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Gene patent lawsuit starts next week

1 February 2010
Appeared in BioNews 543

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.

Boston Patent Group Joins Long List of Amici in Controversial Gene Patent Case |  20 January 2010
Gene Patent Debate Back in the Spotlight
Softpedia News |  27 January 2010
Lawsuit rekindles gene-patent debate
Nature |  26 January 2010
14 November 2011 - by Martin Turner 
In what appears to be the end of a long running legal saga, a ruling by the UK's Supreme Court has found in favour of a patent for a gene and the protein sequence it encodes. Lawyers say that the ruling will make it easier to patent discoveries which do not have a clear demonstrated application, a result that will largely please the private bioscience industry but may alarm many who believe that human genes should not be patentable....
22 August 2011 - by Nishat Hyder 
The NHS may be at risk of being sued over patent infringement, says a new report published by the Human Genetics Commission (HGC), the UK Government's genetics advisory body...
21 February 2011 - by Gozde Zorlu 
The widespread patenting and privatisation of stem cell lines, data and technology could hinder medical research in this field, a group of scientists has warned in a paper published in Science this month....
14 June 2010 - by MacKenna Roberts 
The Australian Federal Court in Sydney is considering groundbreaking legal action of whether private companies can obtain patents on human genes....
6 April 2010 - by Dr Vivienne Raper 
A US judge has invalidated a genetic testing company's patents on two breast cancer genes...
8 November 2009 - by Dr Marianne Kennedy 
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....
22 May 2009 - by Heidi Colleran 
A major lawsuit in the US is challenging the right of private companies to hold patents on genes involved in diseases, as well as their right to offer exclusive genetic tests. The American Civil Liberties Union (ALCU), the Public Patent Foundation (PPF), more than a dozen universities...
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