Case IPR2017-00047
`Patent 6,331,415
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`MERCK SHARP & DOHME CORP.
`Petitioner
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`v.
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`GENENTECH, INC. AND CITY OF HOPE
`Patent Owners
`____________
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`Case IPR2017-00047
`Patent 6,331,415
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`____________
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`PETITIONER’S REPLY IN SUPPORT OF MOTION FOR JOINDER
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`Patent 6,331,415
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MERCK SHARP & DOHME CORP.
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE
`Patent Owners
`____________
`
`Case IPR2017-00047
`Patent 6,331,415
`
`
`____________
`
`
`PETITIONER’S REPLY IN SUPPORT OF MOTION FOR JOINDER
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`Case IPR2017-00047
`Patent 6,331,415
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`Patent Owners’ Response to Petitioner Merck’s Motion for Joinder offers no
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`reason why the present Petition (IPR2017-00047) should not be joined to IPR2016-
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`00710 (“the Mylan IPR”). As such, Patent Owners tacitly concede that joinder is
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`proper and should be granted.
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`Instead of objecting to Merck’s request to join the Mylan IPR, Patent
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`Owners use their Response to argue against institution of Merck’s earlier-filed
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`IPR2016-01373. According to Patent Owners, Merck’s IPR2016-01373 should be
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`not be instituted because of the potential for future estoppel under 35 U.S.C.
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`§ 315(e)(1). Aside from the fact that they lack standing to raise speculative
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`estoppel arguments relating to another pending IPR petition, Patent Owners’
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`interpretation of § 315(e)(1) is flawed for a number of reasons.
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`First, the plain language of § 315(e)(1) makes clear that any estoppel is
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`applied on a claim-by-claim basis. 35 U.S.C. § 315(e)(1) (“The petitioner in an
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`inter partes review of a claim in a patent under this chapter that results in a final
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`written decision . . . may not request or maintain a proceeding before the Office
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`with respect to that claim . . . .”) (emphasis added). Here, there is not complete
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`overlap between the challenged claims in Merck’s IPR2016-01373 and IPR2017-
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`00047. Specifically, IPR2016-01373 challenges claims 15-17 of the ’415 patent,
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`while IPR2017-00047 does not. Patent Owners’ Response thus urges the Board to
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`deny institution of Merck’s IPR2016-01373 petition in its entirety based on a
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`Case IPR2017-00047
`Patent 6,331,415
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`misapplication of § 315(e)(1). Indeed, it would be manifestly unjust to deny
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`Merck’s IPR2016-01373 under these circumstances. Merck has a commercial
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`interest in invalidating claims 15-17. In contrast, it appears that Mylan does not
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`share that same commercial interest and thus did not seek invalidation of claims
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`15-17 in its IPR. Merck’s separate petition should not be denied because some, but
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`not all, of the claims at issue might be invalidated in the present proceedings.
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`Second, Patent Owners’ arguments are inconsistent with the language of
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`§ 315(e)(1) as well as Federal Circuit case law. Estoppel under § 315(e)(1)
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`attaches only as to “any ground that the petitioner raised or reasonably could have
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`raised during that inter partes review.” 35 U.S.C. § 315(e)(1). In Shaw Indus.
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`Group, Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293, 1299-1300 (Fed. Cir.
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`2016), the Federal Circuit held that estoppel under § 315(e)(1) does not apply to
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`grounds presented in an IPR petition but not instituted by the Board. The Federal
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`Circuit explained that “[t]he IPR does not begin until it is instituted” and that “the
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`plain language of the statute prohibits the application of estoppel under these
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`circumstances” because the petitioner could not have reasonably raised the
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`uninstituted grounds in the petition during the IPR. Id. at 1300 (emphasis in
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`original).
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`Here, Merck could not have raised or reasonably raised the grounds
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`currently asserted in IPR2017-00047 in its earlier-filed IPR2016-01373. When
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`Case IPR2017-00047
`Patent 6,331,415
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`Merck filed IPR2016-01373 on July 7, 2016, the Board had already instituted two
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`IPR petitions on the exact grounds raised in the Mylan IPR and in IPR2017-00047.
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`See IPR2015-01624 (“the Sanofi IPR”), Paper 15; IPR2016-00460 (“the Genzyme
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`IPR”), Paper 12. At that time, it was too late for Merck to join the Sanofi and
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`Genzyme IPRs. See 37 CFR § 42.122(b). Had Merck presented the grounds it
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`now asserts in IPR2017-00047 in its earlier IPR, that petition would almost
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`certainly have been denied based on 35 U.S.C. § 315(d) because those grounds
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`would have been duplicative of the then-pending Sanofi and Genzyme IPRs.
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`Moreover, there was no need for Merck to pursue those grounds as they were
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`already part of two instituted IPRs and the Board was scheduled to issue a final
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`written decision on those grounds in early 2017. Thus, it would not have been
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`reasonable for Merck to present in IPR2016-01373 the grounds it now presents in
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`IPR2017-00047.
