Indian Patent Office Unveils AYUSH Patent Guidelines: What Innovators Must Know

The Indian Patent Office (IPO) has recently unveiled the "Draft Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions," aiming to provide clarity and direction for patent applications in the #AYUSH sector, which encompasses Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy. These guidelines are designed to complement the existing 2012 guidelines on traditional knowledge and biological materials, ensuring a robust intellectual property framework that respects India's rich heritage while fostering innovation.

Scope of AYUSH-Related Inventions

The draft guidelines delineate the scope of patentable AYUSH-related inventions into two primary categories:

1. AYUSH Products and Equipment/Devices: This includes novel formulations, therapeutic compositions, and innovative equipment or devices utilized within AYUSH practices.
2. Food Recipes/Nutraceuticals: Culinary preparations and health supplements rooted in AYUSH traditions that offer unique health benefits.

Guiding Principles for Patent Examination

To navigate the intricate balance between traditional knowledge and innovation, the guidelines propose six guiding principles:

1. Extracts and Isolates: Claims focused on extracts or active ingredients inherently present in plants, especially when their use is well-documented in AYUSH systems, may lack novelty or inventiveness. However, innovative processes for obtaining such extracts could be considered patentable, provided they meet the criteria of novelty and inventive step.
2. Combinations of Known Ingredients: Formulations combining known plant, mineral, or animal-derived ingredients for treatments already established in traditional knowledge might be deemed obvious. Yet, specific ratios or combinations leading to unexpected technical effects could establish non-obviousness.
3. Known Active Ingredients: Utilizing an already known active ingredient for the same therapeutic purpose may be presumed obvious. Demonstrating an unexpected technical effect in such combinations is essential to establish non-obviousness.
4. Optimization of Traditional Formulations: Routine experimentation to determine optimal or workable ranges of traditionally known ingredients does not qualify as inventive.
5. Isolated Components from Known Compositions: Claims targeting individual ingredients from compositions already recognized for therapeutic activity in traditional knowledge may lack inventiveness.
6. Innovations in AYUSH Equipment/Devices: Novel and inventive equipment or devices designed for AYUSH practices may be patentable if they demonstrate advancements over existing prior art.

Implications for Stakeholders

These guidelines underscore the IPO's commitment to safeguarding traditional knowledge while promoting genuine innovation. Inventors and researchers in the AYUSH sector are encouraged to:

• Thoroughly Document Innovations: Ensure that applications clearly differentiate new inventions from existing traditional knowledge.
• Demonstrate Novelty and Inventiveness: Provide substantial evidence of how the invention offers a technical advance or an unexpected effect beyond traditional practices.
• Engage in Prior Art Searches: Conduct comprehensive searches to ascertain the novelty of the invention in the context of existing traditional knowledge and prior art.

Call for Public Feedback

The IPO invites stakeholders, including practitioners, researchers, and industry experts, to review the draft guidelines and provide feedback. Suggestions can be sent to Ms. Anita Jatav, Deputy Controller of Patents & Designs, at [email protected] by February 28, 2025. This collaborative approach aims to refine the guidelines, ensuring they effectively balance the protection of traditional knowledge with the encouragement of innovation in the AYUSH sector.

By establishing these comprehensive guidelines, the IPO seeks to create a conducive environment for the growth and global recognition of #AYUSH systems, ensuring that traditional wisdom and modern innovation coexist harmoniously.

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