In a major triumph for protecting genes as a commons, the US Supreme Court ruled last week that human genes cannot be owned and must be available to anyone for study and medical innovation. The case involved a Utah company, Myriad Genetics, that had claimed patents on “breast cancer susceptibility genes,” which gave the company a monopoly on a $3,000 diagnostic test that could detect heightened risk of getting cancer. The patents were widely criticized for impeding breast cancer research and stifling cheaper, more competitive diagnostic tests.
The Court’s unanimous ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated….” Myriad had claimed that its isolation of the critical BRCA1 and BRCA2 genes in a person – a diagnosis that dramatically increases the risks of cancer in a person -- entitles it to patent those genes to the exclusion of others.
But Justice Thomas held that “separating that gene from its surrounding genetic material is not an act of invention.” The case was brought by an array of doctors, medical researchers and women’s health organizations that objected to the impact of the patents on research, competition and healthcare.
This sweeping ruling rolled back one of the most notorious enclosures of the past generation. It also drew a bright line limiting the capacity to legally own a naturally occurring element of nature. This is a significant legal development that one might not have expected from the Roberts Court. I suspect that the sheer incoherence and contradictions of patent law were just becoming too egregious for any other outcome but this one.
Biotech experts now expect that new diagnostic tests will be offered that dramatically lower the costs of assessing one’s risk of cancer. It is also likely that there will be more robust, innovative research focused on these genes now that the risk of patent infringement has been swept aside. It’s been estimated that there may be about 8,700 gene patents that might be jeopardized by the Myriad decision.
Business models that are based on specific genes will still be possible; it’s just that none will be based on patenting genes outright – a circumstance that a lawyer for the Biotechnology Industry Organization dismissed as “almost yesterday’s I.P. [intellectual property].” Saving face or the new biotech reality? I don't know.
In any case, the new standard for patentability ensures that companies will continue to be able to patent DNA that they synthesize -- so-called cDNA (complementary DNA), a key tool in genetically engineering plants and animals.