Finding a Balance Between Patent Rights and Health Needs: A Focus on Human Rights in Patent Law for Developing Countries – All you need to know about it.

Introduction

Since there are seven different forms of intellectual property, including patents, IPR generally stands for intellectual property rights. It sounds intriguing, doesn’t it? Let’s discuss what a patent is and why it matters to people. Why is it thought to be significant for people’s health? As we can see, Part III of the Indian Constitution also defines fundamental rights, which are personal rights. What is more crucial in a developing nation? A “civilised nation,” “people,” “policy,” “government,” etc. The HIV/AIDS crisis in the 1990s and early 2000s marked a turning point in the discussion about access to affordable medicine. Due to patent protections, antiretroviral medications were too costly for many African nations to obtain. This sparked numerous protests ultimately to the 2001 Doha Declaration. This statement affirmed that WTO members could address public health emergencies by enforcing certain regulations, such as mandatory licensing. According to international law, the right to health is a fundamental human right. According to agreements like the International Covenant on Economic, Social, and Cultural Rights (Article 12) and the Universal Declaration of Human Rights (Article 25), nations must ensure that everyone has access to timely, acceptable, and reasonably priced healthcare.

Meaning:

Under Section 2 (m) of the Patent, 1970, ‘patent means a patent for any invention granted under this Act” A patent is an exclusive right granted for an invention. Patents benefit inventors by providing them with legal protection of their inventions. However, patents also benefit the society by providing public access to technical information about these inventions, and thus accelerating innovation^[1] Under section 2(p) Patentee means the person for the time being entered on the register as the grantee or proprietor of the patent. There are following types of patent:-

• Utility Patent
• Provisional patent
• Plant patent
• Design Patent

Right To Health –

The Supreme Court ruled against granting a patent for a cancer drug in the Novartis AG v. Union of India case. They took this action to ensure that people could afford medicine and to prevent businesses from overextending their patent rights.^[2] Numerous international documents acknowledge health as a fundamental right.

• The 1948 Universal Declaration of Human Rights,
• Article 25(1); the 1966 International Covenant on Economic, Social, and Cultural Rights,
• Article 12; and the 2000 UN Committee on Economic, Social, and Cultural Rights, General Comment No. 14.

States have a moral and legal obligation to protect people’s health. With backing from the UN and WHO, many people think that human rights should come first when problems arise. In 2000, the UN Sub-Commission on Human Rights declared that trade and intellectual property laws should be subordinated to human rights. Additionally, the UN Human Rights Council declared in 2009 that IP and trade agreements must handled in a way that backs the right to health.

Objectives

The objectives are as follows:-

1. Supporting new medicines with patent protection while making sure people can afford essential medicines as a basic health right.
2. Let’s look at patent rights, especially under the TRIPS Agreement, and see how they impact access to medicines in developing countries.
3. The right to health in international human rights law and how it relates to getting access to essential medicines.
4. To find out the legal, political, and structural challenges that stop developing countries from making the most of TRIPS flexibilities or putting in place patent reforms focused on human rights.
5. The main goal is to take part in the worldwide discussion about fairness in intellectual property. This is especially important after health crises like the HIV/AIDS outbreak and the COVID-19 pandemic, which showed serious issues in how people access healthcare around the world.

TRIPS Agreement

The 1994 agreement on trade-related aspects of intellectual property rights is known as TRIPS. There are several articles, including Art. 30 (exemption from patent rights), Art. 31 (compulsory licensing), Art. 6 (parallel importation), etc. which reinforces the idea that, in the medical field, patents are more significant than inventions. LDCs are given more time to begin adhering to TRIPS regulations, particularly in the medical field. This provides them with an opportunity to bolster their resources and guarantee that people can continue to obtain the necessary medications during this time.

 India and South Africa proposed a temporary waiver of intellectual property rights for COVID-19-related health technologies between 2020 and 2023. Although the concept received some early support, the final agreement at the 2022 WTO Ministerial proved to be less successful. It postponed talks about adding medications and diagnostic equipment and only addressed vaccines.

Ground Challenge:- A 2025’ Reality : Profit?

For a duration of 20 years, the inventors are entitled to patent their unique concepts and create monopolies. A patent system functions within the framework of the WTO, WIPO, and other organisations. As a result, in developing nations, people may not be able to purchase medicine simply because it is necessary. These days, everything is too costly. Many people cannot afford drugs due to monopolies’ high prices; even a middle-class family cannot afford to purchase them.

1. In a 2023 resolution (A/HRC/RES/52/15), the UN Human Rights Council discusses how intellectual property laws may hinder access to medications. It encourages nations to improve access to these medications by utilising the TRIPS options.^[3]
2. India’s updated National List of Essential Medicines for 2022-2024 includes 384 medicines, with many of them, like cancer, HIV, and TB drugs, having price controls. Patent holders are pushing the government to remove these price caps.
3. The UN Secretary-General’s High-Level Panel recently pointed out that innovation and access go hand in hand. They also stressed that international IP law needs to change to meet public health responsibilities.
4. India’s Open Licensing Policies for Public-Funded Research (2025 Draft Bill) suggests that any drug or vaccine created with public funds should:
5. Have a non-exclusive license
6. Include price control measures
7. Be put in a public health patent database

For example, in 2024, CSIR (Council of Scientific and Industrial Research) made a non-exclusive licensing deal for an anti-diabetic drug with three Indian companies.

The Rights under Developing Countries :-

There is difference between patent rights and human rights which directly effect on developing countries known for its advancement and betterment Let’s see A period of 2023-2025.

