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US appeals court allows Regeneron, Sanofi to continue selling cholesterol drug

PBR Staff Writer Published 10 February 2017

A US appeals court has stayed an order that could have prevented Regeneron Pharmaceuticals and Sanofi from selling their cholesterol drug, Praluent.

The stay order passed by the US Court of Appeals for the Federal Circuit will allow both the firms to appeal against the ruling of a federal judge in a patent infringement case filed by Amgen in the US District Court in Delaware.

Sanofi executive vice president and general counsel Karen Linehan said: "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.

"It is our longstanding position that Amgen's asserted patent claims are invalid and we look forward to moving forward with the appeal process."

In January, the District Court in Delaware gave a ruling that prohibited the two companies from marketing, selling or manufacturing Praulent from 21 February.

The court had delayed its imposition for 30 days to allow the two companies the necessary time to move a motion to seek a stay order.

Amgen, which got the ruling in its favor, had accused Regeneron and Sanofi of infringing its two patents for Repatha (evolocumab) while developing Praulent.

The ruling from the appeals court means that Regeneron and Sanofi can carry on marketing, selling and manufacturing Praluent in the US through the appeal process.

Praulent and Repatha, the two drugs pitted against each other in the ongoing patent infringement lawsuit, are both proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that reduce the bad LDL cholesterol levels.

Regeneron senior vice president, general counsel and secretary Joseph LaRosa said that the companies will continue to strongly defend their case during the appeal process.