ABSTRACT
The tension between patent protection and public health remains central to global health governance. While pharmaceutical patents incentivize innovation, they often create monopolies that restrict access to essential medicines, particularly in developing countries. This research adopts a doctrinal and comparative legal approach to examine how international frameworks, national laws, and judicial decisions reconcile intellectual property rights with the human right to health. Instruments such as the TRIPS Agreement (1995), the Doha Declaration (2001), and the WTO Paragraph 6 Decision (2003) establish flexibilities like compulsory licensing and parallel importation. Indian jurisprudence, including Novartis v. Union of India (2013) and Natco Pharma v. Bayer (2012), highlights mechanisms that safeguard affordability. Comparative perspectives from South Africa, Brazil, Thailand, and the U.S. demonstrate varied strategies, while patent pooling initiatives expand generic access. The findings suggest that balancing patents and health requires international flexibility, strong domestic laws, and judicial enforcement, ensuring innovation coexists with equitable access. This research aims to examine the legal frameworks, policy tools, and flexibilities employed by countries to ensure access to essential medicines for populations that cannot afford them. It explores mechanisms that balance the availability of generic medicines with the protection of pharmaceutical patents, enabling companies to recoup their investments while allowing governments to authorize alternative manufacturers when necessary to meet public health needs.”
KEY WORDS
Compulsory licensing ,Patent protection, Public health, Access to medicine, TRIPS agreement
INTRODUCTION
There is a tug of war going on between companies which have patent protection for drugs and health care issues for the poor. One side there are companies who have done research and development to make and prepare a drug for commercial purposes which can cure a serious health disease so they have the right to avail patent for their work for 20 years so that they can recover the money which they have invested in research and development. The companies have patent protection get monopoly in the market so they can sell the medical drug in very high price on the other hand there are those patients who don’t have enough money to buy medicine for disease like HIV Cancer etc, the cost of these drugs can vary from 1lakhs to 2.5 lakhs per months so the aim of this article is to deal with how countries like India maintain balance between these two. How it will ensure safety for the health care simultaneously while protecting the patent right by utilizing the flexibilities like compulsory licence, and importation of generic medicine. This article used comparative analysis and study of different countries, their laws related to patent protection and their ways to deal with access to essential medicine. This research also has summarized various case law from countries like South Africa, USA and India. This research critically analyzes international instruments such as the TRIPS Agreement (1995), the Doha Declaration on TRIPS and Public Health (2001), and the WTO Paragraph 6 Decision (2003), it also examine Jurisprudence from India, such as Novartis v. Union of India (2013) and Natco Pharma v. Bayer (2012), illustrates by what means statutory mechanisms like Section 3(d) of the Patents Act and compulsory licensing safeguard access to affordable generic medicines.
The main aim of this research is to find out the tools and laws along with the flexibilities countries use in order to maintain proper access of essential medicine to those who themselves can not afford it along with protecting patent rights. It deals with mechanisms that countries developed to provide the generic medicine along with maintaining patent protection of the companies. So that companies can recovery their money but when necessary government can allow other manufacturers to manufacture the same drug to be available for public.
RESEARCH METHODOLOGY
This research adopts a doctrinal and comparative legal research approach to examine the complex relationship between patent protection and public health in the context of access to essential medicines. The doctrinal method is particularly suited for this study as it involves a critical examination of statutes, international agreements, case law, and authoritative commentaries to determine the scope and application of intellectual property rights in relation to public health By focusing on the textual interpretation of legal provisions and judicial decisions, this approach enables a detailed understanding of how different jurisdictions and international bodies have sought to balance the protection of pharmaceutical innovations with the imperative of ensuring affordable access to medicines.
LITERATURE REVIEW
Doha Declaration
The Docha Declaration made it clear to the world that patent protection and law related to patent protection should not become barriers when it comes to ensuring access to generic medicine. It ensures that WTP members can utilise flexibilities like compulsory licensing or parallel import of generic medicine for the access of essential medicine.
WTO Paragraph 6 system( TRIPS Article 31bis)
Paragraph 6 system later became TRIPS article 31bis states a remedy for those counties which do not have sufficient capacity to manufacture pharmaceuticals or unable to manufacture it all can import the same generic drug from other countries. This system grants a compulsory license to countries only to export the same drug to the countries which are incapable of manufacturing on their own.
Article 27 of the South African constitution
Article 27 of south african constitution states that every have a right to excess health case and make an obligation for the government to take reasonable steps to the same, in case of In Minister of Health v. Treatment Action Campaign court held that generic medicine should be provided to the public at affordable price, not providing the same is a violation of section 27.
