BCAction Joins Coalition to Challenge BRCA Gene Patents

By BCAction editorial staff with Selene Kaye of the ACLU

On May 12, Breast Cancer Action joined other women’s health groups, individual women, researchers, genetic counselors, and scientific organizations representing more than 150,000 geneticists, pathologists and laboratory professionals in challenging the legality of gene patents. Yes, that’s right—patents on human genes, the sequences of DNA that exist in our cells and contain instructions for the development and functioning of all living organisms. The lawsuit, filed by theAmerican Civil Liberties Union and the Public Patent Foundation, challenges the legality of the U.S. Patent and Trademark Office’s practice of granting patents on human genes. Specifically, this suit challenges the validity of the patents that grant Myriad Genetics, a private corporation based in Utah, control over the BRCA1 and BRCA2 genes.

Certain mutations along the BRCA1 and BRCA2 genes are associated with a greatly increased risk of developing breast and ovarian cancer. A woman with certain BRCA mutations faces a 36 percent to 85 percent lifetime chance of developing breast cancer and a 16 percent to 60 percent chance of developing ovarian cancer. These staggering numbers mean that the testing for and research on these genes have serious implications for the health of women at risk of hereditary breast cancer.

Myriad’s patents give it exclusive rights to all testing and research on BRCA genes. This monopoly prevents anyone else from so much as examining the genes, and creates barriers to scientific research and medical care relating to breast and ovarian cancer, including:

  • High testing costs: Myriad’s monopoly on the BRCA genes allows it to set the price for a full sequencing test—currently over $3,000. Many qualified geneticists could do the testing for less but cannot because of the patents. Women who do not have insurance that covers the test and who cannot afford Myriad’s price are denied the ability to make informed medical decisions.
  • No second opinions: Myriad controls clinical testing on the BRCA genes. Consequently, women cannot get a second opinion on the full sequencing test. A woman cannot verify that the results she has received from Myriad are accurate or reflect the most up-to-date information. This is particularly alarming given that, for a period of time, Myriad’s testing missed certain mutations that were known to the broader scientific community, resulting in a false negative rate that was estimated to be as high as 12 percent.
  • Undermining research: As the patent holder, Myriad has the right to refuse research licenses, charge high licensing fees, and sue and/or shut down researchers who do not have a license. If a researcher wants to study the BRCA genes, s/he must obtain a license from Myriad or risk being sued for patent infringement. While some researchers have been permitted to study the BRCA genes, Myriad’s patents allow it to claim any commercially valuable outcomes gained from outside research. In this way, Myriad controls the progress and direction of any future research.
  • Blocking the development and availability of alternative tests:Myriad’s patents cover the actual BRCA genes (not simply the genetic test). As a result, researchers cannot develop or offer alternative tests. According to a 2002 article in the Boston Globe, laboratories offering less expensive diagnostic tests for breast and ovarian cancer susceptibility were forced to shut down their testing services after receiving “cease and desist” letters from Myriad.
  • Lack of data sharing and analysis: Myriad’s monopoly on the BRCA genes gives it control over a large data set related to those BRCA genes. There are many mutations among these genes whose connection to cancer is currently unknown. Myriad has the sole right to use—or not use—its data to better understand breast and ovarian cancer genetics and is under no obligation to share these data with the international research community.
  • Limited information for underserved populations: African American, Latina, and Asian American women are disproportionately likely to receive ambiguous results when they are tested by Myriad. Consequently, Myriad’s control of the BRCA genes limits the development of important information that these women—who are more likely to die of breast cancer than white women—need.

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Breast Cancer Action is deeply concerned by the barriers to research and clinical care created by Myriad’s patents. They endanger our members’ health and threaten the progress of patient-based health care. We believe it is wrong for the government to give one company the power to dictate all scientific and medical uses of genes that each of us has in our bodies. We urgently need more and better options for the treatment and prevention of breast cancer, and we cannot afford to have progress stymied by the monopolies that gene patents create.

Our hope is that this lawsuit will result in the invalidation of Myriad’s patents—and potentially other gene patents that impede access to health care—thereby opening the door to scientific advancement and health care access for people grappling with breast cancer, ovarian cancer, and other life-threatening diseases.

For more on Myriad and its gene test, search “Myriad” on the BCA web site.

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