At long last, the final text of the Trans-Pacific Partnership, a free trade agreement among a dozen Pacific Rim nations, has now been made available to the public. The chapter on intellectual property, however, does not appear to have any material changes relating to exclusivity for new biologics from the leaked draft released by WikiLeaks last month. Just as the provisions in the leaked draft did, Articles 18.50 and 18.52 give countries a choice between, on the one hand, at least eight years of exclusivity or, on the other hand, at least five years of exclusivity plus unspecified “other measures” and protection through “market circumstances.” Additionally, the agreement seems to provide for only market exclusivity, not data exclusivity. The TPP bars biosimilar applicants from entering the market during the exclusivity period, but does not appear to prevent them from accessing innovators’ regulatory data.
Overall, the TPP may simply maintain the status quo for biologics exclusivity around the Pacific Rim. Almost all signatories already provide at least five years of exclusivity. Australia and New Zealand have already taken the position that the agreement will not lengthen their biologics exclusivity period. The United States provides twelve years, but it will not have to change its laws. The agreement does, however, require the parties to convene in a decade to review and potentially alter the biologics exclusivity period.
With the text of the TPP complete and public, the Obama administration will now submit the agreement to Congress for an up-or-down vote. Debate is expected to stretch into early 2016.