The Politics of Women's Health

Emerging Issues: Patenting of Human Genes and Women's Health

Since 1980, the U.S. Patent and Trademark Office (USPTO) has issued patents on the genes of living organisms, despite the widespread objection that genes are products of nature and not human-made inventions. The controversy has intensified with the patenting of human genes in the early 1990s.

In 2007, Rep. Xavier Becerra (D-Calif.) introduced the Genomic Research and Accessibility Act (H.R. 977) to prohibit the patenting of human genes and human genetic information. This act cited many justifications, from the points of view of both researchers and patients. Numerous researchers have been concerned that the patenting of and monopoly on a particular human gene reduce information sharing, innovation, quality control, and competition. For health consumers, patenting reduces availability of tests, increases cost, limits alternatives, and prevents second opinions.

The American Civil Liberties Union (ACLU), the Public Patent Foundation, and twenty co‑plaintiffs filed a lawsuit in 2009 against the USPTO, Myriad Genetics, and the University of Utah Research Foundation, charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The suit focused on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers, and for which Myriad Genetics controls the patents—effectively controlling the available testing for important mutations.

Breast Cancer Action and Our Bodies Ourselves— the only two women’s health groups that are co‑plaintiffs—believe that when one company controls all the testing, less information and fewer resources are available to both patients and researchers. Some doctors and researchers involved with the lawsuit contend that this monopoly has long held up not only competing, cheaper tests but also important gene-based research.

In 2010, a U.S. federal district court judge’s ruling in the case invalidated the patents, arguing that the company deserved praise for what is “unquestionably a valuable scientific achievement,” but not a patent, because the “claimed isolated DNA is not markedly different from native DNA as it exists in nature.” Essentially, the relevant genes are found in nature and thus, like other products of nature, are not patentable.

The judge did not address the question of whether the USPTO had violated the Constitution. After the decision, the U.S. Department of Justice withdrew its support for human gene patents, agreeing that genes themselves are not patentable. The ruling has the potential to make the study of and testing for important genetic variations cheaper and more readily accessible. This court decision was appealed in 2010 to a federal appellate court. For updates on the case, visit the ACLU webpage on patenting genes.