Breaking News: Court Grants Permanent Injunction Against Sale of Praluent® in AMGEN V. SANOFI/REGENERON

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For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes with Amgen’s Repatha® (evolucumab). Both products are monoclonal antibodies that target PCSK9 to lower the levels of LDL cholesterol in the blood. In March 2016, after a jury trial found the asserted claims of the patents-in-suit valid. (The defendants had previously stipulated to infringement.)  Amgen then moved for a permanent injunction to enjoin the defendants’ from selling Praluent®, and Judge Robinson heard evidence and argument on Amgen’s motion later in March 2016.

Today, Judge Robinson granted Amgen’s motion. In issuing the permanent injunction, the Court found that the Amgen had demonstrated that it is suffering irreparable harm from the sale of Praluent® and that money damages are inadequate to remedy that harm. The balance of hardship factor was found to be neutral, while the public interest factor was found to weigh in favor of the defendants. The Court’s order indicates that it will delay the imposition of the injunction for thirty days “to allow defendants the opportunity to appeal and request expedited review of this ruling by the Federal Circuit, and/or to encourage the parties to reach an appropriate business resolution.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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