This piece has been authored by S.Abhipsha Dash, Student, Symbiosis Law School Pune

Abstract:

In the course of nation’s legal development Intellectual Property Rights and Competition Laws have evolved as two distinct streams of law for the mass benefit. Both streams of law provide an impetus for innovation and economic growth, which in turn fuels the overall health of the nation. One arena where the laws overlap is in the field of medicine and pharmaceuticals, which gives rise to several concerns. IP laws might grant monopolies to a particular manufacturer or innovator, potentially discouraging other market players. This is where competition laws come into the picture, as they comprise laws that regulate these anti-competitive behaviors by ensuring a level playing field for all participants. One scenario highlighting this conflict is the case of Johnson & Johnson losing patent rights for Bedaquiline, and the promptness shown by other market players in bringing out their own versions of the Tuberculosis medicine. Historically, Johnson & Johnson had a monopoly over the medicine, as it was the first drug to be globally approved in over 40 years due to its lower toxicity compared to other traditional Tuberculosis medications available on the market. This article introduces the topic of IPRs and competition law, addressing Indian antitrust law and significant areas of dispute between the two laws. Finally, it attempts to reconcile the differences.

Keywords:

Tuberculosis, Bedaquiline, Intellectual Property Rights, Competition Law, Patents,

1. INTRODUCTION:

“For good ideas and true innovation, you need human interaction, conflict, argument, debate.” – Mary Parker Follet[1]

Envision a dynamic market characterized by a flurry of invention, originality, and intense rivalry. The intersection of intellectual property rights (IP) with competition law gives rise to a fascinating and intricate legal maze. Intellectual property laws, such as patents, trademarks, and copyrights, encourage authors and innovators by granting them brief monopolies. In contrast, competition law aims to preserve an even playing field by prohibiting the very monopolies that intellectual property rights create.. The complex interplay between competition law and intellectual property (IP) is centered on this seemingly paradoxical dance between encouraging innovation and avoiding market control. We’re going to travel to investigate this fascinating crossroads. We will clarify the main areas of interaction between these two legal systems, showing how they might work in harmony or in opposition to one another. We will examine the obstacles that arise from this overlap, including topics such as patent tangles and unfair licensing contracts, as well as the fine line that must be drawn between preserving innovation and promoting healthy competition.

However, this is not only a conflict-focused story. We will also see how intellectual property law and competition law can cooperate to support a common objective: a vibrant and dynamic market that encourages innovation, safeguards consumers, and supports economic expansion. We’ll look at the laws and rules designed to achieve this fine balance, as well as the ongoing discussions and developing case law influencing this dynamic environment. After all, figuring out how to navigate this intriguing legal labyrinth not only provides the key to comprehending our contemporary economy but also provides priceless insights into how innovation and competition will develop in an increasingly globalized world.

I.I Bedaquiline and its importance in the market

Multidrug-resistant (MDR: resistance to at least isoniazid [INH] and rifampicin [RMP]) strains of Mycobacterium tuberculosis posed a serious challenge to global efforts to eradicate tuberculosis. According to World Health Organization reports, close to half a million people worldwide were infected in 2019 with an RMP-resistant strain, of whom 78% were MDR.

The ancient infectious disease known as tuberculosis (TB) has afflicted humans for thousands of years, with its roots traceable back to prehistoric times. The bacterium that causes tuberculosis (TB), Mycobacterium tuberculosis, likely evolved simultaneously with early human cultures. Skeletal remains from ancient Egypt exhibit symptoms of tuberculosis, providing the earliest known evidence of the illness. Urbanization and social growth led to an increase in tuberculosis cases, which earned the disease the historical nickname “white plague.” The elusive nature of tuberculosis primarily contributes to its lethal consequences. Primarily targeting the lungs, the bacterium can cause a variety of symptoms, including fever, chronic cough, weight loss, and night sweats. TB spreads covertly because it can remain inert in the body for years before becoming an active infection. Furthermore, the emergence of drug-resistant forms presents a contemporary obstacle to tuberculosis control efforts. Despite advances in medical knowledge, tuberculosis continues to be a global health problem. It causes great misery and takes many lives, especially in areas with poor access to healthcare services. Attempts to tackle this age-old enemy continue, highlighting the necessity of further study, better diagnostics, and international cooperation to successfully mitigate its catastrophic effects. A glimmer of hope appeared in the gloom of a tuberculosis-ravaged world where the prospect of antibiotic resistance enveloped hope: Bedaquiline. This ground-breaking medication represents a critical turning point in the battle against this age-old evil and was developed over decades of painstaking research.

