Who should own DNA? All of us

Marcy Darnovsky and Karuna Jaggar write: Most court cases involving patent law are corporate battles, with one company suing another for infringing on its intellectual property rights and, therefore, profits. Big companies fighting over big money can seem painfully irrelevant, especially when so many of us are simply struggling to get by.

But the case coming before the U.S. Supreme Court on Monday challenging two patents is a different animal, with enormous implications for both our health and shared humanity. The patents in question are on two human genes, BRCA1 and BRCA2, commonly referred to as the “breast cancer genes.”

We all have these genes in the cells of our bodies, but certain variants in some people significantly increase the risk of breast and ovarian cancer. Learning whether you have these risk-elevating mutations can be important because it gives you the opportunity to consider increased surveillance (such as cancer screenings and mammography) and even surgery to remove healthy organs.

The patents give one biotechnology company, Myriad Genetics Inc., sweeping control of the two genes. Myriad’s monopoly harms women’s health, impedes cancer research and raises important ethical questions about control over the human genome.

Myriad’s patents cover both the normal versions of the genes and all mutations and rearrangements within them. This monopoly has prevented other scientists and doctors from using the BRCA1 and BRCA2 genes in research, medicine, diagnosis and treatment.

With revenue from the patents approaching half a billion dollars a year, Myriad frequently restricts access to these genes. It sends cease-and-desist notices to prevent other researchers from working with them.

Myriad’s strict patent enforcement means its test is the only available one to determine whether a woman has a genetic variant that increases her risk of cancer. Women cannot get a second opinion about the results, even when faced with a decision about removing healthy organs to reduce their cancer risk. And too many women cannot even have the test because it is too expensive.

Furthermore, since Myriad’s test focuses on the variants that have already been identified, some women, especially women of color, are more likely to get ambiguous results. They are told they have a genetic variant but that Myriad doesn’t know whether it increases their risk of cancer.

The lawsuit before the Supreme Court next week has united women’s health organizations, research groups, genetic counselors and breast cancer patients. The American Civil Liberties Union and the Public Patent Foundation, the lead plaintiffs, make a straightforward argument (full disclosure: Breast Cancer Action is also a plaintiff; Center for Genetics and Society has signed several briefs): U.S. case law and patent statute plainly say that patents can be awarded only for human inventions.

Genes are not inventions but products of nature. You can’t patent the sun; you can’t patent a new species of insect you find in a forest; you can’t patent the speed of light. And you cannot patent human genes. [Continue reading…]

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