BREAKING NEWS: U.S. may agree to less than 12 years of data exclusivity for biologics as part of TPP negotiations

Biosimilar News

As we previously reported, negotiations on the Trans-Pacific Partnership Agreement, for which President Obama has been given fast-track authority to negotiate, are well underway, and leaders have been meeting this week in Maui to iron out what many believe will be the final deal.  One of the most contentious issues has been the data exclusivity period that member-states would need to provide for biologics.  While the BPCIA provides for 12-years of data exclusivity for biologics, some negotiating TPP countries provide much less (e.g., Australia provides for 5 years of data exclusivity).

Reports have emerged that U.S. negotiators have “abandoned a longstanding demand for a 12-year period to lock up clinical trial data on biologic pharmaceuticals as part of an Asia-Pacific trade pact, according to two people briefed on the matter.”  Unofficial drafts of the agreement have previously been released by WikiLeaks and other sources, but there has been no official release of any of the proposed TPP language, so it is unclear what is the current proposal on the table.  A shorter biologics data exclusivity period requirement in TPP would not necessarily mean that such a period will apply in the U.S., since negotiators could agree to a minimum period (threshold) of exclusivity that all member states must adopt.

We will monitor and update this blog with developments on this important issue.

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