Sorting Out Patent Law
The US Supreme Court last week handed down an important decision governing the expanded use of patents in recent years. The Court’s decision, issued in the case of the Association for Molecular Pathology v. Myriad Genetics, centered on the question of whether or not a patent held by the company Myriad Genetics over the BRCA1 and BRCA2 genes was valid. The two genes are closely connected to the development of breast and ovarian cancers, and Myriad had claimed a patent on the genes based on work they had done to discover and isolate the genes. Their patents prevented other researchers or companies from doing work on that gene sequence, and gave Myriad the ability to command higher prices for genetic tests to screen for those types of cancer.
The use of patents to protect innovation is guaranteed by the US Constitution. But the nature of those patents—and more importantly, the question of what can or cannot be patented—has long been contested. Historically, patents have been granted for innovations but not discoveries. The question, of course, is where the line between the two falls. Patent law has historically precluded patents over “products of nature.” But advocates for greater patent protection had contended that gene sequences outside the genome are not found in nature and could thus be subject to patent protection. In its ruling, the Supreme Court rejected this claim, holding that “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” Rather, to claim a patent there must be an “inventive step” or “apply the knowledge.”
It’s difficult to understate the importance of this decision. There are currently more than 2,000 patents for human gene sequences, many of which appear to have been invalidated by the decision. Similarly, in the field of agricultural biotechnology, broad patent claims over the genomes of plant varieties would also be unfeasible. Such patents serve no real purpose other than to enrich the first to discover or sequence the genome. At the same time, they undermine the ability of other researchers to engage in study of specific gene sequences. While the Court’s decision will likely undermine research in some areas, it will likely prove a boon to others.