Sanofi, Regeneron Win New Trial in PCSK9 Patent Dispute

Sanofi and Regeneron today won a new trial in their patent dispute with Amgen over the cholesterol drug Praluent, adding more drama to the battle for dominance over a drug class that has turned out to be less lucrative than experts once imagined.

Trading on Regeneron was halted before news broke that a Federal Circuit Court of Appeals had sent the case back for a new trial. Immediately after the decision, Karen Linehan, Sanofi general counsel and executive vice president, released this statement:

“We are pleased with the Federal Circuit’s decision to remand for a new trial that allows us to present our complete evidence to the jury. It is our longstanding position that Amgen’s asserted patent claims are invalid, and we remain confident in the long-term availability of Praluent for patients.”

In February, Sanofi and Regeneron had to fight to keep Praluent on the market during the appeal following Amgen’s March 2016 victory, when a Delaware jury agreed with 2 patent claims. Today’s ruling also threw out the ban on Praluent sales that had been imposed, and then stayed, by the lower court.

In an email, Amgen said it would continue the court battle. "Our ability to discover and deliver new medicines that benefit patients depends on meaningful patent protection and enforcement that enable significant investments in drug development and clinical trials," the statement read, adding that the Circuit Court had rejected part of Sanofi and Regeneron's claims.

Payers Resist Price

The pharmaceutical giants are battling for market share for a class of cholesterol-fighting injectible drugs called PCSK9 inhibitors, which block an enzyme, proprotein convertase subtilisin/kexin type 9, that affects how the body processes low-density lipoprotein (LDL) cholesterol in the liver. Clinical trials with Amgen’s version, evolocumab, which is sold as Repatha, and Sanofi-Regeneron’s alirocumab (Praluent), showed the drugs should cut LDL cholesterol by up to 60%.

However, despite these results—and recent findings that show some cardiovascular benefit with evolocumab—sales of the PCSK9 inhibitor class have fallen well short of what analysts expected. The $14,000 annual price tag once raised fears of $100 billion being added to the nation’s health tab, but Amgen reported sales of evolocumab were $49 million for the first quarter of 2017.

Health plans and pharmacy benefit managers implemented strict protocols for who could gain access to the drugs, and evidence presented at the spring meeting of the American College of Cardiology showed physicians have a hard time getting past barriers when they prescribe them.

Amgen has offered refunds for payers if a patient experiences a heart attack while taking evolocumab, but outcomes-based pricing contracts are all about the details, according to Immaculada Hernandez, PharmD, PhD.

Topline results for the cardiovascular outcomes study on Praluent are expected later this year. At the most recent meeting of the American Diabetes Association, Sanofi presented results showing benefits for patients with diabetes.

Federal Circuit Cites Errors

In a statement, Sanofi and Regeneron said the Federal Circuit found the trial court erred by:

· Excluding evidence regarding written description

· Excluding evidence on enablement

· Improperly instructing the jury on written description; the court held that the law requires “a written description of the invention,” meaning the claimed antibody itself and not the antigen

· Improperly granting a permanent injunction

The Federal Circuit agreed Amgen's argument patents were non-obvious. However, because evidence was excluded, the court deemed the record incomplete, which meant it could not issue a judgment as a matter of law, according to the statement.

A copy of the Federal Circuit decision is available here.