Malta provides loophole for breast-cancer screen

from Nature

Erika Check

A Maltese biotechnology firm is set to challenge the potential monopoly on breast-cancer screening held by US company Myriad Genetics.

Synergene, which was set up in Malta in 2000, claims to have found a loophole in Myriad's patents, and says that it will launch a diagnostic test for breast cancer next January.

Myriad, which is based in Salt Lake City, Utah, owns patents on the genes BRCA1 and BRCA2, and on tests to detect mutations in these genes. Such mutations are thought to account for a sizeable number of breast-cancer cases.

But Myriad has invoked the wrath of doctors and researchers across Europe by trying to stop them from using their own tests to search for BRCA mutations.

Synergene says that Myriad's patents do not apply in Malta because the country has not signed the European Patent Convention, and Myriad has not applied for separate patents on its diagnostic tests there. Synergene will charge US$2,000 for its new test, which will be similar to that offered by Myriad, and will be performed at Synergene's lab in Malta, says Patrick Willems, the firm's medical director.

Currently, doctors wanting to use Myriad's diagnostic tests must send samples to the company's laboratory in Salt Lake City. Alternatively, they can order similar analyses in Europe, as many labs have devised their own tests for mutations in the BRCA genes. But Willems says that he was frustrated by the European tests at his former job as a clinical geneticist at the University of Rotterdam. "We had to wait four months to get the results back," he says.

Willems adds that European labs may soon have to stop offering their home-brewed tests. European researchers, patient groups and governments have lodged formal complaints against Myriad's patents (see Nature 413, 95–96; 2001). But if their effort fails, academic labs may have to pack up their test kits.

"We will be an alternative to Myriad, even if Myriad succeeds in enforcing its patent in Europe," Willems says.

But some opponents of Myriad's patents are unimpressed. Dominique Stoppa-Lyonnet, a doctor at the Curie Institute in Paris, says that Myriad might be able to prosecute French geneticists who buy tests from Malta. And French researchers probably won't want to pay Synergene's prices, she says, even though the company will charge $760 less than Myriad per test. "It is an interesting situation, but I am afraid it is just another way to make a lot of money," says Stoppa-Lyonnet.