Justices Narrow Patent Enablement Scope in Amgen-Sanofi Case (3)

The US Supreme Court affirmed the narrow scope of a patent law requirement known as “enablement,” siding with Sanofi and Regeneron Pharmaceuticals Inc. in their dispute with Amgen Inc. over cholesterol drugs.

The justices unanimously upheld the US Court of Appeals for the Federal Circuit’s decision finding Amgen’s patents invalid.

The ruling preserves a narrow interpretation of a requirement that patents must contain enough information to enable someone with expertise in the field to make and use the invention. The court clarified that drug patents needn’t specify all potential antibodies they intend to protect. But it said Amgen’s two canceled patents covering its Repatha drug didn’t contain enough information to enable someone with expertise in the field to make and use the invention, or to reach “the full scope” of the claims “without undue experimentation.”

Amgen insists 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,” Justice Neil Gorsuch wrote in the unanimous opinion. “These two approaches, however, amount to little more than two research assignments.”

Sanofi and Regeneron’s win will promote the disclosure of specific inventions and breakthroughs over time without unfairly monopolizing far-ranging research areas, drugmakers such as Pfizer Inc., Eli Lilly and Company, and Genentech Inc. previously told the court.

Amgen in a statement said it’s disappointed in the outcome, but vowed to “continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation.”

The company’s supporters included GSK PLC and AbbVie Inc., which told the court that broader patent claims—like the ones contained in US Patent Nos. 8,829,165 and 8,859,741—encourage the development of widely applicable treatments and insure a reasonable return on investment. The justices disagreed.

“Striking the proper balance between incentivizing inventors and ensuring the public receives the full benefit of their innovations is a policy judgment that belongs to Congress. Since 1790, Congress has included an enablement mandate as one feature among many designed to achieve the balance it wishes,” the opinion said. “Our only duty in this case lies in applying that mandate faithfully.”

Repatha has 70 percent of the US market for PCSK9-inhibiting drugs, leaving its main rival, Sanofi and Regeneron.’s Praluent, with only $130 million in US sales last year, according to Bloomberg Intelligence analyst Marc Engelsgjerd.

“We applaud the Court for their unanimous decision that defends innovation and scientific discovery,” Regeneron, which owns Praluent in the US, said in a statement. Sanofi has “sole responsibility” for Praluent abroad, according to the company.

“The justices rejected an attempt to radically change the longstanding legal standard for patent validity under the enablement doctrine,” Sanofi said in a statement.

MoloLamken LLP represents Amgen. Clement & Murphy PLLC represents Sanofi and Regeneron.

The case is Amgen Inc. v. Sanofi, U.S., No. 21-757, opinion 5/18/23.