviousness rested on the alleged unexpected results of the species. 41

42 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) Holding: Court explained that it was making explicit what was implicit in Gilead: ODTP continues to apply, even to patents that filed after the 1995 URA Act, where two patents that claim the same invention have different expiration dates. Reaffirmed rulings in Sun v. Lilly and other cases that OTDP encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound where a separate, later expiring patent claims nothing more than a method of using that compound. 42

43 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) Reasoning: OTDP is not designed solely to curb abuses made possible from continuation practice, but to prevent an inventor from securing a second, later-expiring patent for the same invention: Patents claiming overlapping subject matter that were filed at the same time with different patent terms due to examination delays at the PTO (citing to 154). Patents claiming overlapping subject matter that claim different priority dates and have different expiration dates. 43

44 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) But this argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing the second, later expiring patent for the same invention.... That problem still exists. Patents claiming overlapping subject matter that were filed at the same time can still have different patent terms due to examination delays at the PTO. See 35 U.S.C. 154(b) (patent term adjustments).... So too where, as here, the applicant chooses to file separate applications for overlapping subject matter and to claim different priority dates for the applications, the separate patents will have different expiration dates since the patent term is measured from the claimed priority date. When such situations arise, the doctrine of obviousness-type double patenting ensures that a particular invention (and obvious variants thereof) does not receive an undue patent term extension. 44

45 Reasoning: 45 AbbVie Inc. v. Kennedy Inst. of Rheumatology 764 F.3d 1366 (Fed. Cir. 2014) The demonstration of utility of the 766 patent relied on the same clinical study that Kennedy relied on to argue that the 442 patent led to unexpected results and merits a separate patent. Thus, the 442 patent merely claimed a known utility of the 766 patent. There is no meaningful distinction between examining the disclosed utility of an earlier patent to determine the overall question of obviousness and looking at the disclosed utility of an earlier patent to determine whether the utility of the later patent was unexpected at the time of the earlier patent. Neither involves improper use of the reference patent s specification as prior art.

46 Magna Elecs., Inc. v. TRW Auto. Holdings Corp., No. 1:12-cv-654 (W.D. Mich, Dec. 10, 2015) Optical system for controlling car high beam headlamps Both patents recite control systems, with variations in data processing techniques. Patents have same priority, term differed due to PTA 149 patent filed first and issued first; accrued PTA 786 (CON) filed later and issued later; no PTA. OTDP used to override statutory grant of PTA under 35 U.S.C

47 Janssen Biotech, Inc v. Celltrion Healthcare Co. Inc., 1:15-cv (D. Mass. Aug. 19, 2016) claims of both patents to generic TNF Abs - deemed not patentably distinct Sept. 4, 2001 Sept. 14, 2004 July 11, 2011 Sept. 4, patent issued 444 patent issued 444 patent expired 471 patent expire First issued patent entitled to 17 year patent term. The second issued patent was filed post-gatt and received 20 years from filing date (1991). 47

48 Janssen Biotech, Inc v. Celltrion Healthcare Co. Inc., 1:15-cv (D. Mass. Aug. 19, 2016) DC granted summary judgment of invalidity of 471 patent for ODP in light of the 444 patent. The court finds that the reasoning in Gilead applies where, as here, the later-issued patent expires earlier because of the change to patent terms resulting from the [URAA]. In essence, the court concludes that the statute was not intended to alter the judicial doctrine of obviousness double-patenting. Therefore, claims of the 471 Patent are invalid for obviousness-type double-patenting in light of the patentably indistinct, earlier-expiring 444 Patent. 48

49 STATUTORY LANGUAGE 35 USC 154 (b) (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. 49

50 REPLACEMENT TERMINAL DISCLAIMER Example 1: U.S. Application No. 10/883,042, now U.S. Pat. No. 7,084,302 Terminal Disclaimer filed on Feb. 17, 2006, which includes the following language: 50

51 REPLACEMENT TERMINAL DISCLAIMER LANGUAGE Example 2: U.S. Application No. 13/616,887, now U.S. Pat. No. 8,980,881 Terminal Disclaimer filed on Oct. 30, 2014, which includes the following language (effective to avoid 35 U.S.C. 154(b)(2)(B)?) : 51

