How the Patents on the Breast Cancer Genes Harm Physicians and Patients

Yesterday, the American Medical Association (PDF) and several other major medical and patient organizations (PDF) filed briefs in support of our lawsuit challenging the patents on two human genes associated with breast and ovarian cancer (the BRCA1 and BRCA2 genes).

Why would the AMA get involved in a patent case? Because “[t]he use of patents . . . to limit the availability of medical procedures places significant limitation on the dissemination of medical knowledge, and is therefore unethical.”

The patents we have challenged claim the actual BRCA1 and BRCA2 genetic sequences and directly violate this ethical principle. While all of us have these two genes in our bodies, the patents give the patent holder the exclusive right to determine who can examine these genes. As a result, Myriad Genetics, one of the defendants in the case, is the sole provider of BRCA1/2 full sequencing testing in the United States. A woman who wants to know whether she has a mutation on these genes that places her at greater risk for cancer, and a physician who wants to order that test for her, have only one option, leading to less access to medical treatment and knowledge.

It does not matter what technique is used to analyze the genes, or whose blood sample is tested (yours, mine, or the six women who are plaintiffs in the case) – the patents grant control over the genes. If you want to confirm your test results through another lab, or if you can’t afford the price Myriad sets, there is nowhere else you can go.

For people concerned about hereditary risk for breast and ovarian cancer, access to information about the BRCA1/2 genes is too important to put in a single company’s hands. As Susan Love, M.D., author of the classic Dr. Susan Love’s Breast Book, describes in the declaration she filed in support of the lawsuit (PDF), genetic test results can dramatically influence a breast cancer patient’s decisions about prevention and treatment. She said: “It is my professional opinion that genes are so fundamental to science, medicine and clinical care that patents should not be granted so as to exclude doctors and geneticists from examining them. Allowing a company to control the BRCA1/2 genes is harmful to the quality of care we can provide our patients.”

We have asked the court to rule on whether the BRCA1/2 gene patents violate patent law, which prohibits the patenting of products and laws of nature, and the Constitution. For more information about the lawsuit, Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., and to read more from the scientific and medical experts who have come out in support of the case, see www.aclu.org/brca