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Rehearing Requested in Major Federal Circuit Case Narrowing Venue in Hatch-Waxman Cases

USA - December 14 2020 Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v…

Andrew D. Cohen, Matthew Weiss.

FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

USA - November 30 2020 FDA has published new draft guidance for industry titled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and…

Jay J. Cho.

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

USA - 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…

Andrew D. Cohen, Aron Fischer, Barbara L. Mullin, Matthew Weiss, William F. Cavanaugh, Jr..

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

USA - November 18 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…

Andrew D. Cohen, Matthew Weiss.

Future of Biosimilars at Issue in Latest Supreme Court Affordable Care Act Case

USA - November 16 2020 On Tuesday, November 10, 2020, the Supreme Court heard oral argument in California v. Texas, a challenge to the Affordable Care Act (the “ACA”)…

Benjamin F. Jackson.