Intellectual Property Rights And Healthcare Accessibility

Author: LawSphereX

Category: Intellectual Property

Published: 2026-08-23T20:21:39.793368+00:00

Updated: 2026-08-30T07:04:57.066Z

INTELLECTUAL PROPERTY RIGHTS AND HEALTHCARE

ACCESSIBILITY Dr. J. Devi, Assistant Professor, Govt. Law College, Chengalpattu Dr. K. Gowri, Assistant Professor, Govt. Law College, Trichy

ABSTRACT

As a founding member of the World Trade Organization, India has an obligation to ratify the Agreement on Trade-Related Aspects of Intellectual Property Rights. The COVID-19 pandemics have brought attention to the issues that were brought up during the negotiations, including high drug prices, market exclusivity, and delayed generics entry. The World Health Organization’s mission to address the intersection of innovation, intellectual property, and medical access has been reaffirmed and expanded over time to include assisting nations in implementing TRIPS flexibilities in cooperation with interested parties.

This study examines how intellectual property affects Indian citizens' ability to obtain medicines and also examines how India complies with the flexibilities granted by the Agreement on Trade-Related Aspects of Intellectual Property Rights and examines the changes made to India's patent legislation and assesses the consequences for public health protection. Keywords: Patent, Intellectual property law, Compulsory Licensing, Access to Medicines, Covid-19, TRIPS, WHO, Market entry, Right to Health, Human Rights, Patents Act.

Introduction

The right to health, which has drawn increasing attention from around the globe, depends on having access to drugs. It is commonly acknowledged that obtaining access to drugs requires a strong intellectual property (IP) framework. Because of the absence of manufacturing capacity, technical sluggishness and voicelessness, developing nations require greater attention from the international community to overcome these obstacles before them. As a result, it needs to bolster multilateral initiatives to carry out worldwide agreements and assist the underprivileged in developing nations in acquiring less expensive medications. However, underdeveloped nations might alter their own intellectual property laws to make drugs more accessible.

This article addresses how the right to health and IP rights, examines how India complies with the flexibilities granted by the Agreement on Trade-Related Aspects of Intellectual Property Rights, examines the changes made to India's patent legislation, and assesses the consequences for public health protection. Numerous international human rights protocols1 and the Indian Constitution2 both acknowledge the right to health as a fundamental human right that stems from an individual's inherent dignity. "Everyone has the same rights regardless of their race, color, sex, language, religion, political views, national or social origin, property, place of birth, or other status. " The right to health and other health-related human rights are protected by legally binding commitments found in international human rights instruments. The WHO Constitution also recognizes the right to health3.

Everyone has a right to the highest attainable standard of physical and mental health. Laws mandate that nations develop and implement laws and policies that guarantee universal access to high-quality healthcare and address the root causes of health inequities, including poverty, stigma, and discrimination. Everyone is entitled to a certain level of living, health care, and well-being for themselves and their families4. The right to health is not specifically mentioned as a fundamental right in the Indian constitution5. But it can be indirectly inferred under Article 21 of Indian Constitution by the Indian Judiciary. Life and individual freedom, including the right to health and a higher quality of life, are safeguarded by Article 21. while extending Article 21's reach and the government's

1 Article 12 of the International Covenant on Economic, Social and Cultural Rights

2 Art.21 of the Indian Constitution

3 Available at https://www.who.int/news-room/fact-sheets/detail/human-rights-and-health accessed on

23.11.2024 at 10.12.p.m

4 Article 25 of the Universal Declaration of Human Rights ,1948

5 Article 21 of the Indian Constitution

obligation to offer medical assistance believed that under a welfare state, the government's main responsibility is to ensure the welfare of all citizens. In a welfare state, the government has an obligation to provide the people with proper medical facilities. By offering medical care to individuals who wish to use those facilities, the government fulfills this duty6. People in less developed nations find it challenging to obtain pharmaceutical resources used to combat the public health crisis because many of them are owned by developed nations under international intellectual property protection, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), where patented medications are prohibitively expensive and generic versions cannot be produced domestically due to a lack of manufacturing capacity.

