Intellectual property protections for pharmaceutical development and the ancillary costs of medicines for consumers have been one of the most hotly debated topics in the media, medical associations and civil society organisations leading into the final round of negotiations for the Trans-Pacific Partnership (TPP) agreement. Nevertheless, after many years of negotiations and multiple rounds of final negotiations, the TPP has finally been concluded.
The issue of data protection for biological pharmaceutical products proved to be a key sticking-point in the most recent round of negotiations. The United States pushed for a longer period of protection (up to 12 years), while Australia and a number of other member states insisted on a shorter 5 year period.1
While specific details of the agreement are not expected to be released for some time, we now know that Australia stood firm against the United States’ push to include an extended data exclusivity period for biological pharmaceutical products. US trade representative Michael Froman has said that the deal will offer a minimum of 5 years’ protection, as well as some ‘minimum time for other measures’.2 While it remains unclear exactly what these other measures will include, it would appear that Australia’s current data exclusivity laws for biological products will continue to apply (Australia already provides for 5 years of protection for data disclosed to regulatory bodies during applications for the approval of new pharmaceutical or agricultural chemical products). However, it will not be known until the final text of the TPP is released whether the ‘minimum time for other measures’ includes a previous US proposal to extend data protection to new data submitted in relation to previously approved pharmaceutical products (eg pharmacovigilance). The proposed period of protection for this class of data was limited to 3 years.
Damian Slizys, Freehills Patent Attorneys