US lawsuit challenges corporate monopoly on gene patents

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, genetic specialists and medical associations, as well as five cancer patients, are suing a biopharmaceutical company, Myriad Genetics (MG) of Salt Lake City, over patents on two genes related to ovarian and breast cancer. The outcome of the US case could have far-reaching implications for genetic research and diagnostics, given that around twenty per cent of human gene sequences are currently patented, including those involved in Alzheimer's disease, muscular dystrophy, colon cancer, and asthma.

MG and the University of Utah Research Foundation (UURF) were granted patents on the breast cancer genes BRCA1 and BRCA2 in the mid-1990s. As well as the gene sequence itself, such patents usually include information on methods of use related to variants involved in disease. The BRCA patents therefore allow MG to offer the only genetic test for women in the US to determine whether they have a mutation in either of these two genes, which cause hereditary forms of breast and ovarian cancer, at a cost of up to $3,000. In contrast, almost all Myriad's BRCA gene patents were revoked or amended in Europe following a series of challenges, and European laboratories can now carry out most BRCA gene testing free of charge.

The plaintiffs claim that exclusive rights to patents and diagnostic tests by private companies not only prohibit faster and cheaper testing by a multitude of companies, but also slow down research into new treatments by other cancer specialists. Anthony Romero, director of the ALCU, argues that when private companies are allowed to hold gene patents, peoples' constitutional right to knowledge about the human body and to make pertinent healthcare decisions are jeopardised. Another plaintiff, Jan Nowak, president of the Association for Molecular Pathology (AMP), went on to say, 'you can't patent my DNA, any more than you can patent my right arm, or patent my blood'.

Dan Ravicher, a patent law professor at Yeshiva University's Benjamin N. Cardozo School of Law (YUBCSL) who is involved with the US case, sets out the long-term objective of the lawsuit; 'it is absolutely our intent that upon victory this will rend invalid patents on many other genes'.

However, supporters of gene patenting argue that protecting intellectual property is central to the success of the biotech industry and crucial for securing investment in later research, since temporary monopolies reward companies for their prior investment. Moreover, a report carried out by the National Academy of Sciences in 2006 did not find any evidence that gene patents significantly limited innovation in research or medical care.