BEYOND PATENTS: EVALUATING DATA EXCLUSIVITY REGIMES THROUGH ACCESS TO MEDICINES AND HUMAN RIGHTS STANDARDS

1.1 Introduction

Data exclusivity regimes have become major obstacles to the accessibility of medicines. These regimes interact with — and in significant ways diverge from — traditional patent protections, with serious implications for the realisation of the human right to health. Patents secure exclusive rights for inventors over a limited duration. Data exclusivity, on the other hand, protects originator pharmaceutical companies from competition by granting them exclusive rights to access the clinical trial data required for drug approval, generally for a term of five to ten years. This creates additional obstacles to the market entry of generic medicines, delaying the availability of cheaper drugs even after patents have expired, or in cases where no patent exists, thereby resulting in extended monopolies that are at odds with public health objectives.¹ Governments utilise data exclusivity periods to prevent generic competition regardless of the patent situation.² This structural barrier infringes upon established rights standards — including availability, accessibility, affordability, and non-discrimination.³ The right to health through access to medicines requires that states make medicines available, accessible, and affordable to everyone without discrimination. Restrictive data exclusivity regimes may be contrary to these obligations in that they delay or limit the access of vulnerable individuals to the medicines that are essential. Governments have a legal obligation under international instruments to ensure access to health care and medicines.⁴

1.2 Research Questions

1. Does the imposition of data exclusivity regimes under TRIPS and TRIPS-Plus agreements undermine states’ obligations under the ICESCR to ensure the availability, accessibility, affordability, and non-discriminatory access to essential medicines?
2. How do different jurisdictions regulate data exclusivity in relation to patent protection, and to what extent do these frameworks balance pharmaceutical innovation with the right to health?

1.3 Data Exclusivity

Data exclusivity (DE) is a protective measure for test data generated by pharmaceutical companies during the clinical trials of new chemical entities (NCEs). This provision ensures that for a specified duration, third parties cannot utilise this data nor seek market approval for similar compounds based on it. The time and resources invested by pharmaceutical companies in generating safety and efficacy data warrant such protection, primarily to prevent generic manufacturers from leveraging this information.⁵

At the heart of the matter is the interpretation of TRIPS Agreement, Article 39.3, which requires protection against the unfair commercial use of undisclosed testing data submitted to a regulatory authority in connection with the grant of marketing approval.⁶ Critically, this provision does not mandate exclusive rights, nor does it prohibit a regulatory authority from relying on that data, nor does it require an extended monopoly.

1.4 Comparative Study of Data Exclusivity Regimes: US, EU, and India

Before the establishment of the TRIPS Agreement,⁷ developed countries — primarily the United States and Europe — had already instituted data exclusivity policies. The United States introduced DE policies for pesticides under the Federal Insecticide, Fungicide and Rodenticide Act, followed by a five-year DE period for new chemical entities (NCEs) and a three-year DE period for new drug authorisations based on new clinical investigations, both established with the passage of the Hatch-Waxman Act of 1984.⁸ The Hatch-Waxman Act also introduced DE periods for studies involving paediatric populations. In the area of biologics, the Biologics Price Competition and Innovation Act established a twelve-year data exclusivity period, with the option of additional exclusivity for interchangeability determinations for biologics.⁹

In Europe, data exclusivity has existed since 1987 through Directive 65/65/EEC, which provided six years of exclusivity at passage, with certain medicinal products receiving ten years of exclusivity. DE periods vary by EU member state, reflecting differing interests in shorter versus longer market protection.¹⁰ Some countries in Asia, such as Singapore and Japan, have DE regimes, while others — including India — do not. Japan provides an additional six years of exclusivity for new drugs to ensure the efficacy and safety of such products.

In India, the Department of Chemicals and Petrochemicals put forward data protection processes in line with Article 39 of TRIPS and formed an inter-ministerial committee to investigate and report on these issues in 2007. The committee — composed of leading professionals — concluded that non-disclosure of marketing approval data would satisfy the requirements of TRIPS, and that it would not prevent the regulatory authority from approving an equivalent product for other applicants in the future.¹¹ Most developed countries impose data exclusivity through legislative means, which creates pressure on less developed countries to adopt similar frameworks.¹²

Successful drugs yield commercial returns that incentivise companies to seek both patent protection and data exclusivity, though there is often a conflation of these two distinct regimes in the Indian context.¹³ The CUSAT Study¹⁴ highlights that non-disclosure of data is a reasonable and TRIPS-compliant alternative to formal data exclusivity. The Indian government continues to engage with these issues, particularly given international pressures towards TRIPS compliance, whilst attempting to maintain a fair balance between access to medicines and innovation incentives in the health system.

