Amgen made an aggressive legal bid to push Sanofi and Regeneron's rival PCSK9 drug off the market when the two were first duking it out in 2015. It didn't work—but Amgen hasn't given up. It's aiming to take the battle to the U.S. Supreme Court instead.
After falling short with its arguments in federal appeals court, Amgen is asking the Supreme Court to strike up a review of the case. Amgen claimed Sanofi and Regeneron stepped on its PCSK9 patents and initially won an injunction against their drug Praluent.
In a petition for a writ of certiorari, Amgen now argues that the U.S. Court of Appeals for the Federal Circuit incorrectly interpreted and ruled on patent law. The company says the court has created its own standard that has resulted in “jurisprudential anarchy.” Amgen markets the PSCK9 cholesterol drug Repatha in a head-to-head battle with Praluent; both products have fallen short of expectations, mostly because payers limited access to the high-priced drugs.
Amgen's filing comes after years of legal back-and-forth between the drugmakers. Amgen sued Sanofi and Regeneron in 2014, and in early 2016, a jury upheld the Amgen patents and the judge in the case granted an injunction against Praluent sales. Sanofi and Regeneron won a stay of the injunction, but analysts believed Sanofi and Regeneron might be forced to pay Amgen royalties.
An October 2017 decision changed all that. The Federal Circuit ruled that the jury was given incorrect instructions, threw out the injunction and ordered a new trial.
In its Supreme Court filing, Amgen says the appeals court’s approach to patent disputes “defies the statute and precedent.” The company argues the court has created its own “possession” standard that doesn’t fit with the Patent Act, and that the court has created new “sub-tests” to implement its standard. Under the standard, the written description for a patent must prove the inventor possessed the invention on the filing date, according to Amgen’s filing.
From Amgen’s perspective, the “ever-shifting demands of those sub-formulations have left innovators no way of predicting what disclosures will be sufficient” to protect their patents.
Since the appeals court decision, Sanofi and Regeneron have been aggressive in promoting Praluent. In March, the partners presented data at the American College of Cardiology showing the drug cut death risks by 29% in the most vulnerable patients. At the same time, the companies said they would discount the med to within a price range of $4,460 to $7,975 per year suggested by cost watchdog ICER.
Two months later, the partners struck an exclusive deal with leading pharmacy benefit manager Express Scripts, agreeing to lower Praluent’s price to win a spot on the PBM’s national preferred formulary.