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Gene test hopes chilled by legal action

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Hopes that life-saving genetic tests will become cheaper and easier to access after a breakthrough United States Supreme Court ruling have been clouded by legal action launched by patent holder Myriad Genetics.

Two companies that offered cut-price screening tests for BRCA 1 and 2 genes in the wake of a Supreme Court judgement that human genes could not be patented have been sued by Myriad Genetics, alleging breach of its patents.

Myriad has filed complaints with the US District Court in the District of Utah against two companies, Ambry Genetics and Gen by Gene Limited, that began offering BRCA 1 and 2 diagnostic tests immediately following the Supreme Court’s decision.

In the action, Myriad claims the companies have infringed 10 of its patents related to tests of the BRCA 1 and 2 genes, mutations of which have been implicated in the occurrence of several cancers including breast cancer.

BRCA testing came to international prominence earlier this year when it was revealed actor Angelina Jolie had had a double mastectomy after tests revealed she was at high risk of developing breast cancer.

The legal action is expected to deter other potential test providers from entering the market until it is resolved, dimming hopes that the Supreme Court decision would quickly pave the way for cheaper and more readily accessible BRCA gene tests.

Under Myriad’s monopoly, the tests have cost between $3300 and $4500 in the United States, but following the Supreme Court ruling this had dropped as low as $1100.
Ambry Genetics said it would vigorously defend itself against the Myriad lawsuit.

“We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing, and Ambry is fully committed to supporting our clients and patients moving forward,” Ambry Chief Executive Officer Charles Dunlop said in a statement.

But Myriad spokesman Ron Rogers told amednews.com its legal action was a “classic patent case” that had nothing to do with issue at the centre of the Supreme Court ruling.

“We consider this to be ordinary, classic patent cases,” Mr Rogers said. “They’re infringing our patents covering the use of primers, probes and arrays, as well as methods of testing.”

While the Supreme Court ruled that human genes could not be patented, Mr Rogers said it nonetheless affirmed the eligibility of patents on complementary DNA, synthetic genetic sequences and new applications for genes that had been discovered.

“Those are the claims that are really at issue in what we consider to be classic patent cases that we recently filed,” he told amednews.com.

The US Supreme Ruling, and the subsequent District Court action, have no legal standing in Australia, but they are likely to be taken into account by the Full Bench of the Federal Court when it rules, possibly within days, on an appeal against a court ruling that upheld Myriad’s patent claim on human genes.

Adrian Rollins