52 FURTHER PROPOSED LANGUAGE FOR REPLACEMENT TD In the event that any patent issued from the subject application gets an extension of patent term by patent term adjustment, the owner does not disclaim the extension of the patent term based on the patent term adjustment, as the term of any patent granted on the instant application has not been disclaimed beyond a specific date. 52

53 IF HAVE PTA, AND PLAN TO USE TERMINAL DISCLAIMER, CONSIDER NON-DATE-SPECIFIC LANGUAGE In the event that any patent issued from the subject application gets an extension of patent term by patent term adjustment, the owner does not disclaim the extension of the patent term based on the patent term adjustment, as the term of any patent granted on the instant application has not been disclaimed beyond a specific date. Statutory rights of PTA should not be taken away by ODP, a judicially- created doctrine but not a statutory doctrine. But avoid 35 U.S.C. 154(b)(2)(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. 53

54 CURRENT LANDSCAPE: AIA CHANGES IMPACTING PATENT REISSUE without any deceptive intention removed by AIA but still subject to ODP 35 U.S.C. 251 (a) IN GENERAL. Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue. (d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS. No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent. 54

55 ODP AND REISSUE PROCEEDINGS New Narrow Claims New prior art discovered, e.g., in pre-litigation diligence; Old prior art not disclosed during original examination, e.g., to hedge inequitable conduct (AIA changes); No recapture/broadening issues. New Dependent Claims New prior art; hedge against possible invalidity/unpatentability/odp attack; No recapture/broadening issues. 55

56 ODP AND REISSUE PROCEEDINGS New Broader Claims (general two-year limit to present and recapture to consider) New products (patent owner or third-party); Unclaimed embodiments or species; Heightened support requirement for broader claims? See Antares Pharma, Inc. v. Medac Pharma Inc., (Fed. Cir. 2014) 56

57 INSTEAD OF REISSUE, KEEP CONTINUATION PENDING FOR ODP AC Dispensing Equipment, Inc. v. Prince Castle, LLC, IPR , Paper (PTAB Oct. 17, 2014) Petitioner requested permission to file a motion to stay the prosecution of the continuation patent application. 57 PTAB: Denied. Patent Owner will not be permitted to obtain in a patent any claims that are not patentably distinct from any claim that is canceled as a result of this proceeding. But whether any of the claims in the 497 patent will be canceled is an issue that is not yet decided and will not necessarily be decided until a final written decision is entered in this case and appeals from it are exhausted. To bar Patent Owner from prosecuting claims now that may be patentably indistinct from the claims under review thus would be premature. It is sufficient, under the current circumstances, for Patent Owner to continue to take reasonable steps to apprise the Examiner of the status of this proceeding.

58 CONSIDER, IN KEEPING CONTINUATION APPLICATION PENDING: 58

59 59 OVERCOMING ODP REJECTIONS

60 DEFEATING DOUBLE PATENTING REJECTIONS Avoid terminal disclaimers. Maintain demarcation in chain of divisionals to keep 121 safe harbor. Boehringer Ingelheim Int l GmbH v. Barr Laboratories, Inc., 592 F.3d 1340 (Fed. Cir. 2010) Rejection traditionally must be based on what previously claimed, not what previously disclosed. Eli Lilly v Teva Parenteral Medicines, Inc., 689 F.3d 1368 (Fed. Cir. 2012) But see Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381(Fed. Cir. 2010) 60

61 TEST FOR ODP In order to negate obviousness-type double patenting, must the second claimed invention be patentable in view of the claim(s) of the earlier patent, either alone or in combination with the prior art? One-way test: is the second claimed invention patentable in view of the earlier patent? No consideration is given to whether the claims of the earlier patent are unobvious in view of the claims of the later, either alone or in combination with the prior art. Two-way test: is either claimed subject matter a mere obvious variation of the other? 61

62 ONE-WAY TEST In re Berg, 140 F.3d 1428 (Fed. Cir. 1998) Genus claims application and species claims application simultaneously filed, but species claims issued first. 62 Board applied the one-way test to find the genus claims unpatentable for ODP. Berg could have put all of the claims in the same application but elected not to, and hence chose to assume the risk as to which application would complete prosecution first. FC: Affirmed. The two-way test is a narrow exception to the general rule of the one-way test. The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the USPTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application. If Berg was unsure whether it had more than one patentably distinct set of claims, it should have filed all of the claims as one application to see if the examiner issued a restriction requirement.

