The Supreme Court of the United States has ruled that companies may not patent human genes. At least, not ones they haven’t made themselves.
Biotech company Myriad Genetics had applied and received patents for the exact location and sequence of two genes implicated in breast and ovarian cancer, BRCA1 and BRCA2. This patent, if upheld, would have given Myriad the exclusive right to create medical tests for isolating those genes for diagnostic purposes and develop gene therapies for treating mutations that make cancer more likely.
However, the Court put a kibosh on most of that.
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” the Court ruled.
This is a big deal because since the mid 2000s, genetic researchers such as Craig Venter have been trying to patent large chunks of the human genome. Patenting the human genome or portions of it would result in an odd scenario in which certain individual people or corporations effectively owned some of the genes which make up all of us — as if they were property to be bought and sold. And that would curtail medical research and treatments as patent owners alone would have the right to create or licenses therapies resulting from knowledge of those genes — or to even study them.
Bye-bye, golden age of personalized, gene-tailored medicine.
The decision is bound to make the American Civil Liberties Union (ACLU) happy. The organization has been campaigning against the patentability of genes.
“Over the past 20 years, at least 41 percent of our genes have become the intellectual property of corporations,” genomics professors Christopher E. Mason and Jeffrey Rosenfeld said on the ACLU’s blog recently. “These patent claims contradict an intuitive sense that our DNA is no less ours than our lungs or kidneys.”
The ruling does not mean, however, that no genes can be patented.
Scientists can and do create what is called composite DNA (cDNA) out of components of naturally occurring DNA. CDNA, the Court found, is patentable because it is artificially created. “CDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments,” the Court’s decision reads. “Its creation results in a … molecule, which is not naturally occurring … the lab technician unquestionably creates something new.”
“The Court clearly wants to prevent patents from extending rights too far beyond the invention that gave rise to the patent, nothing that ‘[p]atent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘imped[ing]the flow of information that might permit, indeed spur, invention,'” patent attorney William Mulholland told me via email. “The decision attempts to strike that balance in delineating between these two types of genetics claims.”
Interestingly, however, this decision will likely cause corporations to create more gene variants than ever before, since those are patentable.
Franken-world, here we come?