UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-00040
`U.S. Patent 7,326,708
`__________________
`
`
`
`PATENT OWNER’S SURREPLY TO PETITIONER’S REPLY
`TO PATENT OWNER’S PRELIMINARY RESPONSE
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`
`

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`
`
`I.
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`TABLE OF CONTENTS
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`The Discretionary Factors as a Whole Favor Denial of Institution. ................ 1
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` Mylan’s Case Citations Do Not Shift the Weight of Becton
`Factors (a)–(e), Which Uniformly Favor Denying Institution. ............. 2
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`
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`
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`There Is No “Additional Evidence” Under Becton Factor (f) for
`the Board to Consider. ........................................................................... 4
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`It Is Undisputed that Institution Would Be Wasteful,
`Duplicative, and Prejudicial to Merck. ................................................. 5
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`II. Mylan’s Request for Discovery on Antedation Does Not Warrant
`Institution of Trial. ........................................................................................... 7
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`i
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`
`
`TABLE OF AUTHORITIES
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`Agrinomix, LLC v. Mitchell Ellis Prods., Inc., IPR2017-00525, Paper 8
`(P.T.A.B. June 14, 2017) .................................................................................. 4, 5
`
`Bentley Motors Ltd. v. Jaguar Land Rover Ltd.,
`IPR2019-01539, Paper 9 (P.T.A.B. Mar. 10, 2020) ............................................. 6
`
`Garmin Int’l, Inc. v. Cuozzo Speed Techs., LLC,
`IPR2012-00001, Paper 26 (P.T.A.B. Mar. 5, 2013) ............................................. 8
`
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017)............................................. 6
`
`Mylan Pharms., Inc. v. Bayer Intellectual Property GmbH,
`IPR2018-01143, Paper 13 (P.T.A.B. Dec. 3, 2018) ............................................. 5
`
`NHK Spring Co. v. Intro-Plex Techs., Inc.,
` IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018)........................................ 1, 6
`
`Pfizer, Inc. v. Genentech, Inc.,
`IPR2018-00330, Paper 13 (P.T.A.B. July 9, 2018) .............................................. 3
`
`Sandoz Inc. v. Pharmacyclics LLC,
`IPR2019-00865, Paper 8 (P.T.A.B. Sept. 26, 2019)..................................... 1, 2, 6
`
`TRW Automotive US LLC v. Magna Elecs.,
`IPR2014-00261, Paper 19 (P.T.A.B. June 26, 2014) ....................................... 3, 4
`
`35 U.S.C. § 314(a) ............................................................................................. 1, 5, 7
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`35 U.S.C. § 325(d) ............................................................................................. 1, 4, 7
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`37 C.F.R. § 42.51(b)(1)(iii) ........................................................................................ 7
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`37 C.F.R. § 42.51(b)(2) .............................................................................................. 8
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`37 C.F.R. § 42.65(a) ................................................................................................... 5
`
`H.R. Rep. No. 112-98, pt.1 (2011)............................................................................. 4
`
`ii
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`

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`Nothing in Petitioner Mylan’s Reply (Paper 13) changes that the balance of
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`factors under 35 U.S.C. §§ 325(d) and 314(a) strongly favor the Board’s exercise
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`of discretion to deny institution. As to § 325(d), it is inconceivable that the
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`Examiner did not consider the published application and patent on the sitagliptin
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`compound given the spare record and their prominence in that record. Mylan does
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`not dispute that the language of the statute plainly does not require a rejection for
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`the Board to exercise its discretion on these facts. As to § 314(a), Mylan does not
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`dispute that institution would lead to wasteful, expensive, and duplicative litigation
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`in light of the parallel MDL proceedings in the district courts. Instead, Mylan’s
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`Reply improperly isolates various factors—contrary to NHK Spring—and relies on
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`factually distinguishable case law. Finally, as to Merck’s evidence antedating WO
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`’498, Mylan’s baseless evidentiary objections only further support the Board’s
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`exercise of discretion in this case to avoid needlessly duplicating complex
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`discovery in a forum bound by strict statutory deadlines.
