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2 Inter Partes Review (IPR) Proceedings for Biotech and Pharmaceutical Patents: Key Strategies for U.S. Patent Owners June 17, 2015 Presented By: Jennifer A. Reda Assistant General Counsel, Johnson & Johnson Irena Royzman Partner, Patterson Belknap Webb & Tyler LLP Steven A. Zalesin Partner, Patterson Belknap Webb & Tyler LLP Association of Corporate Counsel

3 Overview Trends in IPRs of Orange Book and BPCIA Patents Patent Owner Preliminary Response Trial 3

4 Trends in IPRs of Orange Book and BPCIA Patents Jennifer A. Reda Assistant General Counsel Johnson & Johnson 4

5 IPRs of Orange Book Patents By the Numbers Data as of June 2,

6 IPRs of Orange Book Patents By the Numbers 116 IPR Petitions (16 from Hedge Funds) 48 Institution Decisions 11 Settled 57 Pending 15 Denials (31%) 33 Trials Instituted (69%) 6 Data as of June 2, 2015.

7 IPRs of Orange Book Patents By the Numbers 33 Trials Instituted 12 Final Dispositions 21 Pending 4 FWDs (all for patentees) 7 Settled 1 Adverse Judgment Data as of June 2,

8 IPRs of Orange Book Patents Generics 8

9 IPRs of Orange Book Patents Innovator Drugs 9

10 IPRs of Orange Book Patents Why Generics File? Second bite at the No presumption of validity Lower standard of proof Broader claim construction No standing requirement 10

11 IPRs of Orange Book Patents What Patents? Formulation Method of use Compound 11

12 IPRs of Orange Book Patents Parallel Litigation 94% Data as of June 2, 2015, excluding IPRs filed by hedge funds. 12

13 IPRs of Orange Book Patents Involvement of Trial Counsel 1 97% Data as of June 2,

14 IPRs of Orange Book Patents Stays Cases Decision 30-Month Stay Viiv Healthcare Co. et al., v. Mylan Inc. et al., CA: (D. Del.), Judge Andrews Denied Yes Reckitt Benckiser Pharm., Inc. et al., v. Biodelivery Sci. Int l, Inc., CA: (E.D.N.C.), Judge Boyle Denied (as moot) No Depomed, Inc. v. Purdue Pharma L.P. et al., CA: (D. N.J.), Magistrate Judge Bongiovanni Eli Lilly & Co. et al., v. Accord Healthcare Inc., USA et al., CA: (S.D. Ind.), Judge Barker Hyperion Therapeutics Inc. v. Par Pharm. Inc., CA: (E.D. Tex.), Judge Gilstrap Granted Denied (w/o prejudice) Pending No Yes Yes Stays requested as of June 2,

15 IPRs of Orange Book Patents Hedge Funds Hayman Capital Management (Kyle Bass) Ferrum Ferro Capital (Kevin Barnes) 15 IPR Petitions (all pending) 1 IPR Petition (pending) Data as of June 2,

16 IPRs of Orange Book Patents Hedge Funds "Hedge fund manager Kyle Bass has opened a new door to abuse of the US patent system, exploiting the USPTO's patent challenge proceeding as part of his cynical shortselling strategy against innovative biotech companies that are delivering transformative therapies to patients in need." BIO President and CEO Jim Greenwood, February 11,

17 IPRs of Orange Book Patents Targeted Companies 17 Data as of June 2, 2015.

18 IPRs of BPCIA Patents By the Numbers 4 IPR Petitions 1 Disclaimed claims 3 Pending Data as of June 2,

19 IPRs of BPCIA Patents What Patents? Dosing regimen Combination therapy 19

20 IPRs of BPCIA Patents Timing (Hospira) June 2013 Hospira filed petition for IPR of EPO patent September 2013 Patent owner disclaimed challenged claims December 2014 Hospira submitted biosimilar application (18 months after filing IPR petition) 20

21 IPRs of BPCIA Patents Timing (BI) December 2014 BI filed three petitions for IPR of Rituxan patents July 2015 IPR institution decision expected July 2016 Final written decision expected (if instituted) 2016 Completion of BI's Phase III clinical trials 21

22 IPRs of BPCIA Patents Parallel Litigation? "We are aware of no decision in which we have found a case or controversy when the only activity that would create exposure to potential infringement liability was a future activity requiring an FDA approval that had not yet been sought." Sandoz Inc. v. Amgen Inc., 773 F.3d 1274, 1279 (Fed. Cir. 2014). 22

