Impact Of Compulsory Licensing On Access To Medicines In India - A Pandemic Perspective

Author: LawSphereX

Category: General Law

Published: 2026-08-23T20:16:39.658807+00:00

Updated: 2026-08-26T17:11:15.106+00:00

IMPACT OF COMPULSORY LICENSING ON ACCESS TO

MEDICINES IN INDIA: A PANDEMIC PERSPECTIVE

Nandita Veeresh Mamani, CHRIST (deemed to be) University, Bengaluru, Karnataka

ABSTRACT

One crucial legal tool enabling governments to approve the manufacturing of copyrighted medications without the patent holder's approval is compulsory licensing, especially in public health emergencies. With an emphasis on its function during pandemics, this study investigates how mandatory licensing affects access to medications in India. It examines the Indian Patent Act, 1970's legal structure, focusing on Sections 84 and 92, and assesses how India has applied these provisions to guarantee the accessibility and cost of necessary medications. The study examines critically how well mandatory licensing works to alleviate drug shortages and lower drug costs, especially during emergencies like the COVID-19 pandemic. It also evaluates obstacles to implementing compulsory licensing, such as opposition from the pharmaceutical business, pressures from global commerce, and procedural barriers.

To improve public health readiness for upcoming pandemics, the study ends with policy proposals for fortifying India's mandatory licensing system. It promotes a well-rounded strategy that guarantees fair medication access while encouraging creativity and pharmaceutical development. Keywords: Access to medicines, Compulsory Licensing, COVID-19, Patent Law, Public Health.

Introduction

A monopoly right over an innovation granted by a court of law is referred to as a patent. It is

not always required to secure inventions only through patent protection, and specific innovations are not patentable. Different forms of intellectual property rights may be used to protect the final product that results from innovation. Simply put, the patent office issues a legal document called a patent to an inventor to protect the subject matter being considered for protection. The government grants an inventor a patent, a legally protected exclusive right that prevents anyone from using the innovation without the inventor's consent. In essence, a patent is an inventive protection grant. In contrast, a patent will only be granted if and when the invention satisfies the requirements for patentability. There are very few differences in how these patentability requirements are perceived, and they are universal.

In order for the invention to be eligible for patenting, the inventor must make sure that it has one or more innovative components; if not, the invention will not be eligible. The innovation must be novel and not readily apparent to the general audience. This implies that the idea shouldn't seem obvious or easy to implement to anyone with experience in innovation. To be considered a utility model, an invention's technique or embodiments must have a commercial market; otherwise, they would be considered ineligible. Whether a novel and non-obvious invention has some industrial use determines its patentability. If so, the invention satisfies the requirements for patentability and is eligible for patent protection. Nothing is regarded as innovative if it has already been recognized in the public domain. The patent lasts 20 years, starting when the application is submitted.

It can only be used in the nation where it has been approved. Therefore, any legal action for patent infringement or invasion may be obtained in that nation. Each country must submit a patent application to obtain patent protection in foreign nations. India's patent system is governed by the Indian Patent Act of 1970. Under Indian patent law, a patent can only be obtained for an innovative and valuable invention. An exception to the general rule that a patent owner has the sole right to use their patented goods is mandatory licensing. It is a procedure wherein a government grants a license or permits a third party to utilize a patent's rights without the owner's consent. Compulsory licensing aims to promote industrial development and maximize resource utilization.

2. LEGAL FRAMEWORK OF COMPULSORY LICENSING IN INDIA

Compulsory licensing is essential to preserving public health security because it allows

governments to authorize the production of copyrighted drugs without the patent holder's approval, particularly in times of emergency. The main goal of compulsory licensing is to strike a balance between protecting intellectual property rights and ensuring that people have access to life-saving drugs, especially in developing countries where high drug prices often make vital treatments prohibitively expensive1. In India, compulsory licensing is regulated by the Indian Patent Act of 1970, which combines clauses from the Doha Declaration on Public Health and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The Act outlines particular instances for granting compulsory licenses they are: Compulsory Licensing: Section 84 Any interested party may petition for a compulsory license three years after a patent is granted.

At least one of the following must be demonstrated by the applicant: -The public cannot purchase the patented invention at a fair price or -The public's fair expectations are not fulfilled or -India is not working on the patented invention2. Indian courts have decided many cases under this clause throughout the years, influencing the nation's public health and patent law jurisprudence. Here are a few of the most noteworthy case laws: Natco Pharma Ltd. v. Bayer Corporation (2014)3 is one of the most important cases under Section 84, as it was the first time a compulsory license was ever granted in India. The patent for Sorafenib Tosylate (Nexavar), a life-saving medication used to treat liver and kidney cancer, was owned by the German pharmaceutical corporation Bayer Corporation.

