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Exclusivity Period of Biologics Remains a Hurdle in Trans-Pacific Partnership Talks

The latest round of talks over the Trans-Pacific Partnership (TPP), a proposed Pacific Rim free-trade agreement, has ended with disagreement on a number of key issues, including the non-patent exclusivity period for biologic medications. In late July, trade representatives of a dozen nations, including the United States, Canada, and Japan, met in Maui to hash out remaining disagreements, including the exclusivity period for biologics. By the time the talks adjourned, no agreement was reached.

There have been reports, however, that the United States abandoned its longstanding demand for 12 years of exclusivity for biologics and may be willing to accept a seven- or eight-year exclusivity period as part of an agreement on the TPP. According to the reports, a shorter period “wouldn’t take effect unless the entire TPP, a wide-ranging pact, is concluded, and the U.S. could still maintain a longer period for itself.” Japan and Canada provide eight years of exclusivity for biologics while all the other TPP participant nations provide shorter periods or no exclusivity at all.

Whether or not the United States has truly backed down is difficult to say, due to the intense secrecy surrounding the talks. Either way, it appears that the period of exclusivity in the United States, which has significant bipartisan support in Congress, would remain unchanged.

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