TRIPS Agreement
According to article 27 and 33 of TRIPS (Trade-Related Aspects of Intellectual Property Rights, 1995,) all the member of WTO are suppose to grand patent for all innovation in all sectors including pharmaceuticals with any discrimination for 20 years and article 28 state that companies which have patent protection can sell produce use such invention on the other hand had TRIPS show some flexibilities which suggest under article 31 government can allow production od patented medicine if the requirements is high or it necessary for public health, article 6( pallaral import) which suggest that countries can import the same drug which have same healing properties from somewhere else where it is cheaper. And article 30 suggest that the countries when necessary can commence production of patent medicine with patent expires
[1]These flexibility are further defined under Doha declaration of TRIPS agreement which says that the WTO members are not restricted from taking measures to protect public health.” and TRIPS should be interpreted in a manner that it always promotes public health and assets of medicine to all. All members are free to utilise the flexibility provided in TRIPS to promote public health, which are provided under Article 31, 6, 33 and 27
[2]30 August 2003 WTO General Council Decision created a mechanism (called the Paragraph 6 System). state that a country having insufficient capacity to manufacture medicine can import generic medicines from other countries in other words It increase the scope of complicate licensing, earlier to this decision it was presumed that compulsory licensing can be used within country but this decision made a wider for better public health[3]
Indian view
India utilises the flexibility of compulsory licensing for maintaining balance between patent protection and access of medicine to all. Section 3(d) of patent act 1970 plays a vital role in ensuring the same and states that new forms of the same medicine can not be patented. Companies try to delay generic medicine and try to increase their monopoly by making trivial modifications( like better absorption and stability) known as evergreening. This section grants no patent for the same. When it comes to balance in Indian situations it is clearly visible that the government tends to protect public health. There are several cases regarding this
Novartis AG v. Union of India & Others: Novartis applied for a patent in India for a modified version (beta crystalline form) which is a cancer drug Glivec (imatinib mesylate). Patent registrar rejected the patent application under section 3(d) which states no patent for evergreening. The Supreme Court upheld the rejection and the reason that medicine or drug is incapable of showing any enhancement in therapeutic efficacy.” therefore no patent granted
[4] Roche v. Cipla Ltd. (Delhi High Court) : Cipla Ltd was a company selling and manufacturing a generic form of medicine drug (Erlotinib anti-cancer drug, marketed as Tarceva) which can cure cancer.Roche which is the company who have patent for the drug sued Cipla for patent infringingment. And prayed for injunction before court but rejected and denied from granting injunction because generic medicine is necessary for citizen who can not pay such huge amount for the drug
[5]In Natco Pharma Ltd. v. Bayer Corporation (2012), the Indian Patent Controller granted India’s first compulsory license under Section 84 of the Patents Act for Bayer’s patented cancer drug Nexavar (sorafenib tosylate). Bayer, who is the real owner of the drug, was selling at a cost of 2.8 lakhs per month which is very costly and only very few hands can get it at this price. Nacto pharma applied for compulsory licensing which was granted by the controller that Nacto will sell the generic medicine at 8000 and 6 percent royal will be given to bayer
The controller granted compulsory license on three grounds that Bayer had not made the drug sufficiently available to the public, the price was not “reasonably affordable,” and the invention was not being “worked” in India (not locally manufactured). Bayer applied for IPAB but failed to overturn the controller decision.This patent rejection allows the generic medicine to be on the market for 8,000 rupees per month otherwise it would be 120000 per month which is not affordable for many hand in india
[6]It is clear that India has achieved balance in patent protection by allowing patent protection only for real innovation and not for evergreening and public health by allowing compulsory licensing so the medicine which which of 120000 per month can be sold for 8000 and become affordable for many hands in india above two judgments are the landmark judgment ensuring patent potent and ensuring access of generic medicine to all.
South africian view
In late 1990s – 2000 south african faced its biggest HIV crisis in which millions of south african
citizens got infected. At that time, life-saving antiretroviral (ARV) medicines were sold at very high prices and treatment cost 10,000 USD per year which is not at all affordable for many hands in South Africa. In 1998 South Africa enacted a law to import generic medicine from other countries where it is cheaper. Pharmaceutical Manufacturers’ Association of South Africa v. President of South Africa (High Court, withdrawn 2001) in this case 39 South African companies sued the South African government arguing that it was a violation of their patent right and TRIPS obligation but after massive pressure from the globe companies dropped the case. And that is how it was a victory for public health
In Minister of Health v. Treatment Action Campaign, In this case the government of south africa limited the availability and distribution of life saving antiretroviral drug Nevirapine, which prevents mother-to-child transmission of HIV that can save millions life south african after the manufacturer declared to sell it for free. The african court confronted the south african government for the same and held that this violated the constitutional right to health care services under Section 27 of the South African Constitution,. Judiciary ordered south african government to make the drug available remove all the restriction from it .
