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...more
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...more
Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s...more
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...more
As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more
4/2/2015
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Biosimilars ,
BPCIA ,
Citizen Petitions ,
Food and Drug Administration (FDA) ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
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