Amgen Gains Victory Against Sanofi in Patent Litigation for Anti-Cholesterol Drug

Sanofi and Regeneron Pharmaceuticals, Inc. issued a statement strongly disagreeing with a US District Court jury verdict that the asserted claims of two Amgen patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid. Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing US patent infringement lawsuit and plan to appeal the judgment.

The decision surrounds Sanofi’s and Regneron’s PCSK9 inhibitor, Praluent (alirocumab), which was approved in July 2015 for use in the US. It is indicated for use as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of “bad” (LDL) cholesterol. Praluent is available in two starting doses that allow physicians to adjust the dose based on a patient’s LDL cholesterol-lowering needs.

Amgen’s Repatha (evolocumab) is a competing PCSK9 inhibitor. Repatha is approved in the United States, Japan, Canada, Australia, Kuwait, Switzerland and in all 28 countries that are members of the European Union as well as in Norway, Iceland and Liechtenstein.

Amgen brought the patent infringement action in federal court in Delaware against Sanofi and Regeneron Pharmaceuticals, with respect to Amgen patents that describe and claim monoclonal antibodies to PCSK9. Before trial, Sanofi and Regeneron acknowledged infringement of seven patent claims in US Patent Numbers 8,829,165, and 8,859,741. The trial proceeded on the defendants’ challenges to the validity of those seven claims. The jury found that defendants had failed to prove the patents invalid for lack of written description and enablement. Prior to the case going to the jury, the court dismissed defendants’ case on obviousness. The court ruled in Amgen’s favor in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies PCSK9.

“It has always been and remains our position that Amgen’s asserted patent claims in this matter are invalid,” said Karen Linehan, executive vice president and general counsel, Sanofi, in a company statement.

The next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future, according to Sanofi.

“This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the US appellate court that hears all biopharmaceutical patent appeals,” said Joseph LaRosa, senior vice president, general counsel and secretary, Regeneron. “Praluent was developed with Regeneron’s proprietary science and technology and represents an important medical advance for patients.”

Source: Amgen and Sanofi

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