"Make no mistake" - it's 8 years on data exclusivity, says USTR


Australia will need to provide 8 years of data exclusivity for biologics according to Deputy USTR Robert Holleyman.

In a speech to the US Chamber of Commerce Global Intellectual Property Center 2015 Global IP Summit, Holleyman made it very clear the US Government expects TPP countries to provide "enhanced protection" for biologics.

"TPP will require, for the first time in a trade agreement, Parties to provide an extended term of effective market protection for biologic medicines, a key element of future medical advancement," he said.

"Make no mistake. This is a landmark provision that sets an important minimum standard through the free trade area," he added.

The final wording of the TPP's intellectual property chapter has provided some public ambiguity in relation to data exclusivity for biologics.

The text says countries can provide a legislated 8-year period, or a 'market protection' period that delivers a "comparable outcome" of 8 years comprised of a legislated 5 year period plus "other measures".

Trade Minister Andrew Robb has been careful to avoid discussing the specifics of the wording in relation data exclusivity for biologics, preferring to focus on the ability for Australia to avoid legislating an 8-year period and using language such as the 'Australian way'.

However, Holleyman confirmed the requirement for 8-years in his speech, pointing to Japan’s process of post-market surveillance as an example of a country providing ‘market protection’ through measures in addition to a legislated period.

"TPP gives partner countries two ways to meet that standard. One way is to provide a minimum of at least 8 years of data protection. The other way is to deliver a comparable outcome through both data protection of at least 5 years plus other measures like regulatory procedures or other administrative actions.

"There are many ways to provide effective market protection that are strong and meaningful. As many of you know, Japan does this through their post-marketing surveillance process, which gives effectively more than 8 years of protection for these drugs," he said.

Holleyman's comments reflect a strongly-held view in the US that Australia will need to enforce the 8 year period in order to comply with the TPP text.

Leading US Senator Orrin Hatch, Republican Chair of the US Senate Finance Committee, recently accused Australia of being "greedy" over its refusal to accept a 12-year data exclusivity period for biologics in the TPP.