Gene patenting: "Unconstitutional and invalid"?

On May 12, 2009, the American Civil Liberties Union, in conjunction with the Public Patent Foundation, filed a lawsuit against Utah-based biotech company Myriad Genetics, which holds patents on the human BRCA1 and BRCA2 genes. These genes are associated with hereditary breast and ovarian cancer, and normally help to restrain cell growth. Mutated versions, however, predispose a person toward developing an aggressive form of breast cancer, usually at an earlier age than the general population. The ACLU, speaking on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, genetic counselors and individual women, charges that Myriad's patents for the two genes are "unconstitutional and invalid."

In the United States, Myriad is the only provider of the test for these genes, and charges more than $3,000 for its full testing panel. Not all insurance providers cover the test. Advocacy groups and researchers are concerned that patients need competing testing options, both for cost and medical reasons.

American researchers must pay a high patent cost to Myriad to use the tests. Any research crossing into commercial use violates the patents, and researchers faced with the high costs of the tests have, in some cases, abandoned their work. Additionally, physicians are required to send their patients' blood to a single location — Myriad's headquarters — for testing so the company can ensure quality control.

Should the ACLU win its suit against Myriad, hundreds of thousands of patents would come into question. About 20% of the human genome is currently patented.

Backstory
Myriad discovered the BRCA1 gene in 1994 and the BRCA2 gene in 1996. Within five years they had received patents both in the United States and internationally covering the BRCA1 and BRCA2 breast and ovarian cancer genes and their use in the development of therapeutic and predictive medical products.
 
In 1998, shortly after receiving its patent on the BRCA2 gene, the company settled a patent infringement case against competitor OncorMed. Myriad obtained OncorMed’s entire BRCA1 and 2 Genetic Testing Program including all testing services, all contacts, all customer lists, exclusive licenses for all current and pending patents, and a financial settlement. OncorMed was acquired by another company later that year.
 
In January 2001 Myriad won a European patent giving the company control over testing for mutations of the BRCA1 gene in Europe. Shortly thereafter, a Parisian research center filed an action with the European Patent Office against Myriad over the breadth of the patent, which they feared might restrict other related research. Several European researchers had already developed their own tests, which detect partial deletions of genes and other factors contributing to breast and ovarian cancers, which Myriad’s tests do not detect. Additionally, some of these researchers were able to offer their tests for a third of Myriad’s price.

International disputes against Myriad are still pending. Some countries, such as Canada, offer their own BRCA tests in violation of Myriad's patents.

Learn more
Cancer Patients Challenge the Patenting of a Gene
John Schwartz, The New York Times, May 12, 2009

ACLU Files Case Challenging Patents on Breast Cancer Genes
Filmmaker Joanna Rudnick comments on the ACLU suit in the Huffington Post and supplies a look inside Myriad Labs from her acclaimed documentary In The Family.

ACLU Challenges Patents on Breast Cancer Genes
Hear from the plaintiffs and connect with more information about the suit.