In the patent feud over rival PCSK9 inhibitors, Amgen isn’t the only pharma company with friends in high places.
One month after the Big Biotech drummed up support from AbbVie, Bristol Myers Squibb and others for its Supreme Court bid, a slew of drugmakers on the opposite side of the argument are coming down in favor of Sanofi and Regeneron.
In multiple briefs filed to the U.S. high court, drugmakers such as Pfizer, Eli Lilly, Ipsen, AstraZeneca and Johnson & Johnson put their chips behind Sanofi and Regeneron, which successfully made the case in a Delaware court to get a pair of Amgen’s Repatha patents invalidated back in 2019.
Alongside those companies, organizations such as the American Intellectual Property Law Association also threw in support for Sanofi.
The high-stakes case stretches back to 2014 when Amgen lodged its original lawsuit against Sanofi and Regeneron. In its case, Amgen alleged infringement by the partners’ rival PCSK9 cholesterol drug Praluent, which was under development at the time as alirocumab.
Praluent and Amgen's Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9.
In 2019, a judge ruled that certain claims of two Amgen patents covering Repatha were invalid, handing the win to Sanofi and Regeneron.
After a rejection at a federal appeals court in 2021, Amgen successfully petitioned the U.S. Supreme Court to hear its bid to revive certain Repatha patents in November.
Now, the U.S. Supreme Court will have the final say on the patents, and on the issue around patent "enablement" that seems to divide the biopharma industry.
The "enablement" requirement states that patents are only valid if they contain enough disclosure to allow a person of ordinary expertise in a relevant trade to make the invention without undue experiments. More specifically, 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—or, effectively to be able to make all variations of the same invention—without substantial effort.
Amgen, for its part, says its patents claim a “pioneering discovery of a class of antibodies that lower bad cholesterol,” a company spokesperson said over email.
Two juries “heard all the evidence and upheld the patents,” the spokesperson said, arguing that in order to incentivize researchers to pursue potentially life-changing and groundbreaking invention, “patents must provide a meaningful scope of protection broader than just the specific examples the inventors disclose.”
Without those protections, the patent system encourages “copyists, not the next big breakthrough,” Amgen contends.
Conversely, it’s been the “longstanding belief” of Regeneron and Sanofi that “all of Amgen’s asserted U.S. PCSK9 patent claims are invalid,” a Sanofi spokesperson said in a statement on behalf of both companies.
When it comes to government support, Sanofi and Regeneron last year swayed the U.S. Solicitor General, Elizabeth B. Prelogar, to their side. In September, Prelogar told the Supreme Court that Amgen's petition "should be denied.” After reviewing the case, the government backed an appeals court's ruling that Amgen's patent claims at issue are invalid because “undue experimentation” would be required to “enable their full scope.”
As for the arguments companies are making in support of the Praluent partners, Pfizer contends that Amgen’s Repatha was “no pioneering invention,” suggesting the PCSK9 target was “known,” as were its effects on LDL levels and its ability to bind to the LDL receptor. Pfizer added that Amgen’s patents are “an attempt to monopolize that highly competitive therapeutic market.”
Eli Lilly, in a brief filed alongside Ipsen and Innovent Biologics, called Amgen’s claims “unbounded both in terms of size as well as biological and molecular diversity,” adding that the number of antibodies that could be preempted by Amgen’s claims number in the “millions, if not billions or more.”
In another amicus brief filed on behalf of AstraZeneca, Bayer, Gilead and Johnson & Johnson, the Big Pharmas claim “overbroad” patents like Amgen’s “present barriers to the research, development, and provision of lifesaving therapies.”
On the other end of the spectrum, Amgen last month amassed support from the likes of AbbVie, BMS and GSK, plus organizations like the National Association of Patent Practitioners and the Intellectual Property Professors.
SCOTUS ought to reject the federal circuit’s “full scope” test, AbbVie argued in an amicus brief favoring Amgen last month.
“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,” the company wrote.
In a separate brief, Bavarian Nordic, Biogen, Bristol Myers, Merck & Co., 3M, Corning and the Association of University Technology Managers further called the “full scope” rule “time-and-resource wasting,” making the argument that the federal circuit’s standard is “wrong as a matter of law and harmful to the innovation process.”
In Amgen’s own brief from December, the California biotech spent almost its entire argument on the “full scope” standard, making the case that it’s against the law and harms innovation.
Editor's note: This story was updated at 2:39pm ET on Feb. 13, 2023, with a statement from Amgen.