Data Exclusivity for Biological Pharmaceuticals: Is New Zealand in Breach of World Trade Organization Law?

Abstract

The protection of intellectual property (IP) rights is riddled with conflicts of interests. The Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter ‘TRIPS Agreement’) introduced standards in order to harmonize IP law enforcement simplifying the task of finding the appropriate level of protection. In some cases IP protective measures result in severe trade restrictions, which can, nevertheless, be justified by virtue of their compliance to TRIPS. However, some trade restrictive intellectual property rights (IPRs) are not covered by TRIPS. This research explores a way in which the enforcement of IPRs falling outside TRIPS can be reconciled with obligations relating to the elimination of trade barriers under the General Agreement on Tariffs and Trade (GATT). The rationale is that TRIPS provides guidance as to the application of Article XX(d) GATT in relation to trade restrictive measures that enforce IPRs. This approach is applied in this article to determine whether, in granting protection to IP in clinical test data relating to biological pharmaceuticals, New Zealand complies with its obligations under the GATT, given that TRIPS does not recognize this IPR and does not provide for its protection.