Alirocumab allowed to stay on US market after appellate court ruling

Sanofi and Regeneron announced that a permanent injunction that would have prevented its PCSK9 inhibitor alirocumab from being marketed in the United States has been overturned by the U.S. Court of Appeals for the Federal Circuit.

The appellate court vacated the permanent injunction granted in January to Amgen, manufacturer of evolocumab (Repatha, Amgen), after a jury ruled in March 2016 that two of Amgen’s patents describing and claiming monoclonal antibodies to PCSK9 were valid, according to a press release issued by Sanofi and Regeneron. Sanofi and Regeneron, manufacturers of alirocumab (Praluent), had admitted to violating them but claimed they were not valid.

The appellate court also ordered a new trial, for which a date has not yet been determined, according to the release.

In February, the appellate court suspended the permanent injunction until the completion of the appeals process, so alirocumab was never pulled from the U.S. market.

According to the release from Sanofi and Regeneron, the appellate court ruled that the trial court had made several errors, including excluding evidence regarding written description, excluding evidence on enablement, improperly instructing the jury regarding written description and improperly granting a permanent injunction.

The appellate court also confirmed the trial court’s ruling that Amgen’s patents were nonobvious, according to the release.

“We are pleased with the Federal Circuit’s decision to remand for a new trial that allows us to present our complete evidence to the jury,” Karen Linehan, executive vice president and general counsel of Sanofi, said in the release. “It is our longstanding position that Amgen’s asserted patent claims are invalid, and we remain confident in the long-term availability of Praluent for patients.”

Amgen stated that its patents are valid and the company will continue to defend them in court.

“Our ability to discover and deliver new medicines that benefit patients depends on meaningful patent protection and enforcement that enable significant investments in drug development and clinical trials,” Amgen stated in an email to Cardiology Today. “We are disappointed by the court’s action in reversing and remanding the district court’s decision with respect to validity of our patents based on select pre-trial rulings. The court, however, also rejected a main argument brought by defendants in seeking to overturn the injunction. We firmly believe in the validity of our patents and we look forward to reasserting our rights in court.” – by Erik Swain

Disclosure: Linehan is an employee of Sanofi.