However, most Indian patients cannot afford the medicine due to its expensive monthly price of ₹2,80,000 1 Shivendra Nath Mishra & Shrey Shalin, Compulsory Licensing in India vis-a-vis Pharmaceutical Industry in the Covid-19, 2 JUS CORPUS L. J. 554 (June-August 2022). Available at https://heinonline-org-

2 The patents act,1970

3 2014(60)PTC 277 (BOM)

(about $3,600) set by Bayer. Natco Pharma, an Indian generic drug maker, responded by requesting a compulsory license, claiming that the medication was not being made in India, was not reasonably priced, and was not widely accessible. Natco was granted permission by the Controller of Patents to manufacture a generic version at ₹8,800 per month, which is almost 97% less expensive than Bayer's initial price. The ruling mandated that Natco give Bayer a 6% royalty and give the medication away for free to at least 600 patients annually. By confirming that exorbitant pricing and non-availability may support compulsory licensing, this decision established a solid precedent and strengthened India's pro-public health position under patent law. In BDR Pharmaceuticals v.

Bristol-Myers Squibb (2013)4, An application for a compulsory license was denied by the Controller of Patents, emphasizing the significance of following the proper procedures. Citing high cost and restricted availability, BDR Pharmaceuticals requested a mandatory license for Bristol-Myers Squibb's patented cancer medication Dasatinib. However, before asking for a compulsory license, as Section 84(6) required, BDR did not attempt to negotiate a voluntary license with the patent holder. The denial strengthened the procedural rigor necessary for such petitions by emphasizing that applicants must sincerely obtain a voluntary license before getting compulsory licensing. An analogous denial occurred in Lee Pharma v. AstraZeneca (2015)5, in which the Indian pharmaceutical firm requested a mandatory license for AstraZeneca's patented anti-diabetic medication, saxagliptin.

Lee Pharma contended that AstraZeneca was not distributing the medication extensively in India and was excessively costly. The Controller of Patents, however, rejected the application, concluding that the applicant had not shown sufficient proof that the medication was not fulfilling the demands of the general public. The ruling clarified that the applicant must demonstrate substantial non-availability or excessively high price; simply being unhappy with pricing or supply levels is insufficient. The idea that mandatory licensure should only be given in cases of actual public health concern was reaffirmed by this judgment. Sec 92: Compulsory Licensing in National Emergencies In situations involving national emergencies, severe urgency, or public non-commercial use,

4 C.L.A.No.1 of 2013

5 C.L.A.No. 1 of 2015

Section 92 of the Indian Patents Act, 1970, mandates compulsory licensing. This clause permits the government to step in when public health is in jeopardy and permits third parties to produce and market patented medications without the patent holder's prior consent. Section 92 permits the government to issue mandatory licenses on its initiative, unlike Section 84, which requires applicants to demonstrate that a medicine is unavailable or costly. Because of this, it is an essential legislative tool for guaranteeing that the general public has access to necessary medications, especially during pandemics and other public health emergencies6. The main advantage of Section 92 is that it gives the government the ability to avoid the threeyear waiting period that Section 84 mandates.

The central government may publish a notice in the Official Gazette stating that mandatory licensing is required in situations when it is convinced that there is a public health emergency, national emergency, or exceptional urgency. After that, any pharmaceutical company can request a mandatory license to produce the patented medication from the Controller of Patents. In order to ensure that the medication is manufactured in sufficient numbers and at a reasonable cost, the Controller may decide to award the license based on the public interest. The implementation of Section 92 in different public health emergencies has been discussed, despite the fact that it has not been employed much. During the 2009 H1N1 (swine flu) outbreak, the government contemplated using Section 92 to guarantee that there was an adequate supply of Oseltamivir (Tamiflu).

However, the necessity for mandatory licensing was lessened by voluntary agreements and local drug manufacture. In a similar vein, India suggested a temporary TRIPS waiver for COVID-19 vaccines and medications during the epidemic, which would have let nations to produce copyrighted medications without requesting licensing. Although Section 92 was not formally used by the government, the pandemic made it clear how crucial it is to have a robust legal framework for mandatory licensing in cases of medical emergency. During the COVID-19 pandemic, the topic of compulsory licensing was given additional significance, especially with the medication Remdesivir, which is an essential treatment for severe COVID-19 cases. In Mylan Pharmaceuticals v.

Gilead Sciences (2020)7, an Indian generic manufacturer named Mylan Pharmaceuticals attempted to create a generic version of Remdesivir, which Gilead Sciences had patented. Several Indian pharmaceutical companies, 6 Subramanian Sankar Ganesh & S. Muthu Praba, Compulsory Licensing and Covid-19 Vaccine, 4 INT'l J. L. MGMT. & HUMAN. 4467 (2021). available at https://heinonline-org-

7 107 F.Supp.3d 541(N.D.W.Va.2015)

notably Mylan, secured voluntary licensing arrangements with Gilead instead of seeking for a compulsory license, which allowed them to produce and distribute the medication at reduced costs. This example illustrated how, in certain situations, voluntary licensing agreements might serve as a more practical substitute for compulsory licensing when it comes to guaranteeing the availability of medications during public health emergencies. The voluntary agreements removed the immediate need for compulsory licensing, but the Indian government contemplated using Section 92 (compulsory licensing in national emergencies).

