The 13th Round: Article 39(3) TRIPS and the struggle over “Unfair Commercial Use”

Abstract

Property Rights (TRIPS) was the first international agreement to provide for some form of protection for regulatory information submitted by companies in order to obtain marketing authorization for a pharmaceutical product.Nevertheless, after more than 20 years from the formation of the agreement, the ultimate meaning of Article 39 (3) thereof remains contentious among scholars and governments. In detail, it is still debated whether the provision mandates for some form of protection against the practice to authorize generic drugs by relying upon the clinical dossier submitted by drug developers or if it tackles otherwise unlawful conducts as data theft and espionage in the pharmaceutical sector. By reassessing the relevant literature on the topic, and by combining old and new arguments, the present paper argues that Article 39(3) does address regulatory reliance practices. However, it also emphasizes that the impact of the provision on developing countries pharmaceutical policies is greatly mitigated by the flexibility left to WTO members to approve generic drugs by referring to prior foreign authorizations. Finally, the paper concludes by reflecting on an issue often overlooked by commentators, that is, the amount of protection necessary to comply with Article 39(3).