Methods to isolate and detect BRCA1 and BRCA2 were patented in the United States by Myriad Genetics. This US patent has been challenged by the American Civil Liberties Union. On March 29, 2010, a coalition led by the American Civil Liberties Union (ACLU) successfully challenged the basis of Myriad’s patents in New York District Court. The patent was invalidated, but the decision was appealed. On July 29, 2011 the United States Court of Appeals for the Federal Circuit made their decision and ruled that Myriad's patents are valid.
Effect on Gene Testing
The conditions of Myriad’s BRCA patent require that the only laboratories legally allowed to test and sequence the genes are the ones affiliated with Myriad. This exclusive control over BRCA testing, guaranteed by the patent, has prevented peer-reviewed validation of the tests provided by Myriad.
Since the BRCA test is marketed directly to the consumer, it is not subject to government oversight by agencies like the FDA. Without this government review, gene tests must be studied and assessed by scientific colleagues in a peer review. However, the kind of studies needed to validate the tests require access to the BRCA genes, which are protected by Myriad’s restrictive patent. Thus, without access to the genes or the methods used to sequence them, peer review of the test’s effectiveness is virtually impossible.
However, the patents have yet to be enforced in Europe, where BRCA research and testing is becoming more widely available, and several laboratories are currently offering their own BRCA testing. The UK firm NewGene offers the test at a very competitive price, to the NHS, its owner, only.
Legal decisions surrounding the BRCA1 and BRCA2 patents hold particular bearing on the field of genetic testing, as the field is relatively young. Until legal guidelines can be applied to the practice of gene testing, progress in the field will likely suffer due to uncertainty. Any decision made regarding the BRCA patents will likely become precedent for future disputes over the use of genes for testing.