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9 May 2017Americas

Sanofi seeks to prevent Praluent injunction

Sanofi and Regeneron have filed the latest round of their appeal to the US Court of Appeals for the Federal Circuit in a bid to stop an injunction against Praluent.

In January, Amgen obtained an injunction against the companies, meaning that they had to stop selling cholesterol-lowering medicine Praluent (alirocumab).

Amgen won a patent dispute at the US District Court for the District of Delaware after Praluent was found to have infringed claims of US patent numbers 8,829,165 and 8,859,741, which cover the drug Repatha (evolocumab).

A few days later, Sanofi and Regeneron revealed plans to appeal against the injunction, and in February, the companies secured a stay.

On Wednesday, May 3, Sanofi and Regeneron submitted a supplemental authority—the Federal Circuit’s decision in Nichia v Everlight Americas, dated April 28, 2017—to support their case.

In the Nichia case, the Federal Circuit reviewed the history of injunctions in patent infringement cases, including eBay v MercExchange, and held that a patentee “must prove that it meets all four equitable factors” of the eBay test to obtain a permanent injunction.

Two of the factors require a plaintiff to show that it has suffered irreparable harm, and that remedies at law are inadequate to compensate for injuries.

Sanofi argued that Nichia is directly relevant.

“The district court granted a permanent injunction despite finding that Amgen had failed to establish one of the eBay factors—that the public interest not be disserved by an injunction.”

The company added: “Nichia makes clear, however, that the permanent injunction cannot stand.”

Amgen filed a response to Sanofi’s letter on Friday, May 5, claiming that the district court had “determined that the public interest weighed slightly against injunctive relief only because of a generalised public interest in ‘having a choice of drugs’ and then granted the injunction.”

The company also said that Sanofi’s argument of having more manufacturers of a life-saving good in the market is not a sufficient basis for denying injunctive relief.

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