30 March 2010
In the latest legal reversal, a US judge has ruled that two patents held by Myriad Genetics for the diagnosis of mutations in the BRCA1 and BRCA2 genes associated with inherited predisposition to breast-ovarian cancer syndrome are invalid.
Legal action was taken against the company along with joint patent holders the University of Utah Research Foundation and the US Patent and Trademark Office last year by the American Civil Liberties Union and the Public Patent Foundation (see previous news). They claimed that the patents, which grant exclusive rights over testing, and for which the patent holders had consistently refused to grant licences to allow any other parties to perform testing, harm at-risk women, for whom it makes accessing testing more difficult and expensive, and stifle research.
District Judge Robert Sweet reportedly said that he was invalidating the patents of the basis that the existence of DNA in an isolated form did not affect the fundamental natural state of or information encoded by that DNA in the human body – that is, isolated DNA is not substantially different from native DNA and hence cannot be patented (see Washington Post article).
Comment: Although this judgement is potentially very significant, the contentious issue of human gene patenting is by no means resolved, since yet another legal counter-move will almost inevitably follow. Cheaper access to BRCA testing in the US is unlikely to become available in the near future. However, it represents another indication that the current system of patenting that may be effective for traditional medical offerings such as pharmaceuticals is not effective for the post-genomic era. Efforts to find a compromise whereby companies can receive a financial return for investment in research without simultaneously stifling further research to the detriment of people’s health must continue.
For more detailed analysis of this judgment, see the Genomics Law Report.