Alirocumab to Remain On Market While Companies Clash Over Patents

Alirocumab, a PCSK9 inhibitor approved for lowering LDL cholesterol levels, will remain available in the US, at least for now, after an appeals court issued a stay of the permanent injunction that had called for the drug to be yanked from the market last month.

Regeneron and Sanofi, who have partnered to manufacture, market, and sell alirocumab, are embroiled in a long-running dispute with Amgen, the makers of evolocumab, another FDA-approved PCSK9 inhibitor. In 2016, a jury ruled that Regeneron/Sanofi infringed upon two valid patents held by Amgen covering the PCSK9-inhibitor drug class.

As a result of the jury’s decision, it was largely expected Regeneron/Sanofi would be forced to pay royalties on the sales on alirocumab, but the US District Court in Delaware ruled in January that the companies had done “irreparable harm” to Amgen. The district court judge ruled that financial restitution for the patent infringement would have been inadequate and granted an injunction halting the sale of alirocumab in the US.

Regeneron and Sanofi have appealed the jury’s verdict, arguing that Amgen’s patent claims related to antibodies targeting PCSK9 are invalid. 

This latest decision—the suspension of the permanent injunction granted by the US Court of Appeals for the Federal Court—will allow Regeneron and Sanofi to keep alirocumab on the market while the appeals process runs its course. A decision is expected sometime this year.

In the meantime, Amgen is set to present data from its 27,500-patient FOURIER trial, a large cardiovascular outcomes study with evolocumab. Last week, the company announced the topline results of the trial, stating that the PCSK9 inhibitor met both its primary and secondary endpoints. FOURIER will be presented at the American College of Cardiology Scientific Sessions in Washington, DC, on March 17, 2017, at 8 AM.