`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS
`LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner.
`
`————————————————
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`————————————————
`
`PETITIONERS’ OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
` 1
`
` Case IPR2017-00853 has been joined with this proceeding.
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`PAGE
`
`INTRODUCTION .......................................................................................... 1
`THE BOARD SHOULD CONSIDER ALL OF PETITIONERS’
`COMMERCIAL SUCCESS EVIDENCE ...................................................... 3
`III. THE BOARD SHOULD CONSIDER THE FULL RECORD OF
`SUBMITTED EVIDENCE, ALL OF WHICH IS RELEVANT AND
`SUPPORTS PETITIONERS’ OBVIOUSNESS POSITIONS ...................... 6
`A.
`Janssen Misrepresents That Certain Exhibits Are Not Discussed
`In The Petition Or Reply Brief ............................................................. 7
`The Full Record Of Evidence Is Relevant, Including Evidence
`That Is Not Specifically Referred To By Pin Cite In The
`Briefing ................................................................................................. 7
`IV. THE BOARD SHOULD CONSIDER THE EXHIBITS OBJECTED
`TO DUE TO LACK OF AUTHENTICITY AND HEARSAY ................... 11
`CONCLUSION ............................................................................................. 13
`
`B.
`
`I.
`II.
`
`V.
`
`
`
`
`
`-i-
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`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`Activision Blizzard, Inc. v. Acceleration Bay, LLC,
`IPR2015-01953, 2017 WL 1418497 (Patent Tr. & App. Bd. Mar.
`23, 2017) ............................................................................................................... 8
`
`BTG Int’l Ltd. v. Actavis Labs. FL, Inc.,
`No. 2:15-cv-05909 (D.N.J. Jan. 30, 2017), ECF No. 274 .................................. 13
`
`Meadwestvaco Packaging Sys., LLC Requester I v. Patent of C.
`Brown Lingamfelter,
`No. 2011-000001, 2011 WL 901354 (B.P.A.I. Mar. 14, 2011) ........................... 4
`
`Nestle Healthcare Nutrition, Inc. v. Steuben Foods, Inc.,
`IPR2015-00249, 2016 WL 4366980 (P.T.A.B. June 2, 2016) ........................... 12
`
`STATUTES
`
`35 U.S.C. § 311 .......................................................................................................... 4
`
`35 U.S.C. § 311(b) ................................................................................................. 3, 5
`
`OTHER AUTHORITIES
`
`Fed. R. Evid. 401, 402 ............................................................................................. 10
`
`Fed. R. Evid. 703 ..................................................................................................... 12
`
`Fed. R. Evid. 801(c) ................................................................................................. 11
`
`Fed. R. Evid. 801(d)(2) ...................................................................................... 12, 13
`
`Fed. R. Evid. 803(6) ........................................................................................... 12, 13
`
`Fed. R. Evid. 803(17) ............................................................................................... 12
`
`ii
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`
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`I.
`
`INTRODUCTION
`
`The patent at issue (U.S. Patent No. 8,822,438, or the ’438 patent) relates to
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`the administration of abiraterone acetate and prednisone to treat metastatic
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`castration-resistant prostate cancer (“mCRPC”).
`
` Abiraterone acetate and
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`prednisone have both been in the prior art since at least the mid-1990s, and both
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`were known to be useful agents in prostate cancer treatment. Janssen now seeks to
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`uphold a patent on the combination of these two agents, arguing that a skilled
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`artisan would not have been motivated to use prednisone—commonly co-
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`administered with other anti-cancer agents—with abiraterone acetate. The prior art
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`provided ample motivation to combine these drugs. Indeed, during prosecution of
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`the ’438 patent, the Examiner found that the claimed method was prima facie
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`obvious over the prior art and allowed the patent to issue solely on the basis of
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`Janssen’s commercial success arguments. Janssen now moves to exclude evidence
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`that reinforces Petitioners’ obviousness positions. The motion has no merit.
