A decision is expected later this month from the U.S. Supreme Court in the case of Association for Molecular Pathology v. Myriad Genetics Inc., which is considering the patentability of isolated human genes claimed in patents held by Myriad Genetics, Inc.
Commentators present at the oral arguments, which were heard in April 2013, have indicated that a number of the Justices expressed scepticism that isolated genomic DNA represents patentable subject matter. Thus, it seems unlikely that the Supreme Court will deliver a decision favourable to Myriad that is consistent with existing US law. However, there was some indication that the Justices were leaning towards a compromise position proposed by the Department of Justice Solicitor General, Donald Verrilli, Jr., which would permit the patenting of artificially created nucleic acid molecules, such as cDNA.
One potential issue with the proposed “compromise position”, is that by excluding isolated genomic DNA from patent protection it will conceivably render protection of inventions directed to genetic diagnostic tests very difficult in view of the earlier US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012). In the Prometheus decision it was controversially held by the Supreme Court that a “relationship” between the concentrations of blood metabolites and response to a therapeutic drug, claimed in patents owned by Prometheus Laboratories Inc., was not patentable because it represented a “principle of nature”. Such a “relationship” most likely would also encompass an invention involving a gene mutation(s) that renders an individual susceptible to developing a disease. If so, a claim directed to the use of a mutation in genomic DNA to determine the susceptibility of developing a disease would not be patentable.
The decision that is finally reached by the U.S. Supreme Court will potentially have serious ramifications in relation to the development of life-saving, gene-related diagnostic tests and their availability to the public. Specifically, the U.S. Biotechnology Industry Organization (BIO) has indicated that an exclusion of genetic material from patentability would potentially invalidate thousands of granted U.S. patents and disturb long-standing, investment-backed expectations of innovative businesses - businesses that have relied on such patents to pursue real-world solutions for life-threatening diseases.
All eyes will be on the U.S. Supreme Court this month to see whether their decision will be a “game changer” for the U.S. biotechnology sector and take the U.S. out of line with the current laws in relation to gene patents that currently exist in Europe and Australia.