`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`Defendant.
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`
`REGENERON’S RESPONSE TO MYLAN’S
`ALTERNATIVE SUBMISSION REGARDING CLAIM CONSTRUCTION
`
`Regeneron has no objection to Mylan filing an additional submission regarding claim
`
`construction. The Court should have the full benefit of the parties’ positions and explanations,
`
`and in any event, Mylan’s “Alternative Submission” (ECF 261) reinforces that Mylan’s experts
`
`agreed with Regeneron’s positions, not Mylan’s, as to the legally salient issues such as the
`
`patent’s repeated disclosure that polysorbate is an organic co-solvent. At the claim construction
`
`hearing, Regeneron will be prepared to address the substance of Mylan’s position, which
`
`squarely violates the Federal Circuit’s repeated guidance that expert testimony is “less reliable”
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`than, and cannot contradict, the patent specification.
`
`Regeneron responds briefly, however, to Mylan’s accusation that Regeneron’s five-and-
`
`a-half-page submission summarizing Mylan’s declarant testimony was “uninvited,
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`unauthorized,” and improper. ECF 261 at 1. To the contrary, it was Mylan’s refusal to make its
`
`declarants promptly available for deposition that warranted Regeneron’s notice. ECF 226-1.
`
`On November 29, Mylan filed its opening claim construction brief. That brief made
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`apparent that Mylan was advancing claim constructions devoid of support in the patents
`
`1
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`
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`Case 1:22-cv-00061-TSK-JPM Document 262 Filed 01/23/23 Page 2 of 4 PageID #: 13092
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`themselves and instead reliant almost exclusively on extrinsic evidence, i.e., the declarations of
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`Dr. MacMichael (addressing the Formulation Patent) and Dr. Jungbauer (addressing the
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`Manufacturing Patent). Two days later, on December 1, Regeneron requested the availability of
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`Drs. MacMichael and Jungbauer for deposition in advance of the parties’ responsive briefs due
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`December 16. Ex. 1 at 2-3 (Dec. 1, 2022 Regeneron Email). Mylan declined to make its experts
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`available during that period and thereby precluded Regeneron from addressing their sworn
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`testimony in its responsive claim construction brief. Ex. 1 at 2 (Dec. 2, 2022 Mylan Email).
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`Accordingly, Regeneron explained, long in advance of submitting its responsive claim
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`construction brief, that if Mylan refused to make its declarants available for deposition in time
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`for the parties’ responsive briefs, then Regeneron would submit a short supplemental brief
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`addressing deposition testimony thereafter. Ex. 1 at 1 (Dec. 5, 2022 Regeneron Email). That is
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`exactly what Regeneron did. ECF 226. Mylan’s characterizations of Regeneron’s filing are
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`without merit.
`
`
`
`Date: January 23, 2022
`
`
`Of Counsel:
`
`David I. Berl (admitted PHV)
`Ellen E. Oberwetter (admitted PHV)
`Thomas S. Fletcher (admitted PHV)
`Andrew V. Trask (admitted PHV)
`Teagan J. Gregory (admitted PHV)
`Shaun P. Mahaffy (admitted PHV)
`Sean M. Douglass (admitted PHV)
`Kathryn S. Kayali (admitted PHV)
`Arthur J. Argall III (admitted PHV)
`Adam Pan (admitted PHV)
`Nicholas Jordan (admitted PHV)
`Haylee Bernal Anderson (admitted PHV)
`Renee Griffin (admitted PHV)
`
`
`
`2
`
`
`
` CAREY DOUGLAS KESSLER & RUBY, PLLC
`
`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`Charleston, West Virginia 25323
`(304) 345-1234
`sruby@cdkrlaw.com
`drpogue@cdkrlaw.com
`
`
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 262 Filed 01/23/23 Page 3 of 4 PageID #: 13093
`
`
`
`
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, SW
`Washington, DC 20024
`(202) 434-5000
`dberl@wc.com
`eoberwetter@wc.com
`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`smahaffy@wc.com
`sdouglass@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`njordan@wc.com
`handerson@wc.com
`rgriffin@wc.com
`
`Andrew E. Goldsmith (admitted PHV)
`Evan T. Leo (admitted PHV)
`Jacob E. Hartman (admitted PHV)
`Mary Charlotte Y. Carroll (admitted PHV)
`Sven E. Henningson (admitted PHV)
`KELLOGG, HANSEN, TODD, FIGEL &
` FREDERICK, P.L.L.C.
`1615 M Street, N.W., Suite 400
`Washington, D.C. 20036
`TEL: (202) 326-7900
`agoldsmith@kellogghansen.com
`eleo@kellogghansen.com
`jhartman@kellogghansen.com
`mcarroll@kellogghansen.com
`shenningson@kellogghansen.com
`
`
`
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`
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`3
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`Case 1:22-cv-00061-TSK-JPM Document 262 Filed 01/23/23 Page 4 of 4 PageID #: 13094
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`
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`CERTIFICATE OF SERVICE
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`I hereby certify that on January 23, 2023 I electronically transmitted the foregoing with
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`the Court. Counsel of record for all parties will be served by the Court’s CM/ECF service.
`
`
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`
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`
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`
`
`/s/ Steven R. Ruby
`Steven R. Ruby
`
`
`
`4
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`
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