U.S. Appeals Court Reverses Ban on Praluent Sales

New trial ordered in dispute between Amgen and Sanofi/Regeneron

A U.S. appeals court has thrown out a ban on the sale of the cholesterol-lowering drug alirocumab (Praluent, Sanofi SA/Regeneron Pharmaceuticals) and ordered a new trial in the case that led to the ban, Reuters reports.

The ruling from the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., is a setback for Amgen, which sells the similar cholesterol drug evolocumab (Repatha) and claimed Praluent infringed its patents. Amgen had won the sales ban after a jury trial, but the Federal Circuit ruled that the jury was given improper instructions.

“This ruling means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent (alirocumab) injection in the U.S.,” Sanofi and Regeneron said in a statement. “The schedule for the new trial has not yet been determined. The companies do not anticipate any new trial proceedings to start in 2017.”

Amgen could not immediately be reached for comment. The California-based company brought its lawsuit against Paris-based Sanofi and New York-based Regeneron in 2014, Reuters noted.

Shares in Regeneron were halted after surging 1.8% and shares of Amgen were off 1%, Reuters said.  

Both Praluent and Repatha are manmade antibodies that work by blocking proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen claimed its patents covered a broad range of antibodies that bind to PCSK9 but did not name Praluent specifically, while Sanofi and Regeneron claimed such broad patents were invalid.

A jury had found Amgen’s patents valid last March. Sanofi and Regeneron did not dispute that if the patents were valid, Praluent infringed them.

In January, U.S. District Judge Sue Robinson in Delaware took the unusual step of blocking sales of Praluent, Reuters reported. She found that, although having both drugs on the market would be in the public interest, Amgen’s patent rights outweighed that concern.

In the latest decision, the Federal Circuit said the jurors were given instructions that could have wrongly led them to believe that describing a protein like PCSK9 was automatically enough to patent a broad class of possible antibodies. The appeals court also found that Robinson improperly excluded some evidence that Sanofi and Regeneron wanted to use at the trial.

The FDA approved Praluent and Repatha to reduce bad cholesterol levels in 2015. The drugs are more costly than other cholesterol drugs, with a list price topping $14,000 annually.

Sources: Reuters; October 5, 2017; Sanofi; October 5, 2017.