Leveraging Patent Reissue for Patent Portfolio Management

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Leveraging Patent Reissue for Patent Portfolio Management Strengthening Patent Portfolios, Correcting Patents, and Understanding the Risks and Limitations of Reissue THURSDAY, NOVEMBER 13, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Donna M. Meuth, Associate General Counsel, Eisai, Andover, Mass Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. Deborah M. Herzfeld, Of Counsel, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. John Mulcahy, Finnegan Henderson Farabow Garrett & Dunner, Reston, Va. 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 Leveraging Patent Reissue for Patent Portfolio Management: Strengthening Patent Portfolios, Correcting Patents, and Understanding the Risks and Limitations of Reissue by Donna Meuth John Mulcahy Deborah Herzfeld Tom Irving Copyright Finnegan, 2014

6 Disclaimer These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law and practice. These materials reflect only the personal views of the joint 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. And not all views expressed herein are subscribed to by each joint author. Thus, the joint authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), and EISAI cannot be bound either philosophically or as representatives of 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 the joint authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), or EISAI. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 6

7 Current Landscape: AIA Changes Impacting Patent Reissue without any deceptive intention removed by AIA 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. 7

8 AIA Makes No Difference on Doctrine of Intervening Rights No 3 rd party intervening rights for claims substantially identical to original patent. May be 3 rd party intervening rights for changed claims if: Alleged infringer made, used, sold, offered for sale or imported prior to the grant of the reissue. Alleged infringer made substantial preparation to make, use, sale, offer for sale or import prior to the grant of the reissue. Where intervening rights are at issue, going for a reissue in view of an IPR/PGR may not have any practical benefit. 8

9 AIA Does Not Affect Existing Rules Against Recapture Precluding Reissue Federal Circuit recapture test. Interplay of the recapture rule and the Orita doctrine. MPEP will be most important to PTO but Federal Circuit decisions could mean more to PTAB. 9

10 Traditional Recapture Subject matter surrendered to obtain the original patent cannot be recaptured by filing a reissue. Consider effect of broadest reasonable claim construction? Surrendered subject matter : 1. The claim scope of the application claims that were canceled/amended in order to obtain the allowance of the patent; or 2. The right to a claim that does not include (in any form) a particular limitation that had been added/argued to overcome a prior art rejection. 10

11 Recapture Must Relate To Change In re Youman, 679 F.3d 1335 (Fed. Cir. 2012) Board upheld examiner rejection for improper recapture of subject matter surrendered in the original application. 3-step recapture rule analysis (see also, MPEP ) 1. determine whether and in what aspect the reissue claims are broader than the patent claims. 2. determine whether the broader aspects of the reissue claims relate to surrendered subject matter. 3. determine whether the surrendered subject matter has crept into the reissue claim. FC: Vacate and remand for Board to perform 3 rd step. 11

12 Prosecution Arguments May Trigger Recapture MBO Labs., Inc. v. Becton, Dickinson & Co., 602 F.3d 1306 (Fed. Cir. 2010) RE 885 patent teaches a syringe that protects against needle-stick injuries by sheathing a contaminated needle in a flange-covered guard. MBO argued that it never surrendered a guard body that could move relative to the syringe's fixed needle. DC: MBO violated rule against recapture. FC: Affirm. MBO clearly and unmistakably surrendered claiming a guard body that moved relative to a fixed needle. MBO twice overcame the examiner's rejections by emphasizing that the prior art disclosed a type of guard that moved relative to a fixed needle. In contrast, MBO stressed that its needle moved relative to the guard by slidably retracting. Also, note: a patentee may violate the rule against recapture by claiming subject matter in a reissue patent that the patentee surrendered while prosecuting a related patent application. 12

13 Claim Construction May Impact Recapture AIA Engineering Ltd. v. Magotteaux Intern. S/A, 657 F.3d 1264 (Fed. Cir. 2011) Magotteaux replaced homogeneous solid solution in original claim 1 with homogeneous ceramic composite in reissue claims. DC: reissue claims had broader scope than original claims; invalid under 35 U.S.C. 251 for impermissibly recapturing subject matter surrendered during reissue examination. FC: Reverse and remand. Error in claim construction lead to error in conclusion of impermissible recapture. With the correct construction (two phrases are synonymous according to patentee s lexicography) there was no broadening, and therefore recapture issue is moot. 13

