Search Results: U.S. Biosimilar Litigation News

Fda Call for Comments on Off-label Communications

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications about unapproved uses of their approved/cleared medical products, including biologics. The public hearing will be held on November…

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BPCIA Litigation Updates: Amgen v. Apotex, Immunex v. Sandoz, Janssen v. Celltrion

A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday.  With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July  opinion in the case must now be…

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Halo Electronics, Inc. v. Pulse Electronics Inc.: the U.S. Supreme Court Establishes a New Framework for Awarding Enhanced Damages in Patent Suits

Yesterday, the Supreme Court announced its decision in Halo Electronics, decision in Halo Electronics, Inc. v Pulse Electronics, Inc., in which the Court rejected the Federal Circuit’s Seagate test and established a new framework for imposing enhanced damages for patent infringement.  Under the new framework, district courts will have greater…

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