Gene patents safe down under

Gene patents safe down under

The Australian government has rejected a ban on gene patents but proposed adding an ethical test to the Patents Act that could cause IP owners some headaches

The government published its response to three enquiries into aspects of its patent system - the Senate Community Affairs Committee inquiry into gene patents, the Advisory Council on Intellectual Property (ACIP) review of patentable subject matter and an Australian Law Reform Commission (ALRC) report on gene patenting and human health - on Wednesday.

Presenting the response Kim Carr, the minister for innovation, acknowledged concern over gene patents, but said that a ban was not the answer.

"We need the incentives provided by the patent system to encourage the development of new technologies. But this government will not allow patent owners to block reasonable access to affordable medical treatments and essential diagnostic tests, nor to stifle legitimate research," he said.

Gene patents have long been a controversial topic in Australia - the Law Reform Commission report dates back to 2002. As in the US, the debate in recent years has focused on Myriad Technologies and its patents covering the BRCA1 and BRCA2 genes.

Some members of Australia's Senate and House of Representatives have also introduced bills that would ban gene patents and other biological materials.

But in September this year, a Senate Committee majority report recommended that those Bills should not be passed.

This week the government has backed that finding in a 38-page response that deals with the recommendations made by the three reports in turn.

For the majority of the recommendations, the government argues that it has either already responded to them, or that they will be dealt with by the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, which is now before the Senate.

But the government did indicate that there would be further reform in three areas: creating an ethical exclusion to patentability; adding a statement of objectives for the Patents Act; and changing the test of patentable subject matter.

The ACIP report published in February this year suggested excluding from patentability "an invention the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public".

The government response states that it will consult widely and then put in place legislation to put this into effect.

The proposal has had a mixed response from patent practitioners. "I do think there are going to be some problems with it," said Wayne Condon, a partner of Griffith Hack. "It's difficult to draw the line between what's ethical and what isn't," he added.

Wayne McMaster, a partner of Mallesons Stephen Jaques, emphasised that the language that is eventually chosen for the exclusion must already have been the subject of judicial interpretation, which will provide some certainty for patent owners.

The government has also accepted an ACIP recommendation that a statement of objectives be added to the Patents Act that will emphasise its intention "that patents should not lead to patients being denied reasonable access to healthcare".

"There were a number of stakeholders who wanted a safety net to ensure that the Patents Act is not misused," said Tania Obranovich, a partner of Davies Collison Cave.

The government has also accepted ACIP's recommendation that the requirement for an invention to be a manner of manufacture be replaced by wording from the 1959 High Court case National Research Development Corporation v Commissioner of Patents.

This states that an invention should be "an artificially created state of affairs in the field of economic endeavour".

"Quite frankly, this test has served us incredibly well," said McMaster.

The Raising the Bar Bill has been delayed in the Senate and is not now expected to be passed until around March 2012 and not to come into force before April 2013.

Despite the rejection by the majority of a Senate Committee, the Patent Amendment (Human Genes and Biological Materials) Bill 2010 is still before parliament. "We are all waiting to see what will happen with these bills in light of the government response," said Obranovich.

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