63 TWO-WAY TEST In re Braat, 937 F.2d 589 (Fed. Cir. 1991) July 17, 1978, Braat app priority date. Jan. 31, 1979, app filed, issued June 24, 1980 as Dil patent. Board: sustained the rejection of the broader Braat claims based on ODP over the Dil patent. Issue: The Board concluded that the rejected claims of Braat are merely obvious variations of the invention the Dil patent. Was it necessary to also determine whether the claims of Dil are patentably distinct from the invention described by the rejected claims of Braat? FC: Reversed the Board decision. The Board erred; it should have applied the two-way test. Since the subject matter embraced by the rejected claims of Braat does not suggest the record carrier recited [in] Dil, we conclude that the claims of the Braat application and the Dil patent are patentably distinct, and that the double patenting rejection was in error. 63

64 TWO-WAY TEST IS A NARROW EXCEPTION TO THE ONE-WAY TEST Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955 (Fed. Cir. 2002) Jan. 10, 1974, 379 app claimed a class of compounds, therapeutic methods of using those compounds, and pharmaceutical compositions comprising those compounds. April 19, 1977, 895 patent issued, claimed a method of treating depression in humans by administering a compound within the class of compounds including fluoxetine hydrochloride. May 20, 1986, 213 patent issued, claimed method for treating anxiety in a human subject in need of such treatment which comprises the administration to such human an effective amount of fluoxetine or norfluoxetine or pharmaceutically acceptable salts thereof. Dec. 2, 1986, 549 patent issued, claimed the administration of fluoxetine hydrochloride to inhibit serotonin uptake in an animal's brain neurons. DC: 549 patent claims not invalid for ODP. 64

65 TWO-WAY TEST IS A NARROW EXCEPTION TO THE ONE-WAY TEST Eli Lilly & Co. v. Barr Laboratories, Inc. (con t) FC, 222 F.3d 973 (Fed. Cir. 2000): Reversed. Species claims of 549 patent were invalid for obviousness-type double patenting over the 895 patent. claim 1 of the '895 patent, when properly construed, already covered the administration of fluoxetine hydrochloride for treating depression. In this case the same party claims a genus in an earlier patent and then claims a species in a later patent. 65 FC en banc: Species claims of the 549 patent invalid for ODP over the 213 patent. the 549 patent simply describes the process by which fluoxetine hydrochloride physically acts on individuals who receive the drug. Therefore, no patentable distinction rests between administering fluoxetine hydrochloride for treatment of anxiety and inhibition of serotonin uptake by administration of fluoxetine hydrochloride. the 213 patent is directed to humans, the 549 patent is directed to animals. Humans are a species of the animal genus. Our case law firmly establishes that a later genus claim limitation is anticipated by, and therefore not patentably distinct from, an earlier species claim.

66 TWO-WAY TEST IS A NARROW EXCEPTION TO THE ONE-WAY TEST Eli Lilly & Co. v. Barr Laboratories, Inc., Judge Newman, dissent When the second patent to issue is (as here) the first patent that was filed, court should apply the two-way test. By applying the rules of cross-reading, double patenting will not lie, for cases in which the first patent to issue is the second patent that was filed, unless the claims cross read; that is, unless the claims of each patent would have been obvious in view of the claims of the other patent. FN 7: The two-way test is only appropriate in the unusual circumstance where, inter alia, the United States Patent and Trademark Office ( PTO ) is 'solely responsible for the delay in causing the second-filed application to issue prior to the first.'" 66

