U.S. top court rejects Amgen over cholesterol medication patent fight

[January 08, 2019]  By Jan Wolfe

WASHINGTON (Reuters) - Amgen Inc on Monday lost its bid at the U.S. Supreme Court to overturn a ruling that kept the Regeneron Pharmaceuticals Inc and Sanofi SA cholesterol-lowering drug Praluent on the market, but the patent dispute among the rival drugmakers will continue in another trial.

The justices declined to hear Amgen's appeal seeking reinstatement of a jury verdict it won against Regeneron and Sanofi in the dispute in which Amgen accused its rivals of infringing its patents relating to its competing drug Repatha and sought to block sales of Praluent.

Amgen had asked the justices to overturn a 2017 decision by the U.S. Court of Appeals for the Federal Circuit that set aside the jury's verdict, nullified a ban imposed by a judge on Praluent sales and ordered a new trial. The sales ban was put on hold while the matter was on appeal, never taking effect.
 

Sanofi and Regeneron said in a joint statement they were pleased with the Supreme Court's action.

"We are confident that the law and the facts support our positions," the companies said, adding that they look forward to the next trial in federal court in Delaware that is scheduled to start on Feb. 19.

Amgen said in a statement it believed in the validity of its patents and was preparing for the new trial.

Praluent is an injectable drug approved by the FDA in 2015 to treat high cholesterol in patients whose cholesterol levels were not controlled by diet and statin treatment. It is created from antibodies that dramatically lower levels of "bad" LDL cholesterol in the blood by blocking a certain protein.

Thousand Oaks, California-based Amgen sued Regeneron and Sanofi in 2014. A jury returned a verdict in 2016 that Amgen's patents relating to Repatha were valid. Paris-based Sanofi and Tarrytown, New York-based Regeneron had stipulated that if the patents were valid Praluent had infringed them.

In January 2018, U.S. District Judge Sue Robinson in Delaware took the unusual step of ordering an end to sales of Praluent. Robinson found that, although having both drugs on the market would be in the public interest, Amgen's patent rights outweighed that concern.

Praluent and Repatha won U.S. approval to reduce LDL cholesterol and have been shown to lower the risk of heart attacks. The drugs are far more costly than other cholesterol drugs, with a list price topping $14,000 annually.

(Reporting by Jan Wolfe and Lawrence Hurley; Editing by Will Dunham)

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