Under this circumstance, the members of the World Trade Organization (WTO) approved a special declaration to address the concerns of developing nations, known as a ministerial declaration, was made during the WTO ministerial conference in Doha. Thankfully, for the benefit of public health generally, the Doha Ministerial Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) significantly encourages access to reasonably priced medicines. The core of this problem continues to be the sustained availability of the required drugs. One of the main objectives to be accomplished to provide fair access to medicines is Universal Health Coverage (UHC), which is listed under Goal of "Good Health and Well- Being" in the Sustainable Development Goals 2030 (SDG 2030)4 established by the UN7.

The administration and enforcement of intellectual property laws seek to strike a balance between many justifiable interests to enhance general well-being. The major components of International Intellectual Property laws are WTO’S Trade Related Aspects of Intellectual Property Rights Agreements, Conventions and Treaties that are governed by the World Intellectual Property Organization. Domestic Intellectual Property laws are mainly influenced by these international principles and rules, which have emanated from the International Convention and Treaties governing TRIPS Agreements. The main purpose of adopting these principles is to streamline the domestic Intellectual Property laws. The major threats among the developed and least developed countries are the exorbitant price of patented medicines.

The major drawbacks behind these countries are Poor Resources, lack of technical knowledge in Research and Development, Materials, Lack of Funds. Hence it is necessary to establish the

6 Paschim Banga Khet Mazdoor Samity v. State of West Bengal, (1996) 4 SCC 37.

7 Available at https://sdgs.un.org/goals accessed on 24.11.2024 at 8.03.p.m

need for improving access to medicines and the strategy in providing equitable access. Trade Related Aspects of Intellectual Property Rights The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) is the most significant international agreement on intellectual property trade aspects. The negotiations surrounding the adoption of the TRIPS Agreement included the Uruguay Round of multilateral trade talks, which were part of the World Trade Organization's formation. It is the first significant intellectual property reform in several decades and sets the groundwork for harmonizing national intellectual property systems.

as stipulated in the agreement, IPRs should be preserved and enforced in a way that balances the rights and obligations of all the parties involved to maximize both producers' and consumers' benefits 8, Criticism of the pact has targeted it on a variety of fronts, most notably by making it difficult for poor nations to participate in the knowledge sector9. It establishes the tone for the substantive provisions to come. It prioritizes 'individual rights' over 'community rights,' and it explicitly acknowledges IPRs as private rights, even though such rights are promoted elsewhere to prevent trade distortions. It recognizes the need for a multilateral set of norms for both working and resolving problems. The WTO members had developed a wise approach known as the TRIPS Agreement on Trade Related Aspects of Intellectual Property Rights.

It imposed mandatory obligation on the part of member states to enact the legislation to protect intellectual property in the respective members’ countries. The TRIPS Agreement makes a balance between individual interest and society’s interest through creating long term benefits to society and industry by placing the invention in public domain and by way of creating short term benefits to the inventors through exclusive monopoly rights. To appeal to poorer countries, it acknowledges "underlying public policy objectives of national systems for intellectual property protection, including developmental and technological interests. " Nation states can use this to protect their constitutional protections while modifying their patent laws to comply with the TRIPS Agreement.

Paris convention for the protection of Industrial Property The Paris Convention established the basic principles of national treatment, territoriality, priority, and the provision of a minimum level of protection. The national treatment rule ensures

8 Article 7 Of the TRIPS Agreement

9 UNDP, op. cit., p. 57.

that nationals of a Convention-member country have the same intellectual property rights as their own nationals in other Convention-member countries, and that they will not be discriminated against10. Non-member country nationals are also covered by the rule if they are citizens of a member country or have a business or industrial enterprise there. The aim of recruiting foreign technology led to the creation of this rule. The topics covered by the national treatment rule have been judged to be confined to these topics because the Paris Convention only deals with matters connected to the acquisition of patents, their scope, length, and termination11. Three categories comprise the Convention's substantive provisions: common rules, priority rights, and state treatment.

