Strategies and pitfalls in inter partes reviews of Orange Book-listed patents. IIPRD 2015 Symposium Grant Shackelford 2015

Transcription

1 Strategies and pitfalls in inter partes reviews of Orange Book-listed patents IIPRD 2015 Symposium Grant Shackelford 2015

2 IPR filings of Orange Book-listed patents continue to increase Q Q Q Q Q Q Q Q Q Q Q Q3 2

3 Filings for AIA reviews of Orange Book-listed patents AIA Proceeding Petitions filed Petitions Denied Petitions Instituted Settlements Final Written Decisions IPR PGR CBM Data as of October 13,

4 Preparing the petition 4

5 Identifying real parties-in-interest 35 U.S.C. 312(a) A real party-in-interest is one that desires review and [a] common consideration is whether the non-party exercised or could have exercised control over a party s participation in a proceeding. There must be more than a parent-subsidiary relationship there must be control. Galderma S.A. v. Allergan Industrie, IPR , Paper No. 14 5

6 Having the power to call the shots Galderma S.A. v. Allergan Industrie, IPR , Paper No. 14 (one individual served as President and Chief Executive Officer of both Petitioner and Parent) Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc., IPR , Paper 88 (petitioner s vice president held the same title in the parent company, conducted negotiations with the patent owner on behalf of both petitioner and parent, and blurred the distinctions between the parent and its subsidiaries.) Compass Bank v. Intellectual Ventures II LLC, IPR , Paper No. 12, at pp (no showing that parent exercised or could have exercised control over subsidiary s filing or that parent funded, directed, and controlled the filing of the petition ). 6

7 Participation in a joint defense group does not establish RPI [I]f Party A is part of a Joint Defense Group with Party B in a patent infringement suit, and Party B files a PGR Petition, Party A is not a real party-in-interest or a privy for the purposes of the PGR petition based solely on its participation in that Group. CB Dist., Inc. v. Fontem Holdings, IPR , Paper No. 19, quoting Office Patent Trial Practice Guide 77 Fed. Reg. 48,756, 48,760 (Aug. 14, 2012) 7

8 Claim Construction Claim construction is a critical legal threshold issue Careful not to undermine non-infringement position Petitioner must support any proposed claim term interpretation with evidence The Board can raise it s own claim construction, even when the parties do not contest the term Amneal Pharms. v. Supernus Pharms., IPR Monosol RX v. Arius Two, IPR

9 Choosing grounds of unpatentability A request to submit additional grounds of unpatentability after institution has failed "[T]he original petition should have included all of the asserted grounds of unpatentability." Research In Motion v. MobileMedia Ideas, IPR , Paper No. 19. The PTAB routinely finds multiple grounds of unpatentability redundant Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co., CBM

10 Estoppel in subsequent AIA reviews The Director may "reject the petition or request because "the same or substantially the same prior art or arguments previously were presented to the Office. 35 U.S.C. 315(d) After a final written decision, the petitioner may not request or maintain a proceeding on any ground that the petitioner raised or reasonably could have raised during that inter partes review. 35 U.S.C. 315(e)(1) 10

11 Apotex v. Wyeth IPR , Paper No. 8 Apotex filed a petition in IPR , asserting 7 grounds of unpatentability, and the IPR was instituted on Ground 2 and the remaining grounds were deemed redundant. Apotex Inc. v. Wyeth LLC, IPR , Paper No. 10 After the oral hearing, Apotex filed a second petition in IPR , asserting previous Ground 6 and a new ground of unpatentability based upon previously disclosed references 11

12 Raised or could have raised Grounds raised during the preliminary proceeding, but not made part of the instituted trial, are not raised or reasonably could have been raised during an inter partes review and cannot be the basis for estoppel under 35 U.S.C. 315(e)(1). Apotex v. Wyeth, IPR , Paper No. 8 12

13 Raised or could have raised Petitioner was aware of, and cited, all of the Ground 2 prior art in the 115 IPR Petition, and therefore reasonably could have raised it during that proceeding. Apotex v. Wyeth, IPR

14 Redundancy "[W]e did not reach the merits of Petitioner s arguments with respect to Ground 1 when considering the 115 IPR. Therefore, we do not exercise our authority to decline an inter partes review of the 828 patent under 325(d)." Apotex v. Wyeth, IPR , Paper No. 8; but see Biodelivery Sciences Int l, Inc. v. RB Pharma LTD., IPR , Paper No

15 Redundancy "[W]e did not reach the merits of Petitioner s arguments with respect to Ground 1 when considering the 115 IPR. Therefore, we do not exercise our authority to decline an inter partes review of the 828 patent under 325(d)." Apotex v. Wyeth, IPR , Paper No. 8; but see Biodelivery Sciences Int l, Inc. v. RB Pharma LTD., IPR , Paper No