1.5 Data Exclusivity and the Right to Health

Public health institutions in several developing countries are unable to provide even minimal essential therapeutic medications because they are typically too costly compared to originator brand medications.¹⁵ The UN and WHO encourage the application of TRIPS flexibilities to facilitate increased importation and manufacture of generic medicines. Data exclusivity may prevent generics from entering the market — as illustrated by the example of Guatemala, where it reduced competition. The pharmaceutical industry argues that data exclusivity safeguards clinical trial data, yet in practice it may limit access to medicines and restrict the capacity of governments to protect public health.

Exclusive rights of this nature, where they bear upon public health, require careful justification. TRIPS exceptions for public health purposes have not been consistently established or utilised. The patent system already compensates originators; if data exclusivity were to operate as an additional licensing mechanism, it would simply postpone generic competition further. Moreover, requiring generic manufacturers to conduct duplicate clinical trials raises serious ethical questions, and a licensing framework for the use of clinical data — rather than providing exclusive rights — would suggest a fairer and more proportionate approach.¹⁶

The TRIPS Agreement under the WTO establishes patent protection standards for medicines, requiring member states to grant patents for at least 20 years. Articles 7 and 8 of the TRIPS Agreement encourage innovation while safeguarding health, highlighting access to affordable medicines. However, challenges in interpreting these provisions call for innovative national approaches that align with TRIPS while prioritising access to essential medicines and upholding human rights obligations under the ICESCR.

Access to medicines is framed under international legal instruments that articulate the right to health — in particular, the Universal Declaration of Human Rights of 1948 and the International Covenant on Economic, Social and Cultural Rights (ICESCR).¹⁷ Article 12.1 of the ICESCR obligates states to realise, at a minimum, the “highest attainable standard of physical and mental health,” while recognising non-discrimination in access to health care. Essential medicines are integral to the treatment of disease and support equality in health care. States are obligated under Article 2.1 of the ICESCR to achieve the progressive realisation of the right to health, subject to available resources, and the provision of essential medicines is included as part of the minimum core content of health rights, as identified by the UN Committee on Economic, Social and Cultural Rights (CESCR).

The ICESCR’s tripartite obligations — to respect, protect, and fulfil — imply that states’ commitments are not limited by national boundaries but extend to compliance with health rights standards through international agreements.¹⁸ Progress has been made in access to medicines for HIV/AIDS and tuberculosis, and there is greater commitment to safe and affordable essential medicines as identified in the Sustainable Development Goals. However, rising costs of patented medicines continue to hinder access, compounded by weak governance in national medicine policies, affecting nearly two billion people.¹⁹

1.6 Conclusion

Data exclusivity regimes, when poorly calibrated, can compound the exclusionary effects of patent systems and contribute to the inability of developing nations to access essential medications. Where DE cannot be demonstrated to produce an economically beneficial effect or to drive meaningful innovation in drug development, developing countries have no sound incentive to implement it,²⁰ particularly where the costs of drug development have already been recovered through an established and predominantly captured market. This calls into question the prolonged monopolistic control exercised over mere incremental innovations — control that limits generic competition and may be in tension with antitrust principles. As currently structured, DE prioritises commercial incentives over public health needs. The appropriate balance should prevent the original dataset from being exploited for commercial gain whilst still allowing others access to life-saving medications. Where necessary, flexible and appropriate use of the TRIPS Agreement should be pursued to strike the best balance between public health and a sufficient return for the pharmaceutical sector.

Legal and policy reform is necessary to realign data exclusivity regimes with social and moral priorities in support of the right to health. Key policy implications include the scope and duration of exclusivity periods, the resulting high prices of medicines, and the negative effect on generic competition — all of which damage public health rights and access to medicines. Current regimes restrict the ability of governments to deploy TRIPS flexibilities during health emergencies and may breach international obligations to protect human rights. Furthermore, the individualised terms of exclusivity impose a heavy burden on access to medicines by vulnerable populations. Reform proposals include:

• Incorporating public health exemptions to exclusivity in times of health crisis;
• Establishing limited scope and duration of exclusivity periods;
• Requiring human rights impact assessments prior to granting exclusivity;
• Rejecting TRIPS-Plus requirements in bilateral and multilateral trade negotiations;
• Fostering partnerships and alternative models of pharmaceutical innovation; and
• Establishing greater transparency in the legislative process governing exclusivity.