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`In its Motion, Janssen seeks to exclude three categories of evidence: (1)
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`expert declarations and exhibits on the subject of commercial success; (2) sections
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`of Petitioners’ expert declarations and exhibits that Patent Owner argues are
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`irrelevant; and (3) certain exhibits Janssen claims are not authentic or constitute
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`inadmissible hearsay.
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`1
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`
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`None of this evidence should be excluded. In order to evade Petitioners’
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`strong commercial success rebuttal, Janssen misconstrues the aim of Petitioners’
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`commercial success arguments by characterizing those arguments as a “ground”
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`for invalidating the ’438 patent. Not so. Petitioners’ arguments simply set forth
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`why the patent examiner possessed an incomplete picture of commercial success
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`when allowing the ’438 patent to issue solely on that basis. Petitioners thus set
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`forth a fulsome commercial success analysis to establish why this secondary
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`indicia does not overcome the obviousness of the ’438 patent.
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`Janssen also asserts that certain exhibits and paragraphs of Petitioners’
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`expert declarations are irrelevant simply because they are not explicitly cited
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`within Petitioners’ Reply or Petition. The record is not limited to the Petitioners’
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`Petition and Reply Brief. The objected-to exhibits are discussed in Petitioners’
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`expert declarations, and the objected-to declaration paragraphs provide highly
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`relevant information and detail supporting Petitioners’ obviousness arguments.
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`Finally, Janssen asserts that numerous exhibits lack authenticity, failing to
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`even mention Petitioners’ supplemental evidence. Janssen also claims three
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`exhibits constitute hearsay, only providing reasoning for two of the three exhibits.
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`All three exhibits do not constitute inadmissible hearsay and should not be
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`excluded.
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`2
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`
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`None of Janssen’s bases to exclude evidence have merit. The Board should
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`consider all the aforementioned evidence, and deny Janssen’s motion.
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`II. THE BOARD SHOULD CONSIDER ALL OF PETITIONERS’
`COMMERCIAL SUCCESS EVIDENCE
`
`Janssen seeks to exclude a whole body of Petitioners’ evidence directed to
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`the secondary consideration of commercial success, erroneously alleging that it is
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`“barred by statute.” But, none of the grounds asserted in the Petition include
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`anything other than “prior art consisting of patents or printed publications.” Paper
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`1 at 3–4; 35 U.S.C. § 311(b). In fact, Petitioner complied with the statute by
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`requesting to cancel the ’438 patent on the basis of three patents or printed
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`publications: O’Donnell, Gerber, and U.S. Patent No. 5,604,213 (the “’213
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`patent”). Paper 1 at 3–4. Petitioners do not seek to cancel the ’438 patent on the
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`basis of commercial success; rather, Petitioners respond to the commercial success
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`arguments Janssen advanced during prosecution of the ’438 patent, which the
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`Examiner ultimately accepted as the sole reason for allowance. Paper 1 at 15–17,
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`51–54, 59–61; see generally Ex. 1017.
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`Janssen misinterprets 35 U.S.C. § 311(b). Section 311(b) pertains to
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`allowable grounds for bringing a petition for inter partes review, not to all
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`evidence the Board may consider during the IPR proceeding. 35 U.S.C. § 311(b)
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`(“A petitioner in an inter partes review may request to cancel as unpatentable 1 or
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`more claims of a patent . . . only on the basis of prior art consisting of patents or
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`3
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`
`
`
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`printed publications.”); see also Meadwestvaco Packaging Sys., LLC Requester I v.
`
`Patent of C. Brown Lingamfelter, No. 2011-000001, 2011 WL 901354, at *10–11
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`(B.P.A.I. Mar. 14, 2011) (rejecting the argument that pre-AIA 35 U.S.C. § 311
`
`bars the Patent Office from considering commercial success evidence offered by a
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`challenger in an inter partes reexamination). Janssen’s lack of commercial success
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`is not the basis of requesting cancellation of patent claims—it is evidence
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`disproving secondary indicia of nonobviousness. Meadwestvaco at *11 (“The
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`[commercial success] evidence objected to by the Patent Owner is not the basis on
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`which these claims are rejected. Rather, the evidence was considered as being
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`pertinent to the Patent Owner’s assertions that the prior art combination would not
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`have been obvious based on secondary considerations.”). Indeed, in the Amerigen
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`IPR, the Board previously weighed both Janssen’s and Amerigen’s commercial
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`success arguments in denying Janssen’s request for rehearing. IPR2016-00286,
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`Paper 23 at 5.
