Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 1 of 21 PageID #: 48038
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`Exhibit 12
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`Exhibit 12
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`REGENERON PHARMACEUTICALS, INC.,
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`MYLAN PHARMACEUTICALS INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`Case No. 1:22-cv-00061-TSK
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`JURY TRIAL DEMANDED
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`CONFIDENTIAL – SUBJECT TO
`PROTECTIVE ORDER
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 2 of 21 PageID #: 48039
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`
`
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`FINAL INFRINGEMENT CONTENTIONS OF PLAINTIFF REGENERON
`PHARMACEUTICALS, INC. FOR U.S. PATENT NO. 11,104,715
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) discloses the following final
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`infringement contentions regarding U.S. Patent No. 11,104,715 (“the ’715 patent”) to Defendant
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`Mylan Pharmaceuticals Inc. (“Mylan”). Regeneron is presently asserting claims 2, 3, 4, 6, 12,
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`13, 14, 15, and 16 from the ’715 patent.
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`Regeneron’s infringement contentions are based on the information currently available
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`to, and known by, Regeneron. Regeneron has only received a limited set of documents from
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`Mylan and has not yet received samples. Regeneron has also not yet obtained complete
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`discovery from third parties that may have information relevant to this patent. Regeneron has
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`also not yet obtained deposition testimony from a number of Mylan witnesses who may have
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`knowledge relevant to this patent. Furthermore, the Court has not yet construed any of the
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`asserted claims of this patent. As a result, Regeneron reserves the right to modify, amend, or
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`otherwise supplement these infringement contentions as the pre-trial phase of the litigation
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`proceeds and as additional information comes to light, and as provided in the case Scheduling
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`1
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 3 of 21 PageID #: 48040
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`Order, the Federal Rules of Civil Procedure, and the Local Rules of the Northern District of West
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`Virginia.
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`This claim chart is provided without prejudice to Regeneron’s right to introduce expert
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`opinions and demonstratives as expert discovery progress, and to produce and introduce at trial
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`all evidence, whenever discovered, related to the proof of currently known and subsequently
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`discovered facts. In addition, the division of each claim into individual limitations below is for
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`convenience only and is without prejudice to Regeneron’s right to argue for a different division
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`
`
` 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
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`
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`at a later date.
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`Date: January 12, 2023
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`Of Counsel:
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`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)
`Arthur J. Argall III (admitted PHV)
`Adam Pan (admitted PHV)
`Nicholas Jordan (admitted PHV)
`Renee M. Griffin (admitted PHV)
`Sean M. Douglass (admitted PHV)
`Haylee Bernal Anderson (admitted PHV)
`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
`
`2
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 4 of 21 PageID #: 48041
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`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`njordan@wc.com
`rgriffin@wc.com
`sdouglass@wc.com
`handerson@wc.com
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`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, NW, Suite 400
`Washington, DC 20036
`(202) 326-7900
`agoldsmith@kellogghansen.com
`eleo@kellogghansen.com
`jhartman@kellogghansen.com
`mcarroll@kellogghansen.com
`shenningson@kellogghansen.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`3
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 5 of 21 PageID #: 48042
`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 5 of 21 PagelD #: 48042
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`Infringement Contentions Regarding U.S. Patent No. 11,104,715 °715 Patent Claim
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 6 of 21 PageID #: 48043
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`1. A method of producing aflibercept
`harvested from a host cell cultured in
`a chemically defined medium
`(CDM), comprising:
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`5
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 7 of 21 PageID #: 48044
`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 7 of 21 PagelD #: 48044
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`Infringement Contentions Regarding U.S. Patent No. 11,104,715 °715 Patent Claim
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 8 of 21 PageID #: 48045
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`(a) providing a hostcell genetically
`engineered to express aflibercept;
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`(b) culturing said hostcell in
`said CDM underconditions suitable
`in whichsaid host cell expresses said
`aflibercept wherein the cumulative
`concentration of nickel in
`said CDMisless than or equalto 0.4
`uM orabout 0.4 uM and one or more
`of the following:
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`Infringement Contentions Regarding U.S. Patent No. 11,104,715 °715 Patent Claim
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`i. the cumulative concentration
`of iron in said CDM is less than or
`equal to 55.0 uM;
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`u1. the cumulative concentration
`of copperin said CDM isless than or
`equal to 0.8 uM;
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 9 of 21 PageID #: 48046
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`Infringement Contentions Regarding U.S. Patent No. 11,104,715 °715 Patent Claim
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 10 of 21 PageID #:
`48047
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 11 of 21 PageID #:
`48048
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 12 of 21 PageID #:
`48049
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 13 of 21 PageID #:
`48050
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 14 of 21 PageID #:
`48051
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 15 of 21 PageID #:
`48052
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 16 of 21 PageID #:
`48053
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 17 of 21 PageID #:
`48054
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 18 of 21 PageID #:
`48055
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 19 of 21 PageID #:
`48056
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 20 of 21 PageID #:
`48057
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`Case 1:22-cv-00061-TSK-JPM Document 620 Filed 09/01/23 Page 21 of 21 PageID #:
`48058
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