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`After Merck filed IPR2016-01373, Patent Owners entered into settlement
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`agreements with Sanofi and Genzyme and the Sanofi and Genzyme IPRs were
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`dismissed before the Board issued a final written decision. IPR2015-01624, Papers
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`39-42; IPR2016-00460, Paper 13. Following these dismissals, the Board then
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`instituted the Mylan IPR. It was only after institution of the Mylan IPR that Merck
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`had the proper procedural opportunity to reasonably raise the grounds in the
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`Mylan, Sanofi, and Genzyme IPRs, which it did via IPR2017-00047 and its motion
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`Case IPR2017-00047
`Patent 6,331,415
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`for joinder. Just as Merck could not have reasonably raised these grounds raised in
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`
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`its IPR2016-01373, Merck could not have reasonably raised the grounds from its
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`IPR2016-01373 in its subsequently-filed IPR2017-00047 due to limitations against
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`adding or altering arguments or expanding the already-instituted grounds of
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`unpatentability on joinder. See, e.g., Samsung v. Arendi, Case IPR2014-01144,
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`2014 Par. App. LEXIS 6121 (Oct. 2, 2014) at *6 (denying joinder where the
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`joining petition’s declaration introduced “argument and evidence that was not
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`presented in” the initial petition). Had Merck raised its earlier grounds in
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`IPR2017-00047, joinder would have been inappropriate and IPR2017-00047 would
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`have simply been dismissed as duplicative of the Mylan IPR and/or Merck’s
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`earlier-filed IPR2016-01373.
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`Thus, contrary to Patent Owners’ allegations, there was simply no time when
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`Merck could have reasonably raised in one petition both sets of grounds now
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`before the Board on the ’415 patent. Accordingly, under both the plain language
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`of the statute and the holding in Shaw, estoppel under § 315(e)(1) is not applicable
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`to IPR2016-01373, as Patent Owners contend. Indeed, Patent Owner’s arguments,
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`would frustrate Congress’s stated goal for IPRs, namely facilitating Board of
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`“questionable patents” via “novel challenges.” See H.R. Rep. No. 112-98 (2011),
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`reprinted in 2011 U.S.C.C.A.N. 67 at 46-48 (explaining that IPRs are “not
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`[intended] to restrict novel challenges of questionable patents.”)
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`Case IPR2017-00047
`Patent 6,331,415
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`Finally, at the very least, Patent Owners’ attempt to apply statutory estoppel
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`is premature. According to the plain language of 35 U.S.C. § 315(e)(1), there must
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`be a final written decision on a first IPR before the second IPR can be subject to
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`estoppel. A final written decision is not expected in the Mylan IPR for almost nine
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`months. It would therefore be premature to deny institution of IPR2016-01373
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`based on any estoppel that may result from the Mylan IPR. Even where a final
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`written decision in a first-filed IPR is imminent, the Board has declined to dismiss
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`a second-filed IPR. Kofax, Inc. v. Uniloc USA, Inc., IPR 2015-01207, Paper 14, at
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`2 (denying as premature a proposed motion to terminate a later-filed IPR when a
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`final written decision in the first-filed IPR was anticipated in five weeks); see also
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`Westlake Servs., LLC v. Credit Acceptance Corp., CBM2014-00176, Paper 15, at
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`21 (declining to terminate a subsequent CBM based on estoppel when the final
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`determination for an earlier CBM was expected in six weeks, finding patent
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`owner’s request “not ripe” for adjudication).
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`For all these reasons, any estoppel arguments are untimely and inappropriate
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`in Patent Owners’ Response to Merck’s Petition for Joinder. Granting joinder of
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`the present Petition with the Mylan IPR does not bar institution of Merck’s petition
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`in IPR2016-01373 with respect to any of the challenged claims of the ’415 patent
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`under 35 U.S.C. § 315(e)(1). Merck should therefore be permitted to both join the
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`Mylan IPR and pursue its petition in IPR2016-01373.
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`Case IPR2017-00047
`Patent 6,331,415
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`DATED: December 12, 2016
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`Respectfully submitted,
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`By s/ Matthew A. Traupman
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`Matthew A. Traupman (Reg. No. 50,832)
`matthewtraupman@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`Katherine A. Helm (pro hac vice pending)
`khelm@stblaw.com
`SIMPSON THACHER & BARTLETT LLP
`425 Lexington Avenue
`New York, NY 10017
`Telephone: (212) 455-2000
`Facsimile: (212) 455-2502
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`Attorneys for Petitioner Merck Sharp &
`Dohme Corp.
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`6
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`Case IPR2017-00047
`Patent 6,331,415
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`CERTIFICATE OF SERVICE
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`I hereby certify that true and correct copies of the foregoing Petitioner’s Reply
`In Support Of Motion For Joinder was served on December 12, 2016 via email to the
`following attorneys of record:
`
`David L. Cavanaugh
`David.Cavanaugh@wilmerhale.com
`
`Robert J. Gunther, Jr.
`Robert.Gunther@wilmerhale.com
`
`Heather M. Petruzzi
`Heather.Petruzzi@wilmerhale.com
`
`Owen K. Allen
`Owen.Allen@wilmerhale.com
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`Adam R. Brausa
`abrausa@durietangri.com
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`Daralyn J. Durie
`ddurie@durietangri.com
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`Joseph M. Lipner
`jlipner@irell.com
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`David I. Gindler
`dgindler@irell.com
`
`Michael R. Fleming
`mfleming@irell.com
`
` s/ Matthew A. Traupman
`Matthew A. Traupman (Reg. No. 50,832)
`matthewtraupman@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`7
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