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The Amgen v. Sandoz Disclosure Disputes Continue

USA - July 27 2017 A theme emerging in biosimilar litigation is when - and how much - discovery is available to reference product sponsors. The Supreme Court in Amgen…

Jenny Shmuel.

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

European Union, USA - March 14 2017 Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission…

Jenny Shmuel, Tasha M. Francis.

Survey of the Safe Harbor in the United States and Europe

Australia, European Union, United Kingdom, USA - December 7 2016 On October 3, 2016, the United States Supreme Court denied Amphastar Pharmaceutical's petition for certiorari regarding the so-called "safe harbor,"…

Brian D. Coggio.

Can Research Product Sponsor Forfeit Right To Sue Under BPCIA?

USA - July 25 2016 In Amgen Inc. v. Apotex Inc., the Federal Circuit addressed the 180-day notice provision of the Biologics Price Competition and Innovation Act of…

Brian D. Coggio.

First-Ever Post-Grant Review Decisions Invalidate Patents

USA - June 14 2016 On June 13, 2016, the Patent Trial and Appeal Board (PTAB) invalidated two livestock valuation patents for being directed to patent ineligible…