On June 13, the Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that human genes cannot be patented in a unanimous decision. Myriad Genetics had obtained patents after discovering genetic mutations that increase a patient’s risk of breast cancer and ovarian cancer, the BRCA1 and BRCA2 genes. This discovery led Myriad to create diagnostic tests that could be used to determine if a patient had these genetic mutations. A group of plaintiffs brought suit to invalidate Myriad’s patents arguing that they claimed unpatentable subject matter, namely products of nature.
Justice Thomas delivered the unanimous opinion of the court, which held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”. The opinion makes clear, however, that no method claims before the Court. The process that Myriad used to isolate the BRCA1 and BRCA2 genes was well known in the field and could not be patented. But, had Myriad created a new method for isolating or manipulating the genes, that method would likely be patentable. Similarly, applications of the information Myriad obtained about these particular genes would also be patentable.
The plaintiffs and their supporters argue that this decision is a win for women everywhere who were not able to access the diagnostic tests created by Myriad. Now, they argue, these tests will be cheaper and more available, hopefully leading to fewer cases of breast and ovarian cancer. The defendants and their supporters argue that this decision removes incentives for innovation and will lead to less research and development in the area of genetic diagnostics.
Whether this decision will have any impact on research in this area will only be known with time. Genetic research is a fast growing area in biotechnology and pharmaceuticals, a fact that will likely continue even in the face of Myriad. But, one thing is certain: the discoverers of genetic markers and mutations will obviously have to adopt new strategies for protecting their innovations, such as patenting the applications of their discovery instead of the gene itself.
– Suzy Fitzgerald