The Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.
In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it.
Amgen had argued Sanofi and Regeneron’s similarly acting drug, Praluent, infringed on those patents, which it said broadly covered all antibodies binding to the PCSK9 protein.
Citing cases involving the telegraph, Thomas Edison and furniture glue, Gorsuch affirmed that patents must enable specialists to make and use the entire scope of a claimed invention. “The more one claims, the more one must enable,” Gorsuch wrote in his opinion.
“[W]e agree with the lower courts that Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation,” Gorsuch added.
Gorsuch acknowledged a patent does not need to disclose each single possible embodiment of the invention. But he added that examples of the claimed class need to have some common thread running through them, which is “as straight down the middle as I think the court could have possibly gotten,” said Jacob Sherkow, a University of Illinois professor who specializes in bioscience law and whose co-authored brief was noted in court’s decision.
Both Repatha and Praluent work by inhibiting PCSK9, which naturally limits liver cells’ ability to remove LDL, or “bad,” cholesterol from the blood. They’ve proven able to powerfully lower cholesterol in testing, making them useful treatments for people for whom statins haven’t worked well enough.
The case, which wended its way through various courts, has divided the pharmaceutical industry with a lot at stake in the $160 billion-per-year market for antibodies.
Sanofi, Regeneron and their allies argued Amgen’s broad claims went beyond what it actually invented and would lead to fewer treatments for patients. Others, including Bristol Myers Squibb, Merck & Co. and AbbVie, had written in support of Amgen.
In taking Sanofi and Regeneron’s side, the court indicated that the inventions Amgen described in its patents weren’t sufficiently detailed to support the company’s claims.
"[Amgen] freely admits that it seeks to claim for itself an entire universe of antibodies,” Gorsuch wrote. “Still, it says, its broad claims are enabled because scientists can make and use every undisclosed but functional antibody if they simply follow the company’s ‘roadmap’ or its proposal for ‘conservative substitution.’ We cannot agree. These two approaches amount to little more than two research assignments.”
The court’s ruling could open the door for challenges to older classes of antibody therapies, Sherkow said. “This decision is probably going to give challengers solace. They're going to have good options when working with the enablement requirements to challenge competitors' patents out there.”
In a statement, Regeneron described the ruling as a rejection of an attempt to "radically change" the legal standards for patents.
"This Supreme Court decision protects access to this medicine and defends our industry and others against overreaching patent claims that cover an entire therapeutic category and could have a chilling effect on bringing life-saving medicines to people in need," said Regeneron CEO Leonard Schleifer in the statement.
Amgen said in an emailed statement it "is disappointed in the outcome, but the company will continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation."
Shares in Amgen, Sanofi and Regeneron all traded down slightly through early Thursday afternoon.
Editor’s note: This story has been updated with commentary from Jacob Sherkow, and Amgen’s statement.