Congressional recognition that the patent system plays a role in supporting U.S. innovation led to the September 16, 2011, enactment of the Leahy-Smith America Invents Act (AIA), P.L. 112-29 . Among many other amendments to the Patent Act of 1952 (the "Patent Act"), the AIA required the U.S. Patent and Trademark Office (USPTO) to "conduct 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." The 2012 decision of the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc. addressed both diagnostic tests and the concept of patentable subject matter. Some observers believe that Mayo v. Prometheus will significantly impact research into biotechnology and personalized medicine in the United States. The Myriad Litigation

Following the Supreme Court's opinion in Mayo v. Prometheus , considerable attention has been placed upon 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 isolated deoxyribonucleic acid (DNA) molecules that encode sequences identical to human genes. If Congress believes that the current circumstances with respect to patentable subject matter are satisfactory, then no action need be taken. Should Congress choose to take action, however, a number of options exist. One possibility is an amendment to Section 101 of the Patent Act stipulating that certain subject matter is or is not patentable. Another option is to allow patents on particular inventions to issue, but to limit the remedies available to proprietors of such patents. Some have welcomed judicial decisions that narrow the scope of patentable subject matter, asserting that these patents are harmful to healthcare and medical research. On the other hand, some believe that patents in these fields provide powerful incentives for innovation and public disclosure of new technologies.
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.