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`The evidence Janssen seeks to exclude demonstrates that a review of the
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`complete commercial success record does not justify commercial success rendering
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`the ’438 patent nonobvious. During prosecution, the Examiner allowed the ’438
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`patent to issue, after numerous obviousness rejections, based on evidence Janssen
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`submitted allegedly showing commercial success. Ex. 1012, 1013. Mr.
`
`Hofmann’s declaration addresses this prosecution history and the Examiner’s
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`4
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`
`
`
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`decision to allow the ’438 patent on the basis of commercial success. Ex. 1017
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`¶¶ 20, 29, 31, 33–34. Mr. Hofmann’s declaration examines numerous factors not
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`before the Examiner during prosecution. For instance, the Examiner did not
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`analyze whether the sales and market share data Janssen submitted had any nexus
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`to the claims. Ex. 1017 ¶¶ 29, 31, 33–34. The Examiner also did not consider the
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`effect of a blocking patent, which excluded all others from making, using, or
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`selling abiraterone acetate at the priority date. Ex. 1017 ¶ 31. Mr. Hofmann also
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`observes that the commercial success metrics Janssen provided to the Examiner
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`were misleading. Id. ¶¶ 35–38. The evidence Janssen seeks to exclude is therefore
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`highly relevant to evaluating whether the Examiner erred in allowing the ’438
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`patent and whether Janssen can, in fact, establish commercial success here.
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`Janssen’s interpretation of 35 U.S.C. § 311(b) is untenable. To the extent
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`Janssen asserts that Petitioners cannot introduce evidence that is not “prior art
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`consisting of patents or printed publications,” Paper 69 at 3, Janssen’s argument
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`would prohibit Petitioners from rebutting Patent Owners’ contentions of
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`commercial success or unexpected results,
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`topics
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`that frequently require
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`consideration of post-priority evidence. Alternatively, if Janssen’s objection is
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`with the fact that Petitioners submitted Mr. Hofmann’s initial declaration and
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`exhibits with its Petition rather than Reply, the Board should just consider this
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`evidence with Petitioners’ reply evidence. Patent Owner also cannot point to any
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`5
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`
`
`
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`prejudice from Petitioners’ submission of Mr. Hofmann’s initial declaration and
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`exhibits with their Petition when, in so doing Petitioners provided Janssen with
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`additional notice and opportunity to rebut Petitioners’ arguments. In fact, Janssen
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`has had the opportunity to respond to this evidence twice—in its Preliminary
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`Response and again in its post-institution Response. Had Petitioners introduced
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`this evidence for the first time with their Reply, Janssen would never have been
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`able to respond. Janssen’s motion to exclude Petitioners’ commercial success
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`evidence is thus without merit and should be denied.
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`III. THE BOARD SHOULD CONSIDER THE FULL RECORD OF
`SUBMITTED EVIDENCE, ALL OF WHICH IS RELEVANT AND
`SUPPORTS PETITIONERS’ OBVIOUSNESS POSITIONS
`
`The record is not limited to the Petition and Reply Brief. Petitioners’ expert
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`declarations and evidence cited therein are relevant to support the positions
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`Petitioners advanced in the Petition and Reply Brief. This evidence gives
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`necessary detail on the relevant knowledge of the POSA at the priority date and
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`provides comprehensive support for Petitioners’ obviousness positions. Janssen
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`cites nothing to support its argument that a Petitioner is required to cite to every
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`exhibit or paragraph of its expert declarations in its Petition or Reply Brief in order
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`to obtain a threshold level for relevancy. But the relevancy of evidence is not so
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`narrow and is judged on the standard set forth in the Federal Rules of Evidence.