67 67 EXAMINER ODP REJECTION

68 68 SEPARATELY PATENTABLE

69 RESPONSE TO EXAMINER REJECTION (related to Chen v. Bouchard Interference) Genus claim 140, species claim 142, intermediate claim 141 all patentably distinct from each other and from 026 patent or the 789 patent. 026 patent recites the species of claim 142 but not the intermediate and only in combination with at least one other anti-cancer agent. At best obvious to try. Genus claim 140 and species claim 142 can be produced by other intermediates. Expert declarations supported; interference instituted on 3 separate counts. General rule is one-way, but two-way test is proper test in this case, (but no ODP under either one-way or two-way). No 026 claim or 789 claim is obvious over genus claim 140, species claim 142, or intermediate claims 141, or vice versa. Office has controlled the rate of prosecution that resulted in the later-filed patent issuing earlier, and the 026 claims or 789 claims could have not been presented in the present application. 69

70 WHEN SHOULD THE TWO-WAY TEST BE APPLIED? Apply two-way test 70

71 71

72 72

73 73

74 74

75 75 COMMON OWNERSHIP

76 PRE-AIA: COMMON OWNER HYPOTHETICAL PROBLEM A and B work for company X A and B have a duty to assign all inventions to company X A comes up with an invention, assigned to X A and B later come up with another invention, assigned to X A A B X A and A+B are considered different persons for determination of availability of A invention as prior art 76

77 PRE-AIA: SOLUTIONS TO THE COMMON OWNERSHIP PROBLEM 1984 Amendment to 103: Subject matter developed by another person, which qualifies as prior art only under subsection (f) or (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person Amendment extended to prior art qualifying under Section 102(e). 77

78 PRE-AIA: JRA COLLABORATION PROBLEM Oddzon Products, Inc. v. Just Toys, Inc., 122 F.3d 1396 (Fed. Cir. 1997) Background Oddzon sued Just Toys for patent infringement; Just Toys alleged patent invalidity Invention created by researchers from more than one organization Two confidential designs disclosed between researchers at the separate organizations Question: Can confidential information shared between the members of a research team be prior art for the purpose of rendering that invention obvious under 103? 78

79 PRE-AIA: JRA COLLABORATION PROBLEM Federal Circuit held: Confidential information exchanged between research partners is available as prior art to invalidate a patent. Except if rights to the invention were assigned to a single entity before creation of that invention. Practical effect Inventions developed through a structured joint research agreement could be rendered unpatentable because parties at separate organizations had collaborated and exchanged information. 79

80 PRE-AIA: SOLUTION TO THE JRA COLLABORATION PROBLEM 2004 Cooperative Research and Technology Enhancement Act ( CREATE ): Extended safe harbor beyond only common ownership to joint research agreements. Only for 103 rejections based upon prior art qualified under 102 (e), (f), or (g). 80

81 AIA: SOLUTIONS TO THE COMMON OWNERSHIP PROBLEM Common Ownership Protection Moved from 103 to (b)(2)(C): U.S. patent filing is not prior art if commonly owned with claimed invention Only an exception to 102(a)(2) U.S. patents, U.S. patent application publications, or WIPO published applications effectively filed, but not published, before the effective filing date of the claimed invention Not an exception to 102(a)(1) (published prior to filing date). Deadline for common ownership effective filing date of claimed invention. CREATE Act provisions (joint development agreements) moved to 100, 102. Common ownership protects against anticipation as well as obviousness rejections (but not against obvious-type double patenting rejections). 81

82 AIA: JOINT RESEARCH AGREEMENTS 102(c) COMMON OWNERSHIP UNDER JOINT RESEARCH AGREEMENTS. Subject matter disclosed and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person in applying the provisions of subsection (b)(2)(c) if 1) the subject matter disclosed was developed and the claimed invention was made by, or on behalf of, 1 or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention; 2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and 3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. 82

83 LIMITATIONS OF 102(b)(2)(C) COMMON OWNERSHIP PROTECTION 102(b)(2)(C) exception does not remove 102(a)(1) prior art, or a double-patenting rejection, or a lack of enablement rejection - a document need not qualify as prior art to be applied in the context of double patenting or enablement. See pp of Examination Guidelines (2/14/13). 83

84 COMMON OWNERSHIP AND DOUBLE PATENTING What about double patenting? MPEP 804(I)(A): "Double patenting may exist between an: issued patent and an application filed by the same inventive entity, or by a different inventive entity having a common inventor, and/or by a common assignee/owner." 84

