By Sandra Park, Staff Attorney, ACLU Women’s Rights Project
When you hear about patents on human genes, women’s rights might not immediately come to mind. Yet, a woman’s right to access medical care, make informed medical decisions, and benefit from scientific research is at the core of this issue.
For the past two decades, the United States Patent Office has granted patents on human genes once they are “isolated,” or removed, from the body and cell. BRCA1 and BRCA2, which are associated with hereditary breast and ovarian cancer, are just two of the estimated 20 percent of human genes that have been patented. Women and men who have certain mutations on these genes are much more likely to experience cancer in their lifetimes. For that reason, physicians and genetic counselors recommend genetic testing for some patients with a significant family or personal history of breast or ovarian cancers, so that they can more fully understand their risk of developing future cancers and to help inform medical decisions.
However, because a company called Myriad Genetics controls the patents on the BRCA1 and BRCA2 genes, there is only one laboratory in the United States that provides BRCA sequencing — Myriad's. The human cost of patents on genes has the potential to be devastating for women and their families.
Myriad’s patents enable it to threaten other laboratories that offer testing. Its monopoly has barred patients from accessing alternate tests that might more effectively detect mutations or comprehensive second opinions about their results. It also allows Myriad to charge a high price for its tests, a price that has increased as the cost of genetic testing, in general, has dramatically decreased. Furthermore, Myriad's refusal to share the data it has collected on BRCA1 and BRCA2 mutations raises serious questions about whether it is undermining research and scientific progress.
The American Civil Liberties Union and Public Patent Foundation filed a lawsuit challenging these patents on behalf of pathologists, geneticists, women's health organizations and patients. Our lawsuit challenges the government’s policy of gene patenting, and its outcome could have far-reaching effects on other patents that have been issued, including on genes relating to ovarian cancer, Alzheimer’s disease, and muscular dystrophy.
Myriad’s patents are invalid because they cover natural phenomena, which the Supreme Court long has shielded from patenting. The federal district court agreed, and in a landmark ruling concluded, for the first time, that genes are not patentable subject matter because they are products of nature. On appeal, a divided Federal Circuit partially reversed the district court’s ruling, holding that companies can obtain patents on the genes but cannot patent the basic process of comparing genetic sequences.
This decision is extremely problematic for women’s health. By allowing companies to block access to alternate tests and second opinions, charge thousands of dollars for their tests, and chill scientific research, gene patents are threatening women’s – and all patients’ – rights.
No corporation should be able to claim ownership of a woman’s own genetic information. We are considering next steps in the litigation, but to learn more about what you can do, click here.
This blogpost is part of a multi-organizational #HERvotes blog carnival.