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`I.
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`The Discretionary Factors as a Whole Favor Denial of Institution.
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`As explained in NHK Spring, “there is no ‘intent to limit discretion under
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`§ 314(a) such that it is . . . encompassed by § 325(d)’”; the Board may “consider
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`and weigh additional factors . . . under § 314(a).” IPR2018-00752, Paper 8 at 20
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`(P.T.A.B. Sept. 12, 2018) (emphasis added). NHK Spring’s analysis of these
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`factors both individually and as a whole distinguishes this case from Sandoz v.
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`1
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`Pharmacyclics, where the Board observed that unlike in NHK Spring, “Patent
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`Owner does not contend that the arguments advanced in the Petition are
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`substantially similar to those made during prosecution.” IPR2019-00865, Paper 8
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`at 11 (P.T.A.B. Sept. 26, 2019).
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`Here, analysis of the factors under both §§ 325(d) and § 314(a) together
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`support denial. Merck squarely presented Mylan’s primary art to the Examiner and
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`explained its significance. Mylan’s Petition, meanwhile, suffers from two fatal
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`flaws: one (improper reliance on WO ’498 as prior art for obviousness) dooms
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`nearly half of its Petition on the merits, and the other (its failure to address the 1:1
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`stoichiometry) dooms it entirely. These factors, when considered against the
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`backdrop of instituting in the face of an ongoing MDL, support the Board’s
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`exercise of discretion under both §§ 325(d) and 314(a), and together present a
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`textbook case for a discretionary denial.
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` Mylan’s Case Citations Do Not Shift the Weight of Becton Factors
`(a)–(e), Which Uniformly Favor Denying Institution.
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`Mylan’s attempt to distinguish discretionary factors in isolation through non-
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`controlling case law is unpersuasive. This case does not involve “mere citation of
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`references in an IDS that were not applied by the Examiner.” Paper 13 at 1. It is
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`undisputed that WO ’498 and the ’871 patent share identical specifications and that
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`Merck presented the crux of Mylan’s merits argument to the Examiner in the
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`specification of the challenged patent. “The Examiner presumably was aware of”
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`2
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`
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`these references and their relationship to the claims. TRW Automotive US LLC v.
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`Magna Elecs., IPR2014-00261, Paper 19 at 12 (P.T.A.B. June 26, 2014). Indeed,
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`the Examiner’s first Office Action made non-prior art rejections, including
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`obviousness-type double patenting rejections (“OTDP”) over co-pending
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`applications located by the Examiner. EX1010 at 153–55. The notion that the
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`Examiner would have made these rejections, but would not have considered
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`WO ’498 and the ’871 patent is speculative and illogical, especially here where the
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`references were two of only three cited in the first IDS. EX1010 at 46.
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`Mylan downplays the specification’s discussion of WO ’498, but the cases
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`Mylan cites only underscore its prominence before the Examiner. The prior art in
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`Pfizer v. Genentech was discussed in 4 lines buried in column 19 of the challenged
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`patent and limited to an incorporation by reference, and there was no contention
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`that it was listed in an IDS. See IPR2018-00330, Paper 13 at 4 (P.T.A.B. July 9,
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`2018) (discussing WO 97/04801, “Andya”). In TRW, the prior art was never
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`discussed in the specification and was one of over two hundred references cited.
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`See also IPR2014-00261, Paper 19 at 12 (discussing JP S62-131837,
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`“Yanagawa”); see also U.S. Patent 7,339,149. In contrast, Merck highlighted WO
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`’498 on the first page of the specification as filed and listed WO ’498 and the ’871
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`patent in its first IDS. Together, these references were two out of only seven
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`references listed in total. See EX1010 at 3–4, 46, 123–24, 166.
