The American Civil Liberties Union (ACLU), an influential political, consumer advocacy, and human rights organization in the U.S., recently filed a lawsuit seeking to invalidate the patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2. The group argues that patents on the genes “stifle research that could lead to cures and limit women’s options regarding their medical care,” and that the patents are unconstitutional and invalid because they cover a discovery, not an invention. The ACLU claims that the patents, granted to Myriad Genetics, “prevent any researcher from even looking at the genes without first getting permission from Myriad,” hinder clinical diagnosis, and disincentivize research.
Of course, things aren’t that simple, and some of the ACLU’s claims are patently false. Thousands of researchers “look at” BRCA1 and BRCA2 intensely without regard for Myriad’s patent or even knowledge of the legalities. And, while naturally occurring genes are clearly discoveries, not inventions, regulators and judges have allowed patents on genes and even organisms precisely in order to spur innovation. Identifying gene sequences and functions has been an expensive, laborious, and often fruitless task, and previous rulings allowing patents were intended to compensate universities and companies bold enough to take the risk and make the effort. Moreover, there was no known market for the findings, so it was impossible to ascribe economic value. Without the patent incentive, no private enterprise would have attempted it and innovation would have been hindered. However, since those rulings, there has been a fundamental change in the way genetic research is conducted: inexpensive microarrays, sequencing tools and techniques, and widespread online publication of genetic data have greatly lessened the effort to identify and characterize genes, to the point that today the American Association for the Advancement of Science (AAAS) journal Science spams readers with an advertiser’s invitation to a “30-minute webinar about new solutions for fast, accurate analysis of your gene or protein’s function.” Discovering a gene and its workings is no longer the Quixotic task it once was.
In light of this technology-driven change, the patent “incentive” for the identification and isolation of natural genes is anachronistic. Discovering a gene sequence, while not yet layman’s work, has become too simple a task to merit the incentive of a temporary monopoly that patent protection confers. At the same time, the value of the monopoly is soaring as the uses of genetic data grow. Even genetic engineering – whereby a sequence “similar to” another by, say, 70%, is protected – is approaching the level of “obviousness” that invalidate patents on inventions that anyone skilled in the art might arrive at based on intuition alone. Synthetic biologists are looking to an open-source gene library to foster innovation. As with previous waves of innovation, the legal landscape is changing as the technology matures and the market grows. Ultimately, this particular case will be decided on legal and political niceties that are impossible to predict, but if past history is a guide, the long-term prognosis for gene patents looks very grim.
