Amgen Loses Drug Patent Suit Vs. Sanofi.

"WASHINGTON -- The Supreme Court said Amgen patents relating to its cholesterol drug Repatha shouldn't have been granted by the patent office, handing a victory to rival pharmaceutical firm Sanofi.

The 9-0 decision, written by Justice Neil Gorsuch, makes it more difficult for pharmaceutical companies to obtain broadly worded patents used to block competitors from the market.

The decision ends a lawsuit, dating back to 2014, in which Amgen sought to collect millions of dollars in damages from Sanofi and its partner Regeneron Pharmaceuticals for alleged patent infringement.

The ruling upholds a 2021 decision by the U.S. Court of Appeals for the Federal Circuit, which hears patent appeals.

"Amgen is disappointed in the outcome, but the company will continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation," an Amgen spokeswoman said.

Representatives of Sanofi and Regeneron said the ruling was a win for the public and U.S. innovation.

"This Supreme Court decision protects access to this medicine and defends our industry and others against overreaching patent claims that cover an entire therapeutic category and could have a chilling effect on bringing lifesaving medicines to people in need," Regeneron CEO Leonard Schleifer said.

Sanofi and Regeneron make a rival drug called Praluent, which works by a similar mechanism as Amgen's Repatha.

Repatha and Praluent can reduce the risk of heart attacks and strokes in people with heart disease. The two drugs present a new way to lower "bad" LDL cholesterol by blocking a protein called PCSK9. Insurers initially declined to pay for the medicines because of their price, which totaled more than $14,000 annually per patient.

Amgen initially sought a court injunction to force Praluent off the market, but the request was ultimately denied by the U.S. Court of Appeals for the Federal Circuit.

In recent years, sales of Amgen's Repatha have picked up partly because of the company's aggressive discounting strategy. Repatha sales last year were $1.3 billion; Sanofi and Regeneron's Praluent 2022 sales were 376 million euros, equivalent to $408.2 million." [1]

1. Business News: Amgen Loses Drug Patent Suit Vs. Sanofi. Wolfe, Jan;
Walker, Joseph.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 19 May 2023: B.3.