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A team that has just been granted British patent rights on a gene whose mutations are linked to breast cancer has licensed the use of the genetic data in an unusual agreement that requires the exclusive licensee to meet strict conditions for what the team views as ethical use of any diagnostic tests it develops.

These include broad sublicensing of diagnostic tests to other concerns, a requirement for pre- and post-test counselling, and a ban on direct advertising of screening tests to the public. The use of the techniques will be made freely available to Britain's National Health Service (NHS).

The London-based Cancer Research Campaign Technology (CRCT) and its US partner, Duke University in Durham, North Carolina, have been granted a British patent for the full-length coding sequence of the gene, thought in its unmutated state to produce a tumour suppressor protein.

But the US patent situation remains open. Both CRCT/Duke and their major competitor in the race to find the gene — Myriad Genetics of Salt Lake City, Utah — have applied for BRCA2 patents. Myriad announced its move the day before the CRCT/Duke team published its discovery of the mutation in 1995 (see Nature 378, 789; 1995). A decision by the US Patent and Trademark Office is not likely for at least two years.

CRCT/Duke's rights under the British patent include pharmaceuticals, diagnostic methods and a method for producing the protein manufactured by the gene. The US company Oncormed of Gaithersburg, Maryland, has been granted an exclusive worldwide licence to the patent for diagnostic services and products.

In return, Oncormed has agreed to sublicense diagnostic tests broadly to hospitals, nonprofit organizations and commercial groups. As a condition of receiving the licence, it has granted the UK NHS a free licence to practise BRCA2 testing. “Our goal is to broadly license gene discoveries for diagnostic purposes,” says Leslie Alexandre, Oncormed's corporate affairs vice-president.

One author of the Nature paper, Mike Stratton, professor of cancer genetics at the Institute of Cancer Research, Sutton, says that his group's intention in patenting BRCA2 was to prevent it from becoming the exclusive province of one commercial interest. Taking out the patent was “the only way of defending the gene” and of having “some control over its future”, he says.

In choosing to grant an exclusive licence to Oncormed, he says, CRCT set down four principles that the company promised to adhere to: that it would sublicense diagnostic tests to other concerns; that access to diagnostic tests should be only through doctors, with thorough pre- and post-test counselling; that no attempt should be made to “drum up business” through advertising to the public; and that the NHS, which contributed to the gene's discovery, should not be charged a licence fee.

Patricia Murphy, a geneticist at Albany Medical College in New York state and a consultant to Oncormed, says that to her knowledge the arrangement is the first of its kind. Typically, she says, “the reason you get an exclusive licence is to capture the market and prevent others from doing the testing”.

But some say that agreements with private companies cannot be substituted for government regulations requiring that genetic testing be conducted ethically and responsibly. One critic is Neil Holtzman, the director of genetics and public policy studies at the Johns Hopkins Medical Institutions in Baltimore, Maryland.

Holtzman chaired the task force on genetic testing of the Working Group on the Ethical, Legal and Social Implications of Human Genome Research, established by the US National Institutes of Health and the Department of Energy. “I would not entrust a company, as apparently CRCT has done, to ensure that all testing will be appropriate,” says Holtzman. “I think you need external control and review.”

Stratton's group once collaborated with Myriad, but fell out with it in 1994 when Myriad filed for a broad patent on the other breast cancer gene, BRCA1 , which its scientists discovered in collaboration with researchers at the University of Utah. CRCT and Stratton say that they have profound philosophical differences with Myriad about how widely available the diagnostic and therapeutic applications of patented genes should be made.