23 IPRs of BPCIA Patents Patent Dance? 23

24 Patent Owner Preliminary Response Irena Royzman J.D., Ph.D. Partner and Co-Chair of Biotechnology Practice Patterson Belknap Webb & Tyler LLP 24

25 Timeline for IPR Proceedings U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 25

26 Preliminary Response To File? Pros Potentially avoid IPR Present claim construction Cons Preview positions for petitioner 26

27 Preliminary Response By the Numbers 116 IPR Petitions for Orange Book Patents 74 with PR 5 with no PR 3 settled prior to PR due date 34 PR not due 2 joined to existing trial 3 instituted 27 Data as of June 2, 2015.

28 Preliminary Response Threshold for Institution "The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition." 35 U.S.C. 314(a). 28

29 Preliminary Response 15 Decisions Not to Institute 15 IPR Denials 2 for statutory bar 2 for multiple proceedings 1 for no prior art 3 for no anticipation 7 for nonobviousness Data as of June 2,

30 Preliminary Response Arguments Technical defects Improper claim construction Substantive gaps 30

31 Preliminary Response Technical Defects Statutory bars Multiple proceedings Real party-in-interest (RPI) Incorporation by reference 31

32 Preliminary Response Statutory Bars Barred if petitioner or RPI previously filed a civil action asserting invalidity An affirmative defense of invalidity does not bar A counterclaim of invalidity does not bar 35 U.S.C. 315(a); 32

33 Preliminary Response Statutory Bars Barred if petitioner, RPI or privy was sued for infringement more than 1 year ago Does not apply to request for joinder Clock starts when complaint is served, or a waiver of service is filed Amended complaint does not reset clock 35 U.S.C. 315(b); Amneal Pharm., LLC, v. Endo Pharm. Inc., IPR , Paper 14 (PTAB, July 25, 2014). 33

34 Preliminary Response - Multiple Proceedings "In determining whether to institute or order a proceeding under...chapter 31, the Director may take into account whether, and 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. 325(d). 34

35 Preliminary Response Multiple Proceedings (Different Petitioner) "The instant Petition, therefore, presents 'the same or substantially the same prior art [and] arguments [that] previously were presented to the Office' in the 115 Petition. Under 35 U.S.C. 325(d), this is a basis to exercise our discretion to deny IRDP's Petition." Initiative for Responsibility in Drug Pricing LLC v. Wyeth LLC, IPR , Paper No. 8 (PTAB, February 13, 2015). 35

36 Preliminary Response Multiple Proceedings (Same Petitioner) "Patent Owner asks us to exercise our discretion under 35 U.S.C. 325(d) and deny this Petition. Patent Owner argues that the Petition is redundant 'because it substantially repeats the same arguments and relies substantially on the same prior art that the same Petitioner relied upon in its earlier ['325 IPR] Petition regarding the same claims of the same patent.' We agree." Biodelivery Sci. Int'l, Inc. v. RB Pharm. Ltd., IPR , Paper No. 12 (PTAB, December 19, 2014) (emphasis in original, citations omitted). 36

37 Preliminary Response RPI The requirement to identify RPIs and privies "seeks to protect patent owners from harassment via successive petitions by the same or related parties, to prevent parties from having a 'second bite at the apple,' and to protect the integrity of the USPTO and Federal Courts by assuring that all issues are promptly raised and vetted." U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 37

38 Preliminary Response RPI "[T]he Petition should also be denied because it fails to name all of the real parties-in-interest (RPIs). The funding of an IPR is an important factor that the Board must consider in determining whether a party is an RPI. Yet Petitioner, a hedge fund, does not name the investors funding the Petition." Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR , Paper No. 10, Patent Owner Preliminary Response (May 26, 2015) (citation omitted). 38

39 Preliminary Response Incorporation by Reference "Incorporation 'by reference amounts to a selfhelp increase in the length of the [] brief[,]' and 'is a pointless imposition on the court's time. A brief must make all arguments accessible to the judges, rather than ask them to play archeologist with the record.'" Cisco Sys., Inc. v. C-Cation Tech., LLC., IPR , Paper No. 12 (PTAB, August 29, 2014). 39

