Amgen Patents for Cholesterol Drug Repatha Upheld by Jury

(Bloomberg) -- A U.S. jury upheld two patents for Amgen Inc.’s cholesterol-lowering drug Repatha, dealing a blow to Sanofi and Regeneron Pharmaceuticals Inc., which make a similar medication called Praluent.

Billions of dollars in anticipated sales for the competing drugs are at stake in the latest chapter in a legal fight that began in 2014 and included a rare sales ban on Praluent that ultimately was vacated. Repatha alone, which treats extremely high levels of “bad” cholesterol, is expected to bring in $2.21 billion in 2022.

Sanofi and Regeneron already had conceded that their drug infringes Amgen’s patents, a common legal tactic to narrow the case. On Monday, jurors in Wilmington, Delaware, rejected their argument that the patents didn’t adequately describe the invention or explain how to make the full scope of antibodies the patents cover, though they agreed that some aspects of one of the patents were invalid. The court will ultimately determine how much the companies owe Amgen in royalties on the sale of Praluent.

Sanofi and Regeneron plan to appeal the part of the verdict they lost. Meanwhile, they said, “the verdict does not impact U.S. physicians and patients’ access to Praluent.”

Amgen’s chief executive officer, Robert A. Bradway, said the decision “protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases.”

Potential Blockbusters

Praluent and Repatha belong to a category of drugs known as PCSK9 inhibitors, designed to help patients with ultra-high bad, or LDL, cholesterol who can’t get their condition under control with widely used statins such as Pfizer’s Lipitor. Praluent, given in low doses, is designed to reduce cholesterol levels without allowing them to go so low that they might be harmful, according to Sanofi and Regeneron.

Analysts tout the cholesterol-lowering drugs as potential blockbusters, with Amgen’s Repatha estimated to bring in $2.21 billion in 2022, according to an average of nine analyst forecasts compiled by Bloomberg. Sanofi is expected by analysts to record Praluent sales of about 704 million euros ($800 million) in 2022, according to an average of four analyst forecasts compiled by Bloomberg.

Sanofi and Regeneron on Feb. 11 announced that, starting in early March, they’d slash the U.S. list price of Praluent to $5,850 a year, about 60 percent of its original price. It was the latest in a volley of competing price cuts. Amgen, based in Thousand Oaks, California, reduced the U.S. list price of Repatha in October from more than $14,000 a year to $5,850, also roughly a 60 percent cut.

Praluent provided U.S. sales of $181.3 million to Regeneron in 2018, the Tarrytown, New York-based company said Feb. 7 in its annual report. It generated U.S. sales of 154 million euros for Sanofi, the Paris-based company said the same day in its preliminary annual report.

In October 2017, the U.S. Court of Appeals for the Federal Circuit vacated a district judge’s order banning Praluent sales. The decision allowed Sanofi and Regeneron to continue selling the drug while the dispute continued. The sales ban was a rare instance in which a medicine was to be pulled from the market.

The case is Amgen Inc. v. Sanofi, 14-cv-1317, U.S. District Court, Delaware (Wilmington).

--With assistance from Susan Decker.

To contact the reporter on this story: Christopher Yasiejko in Wilmington, Delaware, at cyasiejko1@bloomberg.net

To contact the editors responsible for this story: David Glovin at dglovin@bloomberg.net, Peter Jeffrey, Steve Stroth

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