The recent enactment of the Leahy-Smith America Invents Act (AIA), P.L. 112-29, suggests congressional interest in patents on diagnostic methods. In particular, section 27 of the AIA required the U.S. Patent and Trademark Office to conduct a study on the patenting of genetic diagnostic tests.
The 2012 decision of the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc. also addressed these sorts of patents.
The Court’s decision arguably placed severe limitations on the ability of inventors to obtain diagnostic method patents. Some observers have welcomed Mayo v. Prometheus, asserting that patents on diagnostic methods are harmful to healthcare and medical research. On the other hand, detractors of the
opinion state that patents provide powerful incentives for innovation and public disclosure of new technologies. They believe that the Supreme Court’s decision will negatively impact medical research in the areas of biotechnology and personalized medicine.
The holding in Mayo v. Prometheus may impact another well-publicized litigation, Association for Molecular Pathology v. U.S. Patent & Trademark Office. More commonly known as Myriad—after the name of the patent holder—this litigation may determine whether patents may appropriately issue on human genes.
Congressional policymakers may contend that current circumstances with respect to patentable subject matter are satisfactory and therefore may advocate that no further legislative action need be taken. Should Congress choose to take action, however, a number of options exist. One possibility is an amendment to the Patent Act stipulating that certain subject matter is or is not patentable. Another is to allow patents on particular inventions to issue, but to limit the remedies
available to proprietors of such patents.