Proceeding of The Future of Life - Legal, Scientific, and Geopolitical Challenges (TFOL2025)

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Leveraging India’s Patent Regime for Affordable Orphan Drug Development: A Pathway for Not-for-Profit Innovation

Authors
Swathi G1, *, Asha Sundaram2
1Saveetha School of Law, SIMATS, Chennai, India
2Saveetha School of Law, SIMATS, Chennai, India
*Corresponding author. Email: swatisekar@gmail.com
Corresponding Author
Swathi G
Available Online 13 March 2026.
DOI
10.2991/978-2-38476-555-3_13How to use a DOI?
Keywords
Orphan drugs; Not-for-Profit; Pharmaceuticals; Patents; Law
Abstract

India’s distinctive patent law environment presents unique opportunities for not-for-profit organizations aiming to develop orphan drugs for rare diseases. Section 3(d) of the Indian Patent Act, which restricts the patentability of new forms of known substances lacking enhanced therapeutic efficacy, reduces intellectual property barriers that typically hinder drug repurposing efforts in other jurisdictions. The legal framework explored in this paper combined with India’s compulsory licensing regime, offers a strategic advantage for mission-driven entitles seeking to advance treatments for underserved patient populations. This paper explores how not-for-profit organizations can leverage these legal provisions within the broader regulatory eco-system, encompassing ‘National Policy for Rare Diseases of 2021’, ‘Drugs and Cosmetics Act’ and patent protection strategies. Through critical analysis of these legal and institutional frameworks, this paper finally proposes actionable strategies for strengthening orphan drug development by not-for-profit entities in India, ultimately aiming to deliver accessible and affordable treatments to individuals affected by rare diseases.

Copyright
© 2026 The Author(s)
Open Access
Open Access This chapter is licensed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

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Volume Title
Proceeding of The Future of Life - Legal, Scientific, and Geopolitical Challenges (TFOL2025)
Series
Advances in Social Science, Education and Humanities Research
Publication Date
13 March 2026
ISBN
978-2-38476-555-3
ISSN
2352-5398
DOI
10.2991/978-2-38476-555-3_13How to use a DOI?
Copyright
© 2026 The Author(s)
Open Access
Open Access This chapter is licensed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

Cite this article

risenwbib
TY  - CONF
AU  - Swathi G
AU  - Asha Sundaram
PY  - 2026
DA  - 2026/03/13
TI  - Leveraging India’s Patent Regime for Affordable Orphan Drug Development: A Pathway for Not-for-Profit Innovation
BT  - Proceeding of The Future of Life - Legal, Scientific, and Geopolitical Challenges (TFOL2025)
PB  - Atlantis Press
SP  - 191
EP  - 206
SN  - 2352-5398
UR  - https://doi.org/10.2991/978-2-38476-555-3_13
DO  - 10.2991/978-2-38476-555-3_13
ID  - 2026
ER  -