How Myriad's GCAT got out of the bag

The past two decades have produced a plethora of patents for DNA diagnostic tests to determine people's susceptibility to common, life-threatening disorders like cancer, cardiovascular disease, hypertension and neurodegenerative diseases like Alzheimer's disease and motor neuron disease.

Such patents can be enormously lucrative to the companies that own them, but the companies, in turn, claim to render a public service by making the potentially life-saving tests widely available.

But the boundary between corporate altruism and avarice moves with the tides of community, media and political opinion -- and woe betide any company perceived to be exercising a patent in a way that puts profit before public good, or that restricting life-saving research into the disease in question.

This year, Salt Lake City-based gene-testing company Myriad Technologies has seen the European Patent Office (EPO) revoke two valuable patents on its DNA tests for susceptibility to breast cancer.

The EPO had issued four European patents on Myriad's proprietary DNA diagnostics for detecting high-risk variants of two key tumour-suppressor genes involved in breast and ovarian cancers, BRCA1 and BRCA2.

But last February, the EPO revoked Myriad's only European patent on the BRCA2 gene, in favour of a UK charity. Then, on May 17, the EPO revoked one of Myriad's three patents on the BRCA1 gene test, issued in January 2001.

The BRCA1 and BRCA2 tests have been commercialised in Australia, New Zealand and Asia by Melbourne biotech Genetic Technologies Limited (ASX:GTG) under an reciprocal arrangement that gives Myriad rights to GTG's broad patent on DNA diagnostics based on non-coding DNA.

GTG was caught up in its own patent controversy last year, during the International Congress of Genetics in Melbourne. Several eminent geneticists, including British Nobel laureate Sir John Sulston, and Human Genome Project coordinator Dr Francis Collins, strongly criticised the company's patents on non-coding DNA for detecting disease susceptibility haplotypes.

But after the first GTG patents were issued in the early 1990s, a decade passed without no opposition in any jurisdiction. Nobody appeared to realise their significance, or their broad applicability to gene-testing.

European patent law requires oppositions to be lodged within nine months issue -- and in contrast to GTG's experience, Myriad's breast-cancer tests encountered strong opposition from the date of issue. The decision was widely criticised in the media and in the European parliament.

GTG's managing director, Dr Mervyn Jacobson, says the opposition to Myriad's BRCA1 patent was filed in October 21, 2001 by a group of agencies and research institutes led by the Institut Curie in Paris.

"Another group of community organisations also filed, but its case was based more on concerns about the company's attitude -- its corporate style and its costing structure for the test," says Jacobson.

He said some opponents objected to the company's restrictive policy, which required all tests to be sent to its US headquarters. Others simply thought its charges were too high.

"All this might be true, but these are not acceptable grounds for opposition. Oppositions must be based on respect for the technical aspects of the patent rules," Jacobson urges.

Myriad's original patent filing in 1994 contained several errors in the DNA sequence of the BRCA1 gene. In 1995, the company had submitted a revised sequence, correcting the errors -- a normal procedure, according to Jacobson.

But it turned out that the new sequences had already been published. While the EPO panel that reviewed the case had not formally announced its reasons for revoking the patent, the Institut Pasteur opposition apparently asserted this earlier publication of the correct sequences met the definition of 'prior art', which meant the Myriad patent lacked novelty.

Jacobson says the decision doesn't affect Myriad's two other European patents on the BRCA1 test, and Myriad has reportedly said it will exercise its right to appeal the EPO panel's decision.

Although Myriad filed its BRCA1 patent in 2001, Jacobson says it has not yet sought to enforce either its BRCA1 or BRCA2 patents in Europe. Should its lose its appeal, Myriad has a fall-back position. Under its agreement with GTG, it has the right to commercialise GTG's non-coding DNA patents in Europe, at least as they apply to the BRCA1 and BRCA2 genes.

Says Jacobson, "It may well be that Myriad is appreciative of having access to patents like ours. It may well be that their plans in Europe are dependent to some degree on our support for their parents.

"It's just an example of the need to be incredibly stringent in following the rules precisely, which is what we have done with our patents."