Court Rules Against Patents on Breast Cancer Genes
A New York District Court judge ruled yesterday that patents on the human BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer, are invalid because the patents were "directed to a law of nature and were therefore improperly granted." The ruling (see PDF) did not consider claims that the patents are unconstitutional.
Myriad Genetics and the University of Utah Research Foundation currently hold patents on the BRCA1 and BRCA 2 genes and have exclusive rights to perform diagnostic testing on the genes. The patents allow Myriad to restrict outside research on the genes and monopolize predictive cancer tests, for which the company charges $3000, that check for mutations in an individual's genes.
Judge Robert Sweet ruled that "the isolation of the BRCA1 and BRCA2 DNA, while requiring technical skill and considerable labor, was simply the application of techniques well-known to those skilled in the art...The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent."
The American Civil Liberties Union (ACLU) and the Public Patent Foundation originally filed the lawsuit last year on the grounds that genes cannot be patented because they are "products of nature" and that the patents violate the First Amendment by restricting research. Plaintiffs included individual women, women's health groups, and science associations and professionals. Arguments in the case were heard in February.
ACLU staff attorney Chris Hansen said in a press release that the "ruling is a victory for the free flow of ideas in scientific research. The human genome, like the structure of blood, air, or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."
The current lawsuit is the first to challenge gene patents as a civil rights violation and its outcome could have a far-reaching impact in genetic research as 20 percent of all human genes are currently patented; including those associated with Alzheimer's disease, muscular dystrophy, and asthma. Law professor Kenneth Chahine, who filed an amicus brief in support of Myriadï¿½s case, told the New York Times, "If a decision like this were upheld, it would have a pretty significant impact on the future of medicine...The industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection."
According to the National Cancer Institute at the National Institutes of Health, women with BRCA1 or BRCA2 are 3 to 7 times more likely to develop breast or ovarian cancer than other women.
Media Resources: ACLU Press Release 3/29/10; New York Times 3/30/10; Feminist Daily Newswire 2/2/10; National Cancer Institute; US District Court Ruling 3/29/10