Intellectual property waiver debates during pandemics

Introduction

Intellectual property waivers during pandemics refer to proposals to temporarily suspend or relax certain intellectual property rights to improve access to essential medicines, vaccines, diagnostic technologies and medical equipment during a public health emergency. These debates became particularly important during the COVID-19 pandemic, when many countries faced shortages of vaccines, medicines and medical supplies.

The central issue is the conflict between patent protection and public health requirements. Pharmaceutical companies argue that intellectual property rights encourage research, investment and innovation. Developing countries and public health organisations argue that strict patent enforcement may restrict affordable access to essential medical technologies. Therefore, pandemic-related IP waiver debates involve balancing commercial interests with the right to health and international public health obligations.

Meaning and scope of intellectual property waivers

An intellectual property waiver is a temporary relaxation of certain legal obligations relating to intellectual property protection. It does not necessarily mean permanently cancelling patents or transferring ownership to governments.

During pandemics, proposed waivers may cover:

Patents relating to vaccines, medicines and diagnostic technologies.

Copyright protection for certain technical materials and software.

Industrial designs used in medical equipment.

Trade secrets and confidential manufacturing information.

Protection of undisclosed test data.

The main objective is to enable additional manufacturers to produce essential medical products without facing certain legal restrictions. However, patent waivers alone may not be sufficient because manufacturing vaccines and advanced medicines also requires specialised equipment, technical knowledge, skilled personnel and regulatory approval.

International legal framework

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), administered by the World Trade Organization (WTO), establishes minimum standards for intellectual property protection.

Article 27 deals with patentable subject matter, while Article 28 provides patent rights. Article 31 permits compulsory licensing under specified conditions, allowing governments to authorise the use of patented inventions without the patent holder's consent, subject to legal safeguards and remuneration.

Article 31bis provides an additional mechanism for exporting pharmaceutical products manufactured under compulsory licences to countries with insufficient manufacturing capacity.

During COVID-19, India and South Africa submitted a proposal to the WTO in October 2020 seeking a temporary waiver of certain TRIPS obligations concerning COVID-19 prevention, containment and treatment technologies. The proposal was supported by several developing countries.

In June 2022, the WTO Ministerial Decision introduced a limited framework concerning the use of patents for the production and supply of COVID-19 vaccines. However, it did not adopt the full waiver originally proposed and did not automatically suspend every category of intellectual property protection.

Indian legal framework

India's intellectual property framework provides several mechanisms for addressing public health emergencies.

1. Patents Act, 1970

The Patents Act contains important provisions for balancing patent rights and public interest:

Section 47: Subjects certain patents to conditions, including government use for specified purposes.

Section 84: Allows compulsory licensing after three years from the grant of a patent, subject to statutory grounds.

Section 92: Permits compulsory licensing through government notification in circumstances involving national emergencies, extreme urgency or public non-commercial use.

Section 100: Authorises government use of patented inventions for government purposes, subject to statutory requirements.

Section 107A: Provides the regulatory review or Bolar exception and certain parallel import provisions.

These provisions can help increase access to patented medicines during public health emergencies without requiring the complete removal of patent protection.

2. Constitutional framework

Article 21 of the Constitution protects the right to life, which the Supreme Court has interpreted to include important dimensions of health and medical care. Article 47 directs the State to improve public health and nutrition. These constitutional principles support government measures aimed at ensuring access to essential healthcare.

3. Competition law

The Competition Act, 2002 may become relevant where intellectual property rights are used in ways that produce anti-competitive effects. Section 3 addresses anti-competitive agreements, while Section 4 prohibits abuse of dominant position. The mere exercise of patent rights, however, does not automatically constitute an infringement of competition law.

Important case laws

1. Novartis AG v. Union of India (2013)

The Supreme Court rejected Novartis's patent application for a modified form of an existing pharmaceutical substance because the statutory requirement under Section 3(d) was not satisfied. The judgment is significant because it demonstrates India's approach to preventing evergreening and maintaining access to affordable medicines. Its reasoning is relevant to pandemic-related debates over pharmaceutical patents.

2. Bayer Corporation v. Union of India (2014)

The Intellectual Property Appellate Board upheld the compulsory licence granted to Natco Pharma for Bayer's patented cancer medicine, Nexavar. The decision recognised the importance of affordability, reasonable public requirements and availability of patented medicines in India. It provides an important precedent for understanding compulsory licensing as a public-interest mechanism.

3. F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2008)

The Delhi High Court considered a pharmaceutical patent dispute involving the cancer drug Erlotinib. The judgment addressed patent infringement and the public interest in access to medicines. It is relevant to the broader debate concerning the relationship between pharmaceutical patent protection and affordable healthcare.

4. Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996)

The Supreme Court held that the State has a constitutional obligation to provide adequate medical facilities. It recognised that failure to provide timely medical treatment may violate Article 21. The judgment supports the constitutional importance of healthcare access during public health emergencies.

Arguments supporting and opposing waivers

Supporters argue that temporary waivers can increase manufacturing capacity, reduce dependence on a limited number of suppliers and improve access to affordable medical products. They particularly emphasise the needs of developing countries with limited purchasing power.

Opponents argue that weakening intellectual property protection may discourage pharmaceutical investment and reduce incentives for future research. They also point out that manufacturing complex vaccines requires technical expertise and technology transfer, not merely permission to use patents.

A balanced approach may therefore combine limited IP waivers, compulsory licensing, voluntary technology transfer, public funding and international manufacturing cooperation.

Conclusion

Intellectual property waiver debates during pandemics reflect the need to balance innovation with public health protection. The TRIPS Agreement, India's Patents Act, 1970 and constitutional principles provide mechanisms for addressing conflicts between private patent rights and public healthcare needs. The COVID-19 experience demonstrated that effective pandemic responses require more than patent flexibility: they also require technology transfer, manufacturing capacity, international cooperation and equitable distribution of medical products.

Legal clarification: The cited judgments do not directly decide the legality of a pandemic-wide TRIPS waiver. They establish relevant principles concerning pharmaceutical patentability, compulsory licensing and the constitutional right to healthcare.