Stepping into a case that could have wide-ranging effects on scientific researchers, the U.S. Department of Justice on Friday filed a brief that opposes the patentability of genes. The filing represents a reversal of position for the government, which for decades has allowed the U.S. Patent and Trademark Office to grant patents on individual genes.
In May 2009, the American Civil Liberties Union organized a lawsuit on behalf of four breast cancer patients, scientific researchers and professional societies that challenged the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes. Mutations in these two genes are highly correlated with development of breast cancer, and Myriad used its patents to develop exclusive tests that determined cancer risks.
In March, a New York District Court judge ruled in favor the plaintiffs, arguing that, as products of nature, genes are not patentable. The defendants appealed, and, while a final ruling is being contemplated, the Justice Department decided to file an amicus brief stating its position. While the brief itself was not filed in support of either party, its contents favor the plaintiffs’ point of view concerning the ability to patent genes. The government agreed that forms of recombinant DNA, including vectors, cDNA and various other genetically modified materials, were “in every meaningful sense the fruits of human ingenuity,” thus qualifying them as “‘human-made inventions’ eligible for patent protection.” By contrast, it said that “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible.”
The ability to patent genetic material dates to 1980, when the U.S. Supreme Court, ruling in Diamond v. Chakrabarty, held that products of genetic engineering were patentable, as they represented significant modifications to an existing “product.” Researchers and companies interpreted the ruling to pertain to all genetic-related material (whether “natural” or modified) and seized upon this decision to gain patent protection for their experimental discoveries, resulting in nearly 20 percent of the 23,000 human genes being covered under patents. Basic researchers long have argued that such an arrangement restrains scientific discovery, though in 2006 the National Research Council issued a report indicating that such patents “rarely impose significant burdens on biomedical research.” The report did warn that “there are reasons to be apprehensive about their future impact on scientific advances in this area.”
What are your thoughts on the case? Do you agree with the government?