3 Chi J Intl L 69
Carlos Marķa Correa
Some developed countries, notably the US and EU, provide for the exclusive use by the originator company, for a limited period, of test and other data submitted for the marketing approval of pharmaceutical products. Other countries allow national authorities to rely on such data to approve subsequent applications. Article 39.3 of the TRIPS Agreement has obliged WTO Member countries to treat such data as a component of intellectual property. This article discusses the interpretation of that provision, and the extent to which the TRIPS Agreement has deferred to Members the determination of the legal means to be used to make protection of intellectual property effective. It concludes that Members may opt for protection against unfair commercial use which allows for the approval of similar products without the use of, or reliance upon, the previously submitted data.