Imagine a battlefield once dominated by multidrug-resistant tuberculosis strains resistant to conventional antibiotics. Years of treatment plans with severe side effects and unpredictable results were involved. This was the lonely scene before Bedaquiline showed up.

Rather than a loud announcement, the journey began with a quiet molecule discovered among the unkempt shelves of abandoned research. Thereafter, years of arduous development were required to overcome obstacles in science and regulations. With every breakthrough and successful trial that overcame the barrier of resistance, the endless possibilities of this game-changer became ever closer to realization. At last, in 2012, Bedaquiline arrived on the scene, boasting a potency never previously seen. It cut through once-invincible bacterial defenses like a warrior wielding a magical weapon, offering hope for healing where none had previously existed.. This was more than just a novel medication; it signaled a paradigm change and a turning point in the fight against tuberculosis.

I.II. History and evolution of ipr:

Intellectual Property Rights evolved in response to historical conflicts that arose between the interests of exporters of products and technology and those of importers or imitators of such products.[2] With the growth of the laissez-faire economy, the market saw an emergence of faster and cheaper methods for substantially replicating original products, leading to a significant need for the development and enforcement of legal frameworks to ensure the rights of original developers and innovators. Thus, IPRs have rapidly evolved from a niche topic discussed only by experts to a significant policy issue in global economic relations, becoming a concept understood by people everywhere. The 1994 TRIPS (Trade Related Aspects of Intellectual Property Rights) [3] agreement successfully established a connection between international trade and individuals intellectual property rights. It succeeded in providing a more cohesive and elevated platform.

Current developments also mark its interaction in the sphere of medicine and pharmacy. Particularly in the 18th and 19th centuries, the patent medicine came to refer to pharmaceutical compounds that were marketed with flashy labels and even flashier claims.

The word “nostrum” comes from the Latin nostrum remedium, which meant “our remedy” in ancient times. Also known as proprietary medications, these mixtures were mostly trademarked but unpatented drugs. In the past, drugs granted government authorization for exclusivity were referred to as patent medicines. The majority of the patent medications from the 19th century were not, in fact, properly patented. Most producers, often small family businesses, employed vegetable extracts with high alcohol content as components. Emanating from England as proprietary medicines manufactured under grants, these medicines were exported to America in the 18th century. The initial English patent medicines to arrive in North America with the early immigrants included Daffy & Elixir Salutis for and griping Dr. Bateman’s Pectoral Drops, and John Hooper’s Female Pills.

I.III. Evolution of competition laws:

The evolution of competition laws traces its origins to the ancient Roman Empire, along with several American antitrust statutes, such as the Sherman Act of 1890 and the Clayton Act of 1914.[4] However, the concept of competition law only gained significant impetus after World War II. Articles 81 and 82 of the 1957 Treaty of Rome include the competition law provisions that were adopted by the European Community. Since more than a hundred governments now have established competition laws, any business hoping to expand internationally cannot afford to disobey them.

With the advent of Liberalisation, Privatisation, Globalisation reforms under the Hon’ble Prime Minister Manmohan Singh in the year 1991, India opened it’s market for international players  as a result of which Indian markets faced competition both inside and outside the market. This made its necessary to enact the Competition Act of 2002[5] in order to provide strict legal guidelines for the administration of justice in business disputes. It has been demonstrated that a robust and equitable competitive system improves economic efficiency. The Competition Act was approved by the Indian Parliament in 2002, and the President signed it into law in January 2003. On October 14, 2003, the government founded CCI in order to carry out the Act’s aims. The Honorable Supreme Court and Honorable Chennai High Court heard challenges to a few of the Act’s provisions. The Government vowed to implement certain Act modifications in retaliation. The 2006 introduction of this amendment bill to Parliament resulted in its adoption in 2007.

1. Rise of tuberculosis and incentives to eradicate it:

By the middle of the 19^th century, the manufacture of products similar to the English medicines that arrived in America had become a major industry. Often high in alcoholic content, these remedies were very popular with those who found the ingredients to be therapeutic.

Throughout history, Tuberculosis has been referred to by several monikers, such as Consumption, Phthisis, and The White Plague. It is generally caused by Mycobacterium Tuberculosis. In 2014, a study based on genes found in remains from Peru concluded that the age of Tuberculosis is less than 6,000 years. But there are evidences that prove that the infection happened 9000 years ago. In 2008, evidence was first discovered in human remains from the Neolithic Era, dating back 9,000 years, in Atitlán Yam, a settlement in the eastern Mediterranean.

On the dawning of 20^th century, TB was one of UK’s most pressing health problems. Royal Commission was set up in 1901 which evolved into UK’s medical research council by 1919. Tuberculosis in India is a major health problem causing over 2lakh deaths every year. In 2020, the Indian Government made statements to eliminate tuberculosis from the country by 2025 through its National TB Elimination Program. Interventions in this program include major investment in health care. Major health care investments, the Nikshay Poshan Yojana’s provision of supplemental nutrition credits, the planning of a national tuberculosis epidemiological survey, and the execution of a nationwide campaign uniting India’s public and private health systems in pursuit of the disease’s eradication are among the interventions included in this program.

1. Current scenario:

The primary patents on Tuberculosis drug Bedaquiline expired in India and other nations in July[6]. With this, at least three Indian companies—Lupin, Natco, and Macleods—are poised to bring out their generic versions of the drug, highlighting the anti-competitive practices that are unintentionally fostered by granting patents over a product to a single company. The expiry of primary patent opened the markets for generic medicine manufacturer to develop and sell more affordable versions of drug potentially increasing access for patients in low- and middle-income nations. In September, Johnson & Johnson, the original developer of the medicine, confirmed they wouldn’t enforce the patent in 134 low- and middle-income countries, thereby strengthening access for vulnerable populations.

However, the challenge that still looms is J&J still holds patents across 34 high-burden TB countries restricting access and reach of generic medicines there. Generics may still be prohibitively costly for certain patients in situations with limited resources, even though they will probably be less expensive than J&J’s branded equivalent. Strong supply chain management and cooperation between governments, manufacturers, and public health groups are necessary to guarantee a steady and dependable supply of generics to everyone who needs them.

1. Conflict between intellectual property laws and competition laws:

Intellectual property refers to creations of the mind: inventions, literary and artistic works, symbols, designs, etc. An intellectual property right is an intangible right protecting commercially valuable “products of human intellect.”[7] IP is categorized into two groups: industrial property, which covers inventions, patents, trademarks, industrial designs, and geographical indications; and copyright, which covers literary and artistic creations such as plays, novels, poems, films, paintings, drawings, photographs, sculptures, and architectural designs. A broadcaster’s radio and television shows, phonogram makers’ recordings, and performing artists’ performances are among the parties with copyright-related rights. A set of regulations that encourage market competition must be developed in accordance with competition law. The purpose of these is to stop unfair trading practices. Additionally, the dominant company’s abuse of its monopoly in the market is intended to be curbed. Competition law mandates the development of a set of regulations that encourage market competition. The Competition Act of 2002 forbids intellectual property holders from engaging in anti-competitive agreements, as they are in opposition to competition laws. The Act also gives the Indian Competition Commission the authority to punish IPR holders who abuse their dominant position. Moreover, under Section 45[8] of the Act, the Commission may fine parties to an anti-competitive arrangement that violates Section 3[9] of the Act

The major concern between Intellectual Property Rights and Competition Law is often termed as an “unhappy marriage”, concerns that anti-competitive practices adopted by companies who are granted such rights. In simplest terms market power can be abused by setting prices higher than actually required for cost-effective production. The potential harm extends beyond this. When huge profit-making houses are allowed to utilize and distort innovation as per their need they utilize it as a profit-making tool contrary to the nature of invention. Further harm from market dominance may result from granting corporations protection that permits them to impede or stifle innovation. In these conditions, the possibility of sustained rises in living standards is diminished, and market power will restrict the rate of productivity growth over time.

In a nutshell where Intellectual Property Right seems to promote monopolies, competition laws are there to oppose them. Parallel imports and forced licensing are two key strategies used by anti-competition laws to counteract IPR monopolies. According to TRIPS, an IPR holder who is permitted by the state to give up his exclusive ownership of the intellectual property is said to have a compulsory license. Goods entered the nation without the proper intellectual property holder’s consent and lawfully placed on a market are considered parallel imports. There has historically been a connection between increased economic growth and increased innovation. Both at the macro and microeconomic levels, the emergence of new ideas fosters healthy competition. Intellectual property rules aid in preventing unauthorized use of these innovations. Therefore, in order to guarantee the protection of the interests of all parties involved—including the innovator and the general public or consumer—IP and competition rules must be enforced in concert.

