`MERCK SHARP & DOHME CORP.,
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`Plaintiff,
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`MYLAN PHARMACEUTICALS INC.,
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`v.
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`Defendant.
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`Civil Action No. 19-cv-101 (IMK)
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`Case 1:19-cv-00101-IMK Document 192 Filed 06/23/22 Page 1 of 3 PageID #: 11504
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
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`MERCK’S RESPONSE TO
`MYLAN’S NOTICE OF SUPPLEMENTAL AUTHORITY
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`The cited Federal Circuit decision, Novartis Pharmaceuticals v. Accord Healthcare Inc.,
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`Case No. 21-1070 (June 21, 2022), has no bearing on this case. Mylan emphasizes that the
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`majority and dissent agree that, to satisfy the written description requirement, the specification
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`must convey that the inventors had possession of the claimed invention as of the filing date, as if
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`that were somehow in dispute here. Merck, of course, agrees with that hornbook proposition.
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`As explained in Merck’s Responsive Post-Trial Brief (D.I. 176) on pages 34-35, the ’708 patent
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`contains an explicit disclosure of the claimed 1:1 DHP salt of sitagliptin, including “a hydrate
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`thereof,” thereby demonstrating possession. Id. (citing GlaxoSmithKline LLC v. Banner
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`Pharmacaps, Inc., 744 F.3d 725, 730-31 (Fed. Cir. 2014) (holding, on similar facts, that a claim
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`to a compound or “a pharmaceutically acceptable solvate thereof” had written description
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`support)).1
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`1 Novartis involved the absence of support for a “negative limitation” in a method of treatment
`claim. None of the asserted claims here include such a limitation.
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`Case 1:19-cv-00101-IMK Document 192 Filed 06/23/22 Page 2 of 3 PageID #: 11505
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` Respectfully submitted,
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`CAREY, DOUGLAS, KESSLER & RUBY, PLLC
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`/s/ Steven R. Ruby
`Michael W. Carey (WVSB #635)
`Steven R. Ruby (WVSB #10752)
`901 Chase Tower, 707 Virginia Street, East
`P.O. Box 913
`Charleston, WV 25323
`Telephone: (304) 345-1234
`Facsimile: (304) 342-1105
`mwcarey@csdlawfirm.com
`sruby@cdkrlaw.com
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` Dated: June 23, 2022
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`Of Counsel:
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`Bruce R. Genderson (admitted PHV)
`Stanley E. Fisher (admitted PHV)
`David M. Krinsky (admitted PHV)
`Elise Baumgarten (admitted PHV)
`Alexander S. Zolan (admitted PHV)
`Shaun P. Mahaffy (admitted PHV)
`Anthony H. Sheh (admitted PHV)
`Sarahi Uribe (admitted PHV)
`Vanessa Omoroghomwan (admitted PHV)
`Jihad Komis (admitted PHV)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`bgenderson@wc.com
`sfisher@wc.com
`dkrinsky@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`suribe@wc.com
`vomoroghomwan@wc.com
`jkomis@wc.com
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`Counsel for Plaintiff Merck Sharp & Dohme Corp.
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`Case 1:19-cv-00101-IMK Document 192 Filed 06/23/22 Page 3 of 3 PageID #: 11506
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`CERTIFICATE OF SERVICE
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`Undersigned counsel certifies that on June 23, 2022, MERCK’S RESPONSE TO
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`MYLAN’S NOTICE OF SUPPLEMENTAL AUTHORITY was served upon counsel of record
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`through CM/ECF.
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`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
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