3. IMPACT OF COMPULSORY LICENSING ON ACCESS TO MEDICINES

Improving access to reasonably priced medications is one of the main advantages of mandatory licensing, especially in low- and middle-income nations (LMICs). Because patented medications are frequently too expensive for many people, CL allows generic producers to create less expensive substitutes. 3. 1:Enhancing Access to Affordable Medicines The cost of life-saving medications is significantly decreased, which is one of the main benefits of compulsory licensing. A significant portion of the population, especially in developed and under-developing countries, cannot afford necessary medications due to patent monopolies, frequently resulting in exorbitant prescription prices. Compulsory licensing encourages price competition by permitting generic producers to make patented medications, lowering the cost.

Millions of people have benefited from the Indian pharmaceutical industry's compulsory licensing to provide reasonably priced generic copies of pricey medicines8. 3. 2: Addressing Public Health Emergencies In times of public health emergencies, such as pandemics or infectious disease epidemics, mandatory licensing is essential. Governments can grant compulsory licensing to guarantee the quick and broad supply of necessary medications, vaccinations, and therapies. For instance, nations like Brazil and Thailand significantly decreased mortality rates during the HIV/AIDS crisis by expanding access to antiviral medications through compulsory licensing. In the 8 Stavropoulou, C. and Valletti, T. , 2015. Compulsory licensing and access to drugs, The European Journal of Health Economics, 16, pp. 83-94.

framework of COVID-19 vaccines and therapies, issues regarding mandatory licensing have surfaced more recently, underscoring its significance for global health security9. 3. 3: Balancing Intellectual Property Rights and Public Interest Public health benefits from compulsory licensing, but its effects on pharmaceutical innovation and research and development (R&D) are also a source of worry. Pharmaceutical firms contend that patent protection encourages innovation by guaranteeing a return on investment. Companies may be deterred from investing in the creation of novel medications if compulsory licensing is applied excessively.

International agreements like the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and its Doha Declaration offer instructions on the situations in which compulsory licensing might be used to strike a compromise between the interests of public health and intellectual property rights. Challenges and Limitations Notwithstanding its benefits, mandatory licensing has some drawbacks. First, the implementation of mandatory licensing may be delayed by legal and administrative obstacles, which would restrict its immediate public health impact. Second, pharmaceutical firms may respond by cutting back on investments or removing their goods from markets that commonly employ compulsory licensing.

Additionally, their efficacy and quality must be closely regulated to guarantee that generic medications manufactured under compulsory licensing satisfy international health standards.

4. COMPULSORY LICENSING DURING PANDEMICS: A CRITICAL ANALYSIS

The Indian Patents Act of 1970 established the legal process known as compulsory licensing (CL), which permits the government to let third-parties produce a patented product without the patent holder's approval. It protects public health by guaranteeing access to necessary medications, particularly in times of emergency like the COVID-19 pandemic10. India encountered difficulties during the pandemic in guaranteeing the broad availability of vaccines like Covaxin and Covishield and necessary medications like Remdesivir, Favipiravir,

9 ibid

10 Abbas, M., 2013. Pros and cons of compulsory licensing: An analysis of arguments. International Journal of Social Science and Humanity, 3(3), pp.254-258.

and Tocilizumab. The discussion gained prominence as legislators, pharmaceutical firms, and international organizations considered compulsory licenses’ possible effects on innovation and public health. The below gives the challenges and criticisms:

1. Efficiency in Guaranteeing Drug Availability

During the pandemic, India did not use compulsory licensing under Section 92 of the Patents Act despite the urgent need for life-saving medications. Rather, it depended on agreements for voluntary licensing, like Gilead's voluntary licenses for Remdesivir, which restricted access to the drug. Essential medications were in high demand compared to supply, which resulted in shortages and high costs. Better accessibility might have been ensured by a proactive approach to issuing CL, which would have increased local production and reduced costs.

2. Pharmaceutical Companies' Opposition

Pharmaceutical industries contend that Compulsory license deters investment in research and development (R&D) and compromise patent rights. Loss of Monopoly Profits: Businesses spend a lot of money developing new drugs and hope for exclusivity to recoup their expenses. By making it possible to produce generic medications, CL upends this paradigm.

Decreased Incentives for Innovation: Pharma companies may be deterred from creating new medications by frequent CL issuances since they may worry about losing their patent protection. Risk of Market Withdrawal: International pharmaceutical companies may be reluctant to launch new medications in India or postpone their market entry if CL becomes widespread.

