US government, Pfizer and others side with Sanofi and Regeneron in Supreme Court patent case
Pfizer, Viatris, the US government and others on Friday submitted briefs to the Supreme Court backing Sanofi and Regeneron in their fight against Amgen over patents that cover their PCSK9 inhibitors to control cholesterol.
SCOTUS will address what’s referred to as the “enablement” requirement, which essentially spells out how a patent should include both a written description of an invention, and the manner and process of making and teaching skilled artisans “to make and use” the invention.
The US Department of Justice made clear in its brief that Amgen’s inability to invoke the established protections that patent law offers “provides no justification for” upholding their “broad genus claims against respondents’ enablement challenge.”
“Amgen and its amici suggest that the Court need not worry about broad functional claiming’s hold up of innovation under a weakened enablement standard, given the possibility of licensing,” Genentech, AstraZeneca, Bayer, Gilead and Johnson & Johnson wrote in their brief. “The suggestion is misplaced. Licensing is hardly a foregone conclusion, particularly when it comes to biopharmaceutical patents.”
Pfizer similarly said that Amgen’s claims “should fail under any test for enablement,” adding:
Pfizer does not object to an innovator obtaining broad claims for genuine “breakthrough” inventions that satisfy the statutory requirements and are based on a disclosure that is commensurate in scope with the claims. However, the claims at issue are not commensurate with the inventors’ contribution. They are a naked attempt to preempt future innovation and an unwarranted extension of the patent monopoly.
Generic company Viatris also said in its brief that SCOTUS “should tread very carefully before upsetting the ‘delicate balance’ of the patent law.”
In response to the support, Sanofi and Regeneron said in a joint statement via email:
It has been our longstanding belief that all of Amgen’s asserted U.S. PCSK9 patent claims are invalid. Amgen’s attempt to dilute the legal standard for enablement would stifle innovation in all industries. We are pleased by the support from the U.S. Government, as well as from individuals and companies in different industries that believe, among other things, the ability to innovate must be protected. We look forward to oral argument.
Amgen, which filed the initial petition to SCOTUS in November 2021, claims that a prior Federal Circuit decision incorrectly requires patent owners to identify and make all or nearly all possible variations of the invention — without “substantial time and effort.”
“The Federal Circuit identified no reason why patent validity should depend on the cumulative effort required to ferret out every conceivable implementation of the invention,” Amgen wrote. “That test defies this Court’s precedents, which recognize that ‘it is obviously impossible to specify in a patent the precise treatment’ for each of the potentially ‘infinite[]’ variations of a claimed invention.”
The case stems from a patent dispute between Amgen and Sanofi (which worked with Regeneron) over their independently developed but similar PCSK9 inhibitor antibody drugs, Repatha and Praluent, which both reduce low-density lipoprotein cholesterol. The antibodies differ in amino acid sequence and where they bind to PCSK9.
Amgen scored a win in 2019 in an initial trial, but a federal judge in Delaware later overturned that verdict and ruled in favor of Sanofi and Regeneron. That decision was then upheld in the Court of Appeals for the Federal Circuit.
Amgen said in a statement to Endpoints:
Amgen’s patents claim a pioneering discovery of a class of antibodies that lower bad cholesterol, thereby preventing life-threatening heart attacks and strokes. We fully believe that the patents meet the statutory requirements for enablement as the patents disclose the inventors’ work in producing dozens of antibodies and a teaching of how to get the full scope of antibodies claimed. Two juries heard all the evidence and upheld the patents. To incentivize researchers to pursue such life-changing, groundbreaking inventions, patents must provide a meaningful scope of protection broader than just the specific examples the inventors disclose. Without this broader protection, the patent system incentivizes copyists, not the next big breakthrough. This view is shared by many others in our industry and beyond, both large and small companies, and research-based institutions. We look forward to the Supreme Court weighing in on this important issue and restoring the law to the statutory requirements for enablement.
Editor’s note: Article updated with comment from Amgen.
