Personalized medicine, including the application of genomic and molecular data to better target the delivery of health care and determine a person’s predisposition to a particular disease or condition, continues to expand and become the clinical standard of care for many medical conditions or diseases. For the past several years, players in the personalized medicine space have seen the federal courts and the legislature debate the extent to which patent protection is available under U.S. law when it comes to biological molecules and methods of assessing biological molecules (e.g., diagnostic testing).
Recently, the debate has heated as a line of lawsuits have made their way through the legal system with sights set on the Supreme Court. While the technology at issue in these cases is diverse, the questions before the courts always come back to where to draw the line between patent-eligible subject matter (an invention) and patent-ineligible subject matter (an abstract idea, scientific principle or natural phenomenon). By excluding this type of subject matter from patent eligibility, naturally occurring phenomenon, scientific principles, and laws of nature remain available to all innovators and researchers.
These cases have drawn attention and input not only from biotechnology and diagnostics companies and industry organizations, but also from public interest, policy, legal, and medical organizations. In particular, the Myriad case[i], focuses on the patent eligibility of isolated genetic sequences associated with breast cancer and diagnostic methods based on detecting those sequences. How this case is decided will be partly guided by the Supreme Court’s decision in the Prometheus case[ii], for which oral arguments before the Supreme Court were held on December 7, 2011. In the Prometheus case, the parties are arguing over the patent eligibility of biological methods involving measuring drug breakdown products (metabolites) after administering a drug to a patient to assist in determining appropriate drug dosage.
The courts have been presented with a number of policy arguments on the ramifications of either having or eliminating patent protection for these technologies. Perhaps the largest policy debate focuses on whether the market exclusivity provided by patents on genetic sequences or diagnostic methods foster commercialization and thus availability of personalized medicine. Supporters of patent protection for gene patents and diagnostic testing say that this protection enables better patient care by facilitating investment in and commercialization of diagnostic testing and dissemination of data to broaden medical understanding, which in turn leads to new research endeavors and the development of new technologies, and improves long-term public health. Opponents argue that patent protection for these technologies impair patient health by limiting dissemination of medical knowledge and use thereof, limiting access to diagnostic testing by raising testing costs, and prevents access to second opinion testing to confirm diagnosis.
While important, these policy arguments may be outside the scope of the courts’ patent eligibility analysis of genetic sequences, diagnostic testing, and other biological methods under U.S. patent laws. The recently implemented patent reform law (America Invents Act)[iii] made no changes to the patent eligibility standards, but did commission the US. Patent & Trademark Office to study access to second opinion testing for genetic testing, indicating that Congress feels further inquiry is needed before legislative action.
[i] Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, No. 10-1406 (Fed. Cir. July 29, 2011).
[ii] Mayo Collaborative Services v. Prometheus Laboratories, Inc., 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, 79 U.S.L.W. 3554 (U.S. June 20, 2011)(No. 10–1150).
[iii]Leahy-SmithAmerica Invents Act, Pub. L. No. 112-29, 125 Stat. 284, 325 (2011) (to be codified at 35 U.S.C. § 257)(enacted Sept. 16, 2011).