Organisms are complex biological entities that are less easily defined by specific structures than molecules, nucleic acids, and antibodies. Yet these small molecules and biopolymers were the focus of many cases shaping modern patent law, which emphasizes the importance of defining biological inventions in terms of structure. Nor are organisms necessarily fixed in time or reproducible by repeatable methods—as molecules, nucleic acids, and antibodies may be—given their capacity for replication and mutation. And like organisms themselves, names and classifications also change over time as understanding of extant biodiversity advances. But this capacity for change over a 20-year patent term stands in tension with the law’s focus on the state of the art at the time a patent application is filed.
Here, I review the challenges evolution poses for patentees, such as the changing nature of bacterial classifications and short-term evolution that may occur over a patent term, and Federal Circuit decisions relevant to each issue. This work concludes that careful consideration of organisms’ evolutionary histories and the taxonomy and phylogenetics underlying their classification in application drafting may be useful in: (i) mitigating the impact of scientific disagreement (such as the ‘species problem’ in microbiology) in claim interpretation; (ii) limiting the effects of changing classifications on infringement determinations; (iii) describing the diversity within taxa in sufficient detail to encompass later-arising organisms; and (iv) linking the biology underlying an invention to the depth of conservation to bolster compliance with the written description and enablement requirements of 35 U.S.C. § 112(a). Accordingly, patentees might address the challenges that evolutionary uncertainty poses for organism-centered patents by embracing these areas of evolutionary biology.