Reassessing The Data Exclusivity Regime For The Indian Pharmaceutical Industry

Data exclusivity is primarily created to support drug regulation. Some World Trade Organisation (WTO) members use this form of protection for regulatory data submitted for approval of a new chemical entity. This protection prevents competitors from relying on the data submitted by the originator company to obtain regulatory approval for their generic product for a certain period. Some members, including India, protect undisclosed information using the doctrine of breach of confidence. Under this form of data protection, subsequent applicants may enter the market by simply proving that their drug is similar to the first applicant’s drug through bioequivalent studies. This ensures early market entry of generics soon after patent protection expiry without waiting out any other form of exclusivity period. The thesis reassesses data exclusivity for the Indian pharmaceutical industry for two primary reasons. First, there is external pressure from trading partners to implement data exclusivity. Second, it aims to examine whether data exclusivity can address the evolving challenges faced by the Indian pharmaceutical sector. These challenges include persistent concerns related to substandard drugs and mishaps in clinical trials. Additionally, the nature of the Indian pharmaceutical industry is shifting from generic specific to include a more research and development-based industry. Lastly, the thesis discusses the effect on Indian patent law more broadly if India were to adopt data exclusivity. Such an approach could imbalance India’s effort to tailor its patent regime to promote the national interest whilst promoting innovation by becoming an alternative to patent protection.