AYUSH Patent Guidelines: Protecting Tradition, Requiring Innovation

Introduction

The Indian government has taken a definitive step to harmonise intellectual property rights with its rich heritage of traditional medicine. The Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) has issued the “Guidelines for Examination of AYUSH Related Inventions,” establishing a long-awaited, clear framework for patent applications related to Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Sowa-Rigpa (AYUSH).

This initiative moves beyond the general “Guidelines for processing of patent applications relating to traditional knowledge and biological material.” It creates a specific roadmap for protecting innovations within the AYUSH sector, including novel products, specialised equipment/devices, and value-added nutraceuticals derived from these systems. The core message is clear: Genuine, non-obvious scientific advancements in AYUSH are now explicitly welcomed for IP protection, provided they satisfy all criteria under the Patents Act, 1970.

Navigating the Patentability Matrix

The new guidelines are meticulous in defining the boundaries between protected innovation and the public domain of traditional knowledge. Every AYUSH patent application must still meet the foundational requirements of Novelty, Inventive Step, and Industrial Application.

Crucially, the CGPDTM has installed two primary filters to prevent the unjust monopolization of existing knowledge:

1. Mandatory TKDL Search: A compulsory Traditional Knowledge Digital Library (TKDL) search is required to vet applications against documented Indian Systems of Medicine, effectively acting as the first line of defense against “evergreening” or biopiracy.
2. Strict Interpretation of Statutory Exclusions: The guidelines rigorously apply Section 3 of the Patents Act. This means:
   • Essentially Traditional Knowledge (Section 3(p)) is non-patentable.
   • A mere discovery or a new use of a known substance (Section 3(d)) will be rejected unless the invention proves enhanced efficacy.
   • Simple admixtures without a synergistic effect (Section 3(e)) and methods of treatment (Section 3(i)) remain excluded.

The Focus on Innovation: Beyond the Known

For AYUSH inventions to qualify, the innovation must be technical and non-obvious. While claims for extracts or isolates whose uses are already known in traditional systems are typically rejected, the specific process used to obtain them, or an AYUSH equipment/device demonstrating a genuine inventive step (like a modern automated diagnostic tool), may be eligible. This promotes modernization within the sector.

A Non-Negotiable: Compliance with the Biological Diversity Act

The final, but perhaps most critical, component of the new framework is the emphasis on compliance with the Biological Diversity Act (BDA), 2002. Any application relying on biological resources sourced from India must:

• Disclose the source and geographical origin of the material.
• Secure approval from the National Biodiversity Authority (NBA) when required.

The guidelines state unequivocally that non-disclosure or misrepresentation of the source is a severe ground for refusal, opposition, or even revocation. This powerful provision ensures that the promotion of innovation does not come at the expense of India’s sovereign rights over its biological resources and the principles of Access and Benefit Sharing.

Conclusion

CGPDTM has crafted a balanced and robust IP ecosystem. These guidelines are a watershed moment, creating a clear pathway for genuine AYUSH innovators while cementing the legal protection necessary to safeguard India’s profound legacy of traditional medicine.

Expositor(s):  Adv. Archana Shukla