The AYUSH system, which includes Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy, is an integral part of India’s healthcare traditions, with the Ministry of AYUSH dedicated to preserving and advancing these systems by promoting research and innovation. However, with the rise in global interest in traditional medicine, there is an increasing need to protect India’s rich traditional knowledge from misappropriation and unauthorised patents. To address this, the Indian Patent Office issued the draft Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions on January 31, 2025, inviting suggestions on the guidelines from the stakeholders by February 28, 2025.
The draft Guidelines aim to ensure that only genuine innovations receive patent protection while preventing the exploitation of existing traditional knowledge. The guