U.S. Said to Drop 12-Year Lock-Up on Biologics Data in TPP Talks

The U.S. abandoned a longstanding demand for a 12-year period to lock up clinical trial data on biologic pharmaceuticals as part of an Asia-Pacific trade pact, according to two people briefed on the matter.

The shift came as the U.S. faced demands from most other countries involved the Trans-Pacific Partnership negotiations to adopt a shorter minimum period, the people said, requesting anonymity because the talks are ongoing.

Trade ministers gathered for a meeting on the Hawaiian island of Maui are discussing whether to adopt a seven- or eight-year period, or a five-year period, as proposed by Australia, according to the people. It 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.

Keeping data confidential prevents competitors from developing similar drugs more quickly, raising the value of patents. The U.S. move could weigh on drug giants like Pfizer Inc. and Amgen Inc., for whom the new therapies are a lucrative source of revenue.

The patent disagreement is one of many that trade ministers from 12 countries are hoping to resolve during the talks and conclude six years of negotiations on the TPP. The pact, which ranges from agriculture to e-commerce, got a boost last month when the U.S. Congress approved President Barack Obama’s request for an up-or-down vote on any deal.

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