In a monumental step towards bringing sanity to biotech patents, a court ruled that a patent granted for the sequence of a gene associated with breast cancer was invalid. Basically, Myriad Genetics held a patent on the use of the sequence of BRCA1 and BRCA2, genes with alleles associated with high risk of breast cancer. Thanks to its patent, Myriad was the only company able to make tests for these alleles, and medical societies like the Association for Molecular Pathology, the American College of Medical Genetics, the American Society for Clinical Pathology, and the College of American Pathologists filed suit to gain their members access to a competitive marketplace for effective and accurate tests. They were joined by individual doctors and medical advisors who sought to develop new tests for dangerous BRCA variants and were blocked, as well as Breast Cancer Action – a breast cancer patients’ group – and the Boston Women’s Health Book Collective – publishers of Our Bodies, Our Selves – and individual cancer patients and patients with a history of breast cancer who could not afford Myriad’s test. They were represented by the ACLU, which has concerns for the privacy implications of gene patents, and by the Public Patent Foundation at Cardozo Law School, which focuses on blocking undeserved patents and unsound patent policies.
After considering the relevant biology and underlying law, the judge concluded that patenting the sequence of a gene, a longstanding practice, violates the principle that naturally occurring objects cannot be patented. Patent attorneys have gotten around that by technically patenting the mechanism for isolating the sequence, a dodge which the judge recognized as “a lawyer’s trick” and not a meaningful distinction. The isolated genes are still products of nature, not a unique invention.
This does not invalidate patents on organisms with modified genes or genomes, nor does it invalidate the act of modifying a gene in order to insert it into an organism. This does not, by my reading, set up Monsanto’s genetically modified Roundup Ready crops to lose patent protection, though it may free up competitors to develop similar genes, and may give farmers an easier way to protect themselves against a claim when Monsanto asserts patent violations because of crosspollination.
The court was asked to consider the chilling effect on research produced by patents for naturally occurring genes. Fortunately, the decision seems to have avoided that line of argument, as it opens a massive can of worms. In general, I’m inclined to oppose patents and copyright laws that restrict research, artistic development, medical care, or other humanitarian services. On the other hand, I don’t think that’s a call judges ought to be making. I’d rather see the laws themselves fixed when such chilling effects are seen. This judge’s ruling fired a shot across the bow of lawmakers about the abuses of genetic patents, and one hopes lawmakers will listen.
Given the sweeping victory on a summary judgment motion, the ACLU is understandably elated. “We are extremely gratified by this groundbreaking decision,” said Sandra Park, staff attorney with the ACLU Women’s Rights Project. “This is the beginning of the end to patents that restrict women’s access to their own genetic information and interfere with their medical care.” We can hope so. The appeals are inevitable, and are headed toward a notably pro-corporate and anti-woman Supreme Court, so there’s no guarantee that this ruling will hold up, but it’s a good first step.
As John Ball, executive vice president of the American Society for Clinical Pathology put it: “It’s good for patients and patient care, it’s good for science and scientists. It really opens up things.”