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`3
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`Mylan suggests that the Board’s § 325(d) case law requires a prior art
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`rejection, citing TRW and Agrinomix, LLC v. Mitchell Ellis Prods., Inc., IPR2017-
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`00525, Paper 8 (P.T.A.B. June 14, 2017). See Paper 13 at 2–3. These decisions do
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`nothing of the sort. TRW, a pre-Becton decision, simply suggests that burying a
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`reference in a lengthy IDS may not warrant the Board’s exercise of discretion,
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`while in Agrinomix, the Board denied institution where, as here, the prior art was
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`cited in an IDS and described in the specification, see IPR2017-00525, Paper 8 at
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`9. Engrafting a rejection requirement—in a case like this where the art was
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`squarely considered—would be inconsistent with the plain language and legislative
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`purpose of § 325(d) and contrary to the non-exclusive factors of Becton and the
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`Consolidated Trial Practice Guide. See Paper 10 at 20–21; see also Agrinomix,
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`IPR2017-00525, Paper 8 at 10 (citing H.R. Rep. No. 112-98, pt.1 at 48 (2011)).
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`Tellingly, Mylan’s Reply is silent on this statutory conflict. Becton factors (a)–(e)
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`support discretionary denial of the Petition. See Paper 10 at 14–18.
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`
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`There Is No “Additional Evidence” Under Becton Factor (f) for
`the Board to Consider.
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`With respect to Becton factor (f), Mylan contends that there is “additional
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`evidence” that warrants institution, citing two purported “examples” along with
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`Bastin and Brittain. Paper 13 at 4–5. Not so. Mylan’s first cited example is WO
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`’498 itself. Like the petitioner in Agrinomix, Mylan suggests that “various details
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`of [WO ’498] were not substantively appreciated by the Examiner,” IPR2017-
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`4
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`00525, Paper 8 at 9. See Paper 13 at 4. Mylan cites no evidence in support of its
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`argument, which does nothing to “obviate that [WO ’498] was before the
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`Examiner.” Agrinomix, IPR2017-00525, Paper 8 at 9, 11. To the contrary, as
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`discussed above, WO ’498 is the quintessential case of evidence considered by the
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`Examiner and found unworthy of a prior art rejection.
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`Mylan’s second example cites to Dr. Chorghade’s testimony, specifically,
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`the same unsupported and conclusory testimony rendering the Petition deficient
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`with respect to the 1:1 stoichiometric ratio of the claimed DHP salt. Conclusory
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`testimony plainly does not constitute additional evidence. See 37 C.F.R.
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`§ 42.65(a); see also Paper 10 at 18–19, 51 (citing cases). Finally, although Mylan
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`correctly notes that Bastin and Brittain are technically “new,” nothing in these
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`cumulative references adds anything to the disclosures of WO ’498 and the ’871
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`patent that was not already before the Examiner, see Paper 10 at 15–19, and
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`Mylan’s Reply does not identify anything that would so qualify.
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`
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`It Is Undisputed that Institution Would Be Wasteful, Duplicative,
`and Prejudicial to Merck.
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`Mylan’s argument concerning discretion under § 314(a) all but concedes that
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`this IPR would be inefficient. While the AIA “does not guarantee increased
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`judicial efficiency,” Paper 13 at 5, it certainly does not promote judicial waste.
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`“[T]he overall goal of the AIA [is] to ‘make the patent system more efficient by the
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`use of post-grant review procedures.’” Mylan Pharms., Inc. v. Bayer Intellectual
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`5
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`Property GmbH, IPR2018-01143, Paper 13 at 14 (P.T.A.B. Dec. 3, 2018) (quoting
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at
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`16–17 (P.T.A.B. Sept. 6, 2017)). No petitioner can claim a right to institution,
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`particularly where the “efficient administration of the Office” and “integrity of the
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`patent system” are both ill served. Bentley Motors Ltd. v. Jaguar Land Rover Ltd.,
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`IPR2019-01539, Paper 9 at 15 (P.T.A.B. Mar. 10, 2020); see also NHK Spring,
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`IPR2018-00752, Paper 8 at 20.
