The US Patent and Trademarks Office (the USPTO) have publicly released their long-awaited Report to Congress on Confirmatory Genetic Diagnostic Test Activity. The USPTO was required to study a number of issues relating to confirmatory (or second opinion) genetic diagnostic testing pursuant to section 27 of the Leahy Smith America Invents Act, which was signed into law in 2011. Since then, two significant US Supreme Court decisions, Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) and Association for Molecular Pathology v. Myriad Genetics, Inc., 132 S.Ct. 1794 (2012), have changed the patent landscape relating to genetic diagnostic testing. This led the USPTO to conclude that ‘unless and until the legal environment shifts again, it is difficult to conceive of a gene-based diagnostic correlation that could be exclusively protected by a patented means of determining the correlation owned by a single provider’. Thus, these Supreme Court decisions have superseded whatever findings that the USPTO would have been able to make to Congress based on the limited evidence that was available to them. Looking to the future, the main restriction on consumer choice is likely be whether there is sufficient demand to support multiple providers in the diagnostic testing market. The USPTO urged Congress to continue to monitor this space, with particular focus on data sharing and the availability of insurance cover for gene-related diagnostic tests. (Posted by Dianne Nicol).
Read the full report.