[7]Unlike india which use patent law flexibility south Africa relied on constitutional and human right law along with civil society activism to ensure balance between patent protection and public health,
USA view
The Bolar exemption in U.S. law, written in 35 U.S.C. § 271(e)(1) it states that generic manufacturing companies can use patent drug for research and testing which is required for FDA approval in other words and simple words company which manufacturer generic can do all the research and testing related to patented drug while the patent is active so just after the patent expired companies can start selling generic without delay.
[8]Under 28 U.S.C. § 1498, the US government has the right and authority to use or authorize others to use and manufacture the patented drug for public health, at the time of health crisis specially. This law is similar to the Complicatory License, where the USA government can allow Generic manufacturers to use patent medicine with the permission of the patent owner.
[9]Eli Lilly & Co. v. Medtronic, Inc. ,in this cases Supreme court of USA allow manufacturer of generic medicines to use and test patented drug without the expiration of patent, so the medicine can come in to Marked just after patent expires, generally it take year in the process of approval of patented drug be used by generic manufacturer, in this case judiciary provide a shorter way for generic to come in the marked fast just expire of patent
[10]Brenner v. Manson In this case Supreme Court of USA said that patent should not be granted for the invention which is unable to show and prove it use, in other words only those inventions are entitled for which have genuine application and use,
If a patent is grand for those inventions which can’t prove its use will block other researchers with any use.
[11]From the above discussion it is clear that the USA have also made balance between patent protection by recognising the patent owner right and by not granting patent to non useful inventions. On the other hand give priority to public health and make it supreme and the government can use a law known as Bolar Exemption. unlike India or South Africa which use patent flexibility and law.
Braziel view
In 1990 -2000 Brazil also faced a severe HIV/AIDS epidemic and millions of citizens of Brazil needed the drug Antiretroviral ( AVR)which can save the lives of many. To deal with this Brazil government threatened the pharma companies by allowing Compulsory Licenses until they lower the price themselves. This was a major step taken by Brazil government that it started producing generic to deal with such a pandemic in 2007 brazil have granted its first compulsory license earlier too that the drug was imported from Indian companies
Thailand view
Thailand suffered massive HIV crises in the late 1990s to deal with the issue . The Thai government tried to negotiate with a prama company which manufactured a drug antiretroviral which cost in lakhs per month and because of it it was not affordable for many hands. After negotiation, negotiation failed to reduce the price of antiretrovirals. The government to deal with and to make the drug affordable uses compulsory licensing to reduce the cost and to make it affordable for the citizens of Thailand. [12]
Others tool
Patent pooling:– it a mechanism in which multiple patent hold agrees to give the right to the generic manufacturer, on the standard terms which help mitigate the limitation of individual patent, which can make drug unaffordable.The Medicines Patent Pool (MPP), established by UNITAID, is a prime example in the pharmaceutical sector. Through MPP agreements, patent holders license their drugs non-exclusively.Patent pooling reduced the risk of Litigation, It is particularly effective during public health emergencies, as seen with HIV, Hepatitis C, and COVID-19 treatments, where timely access to affordable drugs can save millions of lives. Patent pooling behave as an intermediary between generic manufacturers or patent holders
Patent Pooling mitigate the risk through various machines like:-
- Centralised Licensing :-In centralized licensing multiple patent holders agree to give their patent right under one centralized entity or pool instead of individual negotiation and contract, this licensing allow Generic manufacturer to use multiple patents under one contract, which save a lots of time and give rapid delivery of generic in the marked
- Non Exclusive licensing:- In this licensing a patent holder allows multiple generic manufacturers to manufacture generic through the patent drug, in other words patent holders allow multiple generic manufacturers to use their drug instead of allowing only one individual. It increases the availability of patent drugs and wider distribution will give full control of the manufacturing and it helps in controlling the crisis.
- Clear royalty agreement:-Patent holders get royalty as per pool’s standardized term. It is a transparent form of compensation which reduces the risk of dispute.
AstraZeneca AB and AstraZeneca plc v. Commission (2012)AstraZeneca, a major pharmaceutical company, used a strategy to extend its patent monopoly on the drug Nexium, by filing second patent application and doing certain action to delay the generic Medicines, the commission impose fine on the company because it an abuse of dominant position under Article 102 of the Treaty on the Functioning of the European Union (TFEU).
The court of the European Union upheld the fine and it hurt the competition and consumer.[13]
SUGGESTIONS
1. Utilize TRIPS Flexibilities More Effectively: WTO members, particularly developing countries, should fully embrace provisions on compulsory licensing (Art. 31) and parallel imports (Art. 6) to address public health emergencies.
2. Prevent Evergreening Practices: National legislations should emulate India’s Section 3(d) by refusing patents for minor modifications of existing drugs. This ensures patents are granted only for genuine innovations that add therapeutic value.
