Case 1:22-cv-00061-TSK-JPM Document 77 Filed 09/29/22 Page 1 of 4 PageID #: 2176
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`
`
`Civil Action No. 1:22-cv-00061-TSK
`
`
`
`
`
`
`Defendant.
`
`
`
`
`
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S
`POST-HEARING SUPPLEMENT
`
`During the Status Conference, the Court asked Plaintiff’s counsel what would become of the
`
`patents remaining if only six of the 24 patents currently asserted are ultimately the subject of a first
`
`trial. Regeneron had no concrete answer, and instead only vaguely suggested it would not pursue
`
`preliminary injunctive relief on those remaining patents. The response did not address the enormous
`
`burden on the Court and Mylan of a second wave of litigation, the timing and scope of which is now
`
`unknown, and the unfairness of giving Regeneron “multiple at-bats,” but also failed to address
`
`another relevant provision of the BPCIA.
`
`Under the BPCIA, at the conclusion of the “patent dance” Regeneron had 30 days within
`
`which to select patents from the negotiated list on which to sue, if it wished to preserve a right to
`
`seek lost profits damages. For litigation not brought within that time frame, “the only remedy the
`
`reference product sponsor can get in that action is a reasonable royalty.” Amgen Inc. v. Apotex
`
`Inc., 827 F.3d 1052, 1058 (Fed. Cir. 2016) (emphasis added); see also 35 U.S.C. § 271(e)(6) (“the
`
`sole and exclusive remedy that may be granted by a court … shall be a reasonable royalty.”) This
`
`limitation on damages for untimely, later-asserted patents is intended to disincentivize serial suits
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`AT CLARKSBURG
`
`
`Plaintiff,
`
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`
`
`Civil Action No. 1:22-cv-00061-TSK
`
`
`
`
`
`
`Defendant.
`
`
`
`
`
`
`DEFENDANT MYLAN PHARMACEUTICALS INC.’S
`POST-HEARING SUPPLEMENT
`
`During the Status Conference, the Court asked Plaintiff’s counsel what would become of the
`
`patents remaining if only six of the 24 patents currently asserted are ultimately the subject of a first
`
`trial. Regeneron had no concrete answer, and instead only vaguely suggested it would not pursue
`
`preliminary injunctive relief on those remaining patents. The response did not address the enormous
`
`burden on the Court and Mylan of a second wave of litigation, the timing and scope of which is now
`
`unknown, and the unfairness of giving Regeneron “multiple at-bats,” but also failed to address
`
`another relevant provision of the BPCIA.
`
`Under the BPCIA, at the conclusion of the “patent dance” Regeneron had 30 days within
`
`which to select patents from the negotiated list on which to sue, if it wished to preserve a right to
`
`seek lost profits damages. For litigation not brought within that time frame, “the only remedy the
`
`reference product sponsor can get in that action is a reasonable royalty.” Amgen Inc. v. Apotex
`
`Inc., 827 F.3d 1052, 1058 (Fed. Cir. 2016) (emphasis added); see also 35 U.S.C. § 271(e)(6) (“the
`
`sole and exclusive remedy that may be granted by a court … shall be a reasonable royalty.”) This
`
`limitation on damages for untimely, later-asserted patents is intended to disincentivize serial suits
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 77 Filed 09/29/22 Page 2 of 4 PageID #: 2177
`
`after the biosimilar applicant has negotiated which patents should be immediately litigated. 35
`
`U.S.C. § 271(e)(6)(A), (B); 42 U.S.C. § 262(l)(6)(B)). Regeneron’s claim, which Mylan heard for
`
`the first time yesterday, that it will reduce the number of patents from 24 to six or less at some time
`
`in the litigation that suits it, will not only allow a second wave of litigation, but a second wave in
`
`which Mylan expects Regeneron still will lay claim to the full statutory damages rights available
`
`under the statute, including lost profits.
`
`Accordingly, Regeneron’s suggestion that it will, at some undefined point in the case, limit
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`the number of patents and claims at issue here does nothing to address the unilateral and highly
`
`prejudicial strategic and economic advantage that Regeneron insists on holding over Mylan’s head
`
`with respect to the patents that are not selected for trial. Moreover, if Regeneron were serious about
`
`streamlining the case, and genuine in its representations to Mylan and the Court, Regeneron should
`
`rely on the “extensive pre-suit disclosures” in the patent dance to select and play its best hand in the
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`litigation now, dismissing or limiting the future scope of relief on any remaining patents, as
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`contemplated by Mylan Proposal 2. To be clear, only Mylan’s proposed schedules provide the
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`necessary certainty across all 24 patents Regeneron has chosen to assert. (See, e.g., Doc. 75, Exhibit
`
`B.)
`
`
`
`
`
`Respectfully submitted this 29th day of September, 2022.
`
`
`
` STEPTOE & JOHNSON PLLC
`
` /s/ Gordon H. Copland
`Gordon H. Copland (WVSB #828)
`William J. O’Brien (WVSB #10549)
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8162
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`
`
`1
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`
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`Case 1:22-cv-00061-TSK-JPM Document 77 Filed 09/29/22 Page 3 of 4 PageID #: 2178
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`Of Counsel (admitted pro hac vice):
`
`William A. Rakoczy
`Heinz J. Salmen
`Eric R. Hunt
`Neil B. McLaughlin
`Lauren M. Lesko
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 W. Hubbard St., Suite 500
`Chicago, IL 60654
`(312) 527-2157
`wrakoczy@rmmslegal.com
`hsalmen@rmmslegal.com
`ehunt@rmmslegal.com
`nmclaughlin@rmmslegal.com
`llesko@rmmslegal.com
`
`Counsel for Defendant
`Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
`
`
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`
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`2
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`Case 1:22-cv-00061-TSK-JPM Document 77 Filed 09/29/22 Page 4 of 4 PageID #: 2179
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on the 29th day of September, 2022, I electronically filed the foregoing
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`“Defendant Mylan Pharmaceuticals Inc.’s Post-Hearing Supplement” with the Clerk of the
`Court using the CM/ECF system, which will send notification of such filings to the following
`counsel of record:
`
`
`
`
` David R. Pogue
` drpogue@cdkrlaw.com
` Steven Robert Ruby
` sruby@cdkrlaw.com
` CAREY, DOUGLAS,
` KESSLER & RUBY, PLLC
` 707 Virginia Street, East
` Suite 901
` Charleston, WV 25301
`
`
`David I. Berl
`dberl@wc.com
`Thomas S. Fletcher
`tfletcher@wc.com
`Teagan J. Gregory
`tgregory@wc.com
`Nicholas Jordan
`njordan@wc.com
`Kathryn S. Kayali
`kkayali@wc.com
`Arthur J. Argall, III
`aargall@wc.com
`Shaun P. Mahaffy
`smahaffy@wc.com
`Ellen E. Oberwetter
`eoberwetter@wc.com
`Adam Pan
`apan@wc.com
`Andrew V. Trask
`atrask@wc.com
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, SW
`Washington, DC 20024
`
`
` Attorneys for Plaintiff Regeneron Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`
`
`
`
` /s/ Gordon H. Copland
`Gordon H. Copland (WV Bar #828)
`gordon.copland@steptoe-johnson.com
`William J. O’Brien (WV Bar #10549)
`william.obrien@steptoe-johnson.com
`STEPTOE & JOHNSON PLLC
`400 White Oaks Boulevard
`Bridgeport, WV 26330
`(304) 933-8000
`
`3
`
`
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