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Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

USA - January 20 2017 On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its...

Melanie L. Mayer.

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...

Ewa M. Davison.

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...

Ewa M. Davison.

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...

David Tellekson, Ewa M. Davison.

Biosimilars: Supreme Court calls for Solicitor General’s views in Amgen v. Sandoz

USA - June 23 2016 On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit's decision...

David Tellekson, Ewa M. Davison.