• Interface between IP laws and competition laws in India

Through domestic legislation:

The Constitution’s Articles 38[10] and 39[11], establishes the State’s duty to safeguard and protect a social order in which social, political, and economic justice predominates, as well as its additional duty to distribute ownership and control of the community’s material resources in a way that best serves the common good and prevents wealth concentration, are the foundations of Indian law regarding competition. These requirements gave rise to the MRTP Act, 1969[12], which was also impacted by laws from the US, the UK, and Canada. In response to the WTO’s 1996 Singapore Ministerial Declaration, an Expert Group was established to examine the relationship between trade and competition policy in India. This group began the process of drafting a new competition legislation. In its report delivered to the Ministry of Commerce in January 1999, the Expert Group suggested that a new competition law be drafted, noting that competition policy is a precondition for economic liberalization. A High-Level Committee on Competition Policy and Law was established by the government in October 1999, and it was their responsibility to develop the proposed competition law, which was submitted in November 2000. Section 3(5) of the Competition Act includes a blanket exception for intellectual property rights (IPRs). This provision is justified by the argument that if IPRs are not protected, the vital incentive for innovation will be disrupted, leading to a decline in technological innovation and a corresponding drop in the quality of goods and services produced. But it also draws the line because it forbids the imposition of unjustifiable requirements that are concealed under the pretense of safeguarding intellectual property rights.

Points of conflict in the case of bedaquiline:

Balancing access and innovations:

The tightrope to walk now is finding the right balance between access and innovation. On one hand are the people who are in dire need to access the life-saving drug Bedaquiline to save their life and on the other hand the future of medicine and pharmacy of Tuberculosis is hinged on continued R&D requiring some form of reward for pharmaceutical companies.

The tension unfolds in several ways:

1. Demanding Access:

High costs and unaffordability: High costs and unaffordability: Bedaquiline’s initial price tag was astronomical, putting it out of reach for most patients in resource-limited settings.. This created a stark ethical dilemma which is prioritizing precious individual lives on whom society stands or the overall long-term benefit of long-term research.

• Public Health Emergencies:

MDR-TB is a global health emergency and timely availability of effective and affordable medication is a nodal requirement to curb its spread. The patent expiry offers a glimmer of hope for scaling up treatment and tackling the pervasive disease more effectively.

• Equity and Human Rights:

Essential healthcare access is a basic human right. Denying patients bedaquiline because it is too expensive limits this right and increases the disparity in healthcare between wealthy and developing countries.

• Pressuring Innovation:

Developing new drugs is a costly and risk-laden endeavor. Without strong patent protection and promise of future profits, might be less inclined to take-up such risks just for sake of greater public welfare. Further a robust pipeline of new TB treatment is crucial for combating emerging drug-resistant strains. Weakening patent protection could potentially discourage future investment in this critical area. Businesses require compensation for their investments and efforts. Robust patent protection fosters innovation and the creation of novel, even more potent medications by acting as an incentive.

Role of competition laws in post patent scenarios:

The market cracks open and a new phase of competition begins when patents expire. Competition law is in a fascinating position to play a critical role in this dynamic transformation, especially in the area of important medications like Bedaquiline. Let us examine how competition law supports equitable access to knowledge and innovation by delving into the complex connection that exists between patent expiry and competition.

1. Promoting market dynamics:
2. Breaking Monopolies:

The temporary monopolies that pharmaceutical businesses had are disrupted by patent expiration, which opens the door for generic producers to enter the market. This creates a healthy competitive environment that may lower costs and expand access to reasonably priced medications.

• Ensuring Fair Prices:

Competition Law prohibits anti-competitive practices like predatory pricing or market allocation agreement. This safeguards against pharmaceutical giants leveraging their dominance to stifle competition and maintain artificially high prices even after patent expiry.

• Boosting Innovation:

Healthy competition, in contrast to some worries, can encourage more invention. In an effort to enhance current formulations or create novel delivery systems, generic producers frequently fund research and development, which advances the industry.

• Addressing Challenges:
• Evergreening of Patents:

The threat of perpetual patenting remains, even in light of the recent expiration of the key patent on Bedaquiline, which raises hopes for better access to this life-saving medication. In this contentious practice, pharmaceutical corporations file new patents on slight adjustments or alterations to their current drugs in an effort to maintain their market exclusivity beyond the initial patent term. This has been witnessed in several instances:

1. Dosage form Patents:

J&J, the company that created Bedaquiline first, filed patents for particular dosage forms and medication delivery systems. Although these modifications may provide some convenience or enhancements, detractors contend that they are not substantial enough to justify patent protection, with the intention of extending exclusivity and impeding generic competition.

