In a case styled The Association for Molecular Pathology v. Myriad Genetics, the Supreme Court is confronting the question of whether or not human genes are patent eligible under 35 U.S.C. 101. A decision is expected in the near future. A primary argument of the parties opposing gene patents is that such patents prevent others from conducting research with genes or other basic naturally occurring materials. During the oral argument, there was also discussion of the fact that patents on methods of using genes or methods of making genes or products from genes may still be patent eligible, even if the genes per se are unpatentable.
Because the case involves the question of whether a product of nature can be patented, there is a possibility that the ruling will impact technology derived from other naturally occurring materials beyond genes, such as nanoparticles or graphene. It might potentially impact other areas of biotechnology beyond genes where products of nature are involved, such as stem cells, regenerative medicine, RNAi or antibody technology. The NanoBusiness Commercialization Association submitted an amicus brief to the Supreme Court to point out that prior case law has established a right to conduct research on a patented product, such as to investigate how it works. In addition, other statutory exemptions from patent infringement already exist, such as the safe harbor of 35 U.S.C. 271(e) for research relating to US FDA approval and the limitation on liability for medical practitioners 35 U.S.C. 287(c).
Depending on how the Court rules, nanotech and biotech companies may need to adjust their patent strategies, particularly if certain areas that hitherto have been patentable are declared off limits. Methods of use and process related patents may become more important in the wake of the ruling if genes per se are unpatentable.