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US court backs Sanofi/Regeneron in PCSK9 patent dispute with Amgen

Latest point in tit-for-tat battle between rivals

Repatha

A US district court has handed a win to Sanofi and Regeneron in their five-year-old patent dispute with Amgen over patent rights to their PCSK9 inhibitor cholesterol drugs.

The Delaware court has bucked the trend of recent verdicts going in Amgen’s favour, by overturning an earlier ruling in February that backed the validity of three of five claims from two patents held by Amgen for its Repatha (evolocumab) drug.

Amgen filed a patent infringement complaint against Sanofi/Regeneron in 2014, claiming that their Praluent (alirocumab) PCSK9 inhibitor infringed on those patients. It won an injunction against Repatha sales in the US in 2017, which was overturned by an appeals court later that year.

The three companies started negotiations with a view agreeing a licence deal to settle the disputes, but that effort was abandoned without agreement. Meanwhile, in Europe, Amgen also scored the first victory last month after winning an injunction on Praluent sales in Germany which was blocked by a temporary stay last month.

Commenting on the latest judgment, Karen Linehan, Sanofi’s general counsel, said: “it has been our longstanding belief that all of Amgen's asserted US PCSK9 patent claims are invalid, and we are pleased today's decision reaffirms this.”

As the February ruling found that two of the five claims in Amgen’s patents were invalid, the latest verdict means that Sanofi and Regeneron have effectively invalidated all of Amgen’s patent claims for Repatha.

Amgen has said it doesn’t agree with the Delaware ruling and will seek a review by the appellate court.

The costly legal proceedings come as both companies have been struggling to make much headway in the market with their drugs, forcing them to slash their annual list price from around $14,000 at launch to less than $6,000.

Sanofi/Regeneron and Amgen are expecting the drugs to gather momentum now that they have cardiovascular outcomes data to go along with surrogate results based on LDL cholesterol, although recent sales figures shown little evidence for that.

Repatha brought in $152m in the second quarter 2019, just $4m more than the same period of 2018, while Sanofi made €61m ($68m) from Praluent, a 3% increase, and Regeneron posted flat sales of $74m.

30th August 2019

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