Gene Patents: PTO Undertakes Study on Access to Genetic Testing

Although the litigation over the validity of gene patents is ongoing (petition for certiorari in Association for Molecular Pathology (AMP) v. United States Patent and Trademark Office (PTO) is currently at the Supreme Court; we may know this week if the case is accepted), the 2011 America Invents Act included a provision mandating that the PTO undertake "a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist considering how gene patents affect the ability of patients to obtain second opinions in genetic testing where patent rights may limit or constrain market options" (this is most obviously directed at the conflicts over how Myriad Genetics has managed the genetic testing market for BRCA1 and BRCA2 testing; options for second or confirmatory opinions are limited). A first hearing at the PTO was held last week; a range of views was presented in testimony. The potential accommodation for the special needs of practitioners and patients who encounter patent-related barriers to genetic testing is not a new issue; extensive study by the HHS Secretary’s Advisory Committee for Genetics, Health and Society resulted in a 2010 report which recommended that Congress enact an exemption to patent infringement for those providing genetic testing to patients (in testimony by AMP last week at the PTO, that approach was endorsed). However, the proposal was never enacted, despite an unsuccessful (and controversial) attempt by Rep. Debbie Wasserman-Schultz to add an amendment to the AIA establishing a safe harbor for confirmatory genetic testing; she then sponsored this PTO study requirement. The current PTO study, therefore, could end up with the same recommendation as the SACGHS made (and back to Congress) if the evidence adduced is persuasive to the PTO. This will also be affected by whether the Supreme Court takes the AMP case; if not, pressure will remain on Congress to alleviate patient obstacles to some genetic tests by creating an infringement exemption for the provision of medical services.