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Challenge to gene patents in the US

26 May 2009
By Selene Kaye
Advocacy Coordinator of the Women's Rights Project, American Civil Liberties Union, New York
Appeared in BioNews 509
On 12 May, the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed a lawsuit challenging the US government's practice of granting patents on human genes - specifically, the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. In the last 20 or so years the US Patent and Trademark Office (USPTO) has issued patents on thousands of human genes - the segments of DNA that we all have in our cells - giving private corporations, individuals, and universities the exclusive rights to those genetic sequences and their usage.

The patents on the BRCA genes are particularly broad and offensive. The USPTO has granted Myriad Genetics, a private biotechnology company based in Utah, patents on both the BRCA1 and BRCA2 genetic sequences, on mutations along those genes, on any methods for locating mutations on the genes, without further specification on the type of methods, and on correlations between genetic mutations and susceptibility to breast and ovarian cancer.

This suit is the first to challenge the patentability of human genes in the US. The lawsuit charges, as critics of gene patents have argued for years, that gene patents stifle biomedical research and interfere with patients' access to genetic testing. The lawsuit argues that the patents on the BRCA genes are unconstitutional and invalid given the long-standing precedent in US patent law that 'products of nature' and 'laws of nature' are not patentable. The suit also makes the novel argument that the practice of patenting genes, their correlations with disease, and the thought of comparing two genes violates the First Amendment of the US Constitution and interferes with scientific freedom.  

To be clear, the patent claims being challenged do in fact include claims on the genes themselves. For example, the text of Patent 5,747,282, Claim 1 reads:

'What is claimed is

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.'

Translation: Claim 1 covers the BRCA1 genetic sequence, specifically the wild-type, or what is considered typical, sequence. Because the USPTO grants patents on the genes themselves, it essentially gives patent holders a monopoly over the patented genes and all of the information contained within them. Anyone who uses a patented gene without permission of the patent holder is committing patent infringement and can be sued by the patent holder. Unlike most European countries, the US does not have a research exception for patented items. This means that anyone who wants to study a patented gene, even if they don't intend to derive any profit from their endeavours, must obtain permission. The patent holder has the right to deny these applications. Thus gene patent holders in the US have the right to prevent other researchers from testing, studying, or so much as examining the genes. If the USPTO simply granted patents on particular methods of examining and testing genes, then other scientists and laboratories could develop alternative methods, and research and testing could advance at a much faster pace. This lawsuit is not challenging any patent claims over specific genetic tests.

The patents on the BRCA genes have serious implications because mutations along these genes are responsible for most cases of hereditary breast and ovarian cancers. Genetic tests can detect these mutations and tell women if they are at increased risk of cancer, which in turn informs their decisions about screening, prevention, and treatment options.

Myriad, like other private biotechnology companies in the US, is aggressive in enforcing its patents against other scientists and labs who wish to conduct clinical testing and research on the BRCA genes. This has meant that researchers cannot develop new genetic tests without permission, no one can get a second opinion, and women who receive ambiguous test results have no recourse. Myriad is the sole provider of full sequencing testing in the US, and some women cannot access testing at all because of the high price Myriad charges - currently over $3,000. While the American healthcare system generally encourages competition among private companies that in turn set prices for medical services, gene patents allow for these testing monopolies.

This case could have far-reaching effects beyond the BRCA genes because it challenges the fundamental notion of gene patenting. Twenty per cent of human genes have been patented in the US, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, and asthma.

To read the complaint, plaintiff statements, and more about the case, visit www.aclu.org/brca and to sign a statement of support, visit www.aclu.org/genepatents.

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