85 COMMON OWNERSHIP AND DOUBLE PATENTING If at least one of A+B s claims is not patentably distinct from an issued claim in A s patent then A+B s application is subject to a double patenting rejection, even though A s patent is not available as prior art. See In re Hubbell, No (Fed. Cir. 2013). 85

86 COMMON OWNERSHIP AND Hubbell asked: DOUBLE PATENTING Does obviousness-type double patenting ( ODP ) apply where an application and a conflicting patent have one or more inventors in common, but the inventive entities are not identical and the applications were never commonly owned? Can a terminal disclaimer be filed to overcome ODP in the absence of common ownership? Should a two-way obviousness test apply to overcome ODP? 86

87 COMMON OWNERSHIP AND Background: DOUBLE PATENTING Inventors Hubbell and Schense at CalTech Research resulted in 509 application (earliest priority April 3, 1997) 509 patent assigned to CalTech. Hubbell and Schense left CalTech to join ETHZ. Research resulted in 685 patent (earliest priority August 27, 1998). 685 patent assigned to ETHZ and Universitat Zurich, and issued first. Examiner rejected 509 application based on ODP over 685 patent. 87

88 COMMON OWNERSHIP AND DOUBLE PATENTING Is 685 patent available as prior art under 102 or 103 to the 509 application? BPAI: Yes. Claims of 685 patent (species claims) anticipated representative claim of 509 application (genus claim). 88

89 COMMON OWNERSHIP AND Holding: DOUBLE PATENTING Agreed with BPAI, rejecting Hubbell s argument that ODP should never be applied in the absence of common ownership. Cited In re Fallauz, 564 F.3d 1313, 1315 (Fed. Cir. 2009): ODP is meant to prevent harassment of an alleged infringer by multiple assignees asserting essentially the same patented invention. No JRA, so terminal disclaimer not available. No two-way obviousness analysis: Hubbell partially responsible for delay that caused 685 patent to issue first. 89

90 CONSEQUENCES: JRA TERMINAL DISCLAIMERS Consider consequences of a terminal disclaimer pursuant to a JRA: Can overcome rejection based on ODP; BUT might lead to complications with enforcement. 37 C.F.R (d)(3) a terminal disclaimer in the context of a JRA must: Include a provision waiving the right to separately enforce any patent granted on that application and the patent which formed the basis for the double patenting and that any patent granted on that application shall be enforceable only for and during such period that said patent and the patent which formed the basis for the double patenting are not separately enforced 90

91 CONSEQUENCES: JRA TERMINAL DISCLAIMERS What this means for you? JRA-related terminal disclaimers may greatly complicate patent enforcement issues. Unless certain patents always enforced together, terminallydisclaimed patents no longer enforceable. Potential issues with, e.g., platform technology patents. 91

92 CONSEQUENCES: JRA TERMINAL DISCLAIMERS What steps to take? Evaluate prosecution strategy, and have a plan. Coordinate regarding the filing of any JRA-related terminal disclaimers. Separate enforceability could be issue with potential licensees (who controls enforcement?). 92

93 CONCLUSIONS Be aware of common ownership issues: Inventors move, important to be aware of prior applications/patents with common inventors. Both an upstream and downstream concern. Track prosecution of relevant applications/patents. Do not delay, and be thoughtful about order in which species versus genus claims are prosecuted. Under AIA, 102(a)(2) or 102(a)(2) / 103 problem may be removed by obtaining prior art or entering JRA before filing. 93 But be aware of enforcement issues raised by JRA terminal disclaimers.

94 PATENT TERM ADJUSTMENT AND AIA Previously, USPTO indicated preliminary PTA with the Notice of Allowance Now indicates PTA with the Issue Notification may be different if does not issue on time If PTA is too long, may send a letter to the USPTO If PTA is too short, must file a request to correct within seven months (with extensions) USPTO will issue a Certificate of Correction May file civil suit only if request is denied 94

95 PTA POSSIBILITIES 35 U.S.C. 154(b): Provides PTA should certain USPTO actions take longer than decreed periods of time Guarantee of prompt USPTO responses ( A-Delays ) Guarantee of no more than 3-year application pendency ( B-Delays ) Guarantee of adjustment for delays due to interferences, secrecy orders, and appeals ( C-Delays ) Adjustments are day for day for the amount of delay For this presentation the point is, carefully consider loss of PTA by filing a terminal disclaimer 95

