Amgen Files Patent Infringement Suit Over Cholesterol Drug

Amgen Inc. said Friday that it has filed a patent-infringement lawsuit against Regeneron Pharmaceuticals Inc. and Sanofi SA over their experimental cholesterol drug, alirocumab.

The suit, filed in the U.S. District Court of Delaware, comes as Amgen and Regeneron and Sanofi race to be the first to get their cholesterol drugs to the market.

The suit alleges that Regeneron and Sanofi are violating three Amgen patents with alirocumab, one of an emerging group of medicines that lower cholesterol by targeting a gene known as PCSK.

A representative from Regeneron said the company hasn't been served with any papers in the matter and doesn't infringe any "valid claim" in the asserted patents.

In an attempt to speed the approval process, Regeneron and Sanofi paid $67.5 million to acquire a special voucher held by BioMarin Pharmaceuticals Inc. earlier this year. The voucher entitles the holder to ask the FDA for priority review of a drug application that would otherwise get a standard review, potentially shortening the review process to six months from the standard 10 months.

Amgen is also seeking regulatory approval of its experimental cholesterol drug, evolocumab. Amgen said in August that it had submitted a new drug application to the Food and Drug Administration.

The Amgen suit is seeking an injunction to stop the manufacture, use and sale of alirocumab.

Write to Chelsey Dulaney at [e-mail]

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