The US Supreme Court will hear oral arguments this week to decide whether companies can patent human genes, in a landmark case which could alter the course of US medical research and the battle against diseases such as breast and ovarian cancer.
A coalition of scientists, cancer survivors, patients, breast cancer groups and professional medical associations, which has brought the case, will argue that genes are “products of nature,” like organs of the body, and should not be exploited for commercial gain.
Such patents are illegal and violate the First Amendment, they say. They are challenging patents on two genes linked to breast and ovarian cancer owned by Myriad Genetics, a biotechnology company, because they say the patents have stymied research and the free exchange of ideas.
Myriad, based in Salt Lake City, Utah, will ask the court to uphold the patents, which it says is vital compensation for developing a potentially life-saving test to asses the risks of breast and ovarian cancer and to advance medicine. Myriad’s BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA.
In March 2010, a New York district court agreed with an American Civil Liberties Union challenge to Myriad’s patents on “isolated” forms of BRCA1 and BRCA2, by arguing that genes should not be patented.
However, the US Court of Appeals for the federal court has now ruled twice that the isolated genes patented in Myriad’s case have a “markedly different chemical structure” from DNA within the body.
Breast Cancer Action, one of the plaintiffs in the case, said that the patents have meant that Myriad has become “the gatekeeper of all research on the BRCA gene.”
Karuna Jaggar, executive director of Breast Cancer Action, said that the patents allow Myriad to stifle how researchers, doctors and others can carry out research on the human BRCA genes, to develop an alternative test and to target treatment.
“Myriad is gatekeeping who can do what research on these genes and they are uniquely aggressive in how they control a patent,” Jaggar said.
Nearly 20 percent of the human genome — more than 4,000 genes, including some linked to Alzheimer’s disease and colon cancer — is already covered by at least one patent.
Some are held by companies, while others are held by universities, research institutions and others committed to “open source genomics” who hold them “pre-emptively,” to stop commercial companies from having them.
Jaggar said women currently only have one option if they want to know their genetic risk for breast and ovarian cancer, but the Myriad test is expensive, not always covered by insurance and does not cover all potential causes for hereditary breast cancer.
“The Supreme Court has the opportunity to right this wrong, to correct a problem that could free up human genomics to develop new diagnostic tests” she said.
Many insurance companies do not cover the test because the insurance companies have to negotiate with Myriad, she said.
A brief to the court, filed by the American Civil Liberties Union, states that the patents pre-empt “serious study, clinical examination or commercial or clinical use” of the genes.
Among the plaintiffs are researchers who say they had to halt work because of Myriads patents, and breast cancer survivors who say their health insurance does not cover the US$3,000 test.