14 How Have Patent Reissue Implications Changed Post-AIA? Reissue applications can be merged with ex parte reexaminations. Reissue rules govern merged proceeding. Timing with concurrent PGR/IPR. PGR/IPR instituted before reissue reissue likely stayed. PGR/IPR filed before reissue reissue likely stayed. PGR/IPR filed/instituted after reissue reissue likely stay. See, e.g., Hewlett-Packard Co. v. MCM Portfolio, LLC, IPR , Paper 8 (May 10, 2013), and Changes to Implement Inter Partes Review Proceedings, Post-Grant Review Proceedings, and Transitional Program for Covered Business Method Patents, 77 Fed. Reg. 48,680, (Aug. 14, 2012). Response to Comment 90 asking about effect of a reissue application filed after instutution of a post-grant proceeding: Under the rules, a stay, transfer, consolidation or termination would be an option in this situation and Both whether a stay, transfer, consolidation or termination would be ordered and the order of resolution would depend on particular facts and circumstances. The Board will take into consideration the impact on each proceeding on a case-by-case basis. PGR/IPR PGR applicable for 9 months after reissue on new reissue claims. Reissue effective filing date is patent filing date. IPR is available as normal. What may the role of reissue be in these PGR/IPR proceedings? 14

15 The AIA Post-Grant Options Contrast with Reissue (Other Than Supplemental Examination) Ex Parte Reexam Post-Grant Review When After grant Within nine months of grant (only AIA patents) Threshold showing Grounds SNQ Patents/printed publications 102, 103 More likely than not claim is unpatentable or novel legal question 101, 102, 103, 112 Covered Business Methods PGR After grant, for covered business method patents More likely than not PLUS sued or charged with infringement Inter Partes Review After 9 months of grant (AIA patents) or terminated PGR Reasonable likelihood of success 101, 102, 103, 112 Patents/printed publications 102, 103 Time at PTO Years months months months Anonymity Yes No No No 15

16 The AIA Post-Grant Options Contrast with Reissue (Other Than Supplemental Examination) Ex Parte Reexam Post-Grant Review Covered Business Methods PGR Inter Partes Review Estoppel None Issues raised or reasonably could have been raised Before whom Discovery/ evidence Appeal PTO: raised or could have raised Dist Ct: raised Issues raised or reasonably could have been raised CRU PTAB PTAB PTAB Declaration Only patent owner may appeal to PTAB then Federal Circuit Declaration and discovery Both parties may appeal to Federal Circuit Declaration and discovery Both parties may appeal to Federal Circuit Declaration and discovery Both parties may appeal to Federal Circuit 16

17 But: IPR/PGR Weighted Against the Patent Owner: Reissue Could be Better Burden of proof ISSUE PGR/TPGR/IPR DISTRICT COURT Preponderance of the evidence Clear and convincing evidence Presumption of Validity? No Yes Claim construction Broadest reasonable construction Philips/Markman framework: analyze claims, specification, and prosecution history to determine how claims would be understood by one of ordinary skill in the art Decision maker Patent Trial and Appeal Board (APJs) District court judge or jury no deference 17

18 Rocket Docket Procedure/Timeline for Post-Grant Options: An Opening for Reissue but what about Stays? months Petition PO Prelim. Response Decision/ Institution PO Response/ Motion to Amend Petitioner Reply/ Opposition PO Reply Oral Hearing Final Written Decision PO Discovery on Real Parties in Interest (3 months) PO Discovery (3 months) Petitioner Discovery (3 months) PO Discovery (1 month) Period for Observation & Motions (2 months) Sample timeline from USPTO. 18

19 Statistics: Post-Grant Options (as of Oct. 23, 2014) Petitions filed Trials instituted Petition denied Settlements Final Written Decisions Inter partes review Source: 77% of petitions granted (787/1021). 19

20 SNAPSHOT OF REISSUE APPLICATIONS: 64% GRANT RATE (5668/8845)( ) Reissue applications filed Reissue patents issued Source: USPTO 2013 Annual Report , reissue patents =.2% to 3% of total patent applications filed Volume is similar to that of plant patents. 64% of reissue applications filed issued (5668/8845). Reissue application filing fee: $280 (!) (37 C.F.R. 1.16) 20

21 Thus far Hundreds of claims, entire patents cancelled (in 73% (86/118) of Final Written Decisions, no instituted claims survived)* 15 patents have survived IPR entirely (12.7%)* *As of Oct. 7, Source: Finnegan research; 118 Final Written Decisions. 21

22 IPRs as of Oct. 18, 2014 IPR Case Outcomes % IPR Instituted Claim Disposition % % % At Least One Instituted Claim Survived No Instituted or Substitute Claims Survived Considered Substitute Claims Allowed % % Instituted Claims Conceded by Owner Instituted Claims Cancelled by PTAB Instituted Claims Surviving Finnegan research. 118 Final Written Decisions on the Merits (Consolidating duplicate cases; method may differ slightly from PTAB reported stats). 22

