Regeneron and Sanofi need not pull Praluent off market
09 Feb 2017
A US appeals court yesterday decided that Regeneron and Sanofi need not pull their cholesterol drug Praluent off the market, at least for now.
The court yesterday said the cholesterol drug could remain on pharmacy shelves while it sorted out an appeal in a patent fight with Amgen, which made a competing drug, Repatha.
Some analysts had doubted during the hard-fought fight whether Regeneron and Sanofi, who were partners in promoting Praluent could win.
A trial court had upheld Amgen's patent for its drug Repatha, and Amgen then went on to win an injunction to block Praluent's sales.
US district judge Sue Robinson had supported Sanofi and Regeneron's first attempt to postpone the injunction pending appeal, and the Federal Circuit Court of Appeals had now granted their request for a stay.
In an email, Sanofi said that it was ''pleased'' that the appeals court had stayed the injunction for Praluent, ''giving patients in the US continued access to this important medicine during the appeal process. It is our longstanding position that Amgen's asserted patent claims are invalid.''
According to commentators, the ruling did not guarantee that Regeneron and Sanofi would finally prevail, it merely allowed their drug to remain on sale while the Circuit Court weighed the two sides' arguments in the patent appeal.
In the absence of the appeals court's decision, Sanofi and Regeneron would have been blocked from selling Praluent in the US till the outcome of the patent-infringement case.
An Amgen spokesperson reacted to the court decision saying, "Amgen remains confident in the validity of our patents and the correctness of the jury verdict and district court's judgment. We look forward to presenting our case on the lack of merit in" the appeal by Sanofi and Regeneron.
Praluent and Amgen's competing drug Repatha, which were both approved for sale in 2015, belong to a new class of cholesterol fighters known as PCSK9s. Analysts originally expected the drugs to be multibillion-dollar sellers, but health-insurance plans had restricted their use, partly due to their costs.