Enough with Patenting the Breast Cancer Gene

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To date, about 20 percent of the human genome has been patented, including genes for Alzheimer’s, asthma, colon cancer, and perhaps most famously, breast cancer. This means pharmaceutical companies, scientists, and universities control what research can be done on those genes, and how much resulting therapies and diagnostic tests will cost. That is why, three years ago, a woman named Genae Girard couldn’t get a second opinion on a test showing she carried the breast cancer genes. Her doctor couldn’t help her, because Myriad Genetics holds the patent on the genes, and forbids other doctors or companies from testing for them.

This week, the ACLU, several breast cancer survivors, and professional groups representing more than 150,000 scientists, sued Myriad Genetics over their breast cancer gene patents. Those genes, mutated forms of BRCA1 and BRCA2, are responsible for most cases of hereditary breast and ovarian cancer. They’re also very lucrative, because Myriad has created something of a monopoly. It charges $3,000 per test, which often isn’t covered by insurance. No one else can offer the test, and researchers can’t develop new or cheaper ones (or new therapies for that matter) unless they get permission from Myriad and pay a steep licensing fee. So women have no choice about who performs their tests, and they can’t seek those second opinions. That is no small thing. Tests aren’t 100 percent accurate, and results sometimes come back inconclusive. Women with the BRCA1 and BRCA2 mutations have a 40 to 85 percent chance of developing breast cancer, so a positive result helps them decide whether to have their breasts and ovaries removed to prevent future cancer. But with its lawsuit, the ACLU isn’t just fighting Myriad’s patent—it hopes to end the practice of gene patenting entirely on the grounds that it’s illegal, unconstitutional, and interfering with science.

“If genes are patented...there can be a serious and negative effect on diagnosis and treatment of disease,” the ACLU wrote in its complaint. “The effect of the patents has been to stifle clinical practice and research on the genetic predispositions to breast and/or ovarian cancer. The public, and, in particular, women, have suffered unnecessarily as a result.”

In a survey done a few years ago, 53 percent of laboratories had stopped offering or developing a genetic test because of patent enforcement, and 67 percent felt patents interfered with medical research. It costs $25,000 for an academic institution to license the gene for researching a common blood disorder, hereditary haemochromatosis, and up to $250,000 to license the same gene for commercial testing. At that rate, it would cost anywhere from $46.4 million (for academic institutions) to $464 million (for commercial labs) to test a person for all currently-known genetic diseases.

Though patent law says “products of nature” can’t be patented, genes have long qualified because they’re “isolated from their natural state and purified.” The first ruling allowing for the patenting of a life form came in 1980, in the landmark case of Diamond v. Chakrabarty. Ananda Mohan Chakrabarty, a scientist working for General Electric, had created a bacterium genetically engineered to consume oil with hopes that it could help clean oil spills. When the patent office denied his application citing the law against patenting anything naturally occurring, Chakrabarty sued, and won. His lawyers argued that the bacterium could be patented because it had been altered using human ingenuity.