• Combination Therapy Patents:

Patents for Bedaquiline combinations with other TB medications are also held by J&J. Patent experts and public health campaigners contend that these kinds of patents hinder research into potentially more efficacious medicine combinations and impede innovation.

• Process Patents:

J&J has applied for patents covering particular bedaquiline production techniques. There are worries that these are more about preventing generic manufacturers from entering the market than they are about encouraging true innovation, even though they may involve certain technological breakthroughs.

These leads to the following potential consequences:

1. High and Inflated Prices:

By keeping control over the medication, J&J may be able to keep costs high and restrict access for people who are in dire need of it but live in environments with limited resources.

• Stifled Innovation:

The advancement of the battle against tuberculosis could be hampered if generic producers are dissuaded from funding research and development for substitute or enhanced forms of Bedaquiline.

• Reduced Access to treatment:

In the end, evergreen patenting may result in a bottleneck that keeps Bedaquiline from getting to the thousands of patients who need it to survive.

• Counterfeit Drugs and quality Control:

Bedaquiline’s patent expiration prompts alarms about the possible influx of counterfeit pharmaceuticals and quality control challenges, even though it also promises to provide access to this essential TB drug. Let’s explore this difficult territory:

Threats:

Heightened susceptibility: As more companies enter the market, there is a greater chance that inferior or counterfeit bedaquiline will find its way into the supply chain. As well as being frequently useless and perhaps harmful, these knockoffs damage public confidence in the medical establishment and reputable generic producers.

Monetary motives: Skewed actors may be drawn in by the poor regulatory supervision in some areas and the high demand for bedaquiline, which could result in the creation and sale of illegal goods.

Detection challenges: Distinguishing real bedaquiline from fakes can be challenging, particularly in places with limited resources and no access to advanced testing tools or qualified personnel.

• Quality Control Concerns:

Production capacities: Not all generic producers have the know-how and quality assurance systems required to guarantee reliable production of a sophisticated medication like Bedaquiline. This may result in changes in potency, contaminants, and eventually diminished efficacy.

Vulnerabilities in the supply chain: Imperfections may be able to enter the genuine supply chain through gaps in the distribution and procurement systems, endangering patients.

Legal gaps: Some nations may not have strong enough legal frameworks to properly oversee and enforce quality requirements for imported generic medications, which could result in problems with efficacy and safety.

• Stifled competition in specialized market

Although there is optimism for more access due to bedaquiline’s patent expiring, there may be little competition in its niche market. Bedaquiline, in contrast to popular drugs with a plethora of generic equivalents, fills a special niche for a number of reasons:

Steep Manufacturing expenses: The manufacture of bedaquiline is expensive due to the intricate procedure and strict quality control standards. Due to the high entry barrier, few generic manufacturers are willing to invest in its production, which could limit competition and keep prices above desirable levels.

Limited market size: Compared to prevalent conditions like diabetes or hypertension, MDR-TB, the primary target for Bedaquiline, affects a significantly smaller population but remains a considerable health burden. Some generic producers may find the smaller market size too compelling to warrant the significant expenditure required for production.

Regulatory obstacles and technical know-how are needed to produce Bedaquiline in a safe and efficient manner. Strong quality control procedures and specialist knowledge are also necessary. Further discouraging certain generic producers from entering the market is the difficult and drawn-out process of traversing the strict regulatory procedures in different nations.

Consequences of this limited competition can be concerning:

Unabatedly high costs: In situations where there is insufficient competition, generic manufacturers may not be able to substantially reduce costs, which would make it more difficult for patients in settings with limited resources to receive therapy that is cheap.

Innovation stifled: Weak competition may deter more investigation and development into better MDR-TB formulations, delivery systems, or combination treatments.

Enhanced reliance on J&J: Although the company’s price guarantee provides some respite, sustained reliance on a single supplier carries some risk due to possible supply chain interruptions or modifications in pricing strategies.

