Laura Smalley

The battle over whether U.S. copyright law permits artificial intelligence (AI) training on copyrighted works is no longer a theoretical debate. In 2025, three federal district court decisions began to sketch the boundaries of what counts as fair use in this context.

Growing consensus is emerging that artificial intelligence (AI) may assist biotechnology and life sciences companies to draft patents that satisfy written description and enablement requirements. The U. S. Supreme Court’s decision in Amgen Inc. v. Sanofi reiterated that patentees cannot claim a wide functional class of inventions without providing sufficient guidance or examples to enable others to use the full range of what is claimed (Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)). The Supreme Court did recognize in some cases that disclosing a general property common to a class or genus of embodiments may be enough to satisfy the enablement requirement.

The Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), found that antibody claims defined by their binding and blocking function lacked enablement…. The Supreme Court’s decision relied highly on the unpredictability of the art—scientists cannot always predict how substitutions of even single amino acids will affect the binding and/or blocking function of an antibody. The disclosed methods of identifying species within the scope of the claim were little more than “trial and error.”… The consensus seems to be that Amgen generally forecloses broad genus claims in the biotechnology field. The remaining questions are: Are patent applicants limited to claiming species (e., sequence listings)? What steps may a patent applicant take to obtain broader coverage?

One of the panels at last year’s IPWatchdog’s Life Sciences MastersTM Series addressed the thorny problem of patent eligibility.  I moderated the panel, titled Patent Eligibility and the Life Sciences Industry–What Next?, where the speakers, with input from passionate audience members, discussed the impact of section 101 jurisprudence on innovation in the life sciences industry. Do the limits on what is patent-eligible subject matter created by the courts strike the proper balance or do unpredictable court decisions harm investment and research in the life sciences? While the majority view appeared to be that patent-eligibility reform is necessary, both to provide clarity and to incentivize certain type of inventions, the panel also expressed the idea that some form of section 101 jurisprudence is necessary to prevent “discoveries” from being monopolized, which could also harm innovation.

The Federal Circuit’s denial of en banc rehearing and the Supreme Court’s denial of certiorari review mean the decision in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 967 F.3d 1285 (Fed. Cir. 2020), is the latest word on subject-matter eligibility under 35 U.S.C. § 101. In American Axle, the Federal Circuit applied the Supreme Court’s two-part Alice/Mayo test to hold a method for manufacturing driveline propeller shafts with liners designed to attenuate vibrations invalid as directed to a use of a natural law. The Federal Circuit characterized the claims as simply “[c]laiming a result” without “limiting the claim to particular methods of achieving the result. . . .”  Id. at 1295. The method claims were directed to nonpatentable subject matter because, even though neither the claims nor the specification explicitly referenced a natural law, the method steps required the application of a natural law, “and nothing more.”  Id. at 1297. Although the panel in American Axle stressed its decision was consistent with Supreme Court and Federal Circuit precedent, see 967 F.3d 1295, 1296 (“Our cases as well have consistently rejected such claims as unpatentable.”), its rationale, literally applied, jeopardizes broad categories of patent claims that have traditionally been considered patent-eligible subject matter.