AI-Generated Drug Innovations and Indian Patent Law: Legal Challenges and Ethical Responses

The integration of Artificial Intelligence (AI) into the pharmaceutical sector has redefined drug discovery and development, enabling the generation of novel compounds with enhanced efficiency and precision. However, this transformative progress challenges the foundational tenets of intellectual property (IP) law in India. This paper examines the intersection of AI-generated pharmaceutical compositions and Indian IP laws, with a particular focus on patentability, inventorship, and data exclusivity. The study highlights ambiguities in recognizing AI as an inventor, the complexities of assessing novelty and non-obviousness in AI outputs, and the inadequacy of current legal frameworks in addressing the protection of AI-driven innovations. It argues for a comprehensive overhaul of existing IP laws to include sui generis protections or collaborative inventorship models. Further, it explores international best practices and ethical considerations critical for balancing innovation incentives with public access to essential medicines. The paper concludes by proposing legal, regulatory, and institutional reforms that could empower India to lead globally in responsible and equitable AI-based pharmaceutical innovation.