Ewa Davison

Ewa Davison

Fenwick & West LLP

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Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

8/13/2015 - aBLA Amgen Biosimilars BPCIA Commercial Marketing FDA Generic Drugs Hatch-Waxman License Agreements Patent Dance Patent Infringement Patents Pharmaceutical Manufacturers Pharmaceutical Patents Preliminary Injunctions Sandoz Sandoz v Amgen

Intellectual Property Bulletin Winter 2013: Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor

On January 14, 2013, the U.S. Supreme Court refused to consider the U.S. Court of Appeals for the Federal Circuit's exclusion in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), of post-approval...more

4/5/2013 - Biogen Idec Classen Immunotherapies FDA GlaxoSmithKline Infringement Patents Safe Harbors SCOTUS

Intellectual Property Bulletin - Winter 2013

In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more

4/4/2013 - Covenant Not to Sue Drug Manufacturers FDA Generic Drugs Mootness Nike Public Performance Rights Safe Harbors SCOTUS Standing Trade Secrets Trademarks Transfer of Venue

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