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`Mylan makes much of the Board’s decision in Sandoz v. Pharmacyclics
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`where, as here, a trial in the district court was scheduled to take place after the
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`projected date of a final written decision. But Sandoz itself notes that “the district
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`court timeline was merely one of many factors considered by the Board [in NHK
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`Spring] when denying institution.” IPR2019-00865, Paper 8 at 11. In this case,
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`timing is not dispositive because little, if any, efficiency will be gained: here the
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`district court trial will occur on overlapping art and arguments, as well as claims of
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`the ’708 patent not challenged in the Petition, in any event, see Paper 10 at 24–28.
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`Mylan has no response regarding the prejudice that Merck will suffer—a
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`consideration that was missing in NHK. Mylan does not deny (1) that its Petition
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`raises a small subset of the invalidity contentions at play in the MDL, (2) that the
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`Petition does not challenge all claims of the ’708 patent that are asserted against
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`Mylan and other generic challengers, (3) that Mylan is pressing overlapping
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`6
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`arguments (including OTDP), and (4) that it will take redundant discovery here and
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`in the MDL. See Paper 10 at 24–31. Finally, unlike Sandoz, this is not a case
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`where the only factors favoring discretionary denial lie under § 314(a)—here,
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`factors under § 325(d) present a compelling case for denial. Simply put, this case
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`is closer to NHK Spring than Sandoz.
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`II. Mylan’s Request for Discovery on Antedation Does Not Warrant
`Institution of Trial.
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`Mylan’s arguments concerning antedation of WO ’498 miss the mark.
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`Merck’s point is not just that its evidence is strong—and it is1—but that if IPR is
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`1 Mylan baselessly accuses Merck of “handpick[ing]” its technical documents; in
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`introducing these documents, Merck has been mindful of its duty to “serve relevant
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`information that is inconsistent with [its] position.” 37 C.F.R. § 42.51(b)(1)(iii).
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`Mylan suggests that the age of Dr. Ferlita’s recollections about whether he signed
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`an employment agreement undermines his declaration, but Mylan ignores the
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`corroborating evidence that Dr. Ferlita did sign another agreement when he
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`departed the company (and was in fact a Merck employee) saying that he
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`understood his obligation to assign. EX2005 at 36. Dr. Ferlita’s declaration
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`resolves Mylan’s completeness objection to EX2005, which simply authenticates
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`Merck’s HR records and practices. And the documents attached to Dr. Wenslow’s
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`7
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`
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`instituted, the parties (and the Board) will expend significant resources to litigate
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`this issue, only to resolve about half of Mylan’s challenges. Crucially, Mylan
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`admits that it will seek depositions of non-declarant witnesses, Paper 13 at 8—i.e.,
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`“additional discovery” beyond the scope of the “routine discovery” normally
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`afforded IPR litigants. 37 C.F.R. § 42.51(b)(2); Garmin Int’l, Inc. v. Cuozzo Speed
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`Techs., LLC, IPR2012-00001, Paper 26 at 6–7 (P.T.A.B. Mar. 5, 2013)
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`(precedential). This admission counsels in favor of avoiding duplicative litigation
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`of this issue and, instead, allowing the parties to flesh these disputes out before the
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`district court, where the Federal Rules of Civil Procedure and absence of statutory
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`deadlines provide discovery mechanisms designed to accommodate them. Garmin,
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`IPR2012-00001, Paper 26 at 5–6 (“There is a one-year statutory deadline for
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`completion of [IPR], subject to limited exceptions. What constitutes permissible
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`discovery must be considered with that constraint in mind.” (citations omitted)).
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`*
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`*
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`*
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`For the foregoing reasons and those stated in Merck’s Preliminary Response,
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`the Board should decline to institute Mylan’s Petition for IPR.
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`
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`declaration (EX2004) have a non-hearsay purpose: their existence corroborates Dr.
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`Wenslow’s testimony and his personal knowledge that Merck achieved the 1:1
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`DHP salt prior to the publication date of WO ’498.
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`8
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`
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`Date: March 20, 2020
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`
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`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
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`9
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
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`Pursuant to 37 C.F.R. 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on March 20, 2020, by delivering a
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`copy via electronic mail on the following attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`550 South Tryon, Street Suite 2900
`Charlotte, NC 28202-4213
`(704) 444-2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`
`
`
`
`
`
`10
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`