In SCOTUS filing, Amgen claps back at Sanofi and Regeneron in long-running patent feud

As Sanofi and Regeneron press their patent “enablement” agenda at the U.S. Supreme Court, hoping to keep protections on Amgen’s cholesterol med Repatha on ice, Amgen has accused its rivals of living in a legal fantasy world.

The justices must not “distort” established patent standard by siding with Sanofi and Regeneron, Amgen argued in a response (PDF) filed with the high court this week. To do so would “serve those who would prefer a patent system different from the one Congress enacted,” the company contends.

Amgen successfully convinced the Supreme Court to take up the case back in November. The company wants to reverse a 2019 loss invalidating two Repatha patents. While it’s currently on the backfoot, Amgen threw the first punch in the patent fight when it cried infringement by Sanofi and Regeneron’s cholesterol drug Praluent back in 2014.

The rival drugs, which both help lower “bad” LDL cholesterol by blocking the protein PCSK9, snared U.S. approval just weeks apart in 2015.

Enablement fight

The long-running feud hinges on the legal requirement of “enablement,” which dictates that a patent must contain enough detail to allow a person of ordinary skill in the relevant trade to make or use an invention without “undue” trial and error. The law is meant to ensure inventions truly advance their fields. Since no patent lasts forever, inventions must be clearly described so that others can make and use them once they lose exclusivity. 

Previously, a federal appeals court sided with Sanofi and Regeneron’s argument that the enablement requirement is only met if a patent allows skilled specialists to reach the “full scope” of the claim—i.e., to be able to make all variations of the same invention—without substantial effort.

More recently, the partners amended their argument, contending that a patent fails the enablement requirement if it contains “specific undisclosed embodiments” that skilled experts “cannot predictably reproduce.”

Problem is, according to Amgen, neither argument fits the established legal standard for enablement. Known as the “make and use” standard, the test is “the same whether there are 5 embodiments of the invention or 5,000,” Amgen said.

Within the biopharma world, the case comes down to whether drug patents can cover single molecules or an entire class of medicines. Previously, Sanofi's legal team argued that Amgen's patent claims, if found valid, could allow another company in another field to stake off an entire new class of drugs. Amgen has argued strong protections are needed so that companies don't follow important discoveries with "me-too" drugs without committing research.

In the lead-up to an expected Supreme Court decision this summer, major drugmakers, intellectual property organizations and even the U.S. government have been picking sides.

In late September, the Biden administration’s top lawyer, Elizabeth Prelogar, suggested Amgen’s petition “should be denied.” Meanwhile, companies like Biogen, Bristol Myers Squibb and Merck & Co. have taken Amgen’s side. The Repatha supporters argued in a petition last year that a loss at the Supreme Court would “slow the pace of research and development and hinder innovation.”

Sanofi and Regeneron also ginned up support for their camp earlier this year, with companies like Pfizer, Eli Lilly, AstraZeneca and Johnson & Johnson filing multiple briefs in favor of the partners’ position. The Sanofi supporters largely took issue with Amgen’s purportedly “overbroad” and “unbounded” patents.

No matter the outcome, the PCSK9 patent feud is nearing its end after nearly 10 years in court. Back in November, a spokesperson for Regeneron told Reuters the companies expect the Supreme Court to reach a decision on Amgen’s appeal by the end of June.