23 What Patent Strengthening Benefits Can Reissue Provide In AIA Post-Grant Proceedings Before PTAB, As Well As In District Court Litigation? 23

24 PGR/IPR/Reissue Timing Requirements Related to Litigation Cannot file AIA Post Grant challenge if challenger also filed civil action challenging validity of patent. Petitioner, real party, or privy of petitioner. Does not include counterclaim. No such limitation against Patent Owner s Reissue Cannot file IPR more than 12 months after the petitioner is served with a complaint alleging infringement of patent. No such limitation on Reissue In other words, no such timing requirements on Reissue other than the normal ones, and particularly the two year bar against broadening reissue. 24

25 Petitioner Estoppel: PGR and IPR PGR and IPR Becomes effective once the Board issues a final written decision Applies to any ground that petitioner raised or reasonably could have raised Estoppel applies in subsequent proceedings before the PTO, in civil actions, and in ITC proceedings Reissue has no formal estoppel but can impose limitations No petitioner estoppel if IPR/PGR settled and no PTAB decision on the merits. 317(a) and 327(a): If IPR/PGR is terminated with respect to a petitioner in view of a settlement, no estoppel attaches to petitioner. If no petitioner remains in the IPR/PGR, then Office may terminate the IPR or proceed to final written decision. 25

26 But: Patent Owner Estoppel Could Make Reissue An Interesting Alternative AIA Post Grant Patent owner estoppel. Substantive rule making? 42.73(d)(3) A patent applicant or owner is precluded from taking action inconsistent with the adverse judgment, including obtaining in any patent: i. A claim that is not patentably distinct from a finally refused or canceled claim; or ii. An amendment of a specification or of a drawing that was denied during the trial proceeding, but this provision does not apply to an application or patent that has a different written description. 26

27 In IPR/PGR, Patent Owner Can Theoretically Make Limited Amendments Once Reissue: multiple amendments subject to recapture, broadening, 112 requirements In AIA post grant, Patent Owner must confer with the Board before filing a motion to amend the claims. AIA Post Grant Motion to Amend requirements Only get a reasonable number of substitute claims one-to-one correspondence. Identify the patentable distinction Provide technical facts and reasoning. Provide any construction for any new claim terms. Some representation should be made about the specific technical disclosure of the closest prior art known to the patent owner. Patent Owner prove patentable over ALL prior art, not just grounds of IPR/PGR. PTAB often cites Idle Free Sys. v. Bergstrom, Inc., IPR , Paper 26 (PTAB June 11, 2013) as providing specific guidance to the patentability analysis required. 27

28 Restrictions on Patent Owner Claim Amendments in IPR/PGR: Reissue is Different Motion to Amend requirements (con t) For amended claims, citations to the specification for written description support for not only the patent-at-issue, but also all parent applications. Address basic skill set possessed by one with ordinary skill in the art [I]f a feature Z is proposed to be added to an independent claim to render it patentably distinct from the prior art,... it would be helpful for the patent owner to first focus on feature Z and indicate whether feature Z was known in any context, and if so, then explain why that context is so remote or different from that of the claimed invention that one with ordinary skill in the art would not have applied that teaching to arrive at the claimed invention. IPR , Oracle v. Clouding IP, LLC, paper 15 (July 15, 2013). 28

29 Motions to Amend PTAB may grant motion to amend with respect to canceling claims, but then deny with respect to substitute claims. Intelligent Bio-systems, Inc. v. Illumina Cambridge Ltd., IPR and IPR (PTAB) Following institution Illumina filed a Motion to Amend Claims but not a Patent Owner Response (did file a POPR). IBS filed an opposition to Illumina s Motion to Amend. PTAB: granted Motion to Amend to the extent it requests to cancel claims ; Illumina s Motion to Amend is denied to the extent that it requests entry of substitute claims[.] After considering all the evidence as a whole, we conclude that Illumina has not met its burden in showing that the proposed substitute claims are patentable over the prior art considered in this Decision. Petitioner benefited from Patent Owner s efforts! The idea of reissue is for Patent Owner to benefit from Patent Owner s efforts! 29

30 Claim Amendments in PGR/IPR International Flavors & Fragrances Inc. v. The United States Of America, As Represented By The Secretary Of Agriculture, IPR , Paper 12 (PTAB May 20, 2014) No Preliminary Response filed. IPR instituted. No Patent Owner Response, instead Motion to Amend. (unopposed) cancel all claims substitute new claims First ever motion to amend granted (not just canceled). Reissue is MUCH more flexible for claim amendments 30

