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Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue

USA - January 11 2021 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...

Andrew D. Cohen, Matthew Weiss.

WTO to Discuss Member Proposal to Waive IP Rights for COVID-19 Technologies

Global - January 6 2021 On October 2, 2020, India and South Africa urged the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS)...

Joyce L. Nadipuram.

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FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

USA - November 30 2020 FDA has published new draft guidance for industry titled "Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and...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

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