Amgen Inc. v. Sanofi
Issues
Should the enablement requirement of a patent claim focus on whether the disclosures simply enable skilled people in the field to “make and use” the claimed invention or whether the disclosures accurately enable the “full scope” of the invention – all variations of the invention that fall within the patent claim’s description of the invention; and, would a relatively easy trial-and-error procedure equate to undue experimentation?
This case asks the Supreme Court to clarify whether Amgen’s disclosure of common techniques – a trial-and-error procedure and amino acid substitution technique – is sufficient to satisfy the enablement requirement for Amgen’s patent claim over all antibodies that bind to PSK9 protein and block PSK9 protein’s ability to bind to LDL receptors. Amgen argues that the focus of the enablement standard should be on whether the disclosure leads people to “make and use” the claimed invention and that common techniques do not amount to undue experimentation. Sanofi counters that the disclosures should be specific for broad patent claims and that Amgen’s trial-and-error techniques amount to undue experimentation. This case has significant implications on future innovation in the pharmaceutical industry and the patent law system.
Questions as Framed for the Court by the Parties
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”
Heart disease and cholesterol named elevated low-density lipoprotein (“LDL”) are correlated. Amgen Inc. v. Sanofi, Aventisub LLC. at 1082. When cholesterol is in the blood stream, the LDL receptors remove LDL cholesterol. Id. And the degradation of LDL receptor is regulated by an enzyme named proprotein convertase subtilisin/kexin type 9 (“PCSK9”). Id. at 1082–83.
The authors would like to thank Professor Oskar Liivak for his guidance and insights into this case.
Additional Resources
- Steve Brachmann, Amici Filings in Amgen Encourage the Supreme Court to Correct the Federal Circuit’s ‘Unworkable’ Enablement Standard, IPWatchdog (Jan. 5, 2023).
- Kevin Noonan, Sanofi and Regeneron File Respondents' Brief on Amgen v. Sanofi, JDSUPRA (Feb. 20, 2023).
- Greg Stohr, Amgen Gets High Court Review in Repatha Patent Fight with Sanofi, Bloomberg Law (Nov. 4, 2022).
- Deirdre Wells et al., Supreme Court Poised to Alter Patentability of Pharmaceutical, Life-Science Innovations, Reuters (Nov. 30, 2022).