Roundup: ACLU Sues Over Breast Cancer Gene Patents

The American Civil Liberties Union filed suit Tuesday against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah, arguing that patents for the BRCA1 and BRCA2 genes are invalid. Mutations in the two genes are responsible for a large number of hereditary forms of breast and ovarian cancer. Myriad holds a monopoly on the tests for the mutations with its exclusive license for the patents. The suit carries implications not just for the cost of the test, which can run as high as $3,000, but other biotechnology business models that rely on patents for snippets of genetic code.

Science Progress advisory board member Art Caplan offers a sobering perspective about the gravity of this suit for patent lawyers in his Breaking Bioethics column, even though he thinks a Myriad victory is all but certain. Twenty percent of all human genes are patented, he notes, and most of the worldwide drug industry rests on the legal foundation established by the Myriad patents.

Caplan also explains that patents are a privilege and not a right. Nevertheless, the University of Utah and Myriad invested large sums of money into the research and development of the processes by which the BRCA genes are isolated and purified. The monopoly that the patent provides is intended as a reward for that investment and innovation.

Unfortunately, physicians and researchers cannot reduce the costs of the tests or improve on them by investigating other mutations on the genes. According to the lawsuit, Myriad’s exclusive rights also have “resulted in a disparity in the amount of information known about genetic mutations in BRCA1 and BRCA2 in ethnic groups other than Caucasians.”

The lawsuit also notes that information available from the tests is “critical” in helping patients “decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal.” Moreover, it notes that, “Patients cannot get second opinions on their test results; and patients whose tests come back with inconclusive results do not have the option to seek additional testing elsewhere.” Filmmaker Joanna Rudnick described the difficulty of these health decisions and the impact they have on entire families in an interview with SP last year.

The New York Times notes that the next generation of genetic tests will assess the presence of variations on multiple genes. A scientist working on a multi-gene test would presumably need to pay licensing fees to all of the potential patent holders. In this sense, it is conceivable that gene patents stifle research, innovation, and competition. However, the NYT also links to a 2006 National Research Council report that found “access to patented inventions or information inputs into biomedical research rarely imposes a significant burden for biomedical researchers.”

The Chronicle of Higher Education points out that one of the plaintiffs joining the ACLU, the Public Patent Foundation of the Benjamin N. Cardozo Law School, also brought a patent challenge in 2006 against the Wisconsin Alumni Research Foundation. WARF holds the patents on the human embry­onic stem cell derivation process that James Thomson of the University of Wisconsin-Madison developed, as well as the cells obtained by that process.

Even though the U.S. Patent Office upheld the patents in question in the 2006 suit, WARF modified its licensing procedures so that academic researchers could license the processes without paying a fee, but when a company begins selling a technology based on the patented processes, they then owe royalties to the foundation. As I argued in our stem policy report, “A Life Sciences Crucible,” the WARF arrangement strikes a good balance between spurring academic research and protecting private-sector investments.

Tags: gene patents, genetics, intellectual property

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