After Amgen earlier this year suffered a third consecutive loss in its high-profile PCSK9 patent feud with Sanofi and Regeneron, the company faced two choices: appeal further or drop the issue.
Not content to play sitting duck, Amgen has asked the Supreme Court to step in and review the case.
Amgen wants the U.S. Supreme Court to reverse the Federal Circuit’s decision to invalidate two patents covering the company’s PCSK9 cholesterol med Repatha, the company said in a petition to the court.
The request comes after the U.S. Federal Circuit Court in February deemed several of the company’s patent claims invalid. Amgen sought a rehearing in June, but its request was shot down, leading to this month’s decision to appeal to the Supreme Court.
Amgen’s request to overturn the Federal Circuit’s decision hinges on that court’s interpretation of enablement under patent law. Enablement has historically been viewed as “a question of fact to be determined by the jury,” Amgen argued. Problem is, the Federal Circuit has taken the opposite stance. In Amgen’s case, the court has determined that enablement is “a question of law that [judges] review without deference.”
Amgen first sued Sanofi and Regeneron back in 2014, alleging PCSK9 patent infringement. Amgen at the time asked the court to back broader protections on antibody drugs like Repatha.
Amgen and its supporters have argued that without broader protections, me-too drugs could hit the scene and make minor changes to successful medicines without committing resources to research. Sanofi and Regeneron, for their part, contend that Amgen’s patent claims, if upheld, could allow companies to fend off entire classes of new drugs by offering overly broad protections.