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21 February 2023Big PharmaLiz Hockley

Sanofi backed by big pharma and more in SCOTUS clash

Case focuses on the enablement scope of patents | Amici curiae argue Amgen patents are too broad | Pfizer | Eli Lilly | AstraZeneca | Sanofi | Genentech | Bayer | Gilead Sciences| Johnson & Johnson.

Pfizer, Eli Lilly and AstraZeneca are among the big names in the pharmaceutical industry to throw their weight behind Sanofi in its high-profile Supreme Court clash with Amgen.

Amgen’s bid to overturn a ruling that some of its patents are invalid has captured the industry’s attention as it has called into question the ‘enablement’ issue, and whether a patent description should allow a person skilled in the art to reach the full scope of the claim without undue experiment.

The US Court of Appeals for the Federal Circuit deemed Amgen’s patents, which relate to monoclonal antibodies, to be invalid because they were overly broad and presented too many possible solutions beyond what was claimed.

Amgen aims to overturn this decision, arguing it could stifle innovation and allow competitors to infringe inventions by making minor changes.

In a brief filed this month, Genentech, AstraZeneca, Bayer, Gilead Sciences and Johnson & Johnson voiced their support for Sanofi, arguing that the Federal Circuit’s judgment should be upheld.

Making the case for “balance” in the patent system, they contested that the Federal Circuit’s approach provides the right incentives for innovation, without over-rewarding “the first entity to secure patent rights within an unpredictable field of research”.

Amgen’s patents identified 26 antibodies that bind to certain naturally-occurring proteins, and belong to the functional or genus class of claims.

Eli Lilly also filed a brief along with Ipsen Bioscience and Innovent Biologics, warning against Amgen’s attempt to “remove competition from the market entirely”, as its claims could cover “millions, if not billions” of antibodies that would bind in the same way. “Claims like Amgen’s—defined solely by a functional result and devoid of any structural limitation—are and should remain invalid under 35 U.S.C. § 112,” the firms stated.

Nobel-prize-winning molecular biologist Gregory Winter concurred, arguing in his amicus brief that Amgen’s claimed invention was “simply a hindsight characterisation of that which existed naturally” and lacked guidance on how to make and use the antibodies in question.

“Amgen has actually increased the burden on scientists, forcing them to engage in undue experimentation in order to make, test, and characterise each one of potentially billions of antibodies to determine whether they are covered by Amgen’s claims,” said Winter.

The American Intellectual Property Association (AIPLA) was among the public organisations urging the court to uphold the Federal Circuit’s decision.

In Amgen’s corner

On the other side of the debate, Amgen has its own heavyweight supporters including GlaxoSmithKline and AbbVie. GSK submitted an amicus curiae brief in January, arguing that without the ability to secure patent protection over a genus, “competitors could make closely related species or modifications to a patented compound to avoid infringement while still appropriating the heart of the invention”.

The Chemistry and Law Division of the American Chemical Society also backed Amgen, stating that the Federal Circuit had set a higher bar in its “full scope” test in a way that stifled innovation and posed a threat to potential inventors.

Arguments in the case are set to be heard on March 27.

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More on this story

Americas
28 March 2023   As the US Supreme Court probed the key issue of enablement in Amgen v Sanofi, patent lawyers shared their views on the much-anticipated hearings.
Americas
15 December 2022   As patent attorneys look ahead to 2023's key rulings, Timothy Sendek of Akerman offers insights on the pending enablement case at the Supreme Court.
Big Pharma
18 May 2023   Case concerned the interpretation of a key requirement of the US Patent Act | Amgen’s ‘roadmap’ held to describe step-by-step its own trial-and-error method for finding functional antibodies.

More on this story

Americas
28 March 2023   As the US Supreme Court probed the key issue of enablement in Amgen v Sanofi, patent lawyers shared their views on the much-anticipated hearings.
Americas
15 December 2022   As patent attorneys look ahead to 2023's key rulings, Timothy Sendek of Akerman offers insights on the pending enablement case at the Supreme Court.
Big Pharma
18 May 2023   Case concerned the interpretation of a key requirement of the US Patent Act | Amgen’s ‘roadmap’ held to describe step-by-step its own trial-and-error method for finding functional antibodies.