Report urges curbs on gene patenting | The Australian

Report urges curbs on gene patenting

* Adam Creswell
* From: The Australian
* December 04, 2010 12:00AM


A LONG-AWAITED Senate report has recommended laws be tightened to make it harder for companies to win patents over genetic material.

A two-year inquiry heard that such patents had hindered important medical research.

The report includes a stinging rebuke for the Australian body responsible for issuing patents, IP Australia, with the committee declaring it "strongly rejects" the regulator's reasoning that genetic information "isolated from its naturally occurring state in the human body may be classed as an invention".

And the report recommends a broader exemption for research scientists to allow them freer access to patented material without fear of licensing fees or legal claims.

However, the Senate Community Affairs Committee has stopped short of recommending gene patenting be banned, arguing this may have unintended consequences and should already be implicit within the existing rules.

The inquiry was launched after an outcry over attempts by an Australian company, Genetic Technologies, to exercise patent rights over tests for the two main gene mutations linked to breast cancer, BRCA1 and BRCA2.

The company eventually backed down, but the case drew public attention to the practice of patenting genes, which has since led to court challenges in Australia and the US.

A US court ruled recently such gene patents were not patentable.

NSW Liberal senator Bill Heffernan, who has campaigned for a ban on gene patenting since 2008 and was a member of the Senate inquiry committee, says he "would have preferred it to have gone further" but welcomes its conclusions.

During the last parliamentary sitting a cross-party group of MPs and senators, including Heffernan, introduced private members' bills into the Senate and House of Representatives aimed at preventing patents being issued over human genes.

Biotech patent expert Luigi Palombi says he is pleased with the report and not surprised it baulked at backing an outright ban given "IP Australia, the biotechnology industry and patent attorneys had vigorously argued" against it.

Palombi, with the University of Sydney and Australian National University, says the committee's rejection of IP Australia's approach to date is significant, given that the regulator's rationale has been applied not only to human genetic materials but to those of animals and isolated biological materials more widely, including proteins and viruses.

According to Palombi, the report's 16 recommendations -- which include calls for better transparency and auditing requirements -- also strongly suggest the existing patent system "isn't working very well", despite IP Australia instituting several reviews of its own into its processes soon after the Senate inquiry got under way.

But the professional body for patent lawyers claims the report should "put an end to a highly charged and emotive debate" which has been "constantly fuelled by misinformation".

The Institute of Patent and Trade Mark Attorneys says any changes to patent rules should apply across all technologies rather than singling out genetic science. It insists the process of determining a gene's function and isolating it from its environment "can provide the basis for securing a patent".

The IPTA says without gene patents the cervical cancer vaccine Gardasil "may never have been developed". It adds the absence of gene patents would have no effect on the proprietary nature of the BRCA test that had triggered the inquiry, saying such tests "are separately patented and are entirely unrelated to the ownership [or not] of a gene".
Report urges curbs on gene patenting | The Australian