Biologics Blog

Rehearing Denied in Federal Circuit Hatch-Waxman Venue Case

The Federal Circuit has spoken.  In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc.  A case watched closely by the biotechnology and pharmaceutical industries, the Federal Circuit held in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc. 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 sought rehearing, arguing that the decision was “legal error that departs from [the Federal Circuit’s] long-standing precedents regarding both what is included in the § 271(e)(2) act of infringement and where acts of infringement occur.”  The petition garnered the support of the Pharmaceutical Research and Manufacturers of America (PhRMA), which filed an amicus brief in support of rehearing and reversal.  Mylan opposed the petition, taking the position that the “panel correctly applied black-letter rules of statutory interpretation.”  In the end, Valeant’s requests for rehearing were denied by the panel and the broader court.  The mandate of the court will issue on February 2, 2021.  A certiorari petition to the U.S. Supreme Court, if any, would be filed in approximately 3 months.   

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