31 Let s Look at the Old Claims Old claim 1: A method for repelling arthropods, said method comprising treating an object or area with an arthropod repelling effective amount of at least one isolongifolenone analog and optionally a carrier or carrier material; wherein said at least one isolongifolenone analog has the following formula: wherein. Old claim 8: The method according to claim 1, wherein said at least one isolongifolenone analog is selected from the group consisting of [6 specific analogs] and mixtures thereof. 31

32 Let s Look at the New Claims 32

33 Int l Flavors (con t) PTAB: Motion to Amend Granted Patent Owner showed written description support for amended claims. We conclude that Patent Owner has made a sufficient showing that each of proposed independent claims 27 and 45, as well as each of proposed dependent claims 28-44, as a whole, has written description support in the application as filed. Patent Owner bears burden to overcome prima facie case of obviousness patent owner bears the burden of proof to demonstrate patentability of the proposed claims over the prior art in general, and thus entitlement to the proposed claims. the patent owner should discuss, as well as present evidence, if appropriate, as to the level of ordinary skill in the art, and what was known regarding the features being relied upon to demonstrate patentability of the proposed claims. 33

34 Motion to Amend Granted Int l Flavors (con t) PTAB: Patent Owner provides several publications, as well as the Declaration, to demonstrate the level of ordinary skill in the art, as well as the unobviousness of features being relied upon to demonstrate patentability of the proposed claims. as well as providing evidence regarding what would have been understood by the ordinary artisan as to those features being relied upon to demonstrate patentability of the proposed claim. Specifically, Dr. Zhang concludes, based on the results presented in the Declaration, that the ordinary artisan would not expect that minor structural changes to a known insect, tick, or mite repellent would result in a modified compound having the same repellency as the parent compound.. According to Dr. Zhang, such activity cannot be predicted based on structure alone, but must be determined by experiment. Because the prior art does not provide a reason to modify isolongifolanone to arrive at the modified isolongifolanone compounds of proposed claim 27, nor does it provide a reasonable expectation that such modifications would result in a compound having the desired insect repellent activity, we conclude that the preponderance of the evidence supports the patentability of claim

35 Int l Flavors (con t) Motion to Amend Granted Comments Use case as guide in ex parte matters Way to win on nonobviousness at the PTO in ex parte matters, which of course should be strongly guided by PTAB. Could apply principles to reissue. The claim: selected from the group consisting of but better to say wherein said at least one analog is chosen from and mixtures thereof is strange in juxtaposition with at least one in context of this case 35

36 So, Consider Having Patent Owner in IPR/PGR Go to Reissue But, what about stay of reissue? As seen, only able in IPR/PGR to amend once, and only if Motion to Amend requirements are met. As seen, Patent Owner Estoppel can be quite severe, reminiscent of the body of law of interference estoppel. Bad environment in inter partes IPR/PGR. Particularly the inter partes part of it and the PTOimposed patent owner estoppel. 36

37 So, Consider Having Patent Owner in IPR/PGR Go to Reissue So maybe Patent Owner doesn t amend claims in IPR/PGR and rather provides a patentably distinct but useful claim amendment in reissue, considering likely stay. Reissue likely stayed pending disposal of IPR/PGR within the one year period from institution. If claims of patent canceled in IPR/PGR, Patent Owner wants to look for patentably distinct claims in reissue that are enforceable and still infringed. 37

38 Particularly in Pharma Pursue reissue to get Orange Book-listable claims that are separately patentable over patent claims lost in the IPR/PGR. Generic has to certify against claims. Institute new Hatch-Waxman litigation with narrower claims, but may not get a 30 month stay in view of earlier H-W litigation. But how realistic will this be, particularly if PGR/IPR patent owner estoppel sticks? Owner would be looking for claims that can be enforcec but that are separately patentable over claims lost in PGR/IPR? And isn t the reissue likely to be stayed? Can the reissue beat IPR/PRG to the punch and be resolved BEFORE IPR/PGR? 38

39 Further Considerations for Countering Future IPR Attacks: Develop Validity/Patentability Positions in Reissue 39

40 Reissue May be Best Way to Strengthen Patent In re Tanaka, 640 F.3d 1246 (Fed. Cir. 2011) Tanaka filed a reissue declaration containing the original claims plus an added claim dependent on original claim 1. Examiner rejected the claims because there was no error identified that broadened or narrowed the scope of the issued claims. Board held that it is not reissue error under 35 U.S.C. 251 to add a subgeneric claim where all existing claims in the patent are maintained, both broader and narrower than the added claim. FC: Reversed and remanded. adding dependent claims as a hedge against possible invalidity of original claims is a proper reason for asking that a reissue be granted. In re Handel, 50 CCPA 918, 312 F.2d 943, 946 n. 2 (1963). the omission of a narrower claim from a patent can render a patent partly inoperative by failing to protect the disclosed invention to the full extent allowed by law. MPEP