When it comes to industrial property protection, each Member Country shall give the same safeguards to residents of other Contracting States as it does to its own nationals, according to the Convention's national treatment standards. Under the Convention, nationals of non-Contracting States are also entitled to national treatment if they reside in a Contracting State or operate a legitimate and successful commercial or industrial enterprise there12. The TRIPS Agreement and the Paris Convention's Relationship In several instances, the TRIPS Agreement interacts significantly with the Paris Convention. The provisions of Art. 2. 1 of the Paris Convention are included in the TRIPS Agreement by reference. Compliance with the aforementioned provisions is required in relation to the subject matter of Parts II,III and IV of the TRIPS Agreement.

In effect, the clauses have been incorporated into the TRIPS Agreement. Noncompliance with such provisions may result in a dispute under the WTO's dispute settlement procedure. Certain "Paris-plus" provisions are included in the TRIPS Agreement, such as the prohibition of discrimination in the field of technology13, restrictions on exclusions from patentability14, the possibility of judicial review of any decision to revoke or forfeit a patent15, and the minimum term of protection 16. These provisions apply to all WTO members.

10 Article 2(1) of the Paris Convention for the Protection Of Industrial Property

11 Available at https://www.wipo.int/treaties/en/ip/paris/summary_paris.html accessed on 31. 05.2021 at 04.p.m

12 Ibid

13 Article 27.1 of the TRIPS Agreement

14 Article 27.2 of the Trips Agreement

15 Article 32 of the TRIPS Agreement

16 Article 33 of the TRIPS Agreement

The TRIPS Agreement, on the other hand, contains many "Paris-minus" commitments, allowing WTO countries to minimize the standard of protection provided to patent holders. As a result, by allowing foreign exhaustion, Article 6 of TRIPS erodes patentee rights that are otherwise guaranteed under Article 4bis of the Paris Convention. The TRIPS Agreement limits the legislative policy options available to governments. Compulsory licenses can be awarded17 if the patentee fails to manufacture the patented product domestically. This option is no longer available to WTO members that are members of the Paris Convention. WTO countries must now acknowledge that importation counts as work for the purposes of Art. 5(A)(2) of the Paris Convention under Art. 27. 1.

Members could specify in their legislation that patents in any field of technology be subject to compulsory licenses "to prevent abuse which might result from the exercise of the exclusive rights given by the patent, for example, refusal to work18. " Compulsory licenses of patents on semi-conductor technology can only be issued under TRIPS for two reasons: public non-commercial usage and remediate anti-competitive practices19. A party was not prohibited from issuing compulsory licenses for primarily export purposes under the Paris Convention. On the other hand, TRIPS prohibits compulsory licenses for that specific purpose20. Doha Declaration on Ministerial meeting of public health A public health Doha proclamation on the TRIPS agreement and the TRIPS agreement was adopted on November 14th, 2001.

It mainly talks about how to address the public health issues, which is the main concern for developing and least developed nations as specified in Article

65 paragraph 2 of the TRIPS Council after the transitional time described in paragraph 2 of

Article 65, it was mandated the implementation of the TRIPS Agreement21. The TRIPS Council should have reviewed the implementation process in these nations, including India, at the end of the transitional period on 31 December 1999 for developing nations. The following were compulsory bi-annual reviews. Furthermore, considering any new development that might require a change to the agreement, the review procedure could be done at any moment. Article 31 states that a right of use may be transferred to another person without the agreement of the patent holder, such as by providing a compulsory license. In fact, this was a major victory in terms of reducing the negative effects of extensive patent protection for developed countries.

17 Article 5(2) of the Paris Convention for the Protection of Industrial Property

18 Art. 5(2) of the Paris Convention for the Protection of Industrial Property

19 Article 31 ( c ) of the TRIPS Agreement

20 . Article 31(f) of the TRIPS Agreement

21 Article 71 of the TRIPS Agreement

However, the TRIPS negotiators were unable to agree on a uniform set of criteria for that use. This may be true for other purposes, but it is doubtful, in view of Article 27.1, that granting a compulsory license in order not to operate a patent locally is TRIPS-compatible. For developing countries, there are two alternative approaches.