These reforms place public health interests and access to medicines at the forefront and restructure the framework of data exclusivity to align with respect for human rights and the capacity for pharmaceutical innovation where affordable access to medicines is protected. In conclusion, the interplay between human rights frameworks and intellectual property rights must be reconciled to facilitate better global access to essential medicines, ensuring that health equity and innovation coexist.

Reference(S):

A. Books and Book Chapters

Correa, Carlos M., Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement (2nd edn, Oxford University Press 2020).

Correa, Carlos M., ‘Data Exclusivity for Pharmaceuticals: TRIPS Standards and Industry’s Demands in Free Trade Agreements’ in C.M. Correa (ed), Research Handbook on the Protection of Intellectual Property Under WTO Rules 713 (Edward Elgar 2010).

Nair, Gopakumar G., Intellectual Property Rights: Pharma Industry Perspective 121 (Pharmaceutical Patent Analyst 2014).

Pugatch, Meir Perez, ‘Intellectual Property, Data Exclusivity, Innovation and Market Access’ in Negotiating Health 35 (Routledge 1st edn 2006).

B. Journal Articles

Abbott, Frederick M., ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO’ (2002) 5 Journal of International Economic Law 469.

Adamini, S. et al., ‘Policy Making on Data Exclusivity in the European Union: From Industrial Interests to Legal Realities’ (2009) 34 Journal of Health Politics, Policy and Law 980.

Alexander, G.C., O’Connor, A.B. and Stafford, R.S., ‘Enhancing Prescription Drug Innovation and Adoption’ (2011) 155 Annals of Internal Medicine 99.

Basheer, Shamnad, ‘India’s Tryst with TRIPS: The Patents (Amendment) Act 2005’ (2005) 1 Indian Journal of Law and Technology 15.

Dhar, Bishwajit and Gopakumar, K.M., ‘Data Exclusivity in Pharmaceuticals: Little Basis, False Claims’ (2006) 41 Economic and Political Weekly 5073.

Ehrendt, K.E., ‘The Hatch–Waxman Act: Balancing Competing Interests or Survival of the Fittest’ (2002) 57 Food and Drug Law Journal 247.

Islam, M.D. et al., ‘Impacts of IP Provisions in Trade Treaties on Access to Medicine in Low- and Middle-Income Countries: A Systematic Review’ (2019) 15 Globalization and Health 88 <https://doi.org/10.1186/s12992-019-0528-0>.

Janodia, Manthan D. and Chauhan, Ajay, ‘Data Exclusivity Provisions in India: Impact on Public Health’ (2008) 13 Journal of Intellectual Property Rights 422.

Khanna, Shubhar, ‘TRIPS, Pharmaceutical Patents and Health Care for the Poor in India’ (2016) ILI Law Review 71.

Perry, G., ‘Data Exclusivity — A Major Threat to Access to Affordable Medicines’ (2002) Business Briefing: Pharmagenerics 16.

Adebare, Alfred, ‘Data Exclusivity: The Implications for India’ (International Journal of Law, 2005) <https://www.articlealley.com/article_166562_184.html>.

Bhatnagar, Jaya and Garg, Vidisha, ‘India: Data Exclusivity’ (Mondaq, 2009) <https://www.mondaq.com/india/information-&security–risk-management/779418/98data-exclusivity>.

C. Theses and Working Papers

Zbierska, Katarzyna, Distinctions Between the European Union and the United States on Data Exclusivity (LL.M. Thesis Abstract, MIPLC 2015).

Ragavan, Srividhya, The Significance of Data Exclusivity and Its Impact on Generic Drugs (Texas A&M University School of Law 2017).

D. International, Government and Institutional Reports

Satwant Reddy, Report on Steps To Be Taken by the Government of India in the Context of Data Protection Provisions of Art. 39.3 of the TRIPS Agreement (2007).

UNCTAD–ICTSD, Resource Book on TRIPS and Development 532 (Cambridge University Press 2005).

WHO–EMRO, Public Health Related TRIPS-Plus Provisions in Bilateral Trade Agreements: A Policy Guide for Negotiators and Implementers (2010).

Office of the UN High Commissioner for Human Rights, Report on Access to Medicines (2017) <https://www.ohchr.org/en/issues/health/pages/medicines.aspx>.

E. Treaties and International Agreements

Paris Convention for the Protection of Industrial Property, Art. 10bis (20 March 1883).

Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 UNTS 299.

International Covenant on Economic, Social and Cultural Rights, 16 December 1966, 993 UNTS 3.

Universal Declaration of Human Rights, GA Res 217A (III), UN Doc A/810 (10 December 1948).

WTO, Declaration on the TRIPS Agreement and Public Health (14 November 2001).

