Northern District of Illinois Holds That a Biosimilar Applicant Is Not a Necessary Party to a BPCIA Lawsuit | Kramer Levin Naftalis & Frankel LLP
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The Third Circuit Addresses American Pipe Tolling before a Class Certification Decision | Blank Rome LLP
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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