3. Expand Patent Pooling Mechanisms: Governments and international organizations should promote initiatives like the Medicines Patent Pool, encouraging pharmaceutical companies to contribute their patents. Patent pooling reduces litigation risks, speeds up generic availability, and ensures equitable access.
4. Adopt Tiered Pricing Models: Pharmaceutical companies should adopt differential pricing strategies, selling medicines at lower prices in poorer countries while maintaining profitability in wealthier markets.
5. Strengthen Competition Law Oversight: Regulatory authorities should monitor and penalize abuses where companies misuse patents to block generics, as seen in AstraZeneca v. Commission. Integrating competition law with IP law can curb anti-competitive practices.
6. Invest in Local Production of Generics: Developing nations should build domestic pharmaceutical capacity to reduce reliance on imports and strengthen resilience during pandemics or supply chain disruptions.
7. Foster International Cooperation: Organizations like WHO, WTO, and WIPO should coordinate global procurement and licensing systems, especially for medicines needed in health crises. Collaborative action can prevent inequities like those seen during the COVID-19 pandemic.
CONCLUSION
The study makes it evident that the challenge of balancing patent protection with public health remains central to global health governance. Patents play an essential role in incentivizing pharmaceutical innovation by rewarding investment in research and development. However, unchecked monopolies can create barriers to affordable access, particularly in developing nations, where life-saving treatments often remain beyond reach. This creates a profound ethical and legal dilemma, as the right to health is a fundamental human right recognized internationally.
Through the comparative analysis of India, South Africa, Brazil, Thailand, and the United States, it is clear that different jurisdictions have crafted distinct strategies to strike this balance. India’s adoption of TRIPS flexibilities, including compulsory licensing and its strict approach to evergreening under Section 3(d), has ensured that only genuine innovations are patented while making medicines like cancer treatments more affordable. South Africa, in contrast, has relied on constitutional litigation and human rights principles to compel state action during the HIV/AIDS epidemic. Brazil and Thailand have used the threat or issuance of compulsory licenses as a negotiating tool to lower drug prices, while the U.S. has relied on legal doctrines like the Bolar exemption and government-use provisions to ensure timely generic entry.
Judicial decisions such as Novartis v. Union of India (2013), Natco v. Bayer , Roche v. Cipla (2008), and Minister of Health v. Treatment Action Campaign demonstrates that courts and regulators play a critical role in ensuring that patent law is not abused at the expense of public health. At the international level, the Doha Declaration on TRIPS and Public Health (2001) reaffirmed that intellectual property rules must be interpreted in a manner consistent with safeguarding public health.
At the same time, innovative mechanisms like patent pooling, exemplified by the Medicines Patent Pool, provide collaborative solutions by offering centralized licensing, non-exclusive access, and transparent royalty structures. These mechanisms demonstrate that innovation and access to medicines need not be mutually exclusive but can coexist within a carefully designed legal and policy framework.
Ultimately, the global community must recognize that patents are a means to an end, not an end in themselves. They must support innovation while ensuring that essential medicines remain accessible to all, especially during public health crises. The pursuit of balance is not merely a policy question but a moral imperative rooted in justice, equity, and human dignity.
Author Name:- Shreshth Sahu
College: Shambhunath Institute Of Law
[1] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299 [hereinafter TRIPS Agreement].
[2] World Trade Organization, Ministerial Declaration of 14 November 2001 on the TRIPS Agreement and Public Health, WTO Doc. WT/MIN(01)/DEC/2 (2001) [hereinafter Doha Declaration].
[3] WTO General Council, Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc. WT/L/540 (Aug. 30, 2003).
[4] Novartis AG v. Union of India, (2013) 6 S.C.C. 1
[5]F. Hoffmann-La Roche Ltd. v. Cipla Ltd., I.A. No. 642/2008 in C.S. (O.S.) No. 89/2008, (Del. High Ct. Mar. 19, 2008) .
[6]Natco Pharma Ltd. v. Bayer Corp., Compulsory License Application No. 1 of 2011, Controller of Patents, Mar. 9, 2012 .
Bayer Corp. v. Union of India, (2014) 60 P.T.C. 277 (Bom) .
[7] Minister of Health v. Treatment Action Campaign, 2002 (5) SA 721 (CC) (S. Afr.).
[8] 35 U.S.C. § 271(e)(1) (2024).
[9] 28 U.S.C. § 1498 (2024).
[10] Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990).
[11] Brenner v. Manson, 383 U.S. 519 (1966).
[12] Stephanie T. Rosenberg, Asserting the Primacy of Health Over Patent Rights: A Comparative Study of the Processes that Led to the Use of Compulsory Licensing in Thailand and Brazil, 14 Dev. World Bioethics 83 (2014).
[13] AstraZeneca AB & AstraZeneca PLC v. Comm’n, Case C-457/10 P, ECLI:EU:C:2012:770 (CJEU Dec. 6, 2012).