Appeals Court Allows Sanofi, Regeneron to Continue Selling Cholesterol Drug

By Jonathan D. Rockoff 

A U.S. federal appeals court said Wednesday that Sanofi SA and partner Regeneron Pharmaceuticals Inc. can keep selling their cholesterol drug while they challenge a patent-infringement ruling by a lower court that threatened to halt sales.

The decision, by the U.S. Court of Appeals for the Federal Circuit, gives the two companies a temporary reprieve from a trial court's ruling last month finding their drug Praluent violated patents held by rival Amgen Inc.

Sanofi and Regeneron praised the decision for ensuring patients could keep getting Praluent while the litigation continues, and expressed confidence in their prospects on appeal. "It is our longstanding position that Amgen's asserted patent claims are invalid," the companies said in a statement.

Without the appeals court's decision, Sanofi and Regeneron would have been blocked from selling Praluent in the U.S. while they kept fighting the patent-infringement case. The decision doesn't mean, however, the companies will ultimately prevail.

"Amgen remains confident in the validity of our patents and the correctness of the jury verdict and district court's judgment," a company spokeswoman said. "We look forward to presenting our case on the lack of merit in" the appeal by Sanofi and Regeneron.

Praluent and Amgen's competing drug Repatha, each approved for sale in 2015, belong to a new class of cholesterol fighters known as PCSK9s. Analysts originally expected the drugs to be multibillion-dollar sellers, but health-insurance plans have restricted use, partly because of their price tags.

The U.S. District Court in Delaware ruled early last month that Praluent infringed on Repatha patents, and gave Sanofi and Regeneron 30 days to either settle the dispute or appeal.

Write to Jonathan D. Rockoff at [e-mail]

(END) Dow Jones Newswires

February 08, 2017 19:17 ET (00:17 GMT)

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