Determining When Engineered Biologics May Be Patentable (Law360)

In his recent Law360 article, Goodwin partner Robert Frederickson explains that, over the last several years, judicially created exceptions have increasingly threatened to swallow the statutory rule that any new and useful process, machine, manufacture, or composition of matter is eligible for patent protection in the US. In a highly notable recent case, the U.S. Court of Appeals for the Federal Circuit took up the U.S. District Court for the District of Delaware’s decision in Regenxbio Inc. v. Sarepta Therapeutics, Inc., which held that an engineered biologic used in gene therapy was directed toward a patent-ineligible natural phenomenon. Much to the relief of innovative cell and gene therapy companies — and the multiple amici supporting the plaintiff in the case — the Federal Circuit reversed on February 20, 2026. In its opinion, the Federal Circuit concluded that composition of matter claims covering engineered cells containing DNA from two different organisms chemically spliced together are not patent-ineligible natural phenomena.

Read the full analysis: “Determining When Engineered Biologics May Be Patentable” (Law360)