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Antibody Patents Are Not Immune to § 112: Amgen Inc. v. Sanofi, Aventisub LLC

In Amgen v. Sanofi, the Federal Circuit held that evidence that first came into existence after the priority date may be considered in determining whether a genus patent claim satisfies the written description requirement...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more

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