41 Use of Tanaka Reissue Declaration 41

42 Issues of Obviousness-type Double Patenting (ODP) Can Be Addressed Reissue but Currently ODP is Not Raise-able in IPR or PGR Given the present state of ODP law, that is not necessarily a good thing for the Patent Owner Patent reform efforts to codify, e.g., Goodlatte Innovation Act passed house in 2013 would codify ODP as section 106 Thus, ODP would be a grounds for review in Post-Grant Proceedings immediately after issue 42

43 Obviousness-Type Double Patenting in IPR? No decision yet in IPR. IPR (raised ODP, Patent Owner argued ODP not statutory basis for IPR; terminated due to settlement) IPR , IPR , IPR , IPR , IPR , IPR , IPR Same Petitioner and Patent Owner Petitioner raised ODP but IPRs not instituted for failure to identify real-party-in-interest. But PTAB decision in CBM PGR said no. Obviousness-type double patenting is a judicially created, policy based doctrine, not a statutory ground specified in [the AIA statute]. Therefore, obviousness-type double patenting is not a permissible ground for challenging claims in Covered Business Method review. Apple Inc. v. SightSound Techs., CBM , Paper 13, at 25 (Oct. 8, 2013). 43

44 Later-Issued, First-Expiring is ODP Reference Against First-Issued, Later-Expiring Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) Gilead s U.S. Pat. Nos. 5,763,483 and 5,952,375 commonly-owned, list same inventors, similar written descriptions, BUT do not claim priority to a common patent application and have different expiration dates. Natco: 483 patent was invalid for ODP over 375 patent. Gilead: 375 patent cannot serve as a ODP reference against the 483 patent. timeline from opinion 44

45 Federal Circuit Expands ODP? Gilead (con t) DC: Judgment of infringement. a later-issued but earlier-expiring patent cannot serve as a double-patenting reference against an earlier-issued but later-expiring patent. FC: Vacate and remand. Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?...under the circumstances of this case that it can[.] it is a bedrock principle of our patent system that when 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. And that 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. Such is the case here. 45

46 Federal Circuit Expands ODP? Federal Circuit s example if the 375 patent issued the day before the 483 patent, in Gilead s view, the last twenty-two months of the term of the 483 patent would be an improper extension of patent term. 46

47 Federal Circuit Expands ODP? Federal Circuit s example if the 375 patent issued the day after the 483 patent, those last twenty-two months of the term of the 483 patent would not be an improper extension of patent term. 47

48 Gilead dissent (con t) Judge Rader Dissent Court s new rule expanding the judicially-created doctrine of obviousness-type double patenting unwarranted No reason to apply double patenting does not raise policy concern regarding subsequent extensions of patent term; this case does not involve the potential for harassment by multiple assignees asserting essentially the same patented invention. Instead of claiming priority to the 375 patent family, Gilead filed the application that ultimately issued as the 483 patent as a separate family. In the process, Gilead gave up roughly 10 months of priority. Consequently, the 483 patent is subject to roughly 10 months of intervening prior art. Nevertheless, despite sacrificing almost a year of priority, the court contends that Gilead acted improperly by continuing to pursue claims in the application that issued as the 375 patent. 48

49 Gilead = Expansion or Limited to Facts? Specific circumstances: both patents/applications are post-uraa (subject to 20- year from filing patent term); and patents/applications have different earliest nonprovisional filing dates and therefore different expected expiration dates. What about impact on patents with PTA awards? particularly in patent families with continuations Status: Rehearing denied, July 29, 2014; deadline to file petition for certiorari extended to November 26,

50 Expanding Gilead? Abbvie, Inc. v. Kennedy, 764 F.3d 1366 (Fed. Cir. 2014) Kennedy patents 7,846,442 (the 442 patent) and 6,270,766 (the 766 patent). Both patents are directed towards methods of treating rheumatoid arthritis by co-administering two drugs. AbbVie licensed the 766 patent, but not the 442 patent. FDA approval to sell Humira AbbVie sued Kennedy for a DJ that the 442 patent was invalid under ODP. DC: 422 invalid for ODP. FC: Affirmed. 50

