Families sue over gene patent

US families affected by Canavan disease, a severe genetic condition, are suing the institute that identified the gene involved, reports last week's Science. The Miami Children's Hospital (MCH) obtained a patent on the gene in 1997, and began licensing a genetic test for the illness the following year. But the licence is now the focus of a lawsuit, filed on 30 October by four parents and three non-profit groups.

MCH and Reuben Matalon, the scientist who led the research, are charged with 'misappropriation of trade secrets', based on their use of blood and tissue samples to secure a gene patent without the donors' consent. The legal battle follows a successful thirteen-year partnership between families and researchers, in which families affected by Canavan disease set up a registry of patients and helped to recruit tissue donors.

Canavan disease is caused by a deficiency of the enzyme aspartoacyclase, which leads to a gradual destruction of the central nervous system (brain and spinal cord). The plaintiffs filing the lawsuit object to the $12.50 licensing fee, which they say forced the Canavan Foundation to stop offering families a free genetic test.

Matalon, who receives no royalties from the test, acknowledges that the families helped him by providing samples and 'seed' money for the research project. But he says that MCH provided $1 million a year, and in return asked him to turn over any marketable intellectual property. Judith Tsipis, a biologist who lost a son to Canavan disease, says that the suit 'is not about the Canavan families wanting a piece of the pie' but about having a say in how their contributions are used.