Some 20 percent of the human genome is already patented. But a court ruled yesterday that one company does not have the rights to some of its patents on two genes, BRCA1 and BRCA2, commonly tested for mutations to determine risk for developing breast and ovarian cancers.
The decision [pdf], made March 29 by United States District Court Judge Robert Sweet in New York City, could have major implications for both research and industry. Because it is a district court decision, the ruling does not automatically extend to all U.S. gene patents, but other judges can decide to follow the precedent in future cases.
"If a decision like this were upheld, it would have a pretty significant impact on the future of medicine," Kenneth Chahine, a law professor at the University of Utah, told The New York Times.
Experts expect the company, Myriad Genetics, which together with the University of Utah Research Foundation had seven patents named in the case, to challenge the ruling. Myriad CEO Peter Meldrum said the company has 16 other patents related to the two genes that weren't named in the case, The Wall Street Journal reported.
Opponents of the decision say that a lack of patent protection in this arena could stifle industry innovation because there would be no guarantee that genetic discoveries would be a company or organization's sole property. "These are the discoveries we want to motivate by providing incentives to all the researchers out there," Edward Reines, a California patent lawyer not on the recent case, told the Times.
Those who filed the lawsuit last May, the American Civil Liberties Union (ACLU) and the Public Patent Foundation at the Cardozo School of Law in New York City, asserted that Myriad Genetics (which charges about $3,000 to use its specialized diagnostic tests to look for mutations on the BRCA1 and BRCA2 genes) had an unfair monopoly, the Times reported.
The plaintiffs, joined by individual patients, also maintained that the patents were hampering research rather than fostering it. "The human genome, like the structure of blood, air or water, was discovered, not created," Christopher Hansen, a lawyer for ACLU told the Times. The ACLU and others argued that simply isolating a piece of DNA outside of the body does not render it comparable to other created chemical compounds. "The principal [sic] that an isolated gene is the same as a gene is a broad principal [sic] and may have an impact on other gene patents," Hansen told Bloomberg News.
Although an individual's internal DNA cannot currently be patented, biomedical firms have asserted that the process of isolating genes renders them a product rather than a natural phenomenon—and thus patentable. However, Sweet concluded in his decision that, "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable."
Image courtesy of Wikimedia Commons/National Human Genome Research Institute