51 Two Patents on Combination Therapy claimed priority 766 priority date Oct. 8, patent appln filed Aug.1, patent issued Aug. 7, patent expire Oct. 8, patent appln filed Sept. 12, patent issued Dec. 7, patent expire Aug. 21, 2018 claimed priority 51

52 Claims 766 Claim 8: A method of treating rheumatoid arthritis in an individual in need thereof comprising co-administering methotrexate and an [anti-tnfα] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts. 442 Claim 1: A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate comprising adjunctively administering with methotrexate therapy a different composition comprising an anti-human [TNFα] antibody or a human [TNFα] binding fragment thereof to the individual, wherein the anti-human [TNFα] or fragment thereof (a) binds to an epitope on human [TNFα], (b) inhibits binding of human [TNFα] to human [TNFα] cell surface receptors and (c) is administered at a dosage of mg/kg, and wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis. 52

53 Specifications 766 Specification: a multiple dose regimen of... an [anti-tnf] antibody, when administered adjunctively with methotrexate to an individual suffering from a TNF-mediated disease[,] produces a highly beneficial or synergistic clinical response for a significantly longer duration compared to that obtained with a single or multiple dose regimen of the antagonist administered alone or that obtained with methotrexate administered alone. 442 Specification: identical 53

54 District Court s Claim Construction coadministering : encompass[es] three possibilities for the order of administration of the methotrexate and anti-tnfα antibody... : [ concomitantly ]; methotrexate is begun first and treatment with antibody is then added ( adjunctively ); or antibody is begun first and treatment with methotrexate is then added ( adjunctively )[.] adjunctively : method of administration of methotrexate and an anti-tnfα antibody in which therapy with an anti-tnfα antibody (or fragment thereof) is added to ongoing methotrexate treatment. the 442 patent s adjunctive administration is one of the three forms of co-administration covered by the 766 patent. 54

55 District Court Decision [i]n light of the limited universe of treatment methods within the genus of co-administration defined by claims 8 through 14 of the 766 patent, a person of ordinary skill in the art would have envisaged the species of adjunctive administration defined by claims 1 and 2 of the 442 patent. a person of ordinary skill in the art would not consider there to be a substantial difference between the patient populations identified by claim 8 of the 766 patent and claim 1 of the 442 patent. 442 patent claims invalid for ODP over the 766 patent. 55

56 Federal Circuit Decision We now make explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates. We hold that Kennedy is not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct. 56

57 Federal Circuit Decision Step 1: Construe Claims District court s claim construction of co-administration was correct. 766 patent s specification makes clear that the invention described in the claims is limited to concomitant and adjunctive use. nowhere suggests that the invention includes administration of the antibody alone after discontinuing treatment with methotrexate. We assume, without deciding, that Kennedy's proposed construction of active disease was correct. 442 directed to subset of patients with more severe rheumatoid arthritis; 766 directed to arthritis patients generally. 57

58 Federal Circuit Decision Step 2: Analyze if Claims Are Directed to Patentably Distinct Subject Matter Thus, species are unpatentable when prior art disclosures describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class. Here, we think it is clear that a reader of the 766 patent could have easily envisioned a species limited to sicker patients. the 442 patent merely claims the known utility of the 766 patent and does not claim a species with unexpected results. 58

59 Litigation and Reissue Litigation A reissue application will be stayed if there is concurrent litigation unless The litigation is stayed The litigation is terminated There are no significant overlapping issues The applicant requests examination to continue Will that last point generally be quite likely? If reissue examination continues, NO extension of times are permitted. See MPEP A reissue can be useful in view of litigation, irrespective of any AIA Post Grant proceeding considerations. 59

60 USPTO Claim Construction Standard MPEP 2111: Applies to Both IPR/PGR and Reissue During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. The Federal Circuit s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the broadest reasonable interpretation standard: The Patent and Trademark Office ( PTO ) determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. (Citation omitted.) Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. (Citations omitted.) 60

61 But USPTO Standard For Both IPR/PGR and Reissue Has Limits In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010): The PTO's construction here, though certainly broad, is unreasonably broad. The broadestconstruction rubric coupled with the term comprising does not give the PTO an unfettered license to interpret claims to embrace anything remotely related to the claimed invention. Rather, claims should always be read in light of the specification and teachings in the underlying patent. 61