16 LG Electronics, Inc. v. ATI Techs., ULC IPR LG filed two IPR petitions on the same day, citing different sets of prior art references (Stuttard and Owens v. Rich and Lindholm) The Board denied the grounds based on Stuttard and Owens as redundant with the grounds in the companion IPR 16

17 LG Electronics, Inc. v. ATI Techs., ULC IPR "Petitioner does not argue any error in our determination that Stuttard and Owens disclose substantially the same subject matter as Lindholm and Rich or that the arguments presented in the Present Proceeding are not substantially different from those presented in the Companion Case." 17

18 Denials of petitions for inter partes review of Orange Booklisted patents 18

19 "Conclusary" declarant testimony 37 C.F.R (a) (opinion testimony that does not disclose underlying facts or data is entitled to little or no weight ) Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (a lack of objective support for expert opinion may render the testimony of little probative value in a validity determination ) 19

20 A POSA would recognize that Sandoz Inc. v. EKR Therapeutics, LLC, IPR (inherency arguments failed, in part, because petitioner did not present independent testing evidence in support of its inherency argument, but only relied on conclusions from its expert). Praxair Distribution, Inc. v. Ino Therapeutics, Inc., IPR ("Dr Beghetti, however, does not provide any objective support for his opinion that such patients 'should not be treated with inhaled NO'".... We, therefore, do not give persuasive weight to Dr. Beghetti's unsupported opinion). (Emphasis added). 20

21 Establishing references as prior art Actavis, Inc. v. Research Corp. Techs., Inc., IPR (Petitioner did not prove that the date of publication of a thesis or that the thesis was accessible.) Coalition for Affordable Drugs LLC v. Acorda Therapeutics, Inc., IPR , Paper No. 15 (Petitioner did not prove that temporary posters were publicly accessible and thus printed publications). 21

22 Inadequate anticipation arguments Anticipation arguments failed by combining elements from different embodiments, without declaration evidence showing interchangability of the embodiments. Endo Pharma., Inc. v. Depomed, Inc., IPR , Paper No. 12 A genus that included thousands of compounds did not anticipate, because the disclosure of a genus requires that a POSA would at once envisage each species within the genus. Actavis, Inc. v. Research Corp. Techs., Inc., IPR

23 A hope for a result does not establish obviousness A published pilot study disclosing a hope for a certain result does not constitute an invalidating disclosure, because a hope may or may not come to pass. Coalition for Affordable Drugs LLC v. Biogen MA Inc., IPR , Paper No. 23

24 Denying institution based on lead compound analysis Apotex Inc. v. Merck Sharp & Dohme Corp., IPR , Paper No. 14 (parent compound of claimed prodrug was not a lead compound where the prior art reference identifies 601 compounds without any experimental data) See also Torrent Pharms. Ltd. v. Merck Frosst Canada & Co., IPR , Paper Nos. 8,

25 Patent owner preliminary response 25

26 Patent Owner preliminary response The PO may file a preliminary response to the petition Filed in 86% of proceedings Page limit currently set at 60 pages (IPR) The response is limited to setting forth the reasons why no review should be instituted. The response can include evidence except for presenting new testimony evidence beyond that already of record. The preliminary response shall not include any amendment The PO may file a statutory disclaimer disclaiming one or more claims in the patent. 26

27 Patent Owner preliminary response can raise petition deficiencies Statutory bar (e.g., estoppel) Failure to properly identify real parties in interest References not prior art Prior art clearly omits material limitations of the claims Declaration testimony facially inadequate Plainly incorrect claim constructions Plainly incorrect legal analysis 27

28 Decision on petition 28

29 Disposition of petitions for inter partes review of Orange Book-listed patents Petition Decisions Instituted Denied Percent Instituted % 29

30 "The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable." 35 U.S.C. 314(d) St. Jude Medical, Cardiology Div., Inc. v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014) 30

31 Petition for Rehearing 37 CFR 42.71(d) A party dissatisfied with an institution decision may file a request for a rehearing. 14 days if trial was instituted 30 days if trial not instituted Less than 10% of motions for rehearing have been granted. 31

32 Petition for an expanded panel SOP 1 (Rev. 14) A party in a AIA Review may suggest the need for an expanded panel, because: the proceeding involves an issue of exceptional importance; the Board's decision conflicts with a precedential decision of the Board or an authoritative decision of the Board s reviewing courts; or consideration by an expanded panel is necessary to secure and maintain uniformity of the Board s decisions Conopco, Inc. v. Procter & Gamble Co., IPR , Paper 25 AOL Inc. v. Coho Licensing LLC, IPR , Paper 12 32

