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Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit

USA - April 9 2018 Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act...

USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

USA - March 13 2018 Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for...

Andrew D. Cohen.

Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict

USA - March 8 2018 In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of...

Dorothy D. LeRay.

FDA Approves the First Gene Therapy to Treat an Inherited Disease

USA - January 3 2018 On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and...

Michael R. McDonald.

2017 Biosimilar Approvals in Europe

European Union - December 21 2017 The European biosimilar market has expanded at record pace in 2017. The EMA approved marketing of sixteen biosimilar products referencing seven...

Jacob F. Siegel.