1. Amendment of Article 27.1 in such a way that the import of a patent product does not

correspond to its 'working;'

2. Amendment of 31 incorporating some of the purposes which will allow invocations of the

power to compulsory licensing other than eleven rigorous safeguards. Compulsory licensing It is important to understand the term compulsory licenses before going to the discussion on what TRIPS permits compulsory licenses. Allow a third party to utilize a patent without the approval of the patent owner in exchange for a government-determined royalty. The license is compulsory as it is forced on the patentee to issue license. The amount fixed by the government by way of royalty is far below the profits which could be obtained in the free market. It is not correct to say that the issuance of compulsory license would defeat the very nature of the patent. Though the license may be issued it will not defeat the interest vested with the patentee. The patent granted is still alive, valid and in force.

The patentee can exercise his monopoly rights against all the people excluding government permitted licenses from using his inventions. However, the only restrictions imposed on the patentee is he cannot exercise his control over the market for his patented invention when compulsory license is in force. Developing nations might also draw on the Pre-TRIPS, Paris Convention recognizing that governments could give mandatory licenses to remedy patent abuse, including non-working of patent. Indeed, Article 84(l) (c) of the modified 'The (India) Patents Act, 1970' states that it is one of three reasons for requesting a license. It says, That no innovation has been patented in the Indian territory22. The provisions of Article 83(a) & Sec. 83(b) clarify that local manufacturers of a patented product are really the intended objective of the local work under Article 84(l)(c).

It is in India's interest to pursue a review of Article 31, because the issue is of vital concern and can be challenged in front of the WTO Settlement Agency. The 'period' of compulsory licenses is another crucial issue. " The scope of such an application must be

22 Section 84 of the Indian Patents Act, 1970

restricted to the TRIPS-approved purpose23. "Authorization for such use shall be liable to be revoked if and when the conditions that led to it cease to exist and are unlikely to recur, subject to proper protection of the legitimate interests of the people so authorised. " On a valid request, the appropriate government shall have the power to evaluate the continued existence of certain circumstances24. "In this regard, it may be claimed that a grantee of a compulsory license would be required to invest heavily in the product's research, production, strategic planning, marketing, and promotion. As a result, if there is a constant danger of withdrawal of such license dependant on the cessation of a set of circumstances outside a grantee's control, no domestic firm would be interested in obtaining such a compulsory license.

To make it a realistic proposal, the period of the compulsory license must be co-terminus with the period of the patent. In this regard an amendment was made in the Indian patents act 197025 which provides a condition that the compulsory license shall remain in force for a rest of the term patent granted unless a medium term is in the best interests of the public 26. As a result, this critical issue should be reviewed as soon as possible. "Any such use compulsory license shall be approved primarily for the supply of the Member allowing such use's domestic market27. " The use of the phrase 'predominantly' has become a point of contention. Although this does not rule out the idea of granting a compulsory license for at least part of the export market (needy LDCs), this element must be addressed separately.

"Adequate remuneration shall be paid to the right holder in each situation, taking into consideration the economic value of the authorisation28. ""The available term of protection shall not expire before the end of a period of twenty years counting from the filing date. " This phrase looks to be on the higher end of the scale. Previously, national legislation allowed for other terms, such as 5 years, 14 years, or 17 years. The justification for the increased duration of 20 years was that it took 8-10 years for a patent to be granted, therefore the holder could rarely benefit from its commercial benefits for more than ten or twelve years. In recent years, the evaluation of patent applications has accelerated to the point where a patent can now be awarded in as little as 1-2 years. Furthermore, the product cycle is always evolving. Considering this, it is reasonable to propose

23 Article 31 ( c ) of the TRIPS Agreement

24 Article 31 (g) of the TRIPS Agreement

25 Section 90 (1) (vi) 0f the Indian Patents Act 1970

26 https://ipindia.gov.in/writereaddata/Portal/ev/sections/ps90.html accessed on 30.05.2021 at 07.48.p.m

27 Article 31 (f) of the TRIPS Agreement

28 Article 31 (h) of the TRIPS Agreement

a shorter term by amending Article 33 along the lines outlined as “The applicable term of protection shall not expire before the expiration of a period of twenty years counting from the filing date or ten or twelve years counting from the date of patent sealing, whichever period is shorter29. " It is in India's interest to seek a revision of Article 31 as an issue which is of paramount importance and capable to be called into question before the WTO Settlement Agency. The patent-owning pharmaceutical companies tend to suggest an idea that compulsory licenses should not be utilized. They rejected the compulsory license in to-to. Though it is permissible under TRIPS. Even during the negotiations of TRIPS, the parties discussed the proposal of rejection of compulsory licenses.