33 Patent Owner Response 33

34 Patent Owner s Response Page limit is currently set at 60 pages (IPR) Expert witnesses should have already been retained and up to speed Determine most favorable claim construction Consider district court litigation and infringement Consider amending the claims Prepare evidence of nonobviousness 34

35 Should you file a motion to amend? Uncertainty - a motion to amend is filed before you know how the Board will rule on patentability. Inequitable conduct - what is material prior art that should be filed? Contested by petitioner - ex parte reissue or a pending continuation removes petitioner arguments 35

36 Advantages of ex parte reissue [A]dding dependent claims as a hedge against possible invalidity of original claims is a proper reason for asking that a reissue be granted." In re Tanaka, 640 F.3d 1246, 1249 (Fed. Cir. 2011). IPR: Patent Owner files a single motion to amend, contested by Petitioner Reissue: Patent Owner has many opportunities to work with the Examiner, without petitioner To avoid a stay, Patent Owners have requested adverse judgment in the IPR and proceeded in reissue ContentGuard Holdings, Inc., IPR ; IPR & IPR

37 The Board has consistently rejected evidence of secondary considerations for lack of a nexus Secondary considerations must relate to novel features and not an element in the prior art. Torrent Pharms. LTD. v. Novartis AG, IPR , Paper No. 112 (no nexus for success of a solid oral multiple sclerosis drug, where a solid oral multiple sclerosis formulation was known in the prior art) 37

38 Secondary Considerations - Nexus Evidence of secondary considerations must be tied to patentable features Endo Pharma. v. Depomed, IPR (commercial success and licensing of drug products having the claimed controlled release formulation failed to show a nexus to the controlled release feature) 38

39 Petitioner Reply 39

40 Petitioner's Reply Page limit currently set at 25 pages for response brief and 15 pages for opposition to motion to amend Consider need to retain additional expert witnesses Cannot raise new arguments or evidence, but can rebut arguments raised by Patent Owner Greene's Energy Group, LLC v. Oil states Energy Services, LLC, IPR , Paper No. 37 (Excluding new argument and supporting declaration on reason to modify the primary reference). 40

41 Reply to Opposition to Amendment 41

42 Oral Hearing 42

43 Motion to exclude evidence 37 CFR The motion must identify the objections in the record in order and must explain the basis for the objection. Admissibility, not weight of evidence The Board rarely grants motions to exclude. IPR : excluding as hearsay exhibit that was used to establish a prior art date

44 Oral Hearing Before same three judge panel that decided petition to institute Each side is typically given 45 minutes to 1 hour Petitioner goes first and can reserve time Expect rigorous questioning on technical issues Rarely, live testimony may be presented for the Board, where witness credibility is challenged 44

45 Demonstratives cannot add new evidence to the record Demonstrative should cite to the record Exhibits cannot rely on evidence that is in the record, but not previously presented to the Board no new positions The Board has the power to deny presentation of all exhibits, if some are non-compliant. St. Jude Med., Inc. v. The Regents of the Univ. of MI., IPR , Paper No

46 Final Written Decision 46

47 Final Written Decisions 1) IPR ) IPR ) IPR ) IPR ) IPR CLAIMS INVALID 6) IPR ) IPR ) IPR ) IPR ) IPR ) IPR * CLAIMS INVALID 12) IPR ** CLAIMS INVALID 13) IPR ) IPR ) IPR ) IPR *** CLAIMS INVALID 17) IPR ) IPR *** CLAIMS INVALID 19) IPR * CLAIMS INVALID 20) IPR ** CLAIMS INVALID * Joined Data as of October 13,

48 Claims found patentable 48

49 Amneal Pharms. v. Supernus Pharms. IPR The 406 patent relates to formulations of doxycycline having an immediate-release portion and a delayed- release portion. Without briefing, the Board construed delayed-release portion from testimony at the oral hearing PTAB: secondary reference does not disclose a delayed-release portion See also IPR ,

50 Monosol RX v. Arius Two IPR The 019 patent is directed to a bioerodable device comprising an adhesive layer and a backing layer with a pharmaceutical in one or more of the layers. Bioerodable device The petition and preliminary response construed bioerodable The Board s institution decision concluded that a construction of this term was unnecessary 50

51 IPR contin d At oral hearing the Board inquired into the construction of device Both parties argued for one layer In the final written decision, the PTAB construed device as two or more layers PTAB: Petitioner did not present any evidence that the prior art disclosed a bioerodable device two or more layers 51

