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For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA Litigation

November 19, 2020

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit 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.”  Slip op. at 3.  If the ruling stands, it will restrict venue available against domestic generic drug makers in ANDA cases, and may similarly impact venue in litigation under the Biologics Price Competition and Innovation Act (“BPCIA”).

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