Clades, classifications, and claims: evolution of organisms and their nomenclature in life science patents

Organisms are complex biological entities that are less easily defined by specific structures or sequences than molecules, nucleic acids, and antibodies. Nor are they necessarily fixed in time or reproducible by repeatable methods, given their capacity for replication and mutation. Like organisms themselves, names and classifications also change over time as scientists better understand extant biodiversity. Taxonomy is the field of evolutionary biology concerned with classifying, naming, and identifying organisms, while phylogenetics concerns organisms' evolutionary history and relatedness. Here, I review the challenges evolution poses for patentees, using the examples of evolving influenza viruses and bacterial classifications, and Federal Circuit decisions relevant each issue. I conclude that careful consideration of organisms' evolutionary histories and the systematics underlying their classification in specification drafting allows patentees to: (i) mitigate the impact of scientific disagreement (such as the 'species problem' in microbiology) in claim construction; (ii) limit the effects of changing classifications on infringement analysis; (iii) describe generic categories of related organisms to encompass later-arising ones; and (iv) 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.