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In a long-awaited decision with major implications for commercial and academic research, the US Supreme Court ruled unanimously on June 13 that human genes that are isolated from the body cannot be patented. The ruling invalidated patents held by Myriad Genetics, a Salt Lake City firm that had been granted patents on two genes, known as BRCA1 and BRCA2, that can suggest an increased risk of breast or ovarian cancer. Myriad Genetics used its patents to become the only US commercial supplier of genetic tests for those cancers, which often cost more than $3,000, and filed patent infringement suits against others who conducted testing based on the gene.
The court ruled that while artificial lab-made genes can be patented (Myriad has those, too), naturally occurring genes are not entitled to patent protection. “Myriad did not create anything,” Associate Justice Clarence Thomas wrote in the opinion. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” The Obama administration and the American Civil Liberties Union support that view, as do the groups of cancer patients and geneticists who brought the suit against Myriad.
Bostonia spoke with Michael Meurer, a School of Law professor, the Abraham and Lillian Benton Scholar, and coauthor of Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovation at Risk (Princeton University Press, 2009), about what the decision means for researchers, physicians, and cancer patients.
Meurer: Thousands of US gene patents have been granted, starting in the 1980s. If you’d asked most patent lawyers five years ago whether the Supreme Court would ever conclude that genes are not patentable subject matter, they would have found the question laughable. This is a truly fundamental change in the way that patent law defines patentable subject matter. More important, it is one of several recent decisions by the Supreme Court that weakens the patent system. These decisions have the support of scholars like me who think that the patent system needs to be reformed because on balance it has become an impediment to most kinds of innovation. Innovators find themselves harmed more by the patents of others than they gain from enforcing their own patents.
Most innovations comprise many components or steps, thus an innovator needs to assemble many different chunks of technology. Innovators get patents on their novel contributions and pay royalties to the parties who hold patents on complementary chunks of technology. Innovation is discouraged when there are too many upstream patent owners who must be paid before technology can move forward.
Patents clearly promote pharma R&D. Patents probably also promote biotech R&D, but the wrong kind of patents or too many patents in the biotech sector will slow R&D. It’s not clear whether gene patents are “the wrong kind of patent,” but I suspect they are. The public sector Human Genome Project sequenced all human genes; patent incentives were not necessary because of government funding and funding from NGOs.
The court ruled that some degree of human intervention is required to convert a product of nature into a patent-eligible composition of matter. The Federal Circuit Court held that genes are patentable because the Myriad inventors isolated and purified the genes. The Supreme Court disagreed, and said that is not sufficient human intervention.
The direct effect might not be great, because many biotech patent owners decline to enforce their patents against academics, or offer royalty-free licenses. There might be a significant indirect effect, though. When biotech research is commercialized with the aid of gene patents, there tends to be more secrecy and less sharing of information and materials in connection with ongoing research on the patented gene.
Commercial firms may rely more on secrecy to protect gene discoveries. Also, commercial firms may accelerate development of genetic tests that might still be patentable.
The immediate benefit is likely to be cheaper testing for BRCA1 and BRCA2 mutations. Perhaps the quality of the testing will improve in response to competition.
Not much. Genetically modified seeds are still patentable.
The human insulin gene when isolated and purified was held patent-eligible by the Fed Circuit. The gene was used to produce the insulin protein. The Supreme Court ruling would invalidate that patent if it were still in force. If someone makes an non–naturally occurring gene that codes for a useful protein, such a gene may still be patented.