`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`TEVA PHARMACEUTICALS USA, INC. AND WATSON
`LABORATORIES, INC,
`Petitioners,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case No. IPR2020-01045
`U.S. Patent No. 7,326,708
`__________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2020-01045 | U.S. Patent 7,326,708
`
`The Petition at issue is a “Me-Too” petition brought by Teva
`
`Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. (collectively,
`
`“Petitioners” or “Teva”) after the Board instituted trial on the petition of Mylan
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`Pharmaceuticals Inc. (“Mylan”) in IPR2020-00040 (“Mylan Proceeding”). Paper
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`3, at 1 n.1. Teva filed a motion for joinder within one month of institution of the
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`Mylan Proceeding, seeking joinder. Paper 4. Merck has filed an opposition to the
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`joinder motion, Paper 9, and has participated in two calls with the Board to address
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`various 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 Teva 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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`
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`Case IPR2020-01045 | U.S. Patent 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, the arguments it made in the Preliminary
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`Patent Owner Response in the Mylan Proceeding, which the Board has rejected,
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`preliminarily or otherwise. IPR2020-00040, Paper 21 at 64. However, Merck
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`does not 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 Teva Petition Is Time Barred.
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`If joinder is not ordered in the instant proceeding, Merck opposes institution
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`because Petitioners are time barred from petitioning for inter partes review of U.S.
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`Patent No. 7,326,708. Merck filed patent infringement complaints concerning U.S.
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`Patent No. 7,326,708 on February 13, 2019, EX2039 (Teva complaint); EX2042
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`(Watson Complaint), and the Teva petition was not filed until June 10, 2020.
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`Paper 3 (filed 6/10/2020). Hence, both Petitioners were served with a complaint
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`
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`Case IPR2020-01045 | U.S. Patent 7,326,708
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`alleging infringement of U.S. Patent No. 7,326,708 more than one year prior to the
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`filing of the instant petition. Absent joinder, the Petition is thus time barred. See
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`35 U.S.C. § 315(b).
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`
`
`Date: August 14, 2020
`
`
`
`
`
`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)
`Alexander S. Zolan (Pro Hac Vice)
`Elise M. Baumgarten (Pro Hac Vice)
`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
`azolan@wc.com
`ebaumgarten@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
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`Case IPR2020-01045 | U.S. Patent 7,326,708
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`CERTIFICATE OF SERVICE
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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 14, 2020, by delivering a
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`copy via electronic mail on the following attorneys of record:
`
`Keith A. Zullow
`Sarah J. Fischer
`GOODWIN PROCTER
`The New York Times Building
`620 Eight Avenue
`New York, NY 10018
`kzullow@goodwinprocter.com
`sfischer@goodwinprocter.com
`
`
`
`
`
`
`
`
`
`
`/Anthony H. Sheh/
`Anthony H. Sheh
`Reg. No. 70,576
`
`
`
`
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