• Economic Justification of the complex intertwining

In today’s world of rapid technological development and fast development of ideas, intellectual property rights play a major role in lives of innovators. Economists contend that the issue of “free riders” would surface if everyone was permitted to freely utilize the products of inventive and creative endeavors. Except in a few situations when there was no other option, no one would make investments in innovation or invention because doing so would place them at a competitive disadvantage. Competition can only achieve its target if products of human labour are protected by property rights. Intellectual property rights possess an exclusive monopolistic nature, which is complemented by their marketability and transferability due to their ability to be sold individually. Intellectual Property Rights (IPRs) provide a limited time and absolute monopoly to the holder; yet, this monopoly is susceptible to competition from identical products, trademarks, and other sources. Because innovation and creativity are crucial components of a competitive free market economy, it is contended that the market economy would fail to operate as it should. According to this viewpoint, economic progress and prosperity depend on creativity and innovation. If commodities and services are to be manufactured and utilized as effectively as possible in such an economy, intellectual property rights (IPRs) must be established. People and businesses will invest in research and development because they will know that they are entitled to a property right in the outcomes of their investment; nevertheless, such property rights should only be awarded to those who will maximize profits economically.

• Future recourse for harmonization:

There is an economic logic shared by IP and competition legislation. For the creation of inventive and competitive market circumstances, they are both essential. The promotion of innovation is the shared goal of both programs, and this should never come at the expense of the general populace in order to achieve the goal of a nation’s economic development. Since an equilibrium between both legislations would result in both economic and consumer welfare, the competition authorities must ensure that competition policy and intellectual property laws coexist. The goal of competition laws is to reduce monopolies, unfair commercial practices, and the concentration of market power abuse in the hands of a small number of individuals, such as through cartels and charters. Even though IPRs encourage monopolies and the misuse of an innovator’s monopolistic domination of the market, they also aid in the promotion of innovation and economic progress by encouraging an increasing number of investors to fund R&D and make effective use of its applications. Remember that the monopolistic effect of intellectual property rights (IPRs) is the only reason why there is a conflict between IPRs and competition rules, as mentioned in the sections above. IPRs grant limited-term monopolies which suggests that they offer incentives to innovators and permit them to use their creations for commercial purposes. The inventor’s monopoly ends after the specified amount of time and the invention enters the public domain. Through the establishment of enforceable property rights for those who create novel and advantageous products, more efficient processes, and creative works of expression, intellectual property laws encourage invention and its propagation and commercialization. We can conclude that competition law and intellectual property rights are closely related. Since the IPRs grant certain privileges, the application of competition laws places constraints on them. As stipulated correctly in Indian laws, every right has obligations, restrictions, and limitations. Nothing is absolute.

With the patent expiry of Bedaquiline the fault lines of this conflict between IPR and Competition Laws have started to tremble. With the ability to enter the market, generic producers might lower costs and increase accessibility for everybody. This is in perfect accordance with the purpose of competition legislation, which is nourished by affordability and market dynamism.

But from the IP camp, there are murmurs of disagreement. Generic competition, according to others, may deter future R&D projects and jeopardize the supply of vital drugs for illnesses like tuberculosis. Quality control and the possibility of inferior fake versions overrunning the market are further unresolved issues. However, is it morally acceptable for us to put patent protection ahead of human life? Is it really acceptable to let a drug that is so important to address the world health crisis be kept behind a price barrier? In this legal tug-of-war, these are the most pressing moral issues.

It needs a comprehensive strategy that supports the needs of fair access as well as ingenuity in order to successfully navigate this complex web.

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[1] Six Drivers of Innovation: How to Make Magic Happen for Your Organization

[2] Peng, M. W., Ahlstrom, D., Carraher, S. M., & Shi, W. (2017). An institution-based view of global IPR

history. Journal of international business studies, 48, 893-907.

[3] 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, 33 I.L.M. 1197 (1994)

[4] Act of Oct. 15, 1914, ch. 323, 38 Stat. 73

[5] The Competition Act, 2002, 12 of 2003, (India).

[6] PT Jyothi Datta, Three Indian firms line up to make TB drug Bedaquiline as patent expires, The Hindu BusinessLine (July 18, 2023), https://www.thehindubusinessline.com/news/national/three-indian-firms-line-up-to-make-tb-drug-bedaquiline-as-patent-expires/article67094970.ece

[7] PT Jyothi Datta, J&J to not enforce patents on breakthrough TB drug bedaquiline, The Hindu BusinessLine (Oct. 1, 2023), https://www.thehindubusinessline.com/companies/jj-to-not-enforce-patents-on-breakthrough-tb-drug-bedaquiline/article67368702.ece

[8] The Competition Act, 2002, 12 of 2003, (India). § 45

[9] The Competition Act, 2002, 12 of 2003, (India). § 3

[10] The Constitution of India 1950, art. 38

[11] Constitution of India, 1950, art. 39

[12] The Monopolies and Restrictive Trade Practices Act, 1969 (54 of 1970)