Genes Belong to the Person Born With Them

By Gail Garfield Schwartz

From Advocacy News & Views

Breast cancer survivors should know that private commercial organizations are getting a lock on genes that could improve their health. The lock comes in the form of patents, such as the ones Myriad Genetics holds on the BRCA1 and BRCA2 genes, which are implicated in higher than normal incidence of breast cancer and ovarian cancer. 

The study of BRCA gene mutations has yielded tests that determine whether a woman has these mutations. If she does, she may choose to take prophylactic (preventive) measures against the higher risks associated with the mutations, by having a double mastectomy and/or having her ovaries removed. Myriad also owns these diagnostic tests exclusively. 

Such a monopoly runs completely counter to the concept of patient-centered research that SHARE and other cancer support organizations advocate. 

It is impossible to believe that a gene -- which, after all, one enters the world with -- is justifiably patentable. A gene in fact is the exact opposite of the normally patentable "product" or "technique" or "methodology." Myriad's argument is that their processing of the gene is and must be patentable, and that to protect the processing, the underlying gene itself is within the bounds of the patent. The result is a total control of the gene and the tests Myriad developed.

The American Civil Liberties Union (ACLU) has taken up arms against this travesty. Last month (February 2, 2010) the first court hearing was held on a lawsuit filed by the ACLU against Myriad Genetics and the U.S. Patent Office challenging the whole concept of gene patenting.*

A SHARE Leader, Anne-Marie Kunzler, who has a long career in research and advocacy, participated last fall on a panel of attorneys, an ethicist, and breast cancer survivors who discussed the problems patents cause for women getting tested for genetic abnormalities, and how the patents prevent people from getting the information they need to take care of their health. It turns out that not only does Myriad have exclusive control of the initial patient-requested BRCA1 and BRCA2 tests, but also it has exclusive rights to all tests for these genes. Thus no patient can seek a second opinion from another organization. Nothing could be more contrary to SHARE's strong belief and policy position that second opinions are vital to evidence-based treatment.

It also appears that Myriad can and does restrict information given to subjects tested in a scientific research program, as distinct from individuals seeking a diagnostic test for personal reasons. This is, quite simply, terrible. A subject who tests positive for a gene mutation is prevented from taking whatever steps she thinks necessary to protect herself from the risks of the mutation.

But the harm done to public health goes far beyond this. Information that could further research is under wraps at Myriad. This information would be valuable in many ways, such as improving the test's accuracy and reliability, determining the characteristics of populations that have a large incidence of mutations, and associating the BRCA genes with other genes, proteins, or disease-spreading pathways. It boils down to this:  Myriad sits on a gold mine of scientific facts, contained in the huge database of test results, and these facts should be shared to help anticipate and counter the dangers of the BRCA mutations.

Breast cancer-related genes are not the only genes that have been patented. Genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma, and many other diseases have been patented -- a shocking 20 percent or so of all genes, in total.

In the Family, a film by Joanna Rudnick, who was diagnosed with a BRCA mutation at age 31, is helping to raise awareness of the BRCA patent problem. In the film a representative of Myriad compares its patent to the patent on an iPod, and says the test would not exist but for the patent. Clips from the film can be seen on youtube. Click here for one example.

More information on the lawsuit is available at www.aclu.org/brca. For the latest developments in the case, click here.

See pictures and a short summary of the panel Anne-Marie took part in.

I thank Anne-Marie for calling attention to this issue and for the essay she wrote which informed this blog. I invite comments from her and others who are following the issue. 

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* The lawsuit, Association for Molecular Pathology et al V. U.S. Patent and Trademark Office, et al was filed on May 12, 2009 in the US District Court of the Southern District of New York on behalf of breast cancer and women's health groups (the Breast Cancer Action, the Boston Women's Health Book Collective); scientific associations representing approximately 150,000 professionals (the Association for Molecular Pathology, the American College of Medical Genetics, the American Society for Clinical Pathology, the College of American Pathologists); and numerous individual women, geneticists, and breast cancer specialists.

The lawsuit was filed against the United States Patent and Trademark Office; Myriad Genetics, the company which now holds the patents; and David W. Pershing and Michael K. Young, in their official capacity as Directors of the University of Utah Research Foundation, where the research for the patented genes was conducted.

Posted March 5, 2010.