96 EXAMPLE OF A-DELAY Univ. of Mass. v. Kappos, 903 F.Supp.2d 77 (DDC, Nov. 9, 2012) File application Feb. 4, month April 4, 2006 First Office Action July 13, Years Feb. 4, 2008 Second Office Action Feb. 21, 2008 A-Delay 223 days First OA was a restriction requirement PTO and UMass agreed there should be new restriction requirement UMass argued that PTA should include 223 days between 1 st and 2 nd OA because the first OA was incorrect District Court: No A-delay clock stops when first OA issues No requirement that the first OA be correct A-delay = 465 days 96

97 B-DELAY GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY B-Delays occur if the USPTO does not issue a patent within 3 years of the actual filing date. B-Delays do not include: time after request for continued examination (RCE); time consumed by an interference; time consumed by imposition of a secrecy order; time consumed by PTAB or Federal court review; or any delay at the request of the applicant. 97

98 98 C-DELAYS DELAYS DUE TO INTERFERENCES AND APPEALS C-Delays: 154(b)(1)(C), Issue of patent delayed due to interferences, secrecy orders, and appeals. Appellate review by PTAB or a federal court in which the review revers[ed] an adverse determination of patentability[.] Old: accrues from date Notice of Appeal filed. Now: accrues from date jurisdiction over the application passes to the Board until date of a final Board /court decision in favor of the applicant. Change applicable to any application in which a notice of allowance is issued after September 16, 2012, and any patent issuing thereon (and any timely reconsideration request after Sept. 16, 2012). 37 C.F.R (e).

99 LIMITATIONS ON PTA No Overlap/Double-counting: applies to all of A, B and C-Delay (35 U.S.C. 154(b)(2)(A)) Disclaimed term applies to all of A, B and C-Delay: TERMINAL DISCLAIMER (35 U.S.C. 154(b)(2)(B)) Applicant-caused delay: applies to all of A, B and C-Delay: EXTENSIONS OF TIME (35 U.S.C. 154(b)(2)(C)(i)): reduced by any time applicant failed to engage in reasonable efforts to conclude prosecution of the application. Arqule, Inc. v. Kappos, No. 1:10-cv (D.D.C. June 22, 2011) (weekends/holidays no longer counted against applicant delay) USPTO list of no-no s at 37 C.F.R

100 CALCULATING PTA Under 37 C.F.R (f), PTA is calculated by: Adding any A-Delays, B-Delays and C-Delays together Subtracting any overlap between A-Delays, B-Delays and C- Delays Overlap is calculated by counting delays occurring on the same calendar days Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) Before Wyeth, USPTO interpreted statute as only allowing greater of A-delays or B-delays, not both Subtracting any applicant delays 100

101 CALCULATING PTA: ADD PTE 37 C.F.R (f): Patent Term Extension ( PTE ) is in addition to PTA. 35 U.S.C. 156(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 section154(b)[.]" 101

102 Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014) and Exelixis, Inc. v. Lee, 2014 WL (Fed. Cir. 2014) PTA determination (reversed-in-part) no adjustment time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application s filing. 102 the patent term adjustment time should be calculated by determining the length of the time between application and patent issuance, then subtracting any continued examination time (and other time identified in (i), (ii), and (iii) of (b)(1)(b)) and determining the extent to which the result exceeds three years. Such a reading ensures that applicants recover for any delay[s] due to the failure of the [PTO], without allowing the applicant to recover for any time consumed by continued examination, as the statute requires. Id. 154(b)(1)(B)(i). 102

103 AFFIRMED TIME AFTER ALLOWANCE UNTIL ISSUANCE SHOULD BE COUNTED Federal Circuit in Novartis: time excluded from B-delay for filing a RCE > 3 years after filing ends at allowance, not the issue date. In the present case, time after allowance was not time caused by the continued examination. Because the PTO applied the contrary view in calculating the patent term adjustment for the 155, 518, and 631 patents, those calculations must be corrected

