The recently announced Trans-Pacific Partnership (TPP), a multi-national trade agreement between Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam, and the United States, has been the topic of debate in the current presidential election season for its impact on trade. The TPP also contains several intellectual property provisions of interest to the biopharmaceutical industry.
1. Minimum Periods of Market Exclusivity for Biologics
The nations participating in the TPP currently provide varying periods of market protection for biologics. The United States currently offers the longest period of exclusivity, providing twelve years for biologics, while Brunei currently offers no protection. The TPP attempts to harmonize these periods of exclusivity in Article 18.52, by requiring member nations to either provide eight years of data exclusivity for biologics, or provide five years of exclusivity, coupled with an additional three years of “other measures” that must “deliver a comparable outcome in the market.” The TPP also contemplates transition periods, ranging from five to ten years, to allow nations to put the required protections in place. Some nations, such as Brunei and Malaysia, have also negotiated special provisions to incentivize submission of applications for biologics in those countries.
2. Potential for Inconsistency for Fixed-Combination Dosage Products
Article 18.53 of the TPP proposes a definition of “new pharmaceutical products” that appears to conflict with recent guidance from the U.S. Food and Drug Administration. The TPP defines a new pharmaceutical product as a pharmaceutical product that does not contain a chemical entity that has been previously approved in that country. In contrast, the October 2014 guidance from the FDA indicates that it will award “new product” exclusivity to certain fixed-combination dosage products, even if they contain a previously approved chemical entity, as long as the fixed-combination product also contains at least one new active ingredient.1 This difference between the TPP and the FDAʼs October 2014 Guidance creates some uncertainty regarding the exclusivity periods for fixed-combination products.
3. Broader Enforcement of Trade Secret Rights
Article 18.78 defines and sets forth minimum protections for trade secrets. The TPP obligates member nations to provide criminal procedures and penalties for: (1) unauthorized access of trade secrets, (2) unauthorized misappropriation of trade secrets, and (3) unauthorized disclosure of trade secrets. This provision, along with the other IP provisions of the TPP, was intended to ensure a minimum level of protection for IP rights across all member nations.
1 FDA Guidance for Industry, “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products” at 8; see also 79 F.R. 62163 (Oct. 16, 2014) (announcing adoption of draft Guidance, first published at 79 F.R. 10167 (Feb. 24, 2014)).
Reprinted with the permission of the Orange County Business Journal
