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Tuesday, October 6, 2015

TPP – agreement finally reached!

by Claire McMahon, Associate

For those of you who have been holding your breath, it has been confirmed – trade ministers from the twelve parties to the Trans Pacific Partnership (TPP) reached agreement yesterday, after extensive negotiations which continued over the weekend. The Australian Government has provided a summary of the final TPP market access outcomes here.

Data protection periods for biologic drugs has been one of the major outstanding hurdles for negotiators over the past several months. The United States had been seeking an eight-year data-exclusivity period, having retreated from 12 years after intense opposition from the other parties. Other parties, most notably Australia, have stood firm on a five-year data protection period, as is our existing law.

Over the weekend, the US backed away from its demand, agreeing to a minimum five-year protection period. It appears that those countries that do not have an existing minimum five year protection period have accepted an eight-year protection period. According to US trade representative, Michael Froman, this data protection period will be complemented by 'other government measures'.

Presumably Australia already has sufficient measures in place to comply with these TPP provisions, as Trade Minister Andrew Robb stated today that 'nothing, nothing, will change in our health system'.
As such, the existing Australian data protection period of 5 years will not change. The exceptional position for Australia was justified on the basis of strong patent protection for biologics in Australia which, unlike the US, provides protection for isolated biological molecules.

Australia may prove very lucky the deal was done this weekend.

Tomorrow, the High Court is to hand down its decision in Myriad. If that decision goes against the patentee, the argument that Australia has strong protection for biologicals may evaporate. We will report on that decision tomorrow.

A combined statement from the trade ministers suggests that the final text will not be released for at least several weeks, whilst technical work is completed. We will comment in detail on data protection and other intellectual property provisions once this text is available.

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