104 HYPOTHETICAL IN LIGHT OF GILEAD? Genus patent issues Species patent expires? X Genus patent + PTA expires Species patent issues Earlier-issued genus patent (with PTA), later-issued species patent Does Gilead require filing a TD in the genus based on a later-issued species patent if the two patents, unlike in Gilead, are in the same family? Does In re Berg, 140 F.3d 1428 (Fed. Cir. 1998), provide a counter-argument? species issued first so had to file TD in genus Court suggested to file all claims in one application, but raised Goodman, 11 F.3d 1046, 1052 (Fed.Cir.1993) Another option, prosecute genus claims first and wait for issuance of species claims until rights are sorted out in the genus 104

105 CALCULATE YOUR OWN PTA; KNOW WHAT YOU HAVE AND WHAT MIGHT BE AT RISK THROUGH TERMINAL DISCLAIMER Check USPTO s calculation of PTA to ensure that it is correct o o o Based on data found in PAIR - but not always accurate If you check and the PTA is too long, send a letter to the USPTO Consider a formal policy to always check or always not check Final PTA will be indicated on the face of the issued patent 105

106 CHALLENGING PATENT TERM ADJUSTMENT AIA SEC. 9: A patentee s challenge to the USPTO s PTA calculation that is filed on or after September 16, 2011, must be filed with the U.S. district court for the Eastern District of Virginia ( ED VA ), instead of the U.S. district court for the District of Columbia ( D DC ). 106

107 37 CFR 1.705(b) PROCEDURE FOR CHALLENGING PTA A request for reconsideration must be filed no later than two months from date of issuance* (usually (A) and (B) delay; could also be (C) delay) USPTO determined-pta is now provided no later than date of issuance of the patent (See 154(b)((3)(B)(i)) 37 C.F.R (d): Reconsideration of final PTA must be filed within 2 months of patent issuance, with up to 5 months of extensions 107

108 CONTESTING THE OFFICE S PTA DETERMINATION 35 U.S.C 154(b)(4)(A): Final Determination of PTA by USPTO can be appealed exclusively to the U.S. District Court Applicant must have received a Final Determination in order to appeal to the U.S. District Court Appeal must be filed within 180 days of the date of the Director s decision on the applicant s request for reconsideration (changed from after grant of patent by Technical Amendment) AIA changed the venue from D.D.C. to E.D. Va on September 16, 2011 Appeal exclusively to U.S. District Court added in Technical Amendment to AIA (signed Jan. 14, 2013) Applicants must respect the strict time and venue limitations of the patent statute (Janssen Pharmaceutica N.V. v. Kappos, No. 1:11-cv-969 (E.D. Va. Feb. 10, 2012)) Cannot raise issues that could have been raised before 108

109 APPEAL CASES Filing Date 11/05/2004 Three Years + 1 day from Filing First appeal Filed Appeal decision unsuccessful 11/06/ /18/ /04/ Year Deadline for PTO Action Proper B Delay = 407 days Notes: No C delay because appeal unsuccessful, but B delay = 407 days. Because you filed the appeal after three years, B delay will accrue until jurisdiction over the application passes to the PTAB for review. Days from PTA could be deducted for applicant delay if come under list of no-no s 109

110 PATENT TERM ADJUSTMENT: SUCCESSFUL APPEAL 14 month Years B-Delays 1293 days File Appl A-Delays 838 days Non-Final Notice of Appeal Non-Final Notice of Appeal Reply Brief C-Delay 871 days reopen prosecution, but no RCE and no PTAB jurisdiction yet, so B-Delay clock is still ticking Favorable Issues Appeal Decision Jurisdiction passes to PTAB Clock stops B-Delay and starts C-Delay 110 A Delay = 838 Overlap = 169 B Delay = 1293 Applicant Delays 205 C Delay = 871 Total PTA Adjustments = = = 2628 (7.2 years) Note: PTE, if any, is added to PTA.

111 PATENT TERM ADJUSTMENT: UNFAVORABLE OUTCOME ON APPEAL 14 month Years B-Delays 1293 days No C-Delay because appeal unsuccessful File Appl A-Delays 838 days Non-Final Notice of Appeal Non-Final Notice of Appeal Reply Brief reopen prosecution, but no RCE and no PTAB jurisdiction yet, so B-Delay clock is still ticking Unfavorable Appeal Decision Issues Jurisdiction passes to PTAB Clock stops on B- Delay 111 A Delay = 838 Overlap = 169 B Delay = 1293 Applicant Delays 205 C Delay = none Total PTA Adjustments = = = 1757 (4.8 years) Note: PTE, if any, is added to PTA.

