Case 1:22-cv-00061-TSK-JPM Document 350 Filed 03/13/23 Page 1 of 5 PageID #: 19322
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`Case No. 1:22-cv-00061-TSK
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`JURY TRIAL DEMANDED
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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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`NOTICE OF SUPPLEMENTAL AUTHORITY REGARDING CLAIM
`CONSTRUCTION
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) provides this Notice of
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`Supplemental Authority to inform the Court of a March 10, 2023 decision of the Patent Trial and
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`Appeal Board (“PTAB”) involving one of the patents asserted by Regeneron in this case against
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`Mylan. In that decision, the PTAB declined to institute an inter partes review of U.S. Patent No.
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`11,253,572 (the “’572 Patent”) following a request by another biosimilar company, Apotex Inc.
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`See Exhibit A, Apotex Inc. v. Regeneron Pharmaceuticals, Inc., IPR2022-01524, Paper 9. The
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`PTAB found that Apotex had “not demonstrate[d] a reasonable likelihood of prevailing at trial”
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`on the challenged claims of the ’572 Patent, and so institution of an IPR was not warranted. Ex.
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`A, at 39. Subject to reconsideration by the PTAB, that decision is final and non-appealable.
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`As relates to the claim construction issues that are pending before the Court, the PTAB
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`rejected the argument Mylan is advancing that claim limitations in the ’572 Patent directed to the
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`measurement of gains in visual acuity lack patentable weight. See, e.g., Dkt. 306, ¶¶ 151-57
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`(Mylan Proposed FF&CL); Dkt. 313-2, ¶¶ 76-79 (Regeneron’s responsive arguments in its
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`Corrected Proposed FF&CL). The PTAB found that “the results limitations of the claims are
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`limitations and must be given patentable weight.” Ex. A, at 27 (itals. omitted). The PTAB relied
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`Case 1:22-cv-00061-TSK-JPM Document 350 Filed 03/13/23 Page 2 of 5 PageID #: 19323
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`in part on Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly
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`& Co., 849 F.3d 1049 (Fed. Cir. 2017), in which the Federal Circuit reversed the district court and
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`held that limitations in a method of treatment claim of “arresting or regressing” tissue fibrosis had
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`a limiting role. Ex. A, at 16-17; see also Dkt. 313-2, ¶ 78 (Regeneron Corrected Proposed FF&CL)
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`(discussing the Los Angeles Biomedical Research Institute case). The PTAB found the claims in
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`Los Angeles Biomed to be analogous to the visual acuity results limitations challenged in the ’572
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`Patent. Ex. A, at 18 (“We find in agreement with Patent Owner that the results limitations of the
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`challenged claims are limitations and must be given patentable weight for the same reasons
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`arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed.”) (itals. in
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`original). Similar language appears in some of the claims of U.S. Patent No. 10,888,601 (the “’601
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`Patent”), and the same analysis should apply to those claims.
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`As Regeneron has explained, decisions of the PTAB are not binding on this Court, and the
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`Court need not interpret or assess the patentable weight of the visual acuity limitations of the ’572
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`Patent’s claims to interpret the phrase actually designated for claim construction, which is “Best
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`Corrected Visual Acuity.” Dkt. 313-2, ¶¶ 76, 79. Regeneron nevertheless provides the PTAB’s
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`decision to the Court, given that Mylan previously submitted and relied heavily upon a preliminary
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`institution decision that the PTAB made as to the ’601 Patent. See Dkt. 254.
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`Date: March 13, 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)
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` Respectfully submitted,
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`CAREY DOUGLAS KESSLER & RUBY, PLLC
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`/s/ David R. Pogue
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`707 Virginia Street East
`901 Chase Tower (25301)
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`2
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`Case 1:22-cv-00061-TSK-JPM Document 350 Filed 03/13/23 Page 3 of 5 PageID #: 19324
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`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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`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)
`Rebecca Carter (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
`sdouglass@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`njordan@wc.com
`handerson@wc.com
`rgriffin@wc.com
`rebeccacarter@wc.com
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`Andrew E. Goldsmith (admitted PHV)
`Evan T. Leo (admitted PHV)
`Jacob E. Hartman (admitted PHV)
`Grace W. Knofczynski (admitted PHV)
`Mary Charlotte Y. Carroll (admitted PHV)
`Sven E. Henningson (admitted PHV)
`KELLOGG, HANSEN, TODD, FIGEL &
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`1615 M Street, NW, Suite 400
`Washington, DC 20036
`TEL: (202) 326-7900
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`Case 1:22-cv-00061-TSK-JPM Document 350 Filed 03/13/23 Page 4 of 5 PageID #: 19325
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`Counsel for Plaintiff Regeneron Pharmaceuticals, Inc.
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`Case 1:22-cv-00061-TSK-JPM Document 350 Filed 03/13/23 Page 5 of 5 PageID #: 19326
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`CERTIFICATE OF SERVICE
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`I hereby certify that on March 13, 2023, I electronically filed the foregoing with the Clerk
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`of the Court by using the Court’s CM/ECF system. Counsel of record for all parties will be
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`served by the Court’s CM/ECF system.
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`/s/ David R. Pogue
`David R. Pogue (WVSB No. 10806)
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