Haviland Macy Marie Kebler, Esq., Aidan Hickey, J.D., & Matthew Ersek
The case of Amgen v. Sanofi took center stage at the Supreme Court when oral arguments were heard on March 27, 2023. In what is a culmination of a multiyear patent ligation dispute, the Court confirmed the full scope enablement standard for patent law under 35 U.S.C. §112(a). The Court was called upon by many different stakeholders, as evidenced upwards of thirty amici filing briefs, including Pfizer and the United States. This decision implicates patent seekers, owners and big business nationwide.
Two large pharmaceutical companies, Petitioners Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. and Respondents Sanofi, Aventisub LLC, f/k/a Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals, Inc., and SanofiAventis U.S. LLC exchanged briefs at the Supreme Court regarding an issue of patent law. Specifically at issue here, Amgen appealed the Federal Circuit’s decision, stating in its Petition for a Writ of Certiorari that the decision “defies more than a century of this Court’s precedents.” The patents underlying the question presented to the Supreme Court cover cholesterol-lowering antibodies. The patents-at-issue involve functionally defined genus claims, which are often used in biological and pharmaceutical technology patents.
Patent Law is built on the Quid Pro Quo of disclosure in a manner that allows the public to make use of the patent or build upon it once the inventor’s exclusive right to use has expired. The enablement requirement ensures that the disclosure is specific enough that the public can use the invention once that time is expired. Thus, when an inventor is going through the patent process, they must disclose the invention so that a person skilled in the art would be able to re-create the invention and innovate using the technology. In the case at hand, due to the genus claims, the Federal Circuit found the patents-at-issue failed the enablement requirement because, as written, the patent will not allow the individual to reach the same results without having to perform experimentation or innovation by themselves.
After the multiple years of ongoing litigation, on May 18, 2023, the Court ordered the Federal Circuit’s judgment was affirmed, with Judge Gorsuch delivering an opinion for a unanimous Court. See Amgen, Inc. v. Sanofi, et al., 598 U.S. ____, No 21-757 (2023). In an opinion which reviewed the Court’s history with the Enablement standards, the court noted, “[It] is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class” but “agree[d] with the lower courts that Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.” Id. This case, while not changing the standard reaffirmed the current status of the law and will be influential in future genus patent cases and for those who are inventing and innovating in the biological, pharmaceutical, and chemical technology arena.