112 TIPS FOR TRYING TO MAXIMIZE PTA BUT THEN DO YOUR BEST TO AVOID REDUCTION OF PTA THROUGH A TERMINAL DISCLAIMER Review US PTO s PTA calculation in Notice of Allowance and, if disagree, must act quickly to preserve rights Consider two-prong approach: after patent issues, request reconsideration in US PTO within 2 months and file district court case within 180 days of issuance If application falls under new guidance, may not need to file suit within 180 days, but consider whether there may be questions about which cases fall under new guidance Consider filing another case or amended complaint within 180 days of decision by PTO even if filed earlier Would not want to file too early, get dismissed and then be unable to re-file because deadline had passed 112

113 MAXIMIZING PTA: AVOIDING PITFALLS Respond within 3 months of an action don t take extensions 37 C.F.R (b): >3 months is failure to engage in reasonable efforts to conclude processing or examination and will mean deduction from PTA Respond right at end of 3 months?? Make a telephone election A written restriction requirement is a first action and will stop the 14-month clock A first office action usually takes longer to prepare File electronically, by Express Mail or FAX If mailed by first class, clock runs until response is received in the USPTO, even if includes a certificate of first class mailing Mail delays can end up amounting to weeks of lost PTA 113 Consider filing a CIP rather than a Continuation First action for a CIP typically takes longer than for a Continuation

114 MAXIMIZING PTA: AVOIDING PITFALLS Do not file papers after allowance Ask examiner to make corrections by examiner s amendment If a problem can be corrected by certificate of correction, wait and file after patent issues Avoid Terminal Disclaimers PTA cannot overcome a terminal disclaimer if date certain is disclaimed Consider non-date-specific language if have to file a Terminal Disclaimer to comply with 35 U.S.C. 154 (b)(2)(b) Avoid Requests for Continuing Examination Filing an RCE cuts off any further B-Delays Try to keep prosecution open without filing an RCE Be aggressive and argue against or appeal final rejections 114

115 MAXIMIZING PTA: AVOIDING PITFALLS Make sure replies are complete and do not have an omission PTA is lost for time needed to correct the omission Supplemental replies result in the same loss as an omission Days are counted from the day after the reply with omission was filed, not the date the reply was due Ask examiner if the problem can be corrected in the next reply or by an examiner s amendment 115

116 MAXIMIZING PTA: AVOIDING PITFALLS Timely file Information Disclosure Statements (IDS) File an IDS before the first office action or with a reply Not considered untimely if IDS is filed within 30 days of a communication from the USPTO or a foreign patent office with a certification under 37 C.F.R (d) Earlier rule only included foreign office communications Certification under 37 CFR 1.97(e)(1) does not prevent loss of PTA (within 3-months) Once 3-year deadline has passed, consider paying the issue fee at the last possible moment to maximize (B) delay 116

117 MAXIMIZING PTA: AVOIDING PITFALLS File Appeals if grounds exist and record supports Establish necessary record early in prosecution to support appeal If examiner re-opens prosecution through an office action currently no C-Delay accrues No favorable decision by the Board A-Delay from the Appeal Brief filing until examiner issues an office action to re-open prosecution (any time over 4 months) But New Rule results in B-Delay, if available Currently, some extensions of time during the appeal process do not count against the applicant for PTA But New Rule makes an extension for filing an Appeal Brief applicant delay 117

118 WHAT SHOULD PRACTITIONERS BE DOING? Identify pending applications that cover inventions that are expected to retain value at end of patent term Carefully analyze USPTO s PTA calculation and then do your best not to lose that PTA through a terminal disclaimer Make sure correct under current law Determine if law not being properly applied by USPTO If disagree, must act quickly to preserve rights After patent issues, request reconsideration in US PTO within 2 months and prepare to file district court case within 180 days of decision on request for reconsideration Must file request for reconsideration prior to paying issue fee 118