Bi-partisan Senate Letter asking for 12 years of Data Protection in TPP

Patently BIOtech

Senators Hatch and Kerry, along with 35 other Senators, sent a letter to Ambassador Kirk asking for 12 years of regulatory data protection consistent with U.S. law in the Trans Pacific Partnership Agreement.

We are united in urging you to propose a strong minimum term of regulatory data protection for biologics consistent with U.S. law.

As you are aware, U.S. law provides for a 12-year term of regulatory data protection for biologics and we believe that should serve as the baseline for the administration’s objectives for this aspect of the negotiation.  This 12-year term was the result of careful deliberations in which the U.S. Congress arrived at a bipartisan consensus taking into account and weighin many factors.

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