40 Preliminary Response Improper Claim Construction "We agree with Patent Owner that Stephan's disclosure is directed to formation of a dry, freeflowing powder, not a wet solid, of monoalkali metal cyanurate. A 'wetcake,' as we interpret this claim term, does not encompass a free-flowing powder." Lenroc Co. v. Enviro Tech Chem. Serv., Inc., IPR , Paper No. 12 (PTAB, July 24, 2014) (citations omitted). 40

41 Preliminary Response Claim Construction Standard PTAB (unexpired patents) Broadest Reasonable Interpretation (BRI) In Light of the Specification District Courts PTAB (expired patents) Ordinary & Customary Meaning 37 C.F.R (b) In re Cuozzo Speed Techs., LLC., 778 F.3d 1271 (Fed. Cir. 2015) Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) 41

42 Preliminary Response BRI v. Phillips BRI Phillips "The broadest reasonable interpretation of a claim term may be the same as or broader than the construction of a term under the Phillips standard. But it cannot be narrower." Facebook, Inc. v. Pragmatus AV, LLC, 582 Fed. Appx. 864, 869 (Fed. Cir. 2014). 42

43 Preliminary Response Petitioner's Use of BRI "Petitioner submits, for the purposes of this inter partes review only, that the claim terms are presumed to take on their broadest reasonable ordinary and customary meaning to a POSA in light of the specification of the '524 patent. Petitioner reserves the right to advocate a different claim construction in district court or any other forum if necessary." Sandoz Inc. v. EKR Therapeutics, LLC, IPR , Petition at 5-6 (October 1, 2014). 43

44 Preliminary Response Petitioner's Use of BRI "The Federal Circuit also addressed the corresponding method claim 4 of the '149 Patent, but split in a 2-1 decision in which the majority interpreted the claim more narrowly than the dissent and found it not invalid. However, when interpreted under the broadest reasonable interpretation standard applicable in inter partes review proceedings, claim 4 would have been obvious for the same reasons as the composition claims of the '463 Patent." Ferrum Ferro Capital, LLC v. Allergan Sales, LLC, IPR , Petition at 3 (March 9, 2015). 44

45 Preliminary Response Substantive Gaps (Not Prior Art) "Petitioner does not argue or present competent evidence to show that the LeGall thesis was indexed, cataloged, shelved, or even deposited in the University of Houston library, at any date Because the Petition and the accompanying evidence are insufficient to qualify the LeGall thesis as a 102(b) prior art, we deny the Petition regarding this ground." Actavis, Inc. et al. v. Res. Corp. Tech., Inc., IPR , Paper No. 22 (PTAB, January 9, 2015). 45

46 Preliminary Response Substantive Gaps (Missing Element) "Although the Shell 1998 publication teaches generally that polymers can be combined, there is no specific disclosure of combining PEO and HPMC, which is a required element in each of the challenged claims." Endo Pharm., Inc. v. Depomed, Inc., IPR , Paper No. 12 (PTAB, September 29, 2014). 46

47 Preliminary Response Substantive Gaps (Elements Not Arranged As In Claim) "Petitioner relies on several different embodiments of the Shell 1993 publication to arrive at a teaching of the claimed invention Petitioner cannot establish anticipation by picking and choosing from the elements of different embodiments within the Shell 1993 publication." Endo Pharm., Inc. v. Depomed, Inc., IPR , Paper No. 12 (PTAB, September 29, 2014). 47

48 Preliminary Response Substantive Gaps (No Reason to Modify) "Petitioner has not established that one of ordinary skill in the art would have had a reason to further modify the prodrug bis(poc)pmpa to make the fumarate salt." Mylan Pharm., Inc. v. Gilead Sci., Inc., IPR , Paper No. 15 (PTAB, December 17, 2014). 48

49 Preliminary Response Substantive Gaps (No Reason to Combine) "[W]e are mindful that the Supreme Court has endorsed 'an expansive and flexible approach' to the obviousness analysis. However, '[w]e must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.'" Mylan Pharm., Inc. v. Gilead Sci., Inc., IPR , Paper No. 15 (PTAB, December 17, 2014) (citation omitted). 49

50 Preliminary Response Using District Court Proceedings "The preliminary response may cite evidence supporting the patent owner's contentions. Such evidence may include previously existing declarations, trial testimony, deposition testimony, and expert reports. A preliminary response may not, however, present new testimonial evidence (i.e., testimonial evidence prepared specifically for the purpose of the IPR proceeding) without authorization from the Board." 50

