US Supreme Court to Deal with the Patent Enablement Standard


Emily XiangEmily Xiang is an IPilogue Writer, a Senior Fellow with the IP Innovation Clinic, and a 3L JD Candidate at Osgoode Hall Law School.


For the first time in decades, the US Supreme Court will engage with enablement in patent applications. On November 4th, 2022, the Supreme Court granted certiorari to review the Federal Circuit’s decision in Amgen v Sanofi, against the recommendation of the US government. Specifically, Amgen seeks to appeal a decision from the Federal Circuit, in which the court found Amgen’s patents invalid for lack of enablement. 

The requirement of enablement in US patent law is codified in 35 USC s. 112, which requires that the specification of a patent application “enable any person skilled in the art…to make and use” the invention in question. The issue at hand in Amgen v Sanofi is whether this statutory requirement governs enablement (that the specification teaches 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 the claimed embodiments” without “undue experimentation” (characterized by substantial “time and effort”). 

In 2014, Amgen sued Sanofi for infringing on its patents concerning drugs for lowering cholesterol. The genus patents specifically cover monoclonal antibodies that bind to the PCSK9 protein in the body. The patents disclose the amino acid sequences for 26 antibodies that bind to one or more of 15 residues found on the PCSK9 protein. Importantly, the claims at issue are considered functional ones, in which the antibodies are not claimed based on their structural components but rather on what they do. 

On January 3rd, 2023, many interested parties submitted amicus briefs to offer the Supreme Court their take on the issue to be considered. For instance, in a brief submitted by a group of intellectual property professors, it was argued that the Federal Circuit’s standard imposes “an impossible burden” on patentees and that such a decision represents “a categorical shift in thinking away from teaching the PHOSITA and towards a precise delineation of the boundaries of the claim”. The professors further submitted that such a heightened requirement would be especially burdensome for patentees seeking to protect their innovations in the fields of chemistry and the life sciences, as “a chemical genus with any decently large number of species will never be able to satisfy the new enablement standard”. 

Other parties in support of Amgen presented some other reasons as well. In their amicus brief, the National Association of Patent Practitioners (NAPP) stated that the court’s reasoning “leaves patent practitioners guessing about how to advise client-inventors regarding the extent of disclosure required”. The Alliance of US Start-ups and Inventors for Jobs (USIJ), together with the Innovation Alliance, warned of the adverse impact that the new enablement requirement might have on the effectiveness of patent incentives for investors to contribute towards research and development, especially in the case of startups and smaller companies.

Moreover, the Chemistry and the Law Division of the American Chemical Society (CHAL) has filed a motion for leave to participate in oral argument, claiming a “paramount and unique institutional interest and perspective” – that is, the perspective of individuals and companies working in the chemical, pharmaceutical, and biotechnology fields. CHAL asserts that the Federal Circuit’s enablement standard potentially jeopardizes the benefits of many modern innovations and that adhering to the plain meaning of 35 USC s. 112 should continue to be the prevailing approach.

The Supreme Court’s decision regarding the enablement standard for functional claims could also have wide-reaching implications that spill over into other fields, such as technology and computer-implemented inventions. By too narrowly focusing on the “full scope of the claim” and “undue experimentation” instead of on what those skilled in the art could determine from the specification, it is unclear how broader claims for AI inventions (such as those that describe the desired result to be achieved by the AI rather than its structural components or any specific software solutions) might fare in the face of such a standard. 

Amgen v Sanofi is scheduled to be heard by the US Supreme Court in the upcoming Spring Term.

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