US Supreme Court Weighs Biologics Patents in Amgen vs. Sanofi Case

On March 27, 2023, the US Supreme Court heard oral arguments from Amgen and Sanofi in a case that could have broad ramifications on the state of patents in the United States. The crux of the case concerns the enablement requirement, and whether “genus claims” (i.e., patents that cover various structurally and functionally related chemicals) satisfy it.

Amgen and Sanofi are in dispute over Amgen’s Repatha (evolocumab) and Sanofi’s Praulent (alirocumab), both of which are monoclonal antibodies that lower the levels of low-density lipoprotein cholesterol. Amgen initiated the suit, claiming that Sanofi was infringing on its patent, while Sanofi has argued that the patents themselves are invalid.

All patents are required to fulfill an “enablement” requirement, which has traditionally been defined as allowing “those skilled in the art to ‘make and use’ the claimed invention; genus claims are predicated on this definition of enablement. However, Sanofi is arguing that this definition does not actually fulfill the enablement requirement, and that it instead must enable “those skilled in the art to reach the full scope of claimed embodiments without undue experimentation.” After back-and-forth resolutions in the lower courts, the Supreme Court is now tasked with answering this question surrounding functional language.

If Amgen wins the case, the victory would allow the company to claim all antibodies that use this mechanism of action shared by evolocumab and alirocumab; this would extend to other patents, which has left some companies worried about their intellectual properties. Due to these concerns, as well as the fact that broad patent protection would make it more difficult to bring competitive drugs to market, major pharma companies such as Pfizer, Johnson & Johnson, and Eli Lilly and Company have publicly backed Sanofi (1).

Conversely, if Sanofi wins the case, then that outcome would likely result in the death of broad genus claims. Some, including Kisuk Lee, a patent lawyer specializing in biopharma operations, feel that a Sanofi win could depress innovation. According to Lee, while it requires billions in R&D to bring a molecule to market, it is not incredibly difficult to extrapolate research concerning one molecule to similar ones.

“Nowadays, antibody production is quite automated,” says Kisuk Lee, principal, St. Louis Metro Office. “If you have the roadmap as described in Amgen’s specification, with computer modeling anybody can quickly produce antibodies.”

Depending on how this case is ruled, individuals such as Lee are concerned about how it will impact funding of discovery efforts. If broader patents are struck down, pharma companies will not only need to make more patent applications, an expensive process which Lee notes typically takes three-to-six years, but pharm companies may also not be granted crucial patents that competitors could use for their own molecules.

“If [the Supreme Court] decision only focuses on functional language, there will still be a good outcome for industry,” says Lee. “But if they say broad patent claims hinder competition and follow-on inventions, and you need to provide enabling disclosure for all variants falling within the scope, then it will be really damaging for our industry.”

Source: SCOTUS Blog

1. Wingrove, P. Amgen-Sanofi Patent Case Divides Makers of Antibody Drugs. Reuters, March 27, 2023.