Extraterritorial Patent Infringement: Gene Editing with CRISPR-Cas Perspective

Abstract

The advent of CRISPR, with all its extraordinary potential, has exposed some seams and uncertainties in how U.S. patent law operates extraterritorially. The CRISPR-Cas system can be used to edit the human genome to correct diseases by way of a gRNA that guides a Cas enzyme to a certain DNA sequence location to make a corrective edit. Despite the presumption against extraterritorial patent protection, if an actor exports a component created in the U.S. that, when combined with other components abroad, will infringe a patented invention, the actor can be liable for infringement under 35 U.S.C. § 271(f). By way of an example, consider a patented invention that relates to a Cas9 protein and a DNA-targeting RNA with specific features (gRNA) to produce a modification of the targeted DNA molecule. If a party supplies a library of specific gRNAs for export to be combined with CRISPR-Cas9 in order to practice a patented invention as a whole, there may be 271(f) liability. Notably, the crux of the puzzle rests on the analysis of what a “component” is in such gene editing inventions. Courts could view Cas effector-encoding amino acid sequences, Cas protein domains, Cas effectors themselves, gRNA-encoding nucleotide sequences, exons, or gRNA molecules themselves as components. In this writing, I propose that sequences that encode the Cas effector proteins and the gRNAs be considered components for 271(f) liability purposes.