3. Legal and Administrative Difficulties in the Implementation of Compulsory license

Prolonged Application Process: Access to essential medications is delayed since Compulsory license applications are only allowed under Section 84 three years after the patent is granted. Judicial Challenges: Long-running legal disputes and uncertainty result from patent holders

regularly contesting Compulsory license rulings in court. For instance, in Bayer v. Natco (2012), Bayer vigorously opposed India's first Compulsory license for the cancer medication Nexavar, which caused delays in its implementation. Government Reluctance: The Indian government, fearing foreign repercussions, prefers voluntary licensing over Compulsory license although having legislative requirements11. 4. Limited Compulsory license Use In defiance of the law Since 2012, no Compulsory license has been issued: India did not give Compulsory license for medications such as Remdesivir or Favipiravir, or vaccinations, in spite of the COVID-19 epidemic. Preference for Voluntary Licensing: To lessen the impact of its patent flexibilities, India negotiated voluntary licensing with pharmaceutical companies rather than using Compulsory license.

Underutilization of TRIPS Flexibilities: India's unwillingness to use Compulsory license is in conflict with its rights under the WTO TRIPS Agreement, which makes it less strong in international public health discussions.

5. Delays in Obtaining Inexpensive Drugs

Compulsory license is intended to increase affordability, but in times of public health emergency, it frequently fails because to legal and administrative hold-ups. Example: COVID-19 Vaccine Shortages (2021): India could have increased domestic manufacturing and decreased dependency on foreign manufacturers if Compulsory license had been implemented sooner. Health crises are time-sensitive, meaning that by the time Compulsory license permissions are given, a pandemic may have already peaked, decreasing the effectiveness of the intervention.

6. Issues with Manufacturing and Quality Control

Ensuring Drug Safety: According to some, generic producers might not adhere to the same

11 Kumar, S., 2022. Compulsory licensing of patents during pandemics. Conn. L. Rev., 54, p.57.

efficacy and safety requirements as the original patent holder. Compliance with Good Manufacturing Practices (GMP): Compulsory license grantees are required to follow stringent regulatory requirements, which could be difficult for smaller domestic businesses. Risk of Ineffective Treatment: Generic versions of life-saving medications may not have the intended level of medical efficacy if quality control errors occur, which could result in resistance or treatment failures.

7. Absence of Knowledge and Legal Experience

Many Indian pharmaceutical firms are either ignorant of Compulsory license laws or are afraid of legal action from multinational pharmaceutical behemoths. Absence of Government Assistance: Because the Indian government hasn't actively pushed Compulsory licenses, local producers are reluctant to apply. Legal Reforms Are Needed: A clear and well-publicized Compulsory license framework would make it easier for Indian businesses to negotiate the legal system successfully.

CONCLUSION

India's public health policy has been greatly influenced by compulsory licensing (CL), especially in guaranteeing access to reasonably priced medications in times of medical emergency. Although India has the legal right to issue compulsory licenses under the Patents Act, 1970, and the TRIPS flexibilities, its actual application has been restricted. India depended more on voluntary licensing than compulsory licenses for essential medications and vaccines during the COVID-19 epidemic, highlighting both the benefits and drawbacks of the system. Due to corporate resistance, legal issues, bureaucratic roadblocks, and pressures from international trade, the influence of compulsory licenses on access to medications is still substantial in theory but restricted in practice.

Despite these obstacles, compulsory licenses are essential for maintaining public health security, particularly during pandemics when prompt access to life-saving medications is essential. India must be proactive by improving domestic production capabilities, expediting compulsory license procedures, and fending outside pressure to limit its usage. Making compulsory licenses an efficient mechanism for fair

healthcare access in future pandemics will require a balanced approach that prioritizes public health requirements while safeguarding pharmaceutical innovation.

References:

1. Abbas, M., 2013. Pros and cons of compulsory licensing: An analysis of arguments,

International Journal of Social Science and Humanity.

2. Kumar, S., 2022. Compulsory licensing of patents during pandemics. Conn. L

3. Shivendra Nath Mishra & Shrey Shalin, Compulsory Licensing in India vis-a-vis

Pharmaceutical Industry in the Covid-19, 2 JUS CORPUS L.J. 554 (June-August 2022). Available at https://heinonline-org-christuniversity.knimbus.com/HOL/License--

4. Stavropoulou, C. and Valletti, T., 2015. Compulsory licensing and access to drugs, The

European Journal of Health Economics

5. Subramanian Sankar Ganesh & S. Muthu Praba, Compulsory Licensing and Covid-19

Vaccine, 4 INT'l J.L. MGMT. & HUMAN. 4467 (2021) available at https://heinonline-org-