Supreme Court Finds Amgen’s PCSK9 Patent Claims Go Beyond What It Invented

 
• By Brenda Sandburg

In unanimous decision, court finds Amgen patent offered persons skilled in the art “little more than advice to engage in ‘trial and error.’” Lawyers say the ruling prevents function claims from monopolizing a therapeutic target and retains status quo on enablement requirement.

Supreme Court long shot
Supreme Court issues ruling in Amgen v. Sanofi monoclonal antibody patent dispute • Source: Brenda Sandburg

The US Supreme Court unanimously affirmed an appeals court ruling that Amgen, Inc.’s patents claiming to cover all antibodies that bind to the PCSK9 protein are invalid. The decision is a relief for many in the biopharma sector who were concerned that a finding for Amgen could deter innovation.

Amgen alleged that Sanofi and Regeneron Pharmaceuticals, Inc.’s anti-PCSK9 antibody Praluent (alirocumab) infringes two patents that cover a...

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