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Professors Analyze Supreme Court Decision in Gene-Patenting Case

By Brian McNeill

In Association for Molecular Pathology v. Myriad Genetics, the Supreme Court ruled that naturally occurring isolated biological material is not patentable, but that a synthetic version of genetic material may be patented.

"This is one of the few times that oral argument was completely predictive of the result and the result here follows directly from the Court's ruling last year in Prometheus v. Mayo,” said law professor Margaret Foster Riley who also holds a secondary appointment in the Department of Public Health Sciences at UVA's School of Medicine. She is an expert in biotechnology, bioethics, and health law. “Despite much of the commentary on the case that focused on some of the metaphysical questions potentially raised by the case, e.g. notions of individual property rights in our own genes, the decision is simple and technical. Isolated DNA is a product of nature and not patentable, cDNA or 'synthetic DNA' is not a product of nature, and is patentable.

Margaret Foster Riley
Margaret Foster Riley

In oral argument, some members of the Court were very concerned about the effect of any potential ruling in this case on innovation. Today’s ruling strikes a balance that is likely to promote more innovation than deter it. Current genomic research involving genome wide association studies and genetic/proteomic relationships will be able to proceed without some of the potential limitations posed by patents on isolated DNA. But today's ruling does nothing to restrict patents on cDNA or method patents on genomic discoveries. In that sense, while certainly signaling a new direction, today’s opinion is actually quite conservative."

"I think the question on which the court granted certiorari, 'are human genes patentable,' led pretty clearly to at least one part of the result in this case, the conclusion that isolated genomic DNA (gDNA) is not patent-eligible subject matter,” said law professor Margo Bagley, an expert in biotechnology, intellectual property and patent law. She teaches courses on patent law, international and comparative patent law, and intellectual property.

Margo Bagley
Margo Bagley

"The decision is fully consistent with Diamond v. Chakrabarty’s requirement that an invention be 'markedly different' to something found in nature in order to be eligible for patent protection. Of course, the problem with the 'markedly different' requirement is its malleability, as it makes the patent eligibility question a policy choice (which, for some, may be its chief virtue). Thus, the Court was able to draw a line between naturally occurring but isolated gDNA and non-naturally occurring (but pretty close) complementary DNA (cDNA), even though very reasonable minds at the district and appeals courts, on different rationales, came to completely different conclusions on the 'marked difference' of both of these claimed inventions.

"The language of the decision leaves some room for speculation as to its reach; for example whether it truly goes beyond gDNA to deny patent-eligibility to any isolated and purified naturally occurring compound and whether protection for gDNA could still be achieved by drafting claims differently. But it should pave the way for entities to begin competing with Myriad in offering breast cancer susceptibility testing, potentially at a reduced cost. It arguably also encourages further biotech research and patenting by upholding the eligibility of cDNA claims and articulating a limited scope for its decision.

"Ultimately, the Court’s decision can be seen as conclusion that its line drawing between gDNA and cDNA claims '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.' Nevertheless, finding this policy-based eligibility balance is likely to continue to stymie lower courts faced with claims to new technologies for the foreseeable future."