The ACLU is in court with the U.S. Patent Office and Myriad Genetics over the validity of patents Myriad acquired for the genes BRCA1 and BRCA2. Mutations of these genes are connected to breast and ovarian cancer.
In a press release, the ACLU state, “The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad.” ACLU lawyers claim that Myriad’s patents hamper clinical diagnosis and research on the cancer causing mutations.
Robert Cook-Deegan, a director at Duke University’s Institute of Genome Sciences and Policy states, “If the ACLU wins, it will be game changing in terms of how patents are granted for genetic testing. I really have no feel for how the courts will handle this.”
The plan is to make a judge decide if naturally occurring genes can be patented.
The Supreme Court’s decision in the 1980 case of Diamond V. Chakrabarty states, “A live, human-made micro-organism is patentable subject matter under [Title 35 U.S.C.] 101. Respondent’s micro-organism constitutes a “manufacture” or “composition of matter” within that statute.” One of the distinctive differences between the gene patenting case and this is that the bacteria in question were not naturally occurring like Myriad’s patented genes. Even so, this established that living things could in fact be patented.
The cost of the test for these genes is another driving force behind the suit. Patients with a family history of breast cancer are balking at the $3,000 test to see if their BRCA1 & 2 genes have mutated cancerously. The plaintiff claims the price of these tests would decrease if more companies were allowed to perform them. This would also give patients to get multiple tests from different sources.
The United States is not alone in gene patenting. The Canadian Intellectual Property Office issued over two thousand patents for genes or nucleic acid sequences during the twenty-year period between 1980 and 2002.
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