US court blocks Sanofi, Regeneron from selling Praluent in patent case win for Amgen

The US District Court in Delaware upheld a request from Amgen and granted a permanent injunction preventing Sanofi and Regeneron Pharmaceuticals from marketing, selling or manufacturing the PCSK9 inhibitor Praluent (alirocumab) in the country. Amgen claimed that Praluent infringed two patents covering its own PCSK9 inhibitor Repatha (evolocumab).

The injunction, which follows a jury verdict in March 2016 in Amgen's favour, will not take effect immediately as the court has delayed its imposition for 30 days to allow Sanofi and Regeneron to appeal the decision. "Sanofi and Regeneron admitted that they had infringed our patents, and the jury upheld our patents as valid," noted Amgen CEO Robert A. Bradway, adding "protecting intellectual property is essential to our industry."

However, Karen Linehan, general counsel at Sanofi, said "we will immediately appeal today's ruling, along with the jury's earlier finding upholding the validity of Amgen's patents." Linehan added "it is our longstanding position that Amgen's patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent." Sanofi and Regeneron noted that Praluent "continues to be available to patients at this time."

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In making the ruling, Judge Sue Robinson noted that without the injunction, Amgen would face a loss of contracts with insurers and other market advantages as well as "reputational harm." Robinson indicated that this outweighed the benefit to consumers of having a new treatment on the market. However, Robinson delayed the injunction to "encourage the parties to reach an appropriate business resolution." Otherwise, the patents, which describe and claim monoclonal antibodies to PCSK9, expire in 2029, according to Bloomberg Intelligence analyst Aude Gerspacher.

Praulent was approved by the FDA in July 2015 for the treatment of high cholesterol in certain patients, with Repatha authorised the following month. RBC Capital Markets analyst Michael Yee suggested that the "surprise" ban could mean significantly higher sales for Repatha. "If Praluent was gone from the market the long-term peak sales for Repatha could move from $2 billion to $3 billion to $4 billion worldwide, in theory," Yee commented.

For related analysis, see Physician Views Poll Results: 100-plus cardiologists' feedback on new PCSK9 data and future expectations for drug class.

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