The USPTO has been busy since September 2011, when the America Invents Act (AIA) was signed into law. That’s because Congress gave the USPTO a lot of homework without a lot additional resources. The AIA requires that the Patent Office change a number of rules and fees, and that it investigate certain issues Congress tasked it with handling and write a report summarizing its findings.
Congress directed the USPTO to study effective ways to provide independent genetic diagnostic tests that can verify a diagnosis in situations where gene patents and exclusive licensing arrangements exist that limit genetic diagnostic tests to a single testing facility.
This genetic testing study will also examine the impact that independent re-testing has on providing quality medical care to patients, the existing patent and license holders of an exclusive genetic test, the impact of current practices on testing results and performance, and the role of insurance coverage on the provision of genetic diagnostic tests (including second tests by an independent facility).
So what can we expect from the USPTO over the next few months? Well, within nine months of enactment of the AIA (by June 16, 2012) the USPTO is supposed to report to Congress the findings of the study and provide recommendations for establishing independent genetic diagnostic test options when patents and exclusivity arrangements limit the practical options to one testing facility. As of today, the report hasn’t been issued, but the USPTO Patent Reform Coordinator says that it’s making the final approval rounds before submission.
The USPTO held public hearings on February 16th and March 9th to solicit comments regarding this issue. It also requested comments directed to the narrow question of how recent actions taken by the U.S. Supreme Court in the cases of Mayo Collaborative Services v. Prometheus Laboratories, Inc., — U.S. — (March 20, 2012) and Association for Molecular Pathology v. Myriad Genetics, — U.S. — (vacated and remanded March 26, 2012), may affect the topics Congress requires that it study. The USPTO reopened the comment period for a short time because the Supreme Court acted on these two cases after the comment period expired.
Are you interested in learning more about the other studies and reports Congress asked the USPTO to undertake? You can find a list on the USPTO website. Also, the USPTO has an AIA blog, if you’re dying to hear more about its AIA homework.