The inclusion of provisions that explicitly envision compulsory licenses might be considered as part of an agreement negotiated by developing countries to reduce the harm caused by patents being granted in the first place30. Conclusion The most important aspect of the TRIPS Agreement is its protection of pharmaceutical items, which makes it most noteworthy. According to the TRIPS Agreement, member nations may implement policies that support the agreement's goals in order to safeguard public health and nutrition31. It also allows member countries to adopt steps to prohibit the infringement of intellectual property rights or the use of methods that impede commerce or obstruct the global transfer of technology.

According to Article 27, patentable subject matter and patentable rights are awarded regardless of the location of invention, the technique, or whether the goods are imported or domestically produced. 32. Article 30 of the TRIPS Agreement further says that exceptions to rights conferred33. Article 31 of the TRIPS Agreement also provides that in case of extreme urgency or national urgency, a non-voluntary license may be given to the domestic drug manufacturers without authorization of the right-holder if reasonable requirements are met34. However, article 31 restricts the rights only to domestic use purpose. The first paragraph of the Doha Declaration on Ministerial Conference principally acknowledged the importance of public health challenges when it comes to emerging or

29 Article 33 of the TRIPS Agreement

30 Cynthia.M.Ho , access to medeicine in the global economy international agreements on patents and related rights,p127

31 Article 8 of the TRIPS Agreement

32 Article 27 of the TRIPS Agreement

33 Article 30 of the TRIPS Agreement

34 Article 31 of the TRIPS Agreement

underdeveloped countries, particularly those caused by HIV, AIDS, tuberculosis, malaria, and other diseases. The second paragraph emphasised the importance of incorporating the WTO Agreement on Trade Related Aspects of Intellectual Property Rights into broader national and international efforts to solve such issues. The third paragraph emphasised the necessity of intellectual property protection for developing new drugs. It is also concern about the expense of new drugs. According to the fourth paragraph of the TRIPS Agreement, members are not prohibited from taking actions to preserve public health and should not be prohibited from doing so. Although we affirm our support to the TRIPS Agreement, Also worth mentioning is the fact that the Agreement can and should be construed and implemented in a way that protects human health and, in particular, promotes global access to medications.

The WTO reaffirms that members have the right to take advantage of the TRIPS Agreement's flexibilities to the fullest extent possible in order to achieve their objectives. The fifth paragraph was written in light of paragraph 4 above, and while we honour our TRIPS Agreement commitments, we understand that these flexibilities include35:Each term of the TRIPS Agreement must be construed in light of the Agreement's intent and purpose, as expressed, in particular, in its aims and principles, while applying the customary standards of public international law. In order to provide compulsory licenses, each representative has the ability to do so and the discretion to determine the conditions under which they are granted.

It is understood that public health crises, such as those involving HIV/AIDS, tuberculosis, malaria, and other epidemics, can be considered national emergencies or other situations of extreme urgency, and that each member has the authority to determine what constitutes a national emergency or other situation of extreme urgency. Due to a lack of clarity in this area, the compulsory license clause may become outdated and inappropriate for the purposes for which it was implemented. Furthermore, because any final decision to use a patented innovation under compulsory license may be challenged in court and an injunction to stop its use may be requested, the Act does not fully utilize TRIPS flexibilities. A member state is not required under the TRIPS Agreement to permit an injunction against government usage.

Since both governments have the authority to appropriate a patent innovation without first obtaining a license or engaging in drawn-out talks with the patentee, the US and UK practices differ in this regard and are less burdensome. It has been determined that state involvement through compulsory licenses is essential.

35 Ibid