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`As explained in more detail below, each objected-to declaration paragraph and
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`6
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`
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`
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`exhibit is relevant, and therefore Patent Owner’s request that this evidence be
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`excluded should be denied.
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`A.
`
`Janssen Misrepresents That Certain Exhibits Are Not Discussed
`in the Petition Or Reply Brief
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`To start, Janssen erroneously claims that certain exhibits—Ex. 1050, 1055,
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`1100, 1102, 1103—are not discussed in the expert declaration paragraphs cited in
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`Petitioners’ Petition or Reply Brief. Janssen is incorrect. See Paper 1 at 52 (citing
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`Ex. 1017 ¶ 37 (citing Ex. 1050)); Paper 1 at 52 (citing Ex. 1017 ¶ 38, Attachment
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`B-1 (citing Ex. 1055)); Paper 55 at 18 (citing Ex. 1097 ¶ 96 (citing Ex. 1100));
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`Paper 55 at 19 (citing Ex. 1097 ¶ 98 (citing Ex. 1102)); Paper 55 at 20 (citing Ex.
`
`1097 ¶ 100 (citing Ex. 1103)). Janssen’s motion to exclude these exhibits is
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`therefore without basis.
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`B.
`
`The Full Record of Evidence Is Relevant, Including Evidence
`That Is Not Specifically Referred to by Pin Cite in the Briefing
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`As to the other declaration paragraphs and exhibits, Janssen is throwing
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`stones in a glass house. Janssen complains that Petitioners do not cite to every
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`expert declaration paragraph and exhibit in their Petition or Reply Brief, yet
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`Janssen itself does not cite to every expert declaration paragraph and exhibit in its
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`Preliminary Response and Response. See, e.g., Ex. 2038 (Rettig Decl.) ¶¶ 11–18,
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`21–24, 51–53, 69–76, 78–79, 96, 121–22, 153, 161, 163, and 194–95.
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`7
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`
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`
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`Regardless, “there is no requirement that Petitioner must cite evidence in its
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`Reply or Opposition to be relevant.” Activision Blizzard, Inc. v. Acceleration Bay,
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`LLC, IPR2015-01953, 2017 WL 1418497, at *32 (Patent Tr. & App. Bd. Mar. 23,
`
`2017). The objected-to exhibits are cited in Petitioners’ expert declarations. The
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`entirety of Petitioners’ expert declarations, along with all evidence cited therein,
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`are relevant to provide necessary detail and support Petitioners’ case.
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`The Federal Rules of Evidence set a low threshold for establishing
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`relevance. Janssen’s motion to exclude contains no substantive discussion of why
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`the objected-to evidence is irrelevant. In addition to the Petitioners’ complete
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`statement of the reasons the ’438 patent is unpatentable in their Petition and Reply,
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`the objected-to expert declaration paragraphs and exhibits provide highly relevant
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`information about, inter alia, the POSA’s knowledge and understanding of the
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`prior art, as well as specific information to support Petitioners’ arguments. For
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`instance:
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`• Ex. 1002 (Garnick Decl.) ¶ 30 is relevant because it explains the POSA’s
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`knowledge on first-line mCRPC treatments.
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`• Exs. 1040, 1041, 1046, and 1066 are relevant because they support the
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`prostate cancer and Zytiga sections of Mr. Hofmann’s first declaration (Ex.
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`1017).
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`8
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`
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`
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`• Exs. 1049, 1064, and 1139 are relevant because they are cited or relied
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`upon2 in the lack of nexus portions of Mr. Hofmann’s declarations where
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`Mr. Hofmann discusses his understanding
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`that glucocorticoid co-
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`administration was common in the field.
