Sanofi and Regeneron lose to Amgen in cholesterol drug patent fight

Sanofi and Regeneron are to appeal against a US court decision that could see them paying millions of dollars in royalties to Amgen, which markets a rival cholesterol drug.

Yesterday’s decision in the Federal Court in Delaware ruled that Sanofi and Regeneron’s Praluent (alirocumab) infringes on two patents relating to Amgen’s rival, Repatha (evolovumab).

Later this month a judge will hear Amgen’s case for a permanent injunction that could block Praluent sales unless the companies come to a royalty agreement.

In a joint statement, Sanofi and Regeneron said they “strongly disagree” with the jury verdict that Amgen’s two patents for antibodies targeting PCSK9 are valid, and will appeal.

Joseph LaRosa, general counsel and secretary at Regeneron, said: “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.”

Meanwhile Amgen noted that, before the trial, Sanofi and Regeneron acknowledged infringement of seven patent claims, but that the trial proceeded on the validity of those patent claims. The jury found Sanofi and Regeneron had failed to prove the patents invalid.

Amgen’s chairman and CEO, Robert Bradway, said: “We are thankful that the jury weighed the evidence carefully and recognised the validity of Amgen’s patents on Repatha.”

Both drugs are approved for heterozygous familial hypercholesterolaemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, requiring additional lowering of LDL cholesterol. Amgen’s drug is also approved in homozygous familial hypercholesterolaemia.

Sales have been slow since the two drugs were launched within weeks of each other last summer, although they are expected to pick up once outcomes data has been announced – both drugs have been approved by the US Food and Drug Administration on the basis of their ability to reduce levels of “bad” LDL cholesterol.

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