This paper discusses the differences in patent eligibility in the US and the EU, and how the resulting inconsistencies have specifically affected RNAi research and patents.
Courts around the world have struggled with defining clear distinctions between patentable and unpatentable biotechnological inventions. Gene-editing technology is unlike anything patent systems have seen before and the field continues to rapidly evolve. The changing technology thus challenges both legislators and the judiciary as they attempt to keep patent rules balanced and current. In the landmark case Association for Molecular Pathology v. Myriad Genetics, the US Supreme Court found that naturally occurring DNA sequences were unpatentable. European courts, however, have not yet followed suit, with the European Directive on the Protection of Biotechnological Inventions noting that isolated DNA sequences are patentable subject matter. In fact, the corresponding European patents at issue in Myriad remained valid in the EU despite various oppositions.
RNAi-based research and technology is still in the early stages of its evolution. Thus the relative ease or difficulty of protecting RNAi IP is likely to have a large effect on the growth of this new class of therapeutics.