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REGENXBIO v. Trustees of UPenn, No. 2024-1408 (Fed. Cir. February 20, 2026)
Generally, someone may receive a patent for any new and useful process, machine, manufacture, or composition of matter. However, for over 75 years, courts have made a judicial exception to this rule prohibiting patents from covering natural phenomena. While it is well-known that patents cannot cover natural phenomena, courts often struggle to determine whether natural phenomena that have been modified are eligible for a patent. Last week, the Federal Circuit provided some clarity on this analysis.
U.S. Patent No. 10,526,617 (“the '617 Patent”) is directed toward cultured host cells containing a recombinant DNA made from DNA artificially spliced together from two different organisms. REGENXBIO Inc. filed a patent infringement suit alleging that Sarepta Therapeutics, Inc. infringed several claims of the '617 Patent. The district court granted summary judgment that the claims of the '617 Patent were ineligible because they were directed at recombinant DNA, which was merely a combination of naturally occurring DNA, i.e., a natural phenomena. REGENXBIO appealed.
The Federal Circuit disagreed with the district court because the district court's opinion focused on the individual components of the claimed invention, which were naturally occurring. According to the Federal Circuit, the correct analysis is to determine if the entire claimed invention has “markedly different characteristics” and have “the potential for significant utility” from that which is naturally occurring. Using this analysis, the Federal Circuit determined that even though individual genetic sequences occur in nature, their artificial recombination into a single molecule inserted into a host cell results is “markedly different” than anything found in nature. With respect to utility, the Federal Circuit noted that the claimed host cell with recombinant DNA had the “potential for significant utility” because they were beneficial to gene therapies.
The Federal Circuit's analysis is noteworthy for at least two reasons. First, courts often apply a two-step framework to determine if a claim is patent eligible. In that framework, step one determines if the claim is directed at a judicial exception to patent eligible subject matter such as laws of nature, natural phenomena, or abstract ideas. If so, step two determines whether the claims contains an inventive concept sufficient to transform the judicial exception into something significantly more. The Federal Circuit determined that it did not need to apply that framework here, but if it was necessary to do so, the result would be the same because it determined that the asserted claims were not directed to ineligible naturally occurring subject matter. Second, although utility is not typically part of the eligibility analysis, the Federal Circuit relied on the potential for significant utility to find the claims patent eligible.
In future cases involving patent eligibility related to natural phenomena, instead of relying on the two-step framework, parties should focus on whether the claims are markedly different than what is found in nature (as opposed to isolating or grouping components of nature) and whether the claims have utility.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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