The Trans-Pacific Partnership (TPP): How will it affect your data exclusivity?
Following years of negotiations, the Trans-Pacific Partnership (TPP) Free Trade Agreement (FTA) has finally been agreed by 12 Pacific Rim countries including Australia, New Zealand and the US. The issue of data exclusivity for biologics, which threatened to derail the agreement, has been resolved with a period of up to 8 years agreed upon, but with Australia and a number of other countries only committing to a maximum 5 year period.
Therefore, the TPP FTA will not have any effect on the period of data exclusivity (the period of protection for data provided by an innovator company to a regulatory agency to prove the safety and efficacy of a new product) available in Australia.
No effect on Australian data exclusivity provisions
It has been widely reported that Australia and New Zealand refused to align with the 12 years of data exclusivity provided for data submitted for biologics to the Federal Drugs Administration (FDA) in the US. Instead, a compromise has been reached that will allow Australia to retain its current provision of up to 5 years data exclusivity for all medicines (including biologic medicines).
Are there any changes to patent protection?
No. The much discussed changes to the patent term extension scheme are not to be part of the agreement.
Further information about patent term extension and data exclusivity provisions in Australia, New Zealand and Asia is available in our article of June 2015, /ip-news/pharmaceutical-patent-term-extension-and-data-exclusivity-in-australia,