September 18, 2011

New Patent Reform Act Authorizes Study of Patent Effects on Genetic Testing

The recently enacted America Invents Act (AIA) contains a provision which testifies to the continuing controversy over the patenting of genes, and particularly the impact of such patenting on the availability of genetic tests.  This issue was amply studied by the Secretary's Advisory Commission on Genetics, Health and Society (SACGHS), which concluded that diagnostic genetic testing was most at risk from gene patents (as opposed to other potential uses of the gene, such as for therapeutic applications in gene therapy).  The SACGHS study addressed the problem  by calling for an "an exemption from liability for anyone who infringes a patent on a gene while making, using, ordering, offering for sale, or selling a genetic test for patient care purposes." One purpose of such use is to provide confirmatory test results for a previous testing result.  Despite their recommendation,  no such immunity has found its way into the patent statute. The new AIA now asks the Commissioner of the Patent and Trademark Office (PTO) to investigate how such confirmatory (“second”) opinions can be provided in a situation where a gene patent exists which is exclusively licensed, thus limiting competing alternatives, such as the procurement of a second opinion.  Section 27 of the Act provided this definition: "confirming genetic diagnostic test activity means the performance of a genetic diagnostic test, by a genetic diagnostic test provider, on an individual solely for the purpose of providing the individual with an independent confirmation of results obtained from another test provider’s prior performance of the test on the individual."  So this investigation will focus on the subset of genetic testing requests that seek to confirm (or refute) an already obtained test result.  Should the study reveal significant barriers to confirmatory testing for patients, one possible outcome would be a renewed push for patent infringement immunity for such activities to be legislated (the PTO is to provide Congress with "recommendations for establishing the availability" of such tests (perhaps along the lines of the immunity provided by 35 U.S.C. 287(c), which limits the enforcement of patents against certain medical activities by medical practitioners). 

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