A potential extension to the data exclusivity period for biologic medicines will come down to the final stage of negotiations for the 12-country Trans Pacific Partnership (TPP) agreement.
The next round of negotiations are scheduled for later this month, in Hawaii.
The US is thought to be pushing for a range of inclusions in relation to intellectual property covering pharmaceuticals. While most would have limited or no application in Australia, given existing strong protections, the proposal to extend the data exclusivity period for biologics from 5 to as much as 12 years has generated support from the life sciences sector, including AusBiotech, and also some controversy.
An extension in data exclusivity does not mean an extension in patent life, simply an extension in the period before a company can use an originator's data as the basis for its own drug approval.
The Australian Government is known to be opposing any extension, with Health Minister Sussan Ley and Trade Minister Andrew Robb confirming their opposition in correspondence to stakeholders.
Despite their opposition, it is understood that Australian negotiators have recently confirmed that the extension remains on the table pending the final round of negotiations, including between country leaders.
An agreement by Australia to extend the current data exclusivity period could come down to the willingness of other countries, notably the US, to extend access to domestic agriculture markets.
Another confounding consideration is the ability of any extension negotiated through the TPP to successfully negotiate parliamentary approval.
Acting deputy US Trade Representative and the US negotiator for the TPP, Wendy Cutler, recently said negotiation on the outstanding issues was complex and involved a broad range of sectors, particularly agriculture.