1. In a case known as Cancer Alliance v. Ministry of Health & Roche Kenya, ^[4]public health advocates are taking on the high cost of the cancer drug Herceptin. They argue that Roche’s patent is preventing cheaper generic versions from being available. The Kenyan High Court has accepted the case, but it’s still in progress. The advocates reference Article 43 of the Kenyan Constitution, which supports the right to health, along with some international trade agreements that allow for certain flexibilities. This case could set an important example for discussions on health and intellectual property locally.
   1. In India, Janssen put in 15 patent applications for Darunavir, a medicine for HIV. By 2025, MSF and the Indian Patent Office managed to challenge and oppose 11 of those applications.^[5]

Big Pharma’s Lobbying at WTO and WIPO (2023–2025)

1. The Pharmaceutical Research and Manufacturers of America (PhRMA) and
2. The International Federation of Pharmaceutical Manufacturers & amp; Associations (IFPMA) have been pushing hard against the flexibility of TRIPS.

In 2024, PhRMA even put together a 300-page document for the WTO, arguing that expanding the COVID-era TRIPS waiver would hurt investment in research and development. Some leaked documents reveal that industry groups were directly shaping the talks for the U.S. and EU negotiators during the MC13 meeting in 2024. In 2025,The WIPO Standing Committee on the Law of Patents looked over the Development Agenda Recommendations that were first put in place back in 2007. Countries that are still developing want “Access to Medicines” to be a key part of how all patent standards are evaluated. Talks are still in progress, with India, Brazil, and Egypt coming together to put forward a joint proposal.

Recommendation and Suggestions:-

1. Take advantage of TRIPS flexibilities :-

Developing countries should take advantage of the options available to them under the TRIPS Agreement. This includes things like Compulsory Licensing and Parallel Importation, as well as guidelines from the Doha Declaration on TRIPS and Public Health from 2001. Here are some action points to consider:

• Issue Compulsory Licenses for essential drugs if prices are too high, the drugs aren’t available, or there’s a national emergency.
• Allow Parallel Importation of patented medicines to buy them from cheaper markets.
• Push back against unnecessary patent applications by sticking to stricter standards that prioritize public health. It Create quicker processes to use TRIPS options during health emergencies to avoid delays.

2.  Link public funding to open licensing.

Governments should make it a rule to open up licenses for any medical innovations created with public or taxpayer money. This way, everyone can get affordable access, it encourages the making of generic options, and it matches the idea that everyone has a right to good health.^[6]

3. Set up regional patent review panels:-

The Countries should set up local patent review groups to work together on looking at, opposing, or getting rid of weak patents, especially for important medicines. This can help create consistent standards, lower legal fees, and push back against big pharma.

4. Train judges on patent and health issues :- 

They should Set up training sessions for judges on IP law, the flexibilities in TRIPS, and health rights. This will help them make smarter and fairer decisions in patent cases.

5. Change national patent laws.  

We should Update the national laws to have clear rules for patents, allow for challenges before and after patents are granted, and make sure to protect public health.

6. Advocate for global IP governance changes :-

The Call for changes at the WTO, WIPO, and WHO to add health impact assessments, automatic waivers during pandemics, and better involvement from countries in the Global South. Ex – Negotiations on the TRIPS waiver from 2021 to 2024.

7. Support civil society and academic organizations :-

We should Support and team up with NGOs, universities, and legal researchers who keep an eye on patents, fight against unfair monopolies, and work to make medicines more accessible. For ex. – MSF and KEI’s work in TRIPS advocacy.

Conclusion

It can be challenging to strike the correct balance between public health demands and patent rights, particularly in developing nations where access to reasonably priced medication is crucial. Examining actual cases, such as the TRIPS waiver negotiations or Africa’s mRNA hub, demonstrates how crucial it is to modify intellectual property laws to comply with human rights. TRIPS has certain flexibilities, but they aren’t used very often, which suggests problems like legal loopholes and international power struggles. Developing nations must act by implementing compulsory licensing, modifying their patent laws, cooperating regionally, and ensuring that publicly funded research stays out of private hands. Globally, intellectual property management must prioritise equity, transparency, and ensuring that necessary medications are Examining actual cases, such as the TRIPS waiver negotiations or Africa’s mRNA hub, demonstrates how crucial it is to modify intellectual property laws to comply with human rights. TRIPS has certain flexibilities, but they aren’t used very often, which suggests problems like legal loopholes and international power struggles. It’s critical to encourage open science, bolster the legal system, and assist community initiatives. The goal is to make the system better for everyone, making sure that profit doesn’t come before the right to health.

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 About Author

Mansha is a law student in her final year who has just finished her examinations in the Department of Legal Studies at Desh Bhagat University in Mandi Gobindgarh, Punjab. She strongly believes that research is the essence of law—without effective research abilities, a lawyer lacks the means to make a significant difference.

With a strong interest in Intellectual Property Rights and Human Rights, Mansha distinguishes herself through her analytical mindset and dedication to addressing socially relevant and often contentious topics. She is especially attracted to issues that impact not only the legal framework but also the daily lives of citizens throughout the country.

Reference

^[2] Novartis AG v. Union of India (2013).

^[3],, U.N. Human Rights Council, Access to Medicines and Vaccines in the Context of the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, Res. 52/15, U.N. Doc. A/HRC/RES/52/15 (Apr. 3, 2023), available  at https://undocs.org/A/HRC/RES/52/15. Last visited 16 june, 2025

^[4] Cancer Alliance v. Ministry of Health & Roche Kenya, Pet. No. 113/2023 (Kenya High Ct.).

^[5] https://patentoppositions.org

^[6] Carlos M. Correa, Guidelines on Public Health and Intellectual Property, WHO/UNDP, 2023.