US judge favors Amgen Inc. in patent lawsuit against Sanofi, Regeneron

January 6, 2017

A federal judge in the state of Delaware in the US has favored California-based multinational biopharmaceutical company Amgen Inc. in a patent infringement lawsuit filed against Sanofi SA and Regeneron Pharmaceuticals, Inc. over a cholesterol drug.

U.S. District Judge Sue Robinson in Delaware ordered a ban on the sales of Praluent, a cholesterol drug from Sanofi and Regeneron. The ban will take effect after 30 days to give Sanofi and Regeneron time to appeal.

Amgen had sought the ban in an October 2014 lawsuit against French multinational pharmaceutical company Sanofi and New York-based biotechnology company Regeneron. It said Praluent, a drug intended to lower “bad” LDL cholesterol by blocking a protein known as PCSK9, infringed its patents related to the protein.

A jury found Amgen’s patents valid in March. After the verdict, the defendants said they planned to appeal to the US Federal Circuit Court of Appeals, which reviews patent disputes.

The companies could still decide to reach a settlement that would give Amgen royalties on Praluent sales.

Both Praluent and Repatha have been approved by the US Food and Drug Administration (FDA) in 2015 to reduce bad cholesterol. The drugs are more costly than other cholesterol drugs, with a list price topping US$14,000 annually.

Sales of the expensive new drugs, seen as potential blockbusters, have been very slow to take off as health insurers and other payers have been reluctant to pay for them. Amgen reported just $40 million in Repatha sales in the third quarter.

Both drugs are in the final stages of enormous trials designed to demonstrate that they can lower the risk of heart attacks and deaths, which is expected to help open the insurer purse strings if successful. So-called outcomes results for Repatha are expected this quarter.

RBC Capital Markets analyst Michael Yee said in a research notethat without the outcomes results, the potential size of the market remained uncertain.


Category: Features, Pharmaceuticals

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