Yesterday, the Supreme Court issued a unanimous decision holding that genes are not patentable, even when there are isolated from the body. The case, Association for Molecular Pathology v Myriad Genetics, addressed the patentability of BRCA1 and BRCA2, also known as the breast cancer genes. Mutations of these genes can increase a woman’s risk of developing breast cancer to between 50 and 80 percent, and her risk of developing ovarian cancer to between 20 and 50 percent. With the genes at issue being so significant to women’s health, and with highly publicized announcements by celebrity Angelina Jolie about her own genetic status, the public and biotech companies alike have had a keen interest in the outcome of this case. The Court has now struck down Myriad’s claims to the breast cancer genes, holding that Myriad found the breast cancer genes but that it did not invent anything.
Despite what would seem like bad news for Myriad, its stock value spiked upward following release of the decision. This unexpected market response was likely due to the second part of the decision, in which the Court held that DNA sequences known as cDNA are patentable because they are man-made and different from the genes from which they are derived. Complementary DNA, or cDNA, has an important role in genetic testing and research, so the patentability of cDNA provides a competitive advantage and incentive for research for biotech companies. However, since genes themselves are no longer patentable, there will be new opportunities for competitors and other researchers to work around the more narrow types of gene related claims. This also means that biotech companies will need to rethink their patent strategies, and many issued patent claims are now invalid.
The full decision can be found here.