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 SUPPLEMENTAL BRIEF
`REGARDING APPLE v. FINTIV
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`
`__________________
`
`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 SUPPLEMENTAL BRIEF
`REGARDING APPLE v. FINTIV
`
`
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`
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`
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`I.
`
`The MDL Has Not Been Stayed And A Stay Is Unlikely.
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`The first factor favors non-institution. For good reason, no party in the ongo-
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`ing MDL (including Mylan) has apprised the DE court of the Petition, much less
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`sought a stay:1 the MDL defendants assert a greater number of invalidity grounds,
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`on a greater number of claims, than does the Petition, and Mylan’s MDL co-defend-
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`ants would not be bound by the result here. Paper 10 at 26–27. Moreover, extensive
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`infringement discovery is required because no MDL defendant has stipulated to in-
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`fringement of the ’708 patent, including the claims Mylan seeks to cancel here.
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`EX2014 ¶ 15. Put simply, the result of this IPR will neither substantively nor pro-
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`cedurally affect the MDL. The MDL court thus is unlikely to stay the case for this
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`IPR, which involves just one of twelve defendants and will not resolve the litigation.
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`Plastic Omnium Adv. Innovation & Res. v. Donghee Am., Inc., No. 16-187-LPS (D.
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`Del. Oct. 27, 2017), ECF No. 196 (EX2024). This is particularly true because the
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`unchallenged ’871 patent (that claims, inter alia, the sitagliptin molecule) expires in
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`July 2022, EX1007; and district court judgments on the ’708 and other patents are
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`needed before expiry of the ’871 patent and potential generic launch. See Caraco
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`Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278, 1283–84 (Fed. Cir. 2008).
`
`
`1 While the WV court was notified of the IPR, EX2019, the DE court has jurisdic-
`
`tion over the MDL and the WV court cannot stay those proceedings, EX2023.
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`1
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`
`
`
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`II. Trials Will Take Place A Short Time After The Statutory Deadline.
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`This factor favors non-institution. Trial in DE will take place 5 months after
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`the statutory deadline, with Mylan’s trial in WV conditionally scheduled 2 months
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`later. Paper 10 at 11. But that is not dispositive: critically, the Board’s final written
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`decision will not result in greater judicial efficiency. Id. at 24–31. Because Mylan
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`and the other MDL defendants raised overlapping invalidity challenges over the
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`same art that cannot be adjudicated here (e.g., OTDP) and a majority of asserted
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`claims are not addressed in the Petition, trial in both DE and WV will be necessary.
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`If Merck prevails in the IPR, the DE trial will still encompass all IPR grounds. Id.
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`III. The Parties Have Invested Substantial Resources In The MDL.
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`This factor favors non-institution. After Mylan moved to dismiss the case on
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`venue grounds, see EX2020, Merck refiled in WV and sought MDL consolidation
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`before the JPML, see EX2021; EX2022; the JPML subsequently ordered consolida-
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`tion, see EX2023. The DE proceedings are active. See EX2015. Substantial com-
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`pletion of document production is due April 22. To date, Merck has produced about
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`2 million pages; Mylan has produced over 20,000 pages; and the remaining defend-
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`ants have produced nearly 700,000 pages. EX2014 ¶ 16. The parties have pro-
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`pounded numerous discovery requests and have spent substantial time responding to
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`them and conferring in an attempt to resolve disputes. Id. Merck filed its opening
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`Markman brief on March 20; defendants will file their brief on May 1; and a hearing
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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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`is scheduled for August 18, about 9 months before a final IPR decision. EX2006 at
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`7–8. Mylan’s delay in filing its Petition also favors non-institution. Mylan served a
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`Paragraph IV notice and statement that raised invalidity arguments over 9 years ago,
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`EX2018 at 2–3, 33, yet did not file its Petition until 9 months after Merck filed suit
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`(and even then on less than all asserted claims). This has “impose[d] unfair costs,”
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`Fintiv at 11, and is prejudicial. Paper 10 at 30–31.
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`IV. The Petition’s Grounds Are A Small, Duplicative Subset Of The MDL.
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`This factor favors non-institution. Mylan has not disputed that all challenged
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`claims are at issue in the MDL, the art and arguments are duplicative of the MDL
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`invalidity contentions, and only a small fraction of the MDL arguments are ad-
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`dressed in this IPR. Paper 10 at 24–25; EX2008 at 8–9; see also Paper 13 at 5–7.
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`V. Merck And Mylan Are Active Litigants In The District Courts.
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`The parties are litigating actively, EX2014 ¶ 8–18, which favors denial.
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`VI. Hatch-Waxman, § 325(d), And The Merits Cut Against Institution.
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`This factor favors non-institution. The Hatch-Waxman Act provides a bal-
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`anced, expedited path for drug companies to resolve patent disputes. 527 F.3d at
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`1294. There is no evidence that Mylan’s Petition will lead to greater efficiency; the
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`opposite is true. Paper 10 at 23–31. The Petition is also weak: its § 103 grounds
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`rely on non-prior art, § 325(d) is implicated, and the Petition ignores the claimed 1:1
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`stoichiometry limitation. Id. at 31–54.
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`3
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`
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`Date: April 14, 2020
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`
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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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.
`
`
`
`4
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`
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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 and
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`correct copy of the foregoing was served on April 14, 2020, by delivering a copy via
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`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
`
`
`
`
`
`
`
`5
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`
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