62 How Does The Federal Circuit Review PTAB Claim Constructions? Deferential review: is the Board s decision reasonable in light of all of the evidence? See, e.g., In re Suitco Surface, Inc., 603 F.3d at 1259 (citing In re Morris, 127 F.3d 1048, 1055 (Fed. Cir. 1997) De novo review; see, In re Baker Hughes, 215 F.3d 1297 (Fed. Cir. 2000) ( [A]lthough the PTO gives claims the broadest reasonable interpretation consistent with the written description... claim construction by the PTO is a question of law that we review de novo,... just as we review claim construction by a district court ). 62

63 Remember: Different Results Are A Very Real Possibility Baxter In re Baxter Int l, 678 F.3d 1357 (Fed. Cir. 2012)(LOURIE, Moore)(Newman, dissenting) Board s decision of unpatentability affirmed despite earlier opposite finding in district court and affirmance by Federal Circuit Considered Federal Circuit s earlier affirmance of validity, but Federal Circuit in this case nevertheless upheld rejections. PTO and courts take different approaches in determining validity and on the same evidence could quite correctly come to different conclusions Different claim construction standards; Different burdens of proof; and Different records. Because the two proceedings necessarily applied different burdens of proof and relied on different records, PTO did not err in reaching different conclusion than district court./fed. Cir. Congress has provided for reexamination system that permits challenges to patents by third parties, even those who have lost in prior judicial proceedings. But if patent owner loses in litigation, cannot use reissue to resurrect the lost claims. But can use reissue to secure claims separately patentable from the lost claims Patent Owner needs to seek such claims that are nonetheless still infringed 63

64 And End of Litigation May Not Be End of Case Fresenius II Fresenius USA, Inc. v. Baxter Int l., Inc., (Fresenius II), 721 F.3d 1330 (Fed. Cir. 2013)(DYK, Prost)(Newman, dissenting) Pending infringement suit must be dismissed as moot after PTO finding of invalidity during reexamination; wipes out $24 M damage award. USPTO s cancellation of the claims divested Baxter of a cause of action for infringement. Patentee argued that earlier final judgment by district court on damages operated as res judicata, precluding challenging district court s underlying holding of validity (upheld in Fresenius I) Majority disagreed, distinguishing between final judgments for the purposes of appeal and final judgments for the purposes of preclusion. Since scope of relief remained to be determined, there was no final judgment binding on the parties or the court. But Fresenius is for the alleged infringer! Paten t Owner would want to try to use reissue to secure separately patentable claims over claims lost at PTAB. 64

65 Reissue and Supplemental Examination When is supplemental examination a better idea than reissue and does reissue basically get the owner to the same place as supplemental examination would but in a shorter time? Would one use a combination of Reissue and Supplemental Examination to insulate reissued claims from allegation of inequitable conduct? 65

66 Supplemental Examination vs. Reissue? Reissue Cure May show prior art is not but-for material AIA eliminated the without deceptive intent requirement Examination Similar to ex parte prosecution RCE s and EOT s endless opportunity to amend Supplemental Examination (ex parte reexamination) Complete cure ex parte reexam if prior art raises a substantial new question of patentability but-for material? 2 Office actions before appeal No RCE s EOT s in limited situations only one opportunity to amend Examiner Regular examination corps Central Reexam Unit 3-examiner panel Timing with special dispatch Similar to ex parte prosecution Costs $3040 initial filing $1780 to issue Control Applicant PTO Error Must admit an error; dependent claim sufficient, see In re Tanaka Initial determination 3 mos Then ex parte reexam $4400 initial filing $12,200 if ex parte reexam No error needed 66

67 Supplemental Examination vs. Reissue IN GENERAL. A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of the patent. The making of a request under subsection (a), or the absence thereof, shall not be relevant to enforceability of the patent under section 282. [ 257(c)(1), 125 STAT. 326] Is this a holy grail of a pre-lit purge of inequitable conduct under a but-for materiality standard? 67

68 Supplemental Examination vs. Reissue 3 months for PTO to indicate whether or not submitted information raises a SNQP. [ 257(a), 125 STAT. 325] If no SNQP, subject to exceptions on previous slide, patent cannot be held unenforceable on considered information ; isn t that but-for materiality? If yes, can trigger reexam But patentee cannot make submissions regarding the art or claims before first Office Action. And some reexams historically have gone on for a long time Assuming the patentee establishes patentability of the claim (either in original or amended form) in the reexamination over the SNQ raised by the information reviewed, the patentee is insulated in subsequent litigation from a charge of inequitable conduct based on that information [ 257(c)(1), 125 STAT. 326], subject to exceptions noted previously. 68

