Patent: Further information: Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.
Methods to isolate and detect BRCA1 and BRCA2 (Breast cancer genes) were patented in the United States by Myriad Genetics. (So just so everyone is clear, this company has effectively patented a part of the human genome, human genes. There are lots of examples of this kind of idiocy, including famously a Texas company patenting Basmati Rice and then seeking to prevent Indian & Pakistani growers from selling their rice under the name Basmati any longer in jurisdictions covered by the patent).
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 Myriads 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. (Is this funny, tragicomic, enraging, befuddling, ludicrous, or just the free-market?)
Thus, without access to the genes (meaning you cannot even study them without paying Myriad a patent license fee, assuming they are willing to grant it, in the USA – like I said, you could not make this up) or the methods used to sequence them, peer review of the test’s effectiveness is virtually impossible. (here I have to disagree, it is impossible unless you pay Myriad for the use of their patents to study their methods to determine if they are actually effective. Genius, I wish I had a patent on you.)
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. (Equally surreal and non-sensical, of course. But cheaper…)
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.