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Legality of breast cancer gene test patent under probe


22/07/2008 -

A patent lawyer has claimed that exclusive rights over a breast cancer gene test used by thousands of Australian women may be illegal and unenforceable.

Biotechnology company Genetic Technologies has announced it will enforce its patent rights over tests for two genetic mutations, BRCA1 and BRCA2, which increase breast cancer risk.

Under the arrangement, the company has ordered the nation's eight public laboratories to stop doing the test so it can offer it exclusively.

The move enforces the company's rights granted by the patent owner, US firm Myriad Genetics. But Australian cancer experts fear the arrangement will drive up the $2,500 test price tag, limiting availability to Australian women and stifling genetic research.

Now Australian National University academic Dr Luigi Palombi, a specialist in biotechnology patents, claims the tests are "unpatentable" and says their validity needs to be tested in an Australian court.

"In my view they're not patentable and should be revoked," he said.

"The Patents Act requires that there be an invention and quite frankly discovering that there is a link between a particular gene mutation and human disease is not what I would call an invention.

"It's a discovery, a great discovery, but not something that should be the subject of a patent that affects price and prevents other scientists using that genetic material to make more discoveries."

He said patents were relevant for medicine and tests developed with cutting edge technology, "but finding an association is not enough".

The specialist is garnering interest from cancer researchers, awareness groups and ministers in mounting a legal test case to challenge the move.

Cancer Council Australia chief executive Professor Ian Olver said commercial interests in genetic material was "concerning" and needed to be further investigated.

"It is certainly of interest to me that this is an area where there is little clarity in Australian law," Prof Olver said.

"There's a very important public interest issue here, with the health of Australian women at stake."

Genetic Technologies business development manager for medical diagnostics, Jonathan Whitty, has said the company is enforcing its rights under law, and argues that claims about price rises and limitations to research are "a farce".

Source: AAP NewsWire

 



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