With One Exception Current Trade Agreements Do No Appear to Include Biologic Medicines in their Data Protection/Data Exclusivity Provisions – Implications for TPP Negotiation

The U.S., acting on behalf of the U.S. biologics industries, will soon be trying to convince parties to the TPP that they should adopt extended data exclusivity for biologics (at least 12 years) as part of the intellectual property chapter.  As part of its marketing strategy, the U.S. is trying to convince parties behind the scenes that biologic data exclusivity is already included in US FTA and indeed in some of the FTA's already binding certain TPP parties.  Contrary to this assertion, there is no precedent for data protection for biologics at all in existing US FTAs, let alone for for the extended data exclusivity that the US will be seeking.  TPP parties should reject the US data exclusivities as TRIPS-plus, both for chemical entity pharmaceuticals and biologics.

Download the latest paper by Health GAP Senior Policy Analyst, Brook Baker for more information 

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