Orphan Drug Development in India: Analysing Patent Law Limitations, Challenges and the Need for Reform

Abstract

The growth of the pharmaceutical industry shows how important the patent system is, because without it, the industry would not have become as large as it is today. However, the potential of patents to foster innovation is constrained in certain areas where commercial viability is limited. Orphan drug is a pharmaceutical product used for diseases that affect a small number of people (rare diseases). What constitutes a rare disease does not have a uniform definition. Although patents offer exclusivity, they fail to sufficiently incentivize orphan drug development due to the small market size and limited potential to recover investments, in addition to other challenges such as statistical hurdles in clinical trials and lack of awareness. This paper examines the limitations of the patent system in encouraging R&D in orphan drugs. It examines the orphan drug landscape, which faces significant unmet demand, and critically analyses India’s approach to orphan drug development by evaluating existing initiatives to identify gaps. It advocates for a balanced framework benefiting both developers and society. Such an approach would be explored by studying global best practices and how they may be adopted in the Indian context.