TPP Update: More Challenges to TPP Proposals as Negotiations Continue

Biosimilar News

As we covered in a previous post, confidential negotiations regarding the Trans-Pacific Partnership Agreement (TPP) are ramping up: the Senate passed fast-track legislation in June, which limits Congress to a yes-or-no vote on the eventual trade agreement with no amendments, and a meeting of the TPP Trade Ministers is scheduled for the end of July.

On Friday, July 17, representatives from Congress, the generic-drug industry, and public health organizations raised further objections to the TPP proposals, mostly in opposition to leaked provisions regarding exclusivity periods for branded biologics and patent-linkage proposals.

As we’ve highlighted in a prior post on the TPP, one of the major objections raised by opponents of the TPP proposals is that the agreement would extend market exclusivity for branded biologics: critics warn that the TPP could expand the U.S. regime of 12 years of market exclusivity for branded biologics to the other eleven TPP countries, where the exclusivity periods currently range from only zero (Brunei) to eight (Japan and Canada) years.  Some have noted that this 12-year exclusivity period appears to be at odds with President Obama’s fiscal year 2016 budget, which proposes reducing the data exclusivity period for biologics to 7 years.

Another predominant concern among those who have voiced opposition to the TPP is the draft agreement’s proposed patent-linkage system, which critics warn could cripple biosimilar entry by preventing TPP nations from approving proposed biosimilars depending on whether there are unresolved patent disputes.

The negotiations and draft proposals remain confidential, with leaked documents being the only public source of information regarding the details of the current proposals.  The Office of the U.S. Trade Representative’s summary of the TPP’s impact on intellectual property rights can  be found here.

We will continue to post updates as negotiations continue and more information becomes available.

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