Challenge to patented breast cancer test

A Maltese biotechnology firm claims it has identified a loophole in the controversial patents on two genetic tests for breast cancer held by US company Myriad Genetics. Synergene says that the patents do not apply in Malta, as the country has not signed the European Patent Convention. It plans to launch its own diagnostic test for inherited breast cancer next January, according to a news report in Nature.

Myriad Genetics has faced a barrage of criticism from scientists, governments and patient groups opposed to the patents that it holds on the genes BRCA1 and BRCA2. People who inherit particular altered versions of either gene are at high risk of developing familial breast or ovarian cancer, so Myriad has patented a test that looks for these alterations. It has tried to stop laboratories across Europe from performing their own BRCA1 and BRCA2 diagnostic tests, although it has not yet succeeded in doing so.

The medical director of Synergene, Patrick Willems, says that the firm will charge $2000 for its BRCA gene tests ($760 less than Myriad), which it will carry out in Malta. 'We will be an alternative to Myriad, even if Myriad succeeds in enforcing its patent in Europe', he said. But some scientists remained unconvinced, fearing that Myriad may prosecute those working outside Malta who order tests from Synergene, and that the cost of tests from either company may be prohibitive.

Sir John Sulston, Nobel-prize winner and former head of the UK's human genome sequencing research group, spoke last week of his determination to keep human genetic information freely available. He told the BBC World Service that the fight was against inappropriate use of patenting and licensing, rather than against business.