12 Pages Posted: 9 Oct 2006
Date Written: September 10, 2006
Test data protection under TRIPS has become a controversial issue in India. Although Data Exclusivity is the norm in the USA and in many European Countries, it is not the only option for India. India can opt for a data protection regime, which is TRIPS compatible with safeguards for protecting test data from 'unfair commercial use'. India can opt for a data protection policy. In implementing it can have provisions for remedies for unfair competition, non-disclosure, trade secret protection compensatory liability regime for using data, sharing data on cost recovery basis, adjustable royalty models. Developing a comprehensive regime for data protection based on the above options is possible. India should amend laws like The Drug and Cosmetics Act, Insecticides Act to give effect to these.
Keywords: TRIPS, test data protection, India, data exclusivity, unfair competition
Suggested Citation: Suggested Citation
Krishna, Ravi Srinivas, Test Data Protection, Data Exclusivity and TRIPS: What Options for India (September 10, 2006). Available at SSRN: https://ssrn.com/abstract=935847 or http://dx.doi.org/10.2139/ssrn.935847