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The Forgotten Provisions of Trips: A Comparative Study of Articles 7 And 8 In Shaping Pharmaceutical Patent Policy in South Asia

Nidhi Sharma Dr. Namrata Yadav

Subject area: Arts, Social Sciences and Humanities  ·  Area of research: Law

DOI: https://doi.org/10.64388/IREV10I2-1720290

Abstract

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is often analysed in terms of its fundamental criteria for intellectual property safeguarding, especially Article 31 concerning compulsory licensing. Articles 7 and 8 have received very little academic scrutiny, since they outline the aims and purposes of the Agreement while establishing the normative structure for patent protection. These regulations acknowledge that intellectual property rights are not unconditional but should facilitate technical advancement, societal benefit, technology dissemination, and public health. The importance of their role has been more evident since the Doha Declaration on the TRIPS Agreement and Public Health, which reiterated the entitlement of Member States to interpret and apply TRIPS in a way that promotes public health and access to medications. This study rigorously examines the influence of Articles 7 and 8 on the formulation of pharmaceutical patent regulations in South Asia. It contends that these rules are not only aspirational declarations but serve as essential interpretive principles that shape the formulation and execution of compulsory licensing frameworks in national law systems. The research conducts a comparative analysis of India, Bangladesh, Pakistan, Nepal, Sri Lanka, Bhutan, and the Maldives to assess how national patent systems integrate the developmental goals outlined in Articles 7 and 8. It moreover examines judicial advancements, legislative strategies, and policy obstacles that persistently influence access to inexpensive pharmaceuticals in the area. The paper asserts that whereas South Asian nations have progressively used the adaptability inherent in the TRIPS framework, significant inequalities persist in legislative execution and institutional capability. Enhancing the domestic implementation of Articles 7 and 8 may foster a more equitable intellectual property framework that safeguards innovation while also serving the wider public good, especially in public health.

Keywords

TRIPS Agreement; Articles 7 and 8; Pharmaceutical Patent Policy; Compulsory Licensing; South Asia.

References

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

[2] World Trade Organization, Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2, adopted 14 November 2001.

[3] World Trade Organization, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540, 30 August 2003.

[4] Protocol Amending the TRIPS Agreement, WT/L/641, adopted 6 December 2005, inserting Article 31bis into the TRIPS Agreement.

[5] Vienna Convention on the Law of Treaties, 23 May 1969, 1155 UNTS 331.

[6] The Patents Act, 1970, Act No. 39 of 1970, India, as amended by the Patents (Amendment) Act, 2005.

[7] The Patents Rules, 2003, India, as amended.

[8] Novartis AG v Union of India and Others, (2013) 6 SCC 1.

[9] Bayer Corporation v Union of India and Others, Order No. 45/2013, Intellectual Property Appellate Board, 4 March 2013.

[10] Controller of Patents, Natco Pharma Ltd v Bayer Corporation, Compulsory Licence Application No. 1 of 2011, order dated 9 March 2012.

[11] F Hoffmann-La Roche Ltd v Cipla Ltd, 2016 SCC OnLine Del 2358.

[12] World Trade Organization, TRIPS and Public Health: Frequently Asked Questions, WTO, Geneva.

[13] World Trade Organization, Module X: TRIPS and Public Health, WTO Technical Cooperation Handbook, Geneva.

[14] World Intellectual Property Organization, Patent-Related Flexibilities in the Multilateral Legal Framework and Their Legislative Implementation at the National and Regional Levels, WIPO Standing Committee on the Law of Patents, SCP/18/5, Geneva, 2012.

[15] World Intellectual Property Organization, Constraints Faced by Developing Countries and Least Developed Countries in Making Full Use of Patent Flexibilities and Their Impacts on Access to Affordable Essential Medicines, SCP/36/6, Geneva, 2024.

[16] World Health Organization, World Intellectual Property Organization and World Trade Organization, Promoting Access to Medical Technologies and Innovation: Intersections between Public Health, Intellectual Property and Trade, 2nd edn, WTO, Geneva, 2020.

[17] World Health Organization, Country Experiences in Using TRIPS Safeguards, WHO Regional Office for South-East Asia, New Delhi, 2017.

[18] World Health Organization, Intellectual Property Rights and Access to Medicines: A South-East Asia Perspective on Global Issues, WHO Regional Office for South-East Asia, New Delhi, 2008.

[19] Sisule F Musungu and Cecilia Oh, The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines?, Commission on Intellectual Property Rights, Innovation and Public Health, World Health Organization, Geneva, 2006.

