U.S., Australia agree on complicated compromise on biologic drugs

Wall Street Journal

5 October 2015 - The U.S. and Australia are in agreement on an elaborate compromise within the Trans-Pacific Partnership to protect the intellectual property of complex drugs known as biologics, according to industry officials and an organization following the talks.

Under the bilateral deal, whose exact language is believed to be incomplete, countries in the trade bloc would have an alternative of either providing eight years of exclusivity to biologic drugs, or providing five years of so-called data exclusivity plus up to three more years under a regulatory framework in the TPP, the people said.

The outline of the U.S.-Australia deal agrees with a document a government official showed The Wall Street Journal at talks in Atlanta and was confirmed by a source briefed overnight on the latest language.

It wasn’t immediately clear whether the other 10 countries had signed onto the deal or whether it could change before the entire TPP trade agreement is completed.

For more details, go to: http://www.wsj.com/articles/u-s-australia-agree-on-complicated-compromise-on-biologic-drugs-1443988019

Michael Wonder

Posted by:

Michael Wonder