Divergent philosophies in pharmaceutical intellectual property: A comparative analysis of regulatory, pricing, and litigation regimes in the United States, European union, and pro-public health jurisdictions

The intersection of Intellectual Property Rights (IPRs) and public health in the pharmaceutical sector presents a foundational global policy challenge: balancing the imperative to incentivize high-risk Research and Development (R&D) against ensuring affordable access to life-saving medicines. This article provides a comparative analysis of pharmaceutical IPR strategies and market structures across major global jurisdictions: The United States (U.S.), the European Union (EU), and pro-public health nations, notably India. The U.S. model is characterized by “managed chaos,” prioritizing robust patent protection and competition-driven generic price collapse. In contrast, the EU employs “fragmented control,” harmonizing regulatory approval while mandating direct government intervention in pricing and reimbursement at the national level. India, representing the pro-public health approach, utilizes strict anti-evergreening laws (Section 3(d)) and compulsory licensing provisions to promote generic affordability. These divergent philosophical starting points result in profound differences in regulatory pathways (Hatch-Waxman vs Multi-Track Authorization), market architecture (PBMs vs State Agencies), pricing paradoxes (high brand/low generic prices in the U.S. vs moderate prices in the EU), and differential biosimilar market success. Ultimately, the analysis reveals that the structure of IPR and market access pathways fundamentally dictates total pharmaceutical spending, commercial strategy, and public health outcomes globally.