The American Civil Liberties Union (ACLU) has asked the US Supreme Court to reconsider its decision to uphold the patent held by Myriad Genetics on two human genes associated with hereditary breast and ovarian cancers.
The lawsuit was filed by ACLU and the Public Patent Foundation on behalf of medical associations including the Association for Molecular Pathology, scientists, patients and women's health groups. It is the latest part of an ongoing battle over the validity of the patents held by Myriad Genetics. The lawsuit claims the patents are illegal and will both hamper scientific research and limit accessibility to medical care.
The ruling over the gene patents has been going back and forth since March 2010, when a district court declared the patents invalid, but was later overturned by the Court of Appeal for the Federal Circuit (CAFC). The decision was passed on to the Supreme Court, which asked the CAFC to reassess their judgement taking into consideration the Supreme Court's recent ruling against a similar patent.
The genes in question, BRCA1 and BRCA2, can be used to detect the risk of breast and ovarian cancer, using tests such as Myriad Genetics BRACAnalysis. Holding patents on the isolated forms of these genes, gives Myriad Genetics exclusive rights to perform these tests.
In a statement from the Association for Molecular Pathology, executive director Mary Steele Williams stated: 'Patents on genes such as BRCA1 and BRCA2 grant diagnostic test monopolies to commercial companies, which often assemble the genetic knowledge acquired through testing in proprietary databases to which the medical community lacks'.
Dr Iris Schrijver, President of the Association for Molecular Pathology, added: 'The result of this lack of competition is increased test costs; decreased patient access; reduced innovation in the development of new test methods; and dramatically reduced knowledge dissemination'.
Following the Supreme Court's instruction to reconsider the case, the CAFC still maintained that although the gene sequences are a product of nature, the process of isolating them requires human intervention that can be patented.
Myriad Genetics President and CEO Dr Peter Meldrum said: 'Importantly, the court agreed with Myriad that isolated DNA is a new chemical matter with important utilities which can only exist as the product of human ingenuity'.
However ACLU attorney Chris Hansen said: 'In our view, the court of appeals did not fully consider or correctly apply the Supreme Court's most recent and relevant patent law decisions'.
Dr Roger Klein, chair of the Association of Molecular Pathology Professional Relations Committee, is 'optimistic the High Court will continue to uphold longstanding precedents that prohibit the patenting of natural phenomena'.
It is likely that Myriad Genetics will be given an opportunity to respond before the Supreme Court decides if the case will be heard or if the CAFC ruling will stand.