52 Purdue Pharm. v. Depomed IPR The 280 patent relates to (1) a controlled-release oral drug dosage form having a drug-to-polymer weight ratio that (2) swells in a dimensionally unrestricted manner to a size exceeding the pyloric diameter, (3) is retained in the stomach during the fed mode, and (4) remains substantially intact until all of the drug is released. PTAB: Braveja discloses 1; the 837 Patent discloses 2, 3, and 4. 52

53 Petitioner did not prove a reason to combine the references Petitioner: It would be natural for a POSA to combine the teachings of the references to achieve the known advantages of formulations retained in the stomach. PTAB: no explanation why a POSA would modify Braveja, which already regulates the release of a soluble drug Purdue Pharma v. Depomed IPR

54 Petitioner did not prove a reason to combine the references Petitioner: A POSA would have known techniques for creating swellable polymer formulations retained in the stomach and that would remain intact PTAB: no reasonable expectation of success because Petitioner did not address the vast array of formulation considerations for combining the references. Purdue Pharma v. Depomed IPR

55 Apotex v. Wyeth IPR The 828 patent relates to a composition of tigecycline, lactose, and an acid at a ph of about Patent: "Tigecycline was a known antibiotic in the tetracycline family and a chemical analog of minocycline. 55

56 IPR contin d Primary reference disclosed stable minocycline compositions, lactose, and an acid at ph 3.5. PTAB: without disclosure of tigecycline's properties, Petitioner did not establish obviousness of substituting tigecycline for minocycline. 56

57 Claims found unpatentable 57

58 Biodelivery Sciences Int l v. RB Pharmas. Ltd. IPR The 832 patent relates to an orally dissolvable film comprising buprenorphine and naloxone. 102(b) reference discloses an orally dissolvable film, comprising buprenorphine and naloxone PTAB rejected Patent Owner s claim construction, requiring oral absorption, and all Patent Owner s related arguments 58

59 Endo Pharm. v. Depomed IPR The 340 Patent related to a controlled release tablet having a matrix of poly(ethylene oxide)) ( PEO ) and hydroxypropyl methylcellulose ( HPMC ), both with specified weight ratios. The 103 primary reference disclosed polymeric matrices for drug tablets; preferred polymers include HPMC and PEO. 59

60 Endo Pharm. v. Depomed IPR PTAB: the primary reference renders obvious all of the claims, except for claim 10, specifying weight ratio of PEO:HPMC. Arguments that the weight ratio is merely an obvious optimization were insufficient. Secondary reference disclosed an encompassing weight ratio of PEO:HPMC 60

61 Torrent Pharms. LTD. v. Novartis AG IPR '283 Patent is directed to a pharmaceutical composition comprising fingolimod and mannitol. Chiba: solid pharmactucial compositions comprising fingolimod and an excipient Aulton: mannitol was a known excipient commonly used in formulation of pharmaceutical materials Patent Owner: the inventors discovered a new reason to combine mannitol and fingolimod that was nonobviousness 61

62 Torrent Pharms. LTD. v. Novartis AG IPR PTAB: "Where the prior art teaches the claimed invention, a claim is not rendered patentable by virtue of being motivated in the inventors' minds by a newly-discovered advantage of the prior art-combination; allowing such a claim to stand 'would remove from the public that which is in the public domain.'" 62

63 Noven Pharms. v. Novartis AG IPR Patent is directed to a composition of 1 to 40 weight percent of rivastigmine in the form of a free base or acid addition salt, 0.01 to 0.5 weight percent of an antioxidant, and an diluent or carrier Enz: compositions for transdermal administration comprising 20% rivastigmine, 40% hydrophilic polymer, acrylate polymer (diluent or carrier),and a plasticizer Sasaki: 0.05 to 1 weight percent tocopherol (antioxidant) improves stability of a drug blended in acrylic adhesive plaster See also IPR , IPR , IPR

64 Combining Enz and Sasaki Petitioner: Sasaki teaches that compounds having an amino group in an acrylic adhesive can undergo oxidative decomposition over the shelf life of the product. Rivastigmine contains an amino group Patent Owner: No teaching of an oxidative degradation problem for rivastigmine, citing pharmaceutical compounds containing an amine, but not an antioxidant. See also IPR , IPR , IPR

65 Combining Enz and Sasaki PTAB: Patent Owners expert s testimony was unsupported by evidence and instead is based upon an assumption drawn from an incomplete analysis of the asserted evidence. Expert s referenced compounds either (1) did not contain an acrylic adhesive or (2) did not describe stability. See also IPR , IPR , IPR

66 Takeaways Battle of the experts. Make sure your expert s conclusions have objective support. The PTAB has so far invalidated claims only over very close, near anticipating, prior art. Do not leave claim construction to the Board. The PTAB has routinely rejected evidence of secondary considerations for lacking a nexus with the patented features. 66

67 Thank you