[20] United Nations Conference on Trade and Development and International Centre for Trade and Sustainable Development, Resource Book on TRIPS and Development, Cambridge University Press, Cambridge, 2005.

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

[22] Carlos M Correa, Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options, Zed Books, London, 2000.

[23] Frederick M Abbott, ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO’ (2002) 5(2) Journal of International Economic Law 469–505.

[24] Ellen FM ’t Hoen, ‘TRIPS, Pharmaceutical Patents and Access to Essential Medicines: A Long Way from Seattle to Doha’ (2002) 3(1) Chicago Journal of International Law 27–46.

[25] Shamnad Basheer and T Prashant Reddy, ‘The “Efficacy” of Indian Patent Law: Ironing Out the Creases in Section 3(d)’ (2008) 5(2) Script-ed 232–266.

How to cite this paper

Nidhi Sharma, Dr. Namrata Yadav "The Forgotten Provisions of Trips: A Comparative Study of Articles 7 And 8 In Shaping Pharmaceutical Patent Policy in South Asia" Iconic Research And Engineering Journals Volume 10 Issue 2 2026 Page 186-192 https://doi.org/10.64388/IREV10I2-1720290
Nidhi Sharma, Dr. Namrata Yadav "The Forgotten Provisions of Trips: A Comparative Study of Articles 7 And 8 In Shaping Pharmaceutical Patent Policy in South Asia" Iconic Research And Engineering Journals, vol. 10, no. 2, Aug. 2026, doi: https://doi.org/10.64388/IREV10I2-1720290
Nidhi Sharma, Dr. Namrata Yadav (2026). The Forgotten Provisions of Trips: A Comparative Study of Articles 7 And 8 In Shaping Pharmaceutical Patent Policy in South Asia. Iconic Research And Engineering Journals, 10(2). doi: https://doi.org/10.64388/IREV10I2-1720290
Nidhi Sharma, Dr. Namrata Yadav "The Forgotten Provisions of Trips: A Comparative Study of Articles 7 And 8 In Shaping Pharmaceutical Patent Policy in South Asia" Iconic Research And Engineering Journals, vol. 10, no. 2, Aug. 2026. Crossref, https://doi.org/10.64388/IREV10I2-1720290
@article{1720290,
      author = {Nidhi Sharma, Dr. Namrata Yadav},
      title = {The Forgotten Provisions of Trips: A Comparative Study of Articles 7 And 8 In Shaping Pharmaceutical Patent Policy in South Asia},
      journal = {Iconic Research And Engineering Journals},
      year = {2026},
      volume = {10},
      number = {2},
      pages = {186-192},
      issn = {2456-8880},
      url = {https://www.irejournals.com/formatedpaper/1720290.pdf},
      abstract = {The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is often analysed in terms of its fundamental criteria for intellectual property safeguarding, especially Article 31 concerning compulsory licensing. Articles 7 and 8 have received very little academic scrutiny, since they outline the aims and purposes of the Agreement while establishing the normative structure for patent protection. These regulations acknowledge that intellectual property rights are not unconditional but should facilitate technical advancement, societal benefit, technology dissemination, and public health. The importance of their role has been more evident since the Doha Declaration on the TRIPS Agreement and Public Health, which reiterated the entitlement of Member States to interpret and apply TRIPS in a way that promotes public health and access to medications. This study rigorously examines the influence of Articles 7 and 8 on the formulation of pharmaceutical patent regulations in South Asia. It contends that these rules are not only aspirational declarations but serve as essential interpretive principles that shape the formulation and execution of compulsory licensing frameworks in national law systems. The research conducts a comparative analysis of India, Bangladesh, Pakistan, Nepal, Sri Lanka, Bhutan, and the Maldives to assess how national patent systems integrate the developmental goals outlined in Articles 7 and 8. It moreover examines judicial advancements, legislative strategies, and policy obstacles that persistently influence access to inexpensive pharmaceuticals in the area. The paper asserts that whereas South Asian nations have progressively used the adaptability inherent in the TRIPS framework, significant inequalities persist in legislative execution and institutional capability. Enhancing the domestic implementation of Articles 7 and 8 may foster a more equitable intellectual property framework that safeguards innovation while also serving the wider public good, especially in public health.},
      keywords = {TRIPS Agreement; Articles 7 and 8; Pharmaceutical Patent Policy; Compulsory Licensing; South Asia.},
      month = {August},
      doi = {https://doi.org/10.64388/IREV10I2-1720290}
  }