Pharma test data protection legal nature

Andrés Rincón Uscátegui ARU_thumb-02

Abstract (full text only in Spanish) Although not an intellectual property asset as such, such as a patent, the protection of test data that demonstrates the safety and efficacy of a drug is an important tool for an industry whose research and development costs are high.  For this reason, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), seeks a minimum standard of protection to prevent the unfair commercial use of such information to the extent that it is not disclosed and involves considerable effort to generate, and which, if not protected, would generate a market imbalance given the failure to recognize such effort.  This article seeks to contribute to the discussion on the legal nature of the protection of test data as an intangible asset, analyzing what the generation of this data implies, what is the risk involved, where lies the nondisclosure of information, why it cannot be considered secret information, its importance to those who are not willing to generate it, and the most appropriate way to protect it.