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

WASHINGTON (Reuters) – The U.S. Supreme Court on Monday declined to take up Amgen Inc’s bid to reinstate a jury verdict it won against rivals Regeneron Pharmaceuticals Incand Sanofi SAin a patent dispute over cholesterol medication.

FILE PHOTO: An Amgen sign is seen at the company’s office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith

The justices turned away Amgen’s appeal of a 2017 decision by a lower court to set aside a jury’s verdict that two Amgen patents were valid and nullify a ban on sales of Regeneron and Sanofi SA’s cholesterol-lowering drug Praluent.

Amgen had argued that the U.S. Court of Appeals for the Federal Circuit misunderstood the statutory requirements for patenting an invention.

Praluent is an injectable biopharmaceutical 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, alleging that Praluent infringed patents relating to Amgen’s competing drug Repatha.

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 blocking 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 sales were allowed to continue during the appeals process.

The Federal Circuit in 2017 threw out the sales ban and ordered a new trial, saying the jury had been given improper instructions on the requirements for patentability.

Praluent and Repatha won U.S. approval to reduce LDL cholesterol in 2015. The drugs are far more costly than other cholesterol drugs, with a list price topping $14,000 annually.

Hurdles to patient access by health insurers and pharmacy benefit managers have led to disappointingly low sales so far. But Amgen’s drug has steadily gained market share since the court ruling.

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

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