Intellectual Property Challenges in Indian Herbal and Ayurvedic Formulations: A Pharmaceutical Jurisprudence Perspective

Abstract

Globalisation and commercialisation of traditional medicine originating in new challenges for the complicated nature of the issue, emerging in pharmaceutical jurisprudence. Globalisation and commercialisation of traditional medicine has ushered in new challenges to the complicated nature of dispute in pharmaceutical jurisprudence[1]. While conventional community-based Traditional Knowledge Systems (TKS) have been developed over centuries and based on community formulations that are non-individualistic and collective, traditional Intellectual Property Rights (IPR) systems focus on individual invention and novelty. This essay assesses the legal protections and regulatory roadblocks pertaining to Ayurvedic and herbal remedies in India.

The importance of important statutory provisions is discussed in this paper, including the Indian Patents Act, 1970, section 3(p) and the Biological Diversity Act, 2002 with a legal-doctrinal perspective[2]. It also reviews the achievements of the Traditional Knowledge Digital Library (TKDL) in combating unapproved patent claim and along with the regulatory demands of the Ministry of AYUSH.

The findings reveal that in spite of the successful implementation of the defensive procedures such as TKDL, indigenous Ayurvedic innovators continue to face restrictions by patents that previously had been granted under the positive/offensive patenting regime. Despite these strides, various regulatory challenges remain, particularly the stringent standards to prove an "inventive step" in multi-herbal products, the convoluted administration requirements imposed by the National Biodiversity Authority (NBA) for Access and Benefit Sharing (ABS) and the troubles of harmonizing traditional alternative products with modern requirements for generic approval[3].  With the existing IPR regime in India being much more defensive, it implies that the proactive innovation of drug and medicine in the AYUSH industry is suppressed unintentionally with some extent by biopiracy. A viable herbal industry can be promoted by adapting the legislation in practice and creating 'sui generis (unique, specialised) models of how the means community ownership or applying a conventional patent standard to the new system of jurisprudence, which moves from clinical science towards the present.

[1] Leonti, M., & Casu, L. (2013). Traditional medicines and globalization: current and future perspectives in ethnopharmacology. Frontiers in pharmacology, 4, 92.

[2] Boruah, J. (2019, March). Access and Benefit Sharing: A Status Under Indian Legal Regime. In Seminar Paper submitted to National Law University and Judicial Academy Assam.

[3] Nomani, M. Z. M., Rahman, F., Rauf, M., & Khan, S. A. (2020). Access and benefit sharing models of biodiversity conservation in international and comparative Law perspective. Advances in Natural and Applied Sciences, 14(1), 1-14.