Footnotes

¹ Pugatch Meir Perez, Intellectual Property and Pharmaceutical Data Exclusivity in the Context of Innovation and Market Access (University of Haifa, ICTSD-UNCTAD Dialogue on Ensuring Policy Options for Affordable Access to Essential Medicines, Bellagio 2008) <http://www.iprsonline.org/unctadictsd818/bellagio/docs9/Pugatch_Bellagio43.pdf> accessed 19 February 2026.

² Krishna Ravi Srinivas, Test Data Protection, Data Exclusivity and TRIPS: What Options for India? (2008) <https://papers.ssrn.com/sol3/papers.cfm?abstract_id=935847> accessed 11 November 2025.

³ S.R. Ludwig, ‘The Medicine Chest: Data Exclusivity — A Necessary Form of Intellectual Property’ (2007) 17 Intellectual Property Today 12.

⁴ M.D. Islam et al., ‘Impacts of Intellectual Property Provisions in Trade Treaties on Access to Medicine in Low- and Middle-Income Countries: A Systematic Review’ (2019) 15 Globalization and Health 88 <https://doi.org/10.1186/s12992-019-0528-0>.

⁵ Bayer Inc v Canada [1999] 1 FC 553 (Fed Ct), aff’d 87 CPR (3d) 293 (Fed Ct App).

⁶ Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), Art. 39.3 (15 April 1994).

⁷ TRIPS Agreement, Annex 1C, Marrakesh Agreement Establishing the World Trade Organization, 1869 UNTS 299, 33 ILM 1197 (1994).

⁸ K.E. Ehrendt, ‘The Hatch–Waxman Act: Balancing Competing Interests or Survival of the Fittest’ (2002) 57 Food and Drug Law Journal 247.

⁹ H. Grabowski, Data Exclusivity for New Biologicals, Duke University Department of Economics, Working Paper 3–9 (2007).

¹⁰ Directive 2004/27/EC of the European Parliament and of the Council, 2004 OJ (L 136) 34, 39.

¹¹ D. Kiruthika, ‘Data Exclusivity and Indian Law’ (2017) 2 International Journal of Legal Studies 45 <http://journal.lawmantra.co.in/wp-content/uploads/2015/89/45.pdf> accessed 12 May 2024.

¹² Jaya Bhatnagar and Vidisha Garg, ‘India: Data Exclusivity’ (Mondaq, 2009) <https://www.mondaq.com/india/information-&security–risk-management/779418/98data-exclusivity> accessed 11 November 2025.

¹³ Adebare Alfred, ‘Data Exclusivity: The Implications for India’ (International Journal of Law, 2005) <https://www.articlealley.com/article_166562_184.html> accessed 12 November 2025.

¹⁴ Satwant Reddy, Report on Steps To Be Taken by the Government of India in the Context of Data Protection Provisions of Art. 39.3 of the TRIPS Agreement (2007) (CUSAT Study commissioned by the Department of Chemicals and Petrochemicals, concluding that non-disclosure is a TRIPS-compliant alternative to data exclusivity); see also Bishwajit Dhar and K.M. Gopakumar, ‘Data Exclusivity in Pharmaceuticals: Little Basis, False Claims’ (2006) 41 Economic and Political Weekly 5073.

¹⁵ Office of the UN High Commissioner for Human Rights, Report on Access to Medicines (2017) <https://www.ohchr.org/en/issues/health/pages/medicines.aspx> accessed 19 October 2024.

¹⁶ Meir Perez Pugatch, ‘Intellectual Property, Data Exclusivity, Innovation and Market Access’ in Negotiating Health 35 (Routledge 1st edn 2006).

¹⁷ Universal Declaration of Human Rights, GA Res 217A (III), UN Doc A/810, Art 25 (10 December 1948); International Covenant on Economic, Social and Cultural Rights, Art 12, 16 December 1966, 993 UNTS 3; Convention on the Rights of the Child, Art 24, 20 November 1989, 1577 UNTS 3.

¹⁸ Gabriel C. Alexander, A.B. O’Connor and R.S. Stafford, ‘Enhancing Prescription Drug Innovation and Adoption’ (2011) 155 Annals of Internal Medicine 99 <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4049188/> accessed 12 May 2024.

¹⁹ Gopakumar G. Nair, Intellectual Property Rights: Pharma Industry Perspective 121 (Pharmaceutical Patent Analyst 2014).

²⁰ L. Diependaele, J. Cockbain and S. Sterckx, ‘Raising the Barriers to Access to Medicines in the Developing World: The Relentless Push for Data Exclusivity’ (2017) 17 Developing World Bioethics.