51 Preliminary Response Key Strategies Look for statutory bars Argue discretionary grounds for denial Evaluate identified parties Argue claim construction Address substantive arguments under alternative claim constructions 51

52 Preliminary Response Key Strategies Identify substantive gaps Not prior art Missing elements Elements not arranged as in claim No reason to modify reference No reason to combine references Make use of existing testimony and admissions from district court proceedings 52

53 Trial Steven A. Zalesin Partner and Co-Chair of Biotechnology Practice Patterson Belknap Webb & Tyler LLP 53

54 Timeline for IPR Proceedings U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 54

55 Trial Cross Examination "The testimony guidelines [] are based on those set forth in the Federal Rules of Civil Procedure, supplemented by the practices followed in several federal district courts" Duration: 7 hrs cross, 4 hrs redirect, 2 hrs re-cross U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , & (August 14, 2012). 55

56 Trial Cross Examination "Consistent with the policy expressed in Rule 1 of the Federal Rules of Civil Procedure, and corresponding 42.1(b), unnecessary objections, 'speaking' objections, and coaching of witnesses in proceedings before the Board are strictly prohibited." U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 56

57 Trial Cross Examination "Examples of objections that would be properly stated are: 'Objection, form'; 'Objection, hearsay'; 'Objection, relevance'; and 'Objection, foundation.'" "Examples of objections that would not be proper are: 'Objection, I don't understand the question'; 'Objection, vague'; 'Objection, take your time answering the question'; and 'Objection, look at the document before you answer.'" U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 57

58 Trial Cross Examination "Once the cross-examination of a witness has commenced counsel offering the witness on direct examination shall not: (a) Consult or confer with the witness regarding the substance of the witness' testimony already given, or anticipated to be given, except for the purpose of conferring on whether to assert a privilege against testifying or on how to comply with a Board order; or (b) suggest to the witness the manner in which any questions should be answered." U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 58

59 Trial Cross Examination Focus on substantive gaps Are opinions offered from perspective of a POSA? Are opinions based on a correct claim construction? Question credibility Make use of district court record 59

60 Timeline for IPR Proceedings U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 60

61 Trial Patent Owner Response Focus on substantive gaps in IPR petition Argue claim construction and present evidence based on alternative claim constructions Make use of direct testimony; expert declarations must be factual and from perspective of POSA Make use of admissions from cross Make use of district court record 61

62 Trial Motion to Amend Extremely rarely granted Limited right to amend No examples of granted motions to amend for Orange Book patents 62

63 Timeline for IPR Proceedings U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 63

64 Trial Oral Hearing Patent owner typically has an hour or less Focus on key substantive gaps Continue to argue claim construction Be prepared to discuss issues that parties have not briefed Provide Board with oral argument slides 64

65 Timeline for IPR Proceedings U.S. PTO Patent Trial Practice Guide, 77 Fed. Reg , (August 14, 2012). 65

66 Trial 4 Final Written Decisions Extensive fact finding Credibility determinations Do not consider objective indicia of nonobviousness Data as of June 2,

67 Trial 4 Final Written Decisions "We credit Dr. Rudnic's declaration testimony that inclusion of a water-soluble polymer in the coating of Sheth's secondary loading portion results in release of drug promptly after administration. Amneal does not cite credible evidence to refute Dr. Rudnic's testimony." Amneal Pharm., LLC, v. Supernus Pharm. Inc., IPR , Paper 94; IPR , Paper 96; IPR , Paper 92 (PTAB, December 9, 2014) (citation omitted). 67

68 Trial Key Strategies Select and engage experts early on Make use of admissions from district court proceedings Seek admissions during cross examination Stay flexible and argue claim construction throughout Focus on substantive gaps Take advantage of trial demonstratives 68

69 Helpful Links PTAB Trial Rules and Practice Guide PTAB Portal HcI5xOSeX_yQRYZAnTXXCg%5B%5B*/!STANDARD? UserIdentifier=searchuser AIA Trial Statistics Representative Orders, Decisions and Notices 69

70 Thank you for your attention. Jennifer A. Reda Assistant General Counsel Johnson & Johnson Irena Royzman Partner Patterson Belknap Webb & Tyler LLP Steven A. Zalesin Partner Patterson Belknap Webb & Tyler LLP This presentation is for general informational purposes only and should not be construed as specific legal advice Patterson Belknap Webb & Tyler LLP

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