Is the grant of a patent the most effective way of encouraging medical research and innovation? This is the question now facing a US Federal court in proceedings being led by the American Civil Liberties Union (ACLU) against Myriad Genetics and the University of Utah Research Foundation, who jointly hold the patents for the BRCA1 and BRCA2 genes (genes which are associated with breast cancer), and the US Patent and Trademark Office (USPTO).
The ACLU filed proceedings in May 2009 alleging that the patents over the BRCA genes are invalid and unconstitutional. The ACLU, together with the Public Patent Foundation, is representing an extensive group of plaintiffs that includes the Association for Molecular Pathology, the American College of Medical Genetics, the College of American Pathologists as well as breast cancer advocacy groups, researchers and individual women.
At the heart of the issues are the plaintiffs’ concerns that Myriad Genetics have been given a mandate to exercise control over the BRCA genes and the exclusive rights to administer diagnostic tests by the USPTO. The plaintiffs argue that this limits options for medical care and testing, and hinders research.
Both sides argued motions before the court last Tuesday, seeking to have the proceedings dismissed. A ruling on the motions is expected in the next few months. Whether the parties succeed on their respective motions, and the final outcome of any eventual trial, will have far-reaching consequences for gene patents and genetic research in the US.
The Australian position
In Australia, the patentability of genes is the subject of a pending Senate inquiry with a report due to be handed down by 18 March 2010.