At first glance, it’s a simple question: Are human genes patentable? So, why is The Supreme Court’s decision on the question this week in Association for Molecular Pathology v. Myriad Genetics the subject of extensive federal litigation, addressed by greater than 45 amicus curiae (third party “friends of the Court”) briefs and reported in health, science and legal media across the country? The answer is anything but simple, spanning issues of statutory interpretation, public health concerns and billions of dollars in corporate interests.
Scientists for Myriad Genetics were the first, in 1994, to isolate and sequence two human genes dubbed BRCA1 and BRCA2. These genes, first identified in 1990 by scientists at UC Berkley, contain mutations and identifying markers of certain types of cancer. After isolating the genes Myriad applied for and was granted several patents covering the isolated genes themselves as well as products and methods for identifying those genes in patients. (U.S. Patents: 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.)
US patent law states that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter…may obtain a patent therefor.” (35 USC 101) A patent grants to the holder a limited 20-year monopoly on the patented subject matter, a grant which the Constitution confers in order to “promote the progress of science and the useful arts.” It is well-settled, however, through decades of patent litigation that one may not receive a patent covering a product of nature. This is aimed at striking a balance between providing researchers and investors with incentive to commit time and money to advancing science through new research and simultaneously preventing profiteers from simply identifying a natural process or substance and suing others for their use of it.
Based on its patents, Myriad held the exclusive right in the US to isolate the BRCA1 and BRCA2 genes.
In this case, the Supreme Court looked to whether Myriad’s isolation of BRCA1 and BRCA2 transformed those genes from a product of nature to a new scientific discovery. Myriad argued that it did. In the first battle in the case, the US District Court for the Southern District of New York rejected Myriad’s argument, writing:
DNA’s existence in an ‘isolated’ form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to ‘isolated DNA’ containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. 101.
This decision held the Myriad patents in suit invalid. On appeal, the Court of Appeals for the Federal Circuit partially reversed the District Court’s decision, stating that, by isolating the genes, Myriad caused them to be “markedly different” from their natural state and therefore patentable. This analysis relied upon precedent of the Supreme Court indicating that “transformation” of a natural product may make it patent eligible
The Supreme Court’s unanimous June 13 decision reversed the CAFC finding and held that isolation of genes, like BRCA1 and BRCA2, does not transform the genes in a way that makes them patentable. Justice Clarence Thomas, on behalf of the Court, wrote, “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated” and that isolated DNA does not have a “markedly different chemical structure” from DNA occurring in its natural state. The Court also stated that Myriad’s process claims were to processes “well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized” at the time of the patent application.
The Court expressly pointed out that this case does not preclude patenting “new applications of knowledge” about DNA sequences or novel and non-obvious processes, and does not address at all the patentability of “DNA in which the order of the naturally occurring nucleotides has been altered.”
While this opinion will invalidate numerous existing patents claiming isolated genes/DNA sequences, the field remains open for scientists and corporations to seek and monetize new methodologies and new, man-made genetic material (known as cDNA) for application in relevant medical areas. Myriad and similar gene patent holders will suffer in the short term, but the industry will otherwise likely be unaffected and the search for patentable products, processes and methods relating to genetic material will continue.