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Litigation Alert: Supreme Court Extends Petrella Rule Barring Laches to Patent Context

USA - March 27 2017 Three years ago, in Petrella v. Metro-Goldwyn-Mayer, Inc., the Supreme Court held that the equitable defense of laches is not available against...

Armen N. Nercessian.

Biosimilars: Solicitor General Recommends Granting Certiorari in Amgen v. Sandoz

USA - December 19 2016 The case involves issues central to the application of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the statutory scheme...

Amy E. Hayden, Ph.D..

Will the Supreme Court review whether FDA-mandated bioequivalence testing to maintain approval falls within the 271(e)(1) safe harbor?

USA - August 15 2016 The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. 271(e)(1) encompasses a generic drug manufacturer’s...

Amy E. Hayden, Ph.D..

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

USA - July 12 2016 Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics...

Amy E. Hayden, Ph.D., David Tellekson.

Supreme Court Leaves Intact PTAB Authority to Institute and Regulate Inter Partes Review Proceedings

USA - June 23 2016 This week in Cuozzo Speed Technologies, LLC v. Lee, the United States Supreme Court decided two important questions related to the power of the...

David Tellekson, Jeffrey Ware.