The life sciences industry has not made the case for an extension to the data exclusivity period for biologic medicines, according to Trade Minister Andrew Robb.
In a speech to the National Press Club in Canberra on Wednesday, Mr Robb also said he doubted the trustworthiness of industry claims an extension would not undermine the PBS.
In a wide-ranging address on the benefits of free trade, the Minister mounted a strong defence of the Government's refusal to back a push by the US for an extension in the data exclusivity period for biologic medicines through the 12-country Trans Pacific Partnership - from the current five years to 12.
Mr Robb said data exclusivity had been "the most difficult issue" for him during the negotiations, expressing significant frustration over the public debate that had often seen data exclusivity confused with patent terms.
Yet he also questioned the validity of claims Australia would benefit from an extension and the trustworthiness of industry assurances over the impact on the PBS.
"On the one hand I get the pharmaceutical companies coming along and giving me their line and their modelling, and then I get the others on the other side of the argument giving me their line, but no one gives you any real substance," he said.
"Why is the 16 (sic) years needed?" asked Mr Robb, appearing to incorrectly assert 16 years when leaks of the draft TPP text clearly show the US limiting its proposal to 12 years.
Mr Robb said he was not convinced industry's assurances over the impact of an extension could be trusted.
Mr Robb said he had invested more time than any of his counterparts in the other negotiating countries building his understanding of data exclusivity.
"I couldn't feel I could defend five years, it I just went in there and said that's the politics in Australia, because if it really needed 16 (sic) years, and we're going to get all the innovation and benefits, the start-ups and all the rest, I would be prepared to go and argue for it in the Australian community.
"But, I have come to a conclusion that more than five years is unnecessary," said Mr Robb, going on to argue current patent terms in Australia offer sufficient protection.
He argued longer data exclusivity periods in the US reflect its lack of protection for gene patents. However, industry sources described as "completely irrelevant" the Minister's attempt to link data exclusivity periods for biologicals and a decision by the full bench of the Australian Federal Court to uphold one company's claim to a patent on fragments of DNA that are defined as BRCA1 gene mutations.
On the wider issue of the TPP, Mr Robb said negotiations could be finalised quickly if issues involving automotives between the US, Mexico, Canada and Japan, were resolved.