India imposes significant barriers for innovators at every step to secure, maintain, and enforce intellectual property (IP). India champions a severely restrictive patentability regime, fails to properly enforce patents, and does not provide regulatory data protection (RDP). These shortcomings present major obstacles for sustained growth and investment in research and development activities and negatively impact access to medicines.

Abolish Restrictive Patentability Criteria

International standards follow a three-part patentability test: novelty, inventive step and industrial application. India’s patent system introduces an extra criterion of “enhanced efficacy” for specific biopharmaceutical innovation. This additional requirement creates an unnecessary barrier to patentability, weakening incentives for vital medical advancements and limiting opportunities for domestic innovation.

Enhance Effective Patent Enforcement Mechanisms

India’s IP framework lacks robust patent enforcement mechanisms. Currently, regulatory authorities can grant marketing and/or manufacturing approvals for generic drugs without any obligation to assess the patent status of the original products. As a result, generic manufacturers may obtain government authorization to market versions of drugs that are still under patent protection.

Introduce Regulatory Data Protection

Before receiving marketing approvals, biopharmaceutical innovators must submit confidential data to regulatory authorities to demonstrate the safety and efficacy of medicines. International rules require governments to protect this confidential data and provide regulatory data protection (RDP). India does not offer RDP, allowing third parties to use the data generated by innovators to secure marketing approvals for generic and biosimilar products.

Aligning its IP policies with global best practices could enhance India’s reputation as an innovation hub, attract more high-value investments, support long-term economic growth and facilitate access to innovative medicines.