69 Supplemental Examination vs. Reissue America Invents Act, SEC. 12 [125 STAT. 325] Allows submission of prior art in your own patents But SE effect does not apply against allegations already raised in district court or ANDA notice para. IV before date of filing request ( 257(c)(2)(A)), [125 STAT. 326] or SE effect shall not apply to any defenses raised in ITC litigation/district court litigation unless SE and any reexam ordered therefrom is finished before the date on which the action is brought ( 257(c)(2)(B)). [125 STAT. 326] New 257(a): A patent owner may request supplemental examination of a patent in the Office to consider, reconsider, or correct information believed to be relevant to the patent[.] [125 STAT. 325] Prior art? Inconsistent positions? Errors? Therasense: Rule 56? 69

70 Supplemental Examination vs. Reissue 257(f), 125 STAT. 327: Nothing in this section shall be construed (1) to preclude the imposition of sanctions based upon criminal or antitrust laws (including section 1001(a) of title 18, the first section of the Clayton Act, and section 5 of the Federal Trade Commission Act to the extent that section relates to unfair methods of competition); (2) to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office; or (3) to limit the authority of the Director to promulgate regulations under chapter 3 relating to sanctions for misconduct by representatives practicing before the Office. Do (1)-(3) compel full disclosure as discussed in Therasense majority and dissent? Are they adequate brakes on affirmative egregious misconduct? 70

71 Supplemental Examination vs. Reissue Fraud exception [ 257(e), 125 STAT ] (e) FRAUD. If the Director becomes aware, during the course of a supplemental examination or reexamination proceeding ordered under this section, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination, then in addition to any other actions the Director is authorized to take, including the cancellation of any claims found to be invalid under section 307 as a result of a reexamination ordered under this section, the Director shall also refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate. What is fraud and what investigation is needed? Is that an attempt to compel full disclosure? Does this make Supp Exam a non-starter? See the next slide: may be useful during litigation 71

72 Source: 72

73 Effect of Reissue Patent is deemed wholly or partly invalid or inoperable due to at least one error: the benefits of Tanaka. Reissue can cure that Unexpired term of the patent: no additional PTA or PTE, but also reissue doesn t adversely affect either. Effective date of claims. Can you foot fault into AIA with a PA on the day the reissue is filed? Intervening rights. 73

74 Effect of Reissue Opening up design-around possibilities. Delicate balance between avoiding prior art and avoiding patent owner estoppel and still being able to prove infringement. Notice what claims Petition did not challenge in IPG/PGR. Probably didn t challenge claims that raised no infringement concerns. Effects of reissue prosecution history. 74

75 Effect of Reissue Combined with PGR Opening up design-around possibilities particularly since discovery in IPR/PGR is not likely to be robust. Discovery is available in IPR/PGR but limited. Routine discovery Exhibits cited in paper or testimony; Cross examination of declarants; Relevant information that is inconsistent with a position advanced by a party. 75

76 Non-Routine, Additional Discovery For additional discovery, has as to meet the five Garmin factors: Request is based on more than a mere possibility of finding something useful. Request does not seek the litigation positions of the other party. Information is not reasonably available from other sources. Request is easily understood. Request is not overly burdensome. Very few motions for additional discovery granted through twoyear anniversary of IPR: the signal is that PTAB cannot resolve cases within twelve month requirement if additional discovery is granted. If not stayed, a successful reissue can be good for litigation also perhaps provide a better case for defeating institution of IPR/PGR 76

77 What Are The Benefits Of Using Reissue Proceedings To Resolve Patent Errors? 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) New Dependent Claims New prior art; hedge against possible invalidity attack New Broader Claims New products (patent owner or third-party) Unclaimed embodiments or species 77

78 What Are The Risks And Limitations Of Using Reissue Proceedings To Resolve Patent Errors? Provoke Interference Add new claims to reissue application. Still need to identify an error; which can be the addition of the new claims. Cannot re-file patent claims and suggest an interference If broadened; must be filed within 2 years. Intervening Rights Applies to past infringement. Consider scope of likely amendment. The greater the difference between patent claims and reissue claims the more likely intervening rights will be triggered. 78

79 Portfolio Management: Consider Impact of Reissue On and Before Ongoing PTAB IPRs and PGRs, Court Litigation, and Licensing Deals 79

80 Instead of Reissue, Keep Continuation Pending 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. 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. 80

81 Donna M. Meuth Associate General Counsel Intellectual Property Eisai, Inc. 4 Corporate Drive Andover, MA Donna_Meuth@eisai.com Thank you. John Mulcahy Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Two Freedom Square Freedom Drive Reston, VA john.mulcahy@finnegan.com Deborah Herzfeld Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC deborah.herzfeld@finnegan.com Tom Irving Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC tom.irving@finnegan.com 81