The influence of TRIPs on the non-patent protection of Pharmaceuticals

摘要

The traditional justification for the limited monopoly granted by the patent system lies in the reward, and thus the incentive, that it provides for innovation. But in determining whether or not to grant a marketing authorisation for a new pharmaceutical the degree of innovation that it represents is not a relevant consideration - what matters is whether the pharmaceutical has an adequate balance of safety and efficacy. Demonstrating that balance to the satisfaction of regulators can be enormously expensive, because many apparently promising pharmaceuticals fail the clinical trials hurdles so that only a small proportion of those that are tested in man ever make it to market. The protection of such regulatory data provides a more direct reward for that type of investment than does the patent system. Thus regulatory data protection, also referred to as data exclusivity, has evolved to the greatest degree, and has become of the greatest importance, in those highly regulated sectors in which product safety and efficacy is paramount, namely pharmaceuticals and agricultural chemicals (such as pesticides and herbicides). This is reflected in its recognition, in relation to those two sectors, as an intellectual property right by Article 39(3) TRIPs, although some jurisdictions extend these principles to other regulated sectors.