Legal challenge to gene patents in US

28 May 2009

The long standing gene patents held by Myriad Genetics, for diagnosing a predisposition to breast and ovarian cancer using BRCA1 and BRCA2  testing, are now facing a legal challenge that could threaten the validity of all gene patents (reported in Science).
In the US District Court of New York, on 12th May 2009, a lawsuit was filed against not only Myriad Genetics but also the US Patent and Trademark Office and the University of Utah Research Foundation. The challenge is lead by the American Civil Liberties Union (ACLU) and the Public Patent Foundation on behalf of breast cancer and women's health groups, individual women, and scientific associations representing around 150,000 researchers, pathologists and laboratory professionals (see ACLU press release).
Numerous mutations in both BRCA1 and BRCA2 genes predispose women to a high risk of getting breast and ovarian cancer. Women with a family history of these diseases often use genetic testing to help decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal. The patents granted to Myriad give the company exclusive rights to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any clinician or US-based researcher from looking at the genes without first getting permission from Myriad. According to the lawsuit, “such monopolistic claims over these genes hampers clinical diagnosis and serves as a disincentive for research”. Additionally, the patents “block women's access to medical information necessary for making vital health care decisions”, as the high price tag may prevent women from being tested or seeking a second opinion.
Comment: Although the scope of the BRCA1 patent has been altered on several occasions (see previous news), both the BRCA2 and amended BRCA1 patents have ultimately been upheld in Europe by the European Patent Office (see previous news). However, even the existing patents are significantly more prohibitive in the US than across Europe, because there is no exemption for research under US patent law.
If this new American challenge is successful, the validity of these and many other gene patents may change across the globe. Far from being limited to these specific patents, the current lawsuit challenges the whole notion of gene patenting, claiming that gene patents are illegal under patent law because genes are "products of nature", which can only be identified not invented. The premise upon which gene patenting is based relates not to the genetic sequence, but to its isolation and purification, a notion that dates back to the early 1900’s when a patent on adrenalin purified from glands was granted. However, although around 20% of all human genes have been patented, the validity of applying this principle to genes has been widely questioned.
The US Secretary’s Advisory Committee on Genetics, Health and Society recently released a draft report for public consultation on gene patents and their impact on patient access to genetic tests, to which the PHG Foundation responded. The draft report was launched prior to the filing of this lawsuit, and falls substantially shy of recommending against gene patenting. Nonetheless, it highlights the increasingly pertinent issue of how the thousands of existing gene patents will affect complete genome sequencing, and vice versa. The outcome of this trial is therefore likely to have far-reaching consequences, not only for clinical genetics, but also for the development and use of commercial full genome sequencing services.

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