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`• Ex. 1086 is relevant because it was used in the Rettig deposition to expose
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`Dr. Rettig’s use of the wrong inhibition values to advance the argument that
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`abiraterone acetate has differential inhibition on the hydroxylase and lyase
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`functions of the CYP17 enzyme. Ex. 1135 at 41:10–50:4. Dr. Rettig’s error
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`is discussed in Petitioners’ Reply. Paper 55 at 9–10.
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`• Ex. 1089 is relevant because it was used in the Vellturo deposition to discuss
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`Janssen’s marketing of prednisone as ameliorating abiraterone acetate’s side
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`effects, rather than as providing anti-tumor effects. Ex. 1136 at 57:14–65:1.
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`
`
` 2
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` Although Ex. 1139 (2015 Taxotere prescribing information) was not cited in Mr.
`
`Hofmann’s second declaration, the 2004 Taxotere prescribing information was
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`cited
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`to support Mr. Hofmann’s understanding
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`that glucocorticoid co-
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`administration was common in the field. Ex. 1134 ¶¶ 25–26. Mr. Hofmann
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`considered both the 2004 and 2015 prescribing information in forming his
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`opinions. Id. at Attachment A-1 (Materials Considered).
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`9
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`
`
`
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`• Ex. 1091 (McKeague Decl.) ¶¶ 17–29 and 31 are relevant because they
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`provide information on prostate cancer, Janssen’s clinical trials, statistical
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`principles, and summaries of why Dr. Rettig has not demonstrated any
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`unexpected
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`results, opinions which are elaborated
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`throughout Dr.
`
`McKeague’s declaration. Ex. 1092–94 are relevant because they support the
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`prostate cancer section of Dr. McKeague’s declaration.
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`• Ex. 1097 (Bantle Decl.) ¶¶ 11–16 and 95 are relevant because they
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`summarize Dr. Bantle’s opinions that are developed throughout his
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`declaration.
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`• Ex. 1104 (Garnick Decl.) ¶¶ 5–9 and 11–13 are relevant because they
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`describe legal standards, reiterate Dr. Garnick’s POSA definition, and
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`summarize Dr. Garnick’s opinions described more fully in his declaration.
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`• Ex. 1104 (Garnick Decl.) ¶¶ 88–90, 92–95, and 119–122 are relevant
`
`because they describe Dr. Garnick’s opinions on lack of unexpected results
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`and nexus, topics also addressed by Dr. McKeague and Mr. Hofmann and
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`discussed thoroughly in Petitioners’ papers.
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`As outlined above, all of the expert declarations and exhibits to which
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`Janssen objects are highly relevant, and none unfairly prejudice Janssen. Janssen
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`has not met its burden of demonstrating that the substance of any of these exhibits
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`or declaration paragraphs merits exclusion under Federal Rules of Evidence 401,
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`10
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`
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`402, or 403. The Board should deny Janssen’s motion to exclude.
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`IV. THE BOARD SHOULD CONSIDER THE EXHIBITS OBJECTED TO
`DUE TO LACK OF AUTHENTICITY AND HEARSAY
`
`Janssen moves to exclude certain exhibits Petitioners have already properly
`
`authenticated—Petitioners timely served supplemental evidence on Janssen on
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`February 8, 2017, including declarations providing proper authentication for the
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`objected-to exhibits (Ex. 1017 [B-1], 1028, 1048, 1049, 1053, 1055, 1057). See
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`Exs. 1153–1154. Petitioners also timely serve supplemental evidence concurrently
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`with this Opposition, properly authenticating all remaining exhibits Janssen objects
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`to for lack of authenticity (Ex. 1088, 1092, 1095, 1117, 1125). See Exs. 1151–
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`1152. All this evidence is now filed with the Board. Handi-Quilter v. Bernina,
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`IPR2013-00364, Paper 30 at 2-3
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`(allowing
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`filing of previously-served
`
`supplemental evidence with opposition to motion to exclude).
