Pharmaceutical Test Data Protection and Demands for Data-Exclusivity: Issues and Concerns of Developing Countries and India’s Position

Data-exclusivity is one of the most controversial issues in the current discussion on pharmaceutical intellectual property policy-making globally. It is aimed at protecting and safeguarding pharmaceutical test data submitted by pharmaceutical companies to drug regulatory authorities (DRA) for the purpose of obtaining marketing approval for new drugs. Most countries require the submission of test data relating to the efficacy and safety of pharmaceuticals and agro-chemicals as a condition for grant of marketing approval. Since the marketing approval process is laborious and expensive, the originators of such regulatory data demand protection for their investments through exclusivity periods, separate from any patent protection for the active ingredient. On the other hand, generic manufacturers advocate minimal protection for such data as they would be able to obtain speedier marketing approvals. Data-exclusivity thus, prevents during a set period of time, a second pharmaceutical applicant from obtaining a marketing authorization for its drug through a facilitated procedure; this procedure entails reliance by the second applicant on preclinical and clinical data generated by a pioneer company that prepared that data to support its own new drug application. The underlying logic of data-exclusivity suggests that it is an expression of trade-secrets, and that as such, data-exclusivity should be independent of patents. Compared with patents, the market power of data-exclusivity is, in theory, less restrictive, mainly because it does not legally prevent other companies from generating their own registration data. However, in practice, the vast financial resources and extended time required for gathering and generating pharmaceutical registration data for a new drug create a market barrier that is too high for generic based companies.