A landmark US lawsuit is due to begin this week in New York which will question the right of private companies to hold patents on disease-related genes and their exclusive license rights to be the sole provider of genetic tests for those diseases. Last May, lawyers from the American Civil Liberties Union (ACLU) and the Public Patent Foundation, filed a legal action that challenged seven US patents for two genes linked to hereditary breast and ovarian cancers. The action was launched on behalf of an alliance of various women's health groups, geneticists, five patients and scientific associations led by the Association for Molecular Pathology against the US Patent and Trademark Office (USPTO) and the patent owners and licensed rights-holder.
The lawsuit is the first challenge of a patented gene on civil rights grounds. An estimated one-fifth of the human genome is patented or has patent applications pending. The controversy is whether these patents advance or hinder research. In November, New York District Judge Robert Sweet decided the case had 'standing' - legitimate constitutional grounds - and green lighted the proceedings, anticipating that resolution of the 'widespread use of gene sequence information' will bear 'far-reaching implications': '…not only for gene-based health care and the health of millions of women…but also for the future course of biomedical research.'
The claimants argue that genes are 'products of nature' and these proprietary rights over the 'most basic element' of an individual's genetic identity should not be enforceable. The lawsuit also argues that corporate monopolies stifle competitive genetic research needed to better understand genetic disease and discover cheaper, better alternative therapies, thereby violating the US First Amendment rights by restricting choice and knowledge in relation to individual health.
In the mid-1990s, the USPTO granted patents for the genetic sequence of the human genes BRCA1 and BRCA2 to the University of Utah Research Foundation (UURF). UURF then exclusively licensed its rights to the Salt Lake City-based biopharmaceutical company, Myriad Genetics, which includes rights over any variations and use of the BRCA genetic sequences. Myriad has aggressively protected its rights halting competing research. Myriad remains the only diagnostic genetic test provider to women in the US for BRAC1 and BRAC2 genetic mutations, charging $3,000 (roughly £1,500) for testing. The claim estimates that 10 per cent of women with breast cancer likely have an inherited predisposition from a parent. In Europe, challenges to these patents forced Myriad to revoke or amend its rights, and European laboratories offer most BRCA gene testing for free.
A study by the National Academy of Sciences in 2006, however, did not find strong evidence to suggest gene patents significantly limit innovation. Supporters of gene patenting argue that protecting intellectual property is paramount to attracting biotech industry investment. Nearly 30 defendants now lend support, arguing temporary monopolies reward companies for their investment - including expensive clinical trials, insurance negotiations and difficult marketing to medical practitioners.
USPTO believed the 'isolated and purified' resulting DNA sequence to be a non-naturally-occurring state, similar to patenting chemicals. Legal uncertainty has led to the less controversial patenting of specific genetic mutations, but exclusive licensing controversially given by university technology-transfer departments proliferates the corporate monopolies over diagnostic testing. This week, the US Department of Health will begin investigations into policy reform of whether non-exclusive licensing should be mandated for the use of publicly funded findings, as encouraged by the US National Institutes of Health.