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`Janssen also moves to exclude Exhibits 1055, 1088, and 1095 as
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`inadmissible hearsay. Beginning with Exhibit 1095, Janssen does not explain why
`
`Ex. 1095 purportedly constitutes hearsay. Janssen has therefore not carried its
`
`burden of showing that Ex. 1095 should be excluded, and its motion to exclude this
`
`exhibit should be denied. Nevertheless, Ex. 1095 (COU-AA-001 Synopsis) is not
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`hearsay because (1) it is not offered to prove the truth of the matter asserted, and
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`(2) it is a party admission. Petitioners do not offer Ex. 1095 to prove the truth of
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`the matter asserted—Dr. McKeague uses Ex. 1095 to highlight that a clinical trial
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`11
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`
`
`
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`result Janssen publicly reported on clinicaltrials.gov conflicts with the number Dr.
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`Rettig uses to advance his unexpected results argument. Fed. R. Evid. 801(c); Ex.
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`1091 ¶ 36. Ex. 1095 is also not hearsay because it is a party admission. Fed. R.
`
`Evid. 801(d)(2).3
`
`Exhibit 1055 (Top 50 pharmaceutical products by global sales, reported by
`
`PMLiVE) falls within the market reports hearsay exception. Fed. R. Evid.
`
`803(17). At minimum, Ex. 1055 should be allowed under Fed. R. Evid. 703 as
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`industry publications like Ex. 1055, and the IMS data underlying the publication,
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`are widely relied upon by economists in the field—including Janssen’s commercial
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`success expert, Dr. Vellturo. Nestle, 2016 WL 4366980, at *7–8; Fed. R. Evid.
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`703; Ex. 2044 ¶ 64.
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`
`
` 3
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` Even if the Board finds that Ex. 1095 constitutes hearsay, it falls within the
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`business record exception to the hearsay rule. Fed. R. Evid. 803(6). And
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`regardless, the Board should allow Ex. 1095 under Fed. R. Evid. 703. See, e.g.,
`
`Nestle Healthcare Nutrition, Inc. v. Steuben Foods, Inc., IPR2015-00249, 2016
`
`WL 4366980, at *7–9 (P.T.A.B. June 2, 2016) (allowing a hearsay exhibit because
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`Rule 703 permits an expert to base an opinion on facts or data that an expert in the
`
`field would have reasonably relied upon).
`
`12
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`
`
`
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`Finally, Ex. 1088 (BTG press release announcing Cougar license) is not
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`hearsay because it is not offered to prove the truth of the matter asserted. Rather,
`
`Petitioners use this document to demonstrate that BTG represented to the public in
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`2004, over two years before the priority date of the ’438 patent, that it had
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`exclusively
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`licensed abiraterone acetate
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`to Janssen predecessor Cougar
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`Biotechnology. Ex. 1134 ¶¶ 11–12, 15. Therefore, based in part on Ex. 1088,
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`others would have understood that the ’213 patent blocked them from pursuing the
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`alleged invention claimed in the patent at issue. Alternatively, Ex. 1088 falls
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`within the party admission exemption4 and the business record exception to the
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`hearsay rule. Fed. R. Evid. 801(d)(2), 803(6).
`
`V. CONCLUSION
`For the reasons set forth above, Petitioners oppose Janssen’s motion to
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`exclude, and Janssen’s motion should be denied.
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`
`
` 4
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` BTG has been added as an assignee to the ’438 patent in a related district court
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`case involving the ’438 patent. Second Am. Compl., BTG Int’l Ltd. v. Actavis
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`Labs. FL, Inc., No. 2:15-cv-05909 (D.N.J. Jan. 30, 2017), ECF No. 274.
`
`13
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`
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`Dated: May 10, 2017
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`14
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`
`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Petitioners’ Opposition
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`to Janssen’s Motion to Exclude was served electronically via email as follows:
`
`Patent Owners:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
`
`Todd L. Krause
`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
`
`
`
`Petitioners:
`
`Samuel S. Park
`Jovial Wong
`Ryan B. Hauer
`Winston & Strawn LLP
`spark@winston.com
`jwong@winston.com
`rhauer@winston.com
`
`
`
`
`
`
`Dated: May 10, 2017
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`1
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`