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Amgen garners wide support from pharma peers in Supreme Court patent fight with Sanofi

In a closely watched patent dispute playing out at the U.S. Supreme Court, Amgen has drummed up support from fellow drugmakers large and small, plus industry associations and intellectual property groups.

As part of Amgen’s case against Sanofi centered on the two companies’ PCSK9 cholesterol drugs, several biopharma companies including AbbVie, Bristol Myers Squibb and GSK, as well as organizations like the National Association of Patent Practitioners and the Intellectual Property Professors, have thrown their support behind Amgen’s appeal in separate briefs filed to the U.S. high court.

The law division of the American Chemical Society even went as far as petitioning to participate in oral arguments to help make a case for Amgen.

A federal circuit court previously sided with Sanofi and its partner Regeneron in throwing out patents on Amgen’s PCSK9 inhibitor Repatha. But entities like GSK argue that the lower court’s ruling goes against common sense and puts an unreasonable burden on the innovator to have a valid patent claim.

The legal fight dates back to 2014, when Amgen sued Regeneron and Sanofi before an official FDA approval for their PCSK9 drug Praluent. As the better seller of the two drugs, Amgen’s Repatha reeled in $963 million sales in the first three quarters of 2022. Praluent only ginned up $334 million sales during the same period.

Back in 2019, a Delaware judge threw out a jury verdict and ruled against Amgen. In 2021, a federal appeals court rejected Amgen’s bid to reverse the ruling. The U.S. Supreme Court took on the case despite U.S. Solicitor General’s recommendation against a review.

The current patent law carries an “enablement” requirement, which states that a patent is valid if it contains enough disclosure to allow a person with ordinary skills in a relevant trade to make the invention without undue experiments. The lower courts ruled that Repatha’s patent claims didn’t meet that standard because they could cover “millions” of antibodies and would therefore require undue experiments to determine which ones actually work.

The dispute centers on the appeals court’s interpretation that a patent description should allow skilled specialists to reach the “full scope” of the claim, namely, to be able to make all variations of the same innovation, without substantial effort.

SCOTUS should reject the federal circuit’s “full scope” test, which could “reduce valid claim breadth, especially in the chemical, pharmaceutical, and biotechnology sectors,” AbbVie said in its amicus brief.

“The test has no basis in the statutory language or structure of the Patent Act, chills innovation and investment, and disserves fundamental congressional objectives embodied in patent law,” AbbVie said.

Bavarian Nordic, Biogen, Bristol Myers, Merck & Co., 3M, material science specialist Corning and the Association of University Technology Managers banded together in a joint amicus brief also in favor of Amgen. Calling the “full scope” rule “time-and-resource-wasting,” the team argues the federal circuit’s standard “is wrong as a matter of law and harmful to the innovation process,” and that it “ignores how innovators actually operate.”

Similarly, the National Association of Patent Practitioners, in its filing, argued the federal circuit has “deviated too far” from established legal practice, and that the “full scope” standard is “unworkable.” The lower court’s decision suggests inventors must lay out “all or an unreasonably large number” of species under a patent claim, the organization said.

Meanwhile, the Intellectual Property Law Association of Chicago asked that the high court vacate the case and return it to the court of appeals. While labeling its brief as in support of neither party, the group argued that claim enablement isn’t “a matter of whether the specification has cataloged all possible embodiments of invention.”

Amgen also filed its own brief in December. The California biotech spent almost its entire argument on the “full scope” standard, contending that it’s against the law and harms innovation.