Biologics Blog

Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue

Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Valeant contends that rehearing is necessary because the panel’s decision conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement occurs” under Section 271(e)(2) of the Patent Act.  By contrast, Mylan contends that the petition for rehearing should be denied because the “panel correctly applied black-letter rules of statutory interpretation” in reaching its decision, and the precedents identified by Valeant are derived from “far-afield cases and ignore the governing venue precedents.” Dkt. 89 at 7-15.

In its opposition, Mylan argues that “the ‘plain language’” of the patent venue statute “‘requires a past act of infringement,’” and that the “text, structure, and purpose of Section 271(e) [] support the panel’s unanimous decision.”  Id. at 8-9.  Mylan also argues that Valeant ignored the “critical precedent” of TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017).  Id. at 12-15.  Finally, Mylan defends against suggestions of “gamesmanship,” pointing out that its “ANDA was prepared and submitted entirely from [its] West Virginia headquarters, its home since the 1960s.”  Id. at 15. 

In addition, one trade organization has filed an amicus brief in the case. Pharmaceutical Research and Manufacturers of America (PhRMA) filed a brief in support of rehearing en banc and reversal.  PhRMA argues that “the panel’s decision improperly excludes an ANDA filer’s future conduct from §271(e)(2)’s infringing acts” and that “[a]ctions under §271(e)(2) should be governed by the general venue statute, 28 U.S.C. §1391, and not by §1400(b).”  Dkt. 87 at 3-12. 

A decision on Valeant’s request for rehearing en banc is expected in the next few months.

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