`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`DR.REDDY’S LABORATORIES INC. and
` DR. REDDY’S LABORATORIES LTD.,
`Petitioners,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
`__________________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
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`The Petition at issue is a “Me-Too” petition brought by Dr. Reddy’s
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`Laboratories Inc. and Dr. Reddy’s Laboratories Ltd. (collectively, “Petitioners” or
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`“DRL”) after the Board instituted trial on the petition of Mylan Pharmaceuticals
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`Inc. (“Mylan”) in IPR2020-00040 (“Mylan Proceeding”). Paper 2. DRL filed a
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`motion for joinder within one month of institution of the Mylan Proceeding,
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`seeking joinder. Paper 3. Merck has filed an opposition to the joinder motion,
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`Paper 7, and has participated in two calls with the Board to address various
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`conditions pertinent to joinder.
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`Pursuant to 37 C.F.R. § 42.107(b), Patent Owner Merck Sharp & Dohme
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`Corp. (“Merck”) hereby files a preliminary response in the above captioned case.
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`I.
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`If Joinder Is Ordered, Merck Reserves All Rights To Present Evidence
`and Argument In Response to the DRL Petition in Its Patent Owner
`Response and Other Papers.
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`In the Mylan Proceeding, Merck filed a Preliminary Patent Owner Response
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`opposing institution. IPR2020-00040, Paper 10. In that filing, Merck argued that
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`the Board should exercise its discretion pursuant to §§ 325(d) and 314(a) to deny
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`institution, and also argued that Mylan’s grounds were deficient because they did
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`not address the stoichiometry required by all challenged claims. Id. The Board
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`granted Mylan’s petition and instituted review in IPR2020-00040 notwithstanding
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`Merck’s Preliminary Patent Owner Response.
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`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
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`For efficiency and to conserve judicial resources, Merck will not restate, in
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`this Preliminary Patent Owner Response, all the arguments it made in the
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`Preliminary Patent Owner Response in the Mylan Proceeding, which the Board has
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`rejected, preliminarily or otherwise. Paper 21 at 64. However, Merck does not
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`waive any such evidence or arguments and reserves all rights in the above
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`captioned or any consolidated proceeding. Patent Owner specifically reserves all
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`rights to submit a Patent Owner Response and/or a Motion to Amend pursuant to
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`37 C.F.R. §§ 42.120 and 42.121. Patent Owner reserves the right to address
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`grounds presented in the Petition should the Board institute inter partes review, to
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`dispute in the Patent Owner’s Response any fact alleged to be material by
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`Petitioners, and to provide material facts in support of Patent Owner’s position.
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`Patent Owner reserves the right to raise any and all arguments against those
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`grounds and in favor of patentability during the trial.
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`II.
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`If Joinder Is Not Ordered, the Board Should Exercise Its Discretion and
`Decline to Institute Trial Under § 314(a).
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`In Merck’s Preliminary Patent Owner Response in the Mylan proceeding,
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`Merck argued that discretionary denial of institution was warranted pursuant to §
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`314(a) because trial on Mylan’s petition would be an inefficient use of the Board’s
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`limited resources given that the same patent, arguments, and evidence were the
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`subject of parallel proceedings in the district courts. IPR2020-00040, Paper 10 at
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`23-30.
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`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
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`In its institution decision, the Board rejected these arguments in part because
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`the Board expected “to issue a final written decision at least five months before the
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`MDL trial date,” Id., Paper 21 at 28 (emphasis in original). The Board also
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`declined to exercise its discretion because of the stage of the MDL proceedings at
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`the time, noting that “a claim construction hearing is not scheduled until three
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`months after the institution due date.” Id.
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`Neither consideration remains true here. First, trial on the DRL petition
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`could lag as much as six months behind the Mylan proceeding and a final written
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`opinion may not be due until after trial in the MDL. See IPR2020-00040, EX 2006
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`(MDL Scheduling Order). Second, claim construction briefing has already
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`concluded in the MDL, and a claim construction hearing was held on August 18,
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`2020. See EX2040 (MDL Docket). Fact discovery is proceeding this Fall and
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`opening expert reports are due in January 2021.
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`These circumstances distinguish the posture of the DRL petition from
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`Mylan’s and warrant discretionary denial under § 314(a). See NHK Spring Co.,
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`Ltd. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8 at 20 (P.T.A.B. Sept. 12,
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`2018) (precedential). Even DRL concedes that absent joinder, “a separate IPR
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`proceeding involving DRL would needlessly duplicate efforts with multiple briefs,
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`experts and hearings on the same patent claims and grounds already being
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`litigated.” Paper 9 at 3. This kind of duplication and waste of resources is of the
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`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
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`exact kind § 314(a) was designed to prevent. See Patent Trial and Appeal Board
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`Consolidated Trial Practice Guide (Nov. 2019) at 59 (“Based on the Board’s
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`experience, one petition should be sufficient to challenge the claims of a patent in
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`most situations. Two or more petitions filed against the same patent at or about the
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`same time . . . may place a substantial and unnecessary burden on the Board and
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`the patent owner and could raise fairness, timing, and efficiency concerns.”) Apart
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`from the ongoing Mylan IPR regarding the same patent, Petitioners and Patent
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`Owner, too, are already involved in ongoing litigation regarding the same patent
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`and arguments in district court. See EX2039 (DRL Complaint).
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`If the Board denies joinder, it should exercise its discretion and not institute
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`an IPR on DRL’s Petition.
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`
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`Date: August 20, 2020
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`
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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
`motion to be submitted)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Alexander S. Zolan (Pro Hac Vice
`motion to be submitted)
`Elise M. Baumgarten (Pro Hac Vice
`motion to be submitted)
`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
`
`
`
`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
`
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`jberniker@wc.com
`azolan@wc.com
`ebaumgarten@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
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`
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`CERTIFICATE OF SERVICE
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`Case No. IPR2020-01060
`U.S. Patent No. 7,326,708
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`
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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 August 20, 2020, by delivering a
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`copy via electronic mail on the following attorneys of record:
`
`Russell W. Faegenburg
`Tedd W. Van Buskirk
`Michael H. Teschner
`LERNER, DAVID, LITTENBERG,
`KRUMHOLZ & MENTLIK, LLP
`20 Commerce Drive, Cranford, New
`Jersey 07016
`(908) 518-6367
`Rfaegenburg.ipr@ldlkm.com
`Tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`MTeschner.ipr@ldlkm.com
`
`
`
`/Anthony H. Sheh/
`Anthony H. Sheh
`Reg. No. 70,576
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`
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