Trans-Pacific Partnership Agreement Reached

Oct. 14, 2015

Earlier this month, the 12 Pacific Rim countries negotiating the Trans-Pacific Partnership (TPP) reached an agreement to improve trade throughout the region. CLSA has been closely monitoring these negotiations due to the significant impact the terms will have on the life sciences sector, including intellectual property protections for innovative biologics.

Under the Biologics Price Competition and Innovation Act (BPCIA), passed in 2010 as part of the Affordable Care Act (ACA), Congress established 12 years of data exclusivity for biologics in the United States. CLSA has advocated maintaining this level of patent protection in TPP negotiations. However, due to the lower exclusivity thresholds held by other countries (as examples, Japan and Canada offer eight, Australia offers five, and Brunei, Mexico and Vietnam offer zero), the length of time an innovative biologic would maintain its patent protection before a biosimilar therapy may be introduced to the marketplace was a major point of contention throughout the negotiations.

Ultimately, the agreement finalized earlier this month includes a hybrid agreement providing five to eight years exclusivity for innovative biologics. More specifically, participating countries will be required to provide at least five years of data protection for biologics and potentially an additional three under the regulatory framework established by the Trade Promotion Authority (TPP).

Although negotiations may have concluded, Congress is still required to approve the terms of the TPP before it goes into effect in the United States. There is no clear timeline for when this agreement will come to the floor given the busy legislative schedule for the remainder of the year, the leadership upheaval in the House, and the contentious politics that have surrounded this agreement since the Trade Promotion Authority (TPA) passed by a narrow margin earlier this summer.

CLSA will continue to collaborate with our national stakeholder associations, including BIO and PhRMA, and engage with the California Congressional delegation to advocate for strong IP protections for innovator products so as to preserve the life blood of the innovation ecosystem.

For questions, please contact Jenny Carey, CLSA’s Director of Federal Government Relations and Alliance Development (