[Answered] Analyze the resilience of Bharat’s ‘anti-evergreening’ patent regime against intensifying global trade pressures. Evaluate whether the strategic utilization of legal levers, such as Compulsory Licensing, is essential to reconcile intellectual property obligations with the constitutional mandate of ensuring affordable healthcare.

Introduction

Bharat’s patent regime, shaped by TRIPS flexibilities, Section 3(d) and constitutional commitments under Article 21, faces renewed global trade pressures, raising critical questions on balancing innovation, sovereignty and affordable public health.

Resilience of Bharat’s Anti-Evergreening Patent Regime

1. Bharat’s patent framework is internationally recognised for its resistance to ‘evergreening’—the practice of extending monopolies through incremental, non-therapeutic modifications.
2. Section 3(d) of the Patents Act, 1970 acts as a statutory sentinel by requiring ‘significant enhancement of therapeutic efficacy’ for patentability of derivatives. This design reflects a conscious policy choice to prioritise access over monopoly rents.
3. The robustness of this regime was judicially affirmed in Novartis AG v. Union of India (2013), where the Supreme Court rejected patent protection for Imatinib Mesylate (Gleevec), clarifying that improved bioavailability or storage stability does not equate to enhanced therapeutic efficacy. This decision preserved India’s generic pharmaceutical ecosystem, enabling affordable cancer treatment domestically and across the Global South.
4. Empirically, this resilience has translated into outcomes: according to WHO estimates, Indian generics reduce drug prices by 60–90% globally, while Bharat supplies nearly 20% of global generic medicines by volume. However, this public-health-oriented stance increasingly attracts geopolitical friction.
5. Trade instruments such as the US ‘Special 301’ Watch List and tariff threats against Indian pharmaceutical exports exemplify ‘hubris-driven tariff sabre-rattling’ aimed at softening India’s IPR posture.

Global Trade Pressures and the TRIPS Context

1. Under the WTO’s TRIPS Agreement, Bharat is obliged to protect intellectual property but retains sovereign policy space through explicit flexibilities.
2. The Doha Declaration on TRIPS and Public Health (2001) unequivocally affirms that member states may prioritise public health and promote access to medicines for all.
3. Despite this legal cover, Bharat has exercised restraint. Since 2005, only one compulsory licence—Natco v. Bayer (2012) for Nexavar—has been issued, reducing prices by nearly 97%. This underutilisation reflects concerns over investor sentiment, retaliatory tariffs and R&D flight, rather than legal incapacity.

Strategic Utilisation of Legal Levers: Necessity, Not Extremism

1. A calibrated activation of statutory levers is essential to reconcile IPR obligations with constitutional mandates. Article 21, as interpreted in Paschim Banga Khet Mazdoor Samity and Mohinder Singh Chawla, imposes a positive obligation on the state to ensure access to healthcare.
2. Beyond compulsory licensing under Sections 84 and 92, Bharat’s Patents Act provides underexplored tools:

• Section 47(4) allows government import and distribution of patented drugs without patentee consent for public institutions.
• Section 66 empowers patent revocation in public interest where enforcement is prejudicial to society.
• Section 92A enables export-oriented compulsory licences, reinforcing Bharat’s role as ‘Pharmacy of the Global South’.
• Section 102 permits state acquisition of patents under eminent domain principles, with fair compensation.

3. Further, abusive patent practices can be addressed under the Competition Act, 2002, as abuse of dominant position—aligning competition law with public health goals, as seen in EU antitrust actions against Big Pharma.

Way Forward: From Defensive to Proactive Health Sovereignty

1. To withstand global pressures, Bharat must institutionalise a coherent patent–public health policy, integrating central and state governments, competition authorities and health ministries.
2. Leveraging TRIPS flexibilities should be viewed not as protectionism, but as rule-based assertion of sovereignty.
3. Simultaneously, fostering indigenous pharmaceutical innovation through public R&D, open science platforms and predictable regulatory pathways can counter the narrative that access and innovation are mutually exclusive.

Conclusion

As Justice V.R. Krishna Iyer argued, law must serve social justice; aligning TRIPS flexibilities with Article 21 ensures Bharat’s patent regime protects innovation without sacrificing the constitutional promise of affordable healthcare.