A lawsuit challenging the patents relating to two genes linked to hereditary breast and ovarian cancer will proceed, a US federal judge ruled last week.
The patents on the BRCA1 and BRCA2 genes are owned by the University of Utah and exclusively licensed to Salt Lake City-based Myriad Genetics. From the late 1990s, Myriad started to contact various institutions demanding the cessation of research on the genes and the testing of woman for risk-carrying mutations.
In May this year the patents were challenged by an alliance of various women's health groups, geneticists and scientific associations including the Association for Molecular Pathology, who led the dispute. The lawsuit, brought against the US Patent and Trademark Office (USPTO), University of Utah Research Foundation (UURF) and Myriad, argues that genes are 'products of nature' and cannot be patented. Backed by lawyers at the American Civil Liberties Union and Public Patent Foundation the lawsuit also claims that the BRCA patents 'stifle research that could lead to cures and limit women's options regarding their medical care'.
In July, the USPTO filed a motion to dismiss the lawsuit, contesting that 'the Court lacks subject matter jurisdiction' and that the plaintiffs 'fail to state a claim for a constitutional violation'. UURF and Myriad also filed their own complaints against the case.
US Federal District Judge Robert Sweet ruled that the lawsuit should proceed, stating that the plaintiffs, 'possess the necessary standing to bring their claims against the defendants', and that the allegations 'are plausible, specific, and form a sufficient basis for [the] plaintiff's legal arguments'.
Judge Sweet said that the outcome could have implications for 'the health of millions of women facing the spectre of breast cancer' as well as the 'future course of biomedical research'.
Indeed, the outcome of the lawsuit is predicted to have far-reaching consequences for the entire practice of gene patenting, beyond that of BRCA1 and BRCA2.
The US court ruled that the hearings will be held on 11 December.
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