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Sanofi & Regeneron deflect Amgen's legal marketing block on Praluent

Published on 09/02/17 at 10:11am

Sanofi and Regeneron have successfully won in a US Court ruling calling for the suspension of the permanent injunction of their diabetes drug injection Praluent (alirocumab) following a patent infringement case by Amgen, meaning the pair are still able to market, sell and manufacture the treatment in the US during the appeal process.

Amgen originally won its two cases in March 2016 accusing the duo of breaching patent on its own drug Repatha. Despite an attempt to overturn it by Sanofi and Regeneron, the case was upheld in January this year. Both drugs were originally approved by the FDA in 2015, with Praluent being the first PCSK9 inhibitor to be approved in the country, indicated as supplementary to diet and maximally-tolerated statin therapy for treating heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, in adults requiring a reduction of LDL cholesterol.

The new ruling deflects a heavy blow to Sanofi and Regeneron that would have seen Praluent removed from sale on the US market on 21 February. The injunction is not valid outside the US.

The two companies were vocal in their challenge of the marketing blockade and plan to continue to dispute the validity of the patent infringement judgement during the appeal process.

“This decision is important for patients in the U.S. who will continue to have access to Praluent during the appeal process giving them a choice in PCSK9 inhibitor treatments to best meet their individual needs,” remarked Karen Linehan, Executive Vice President and General Counsel at Sanofi. “It is our longstanding position that Amgen’s asserted patent claims are invalid and we look forward to moving forward with the appeal process.”

Regeneron Senior Vice President, General Counsel and Secretary Joseph J LaRosa added: “We continue to believe the facts and controlling law support our position in this case. We will continue to vigorously defend our case through the appeal process.”

In the wake of the ruling, Amgen Spokeswoman Kristen Davis noted her confidence that Amgen would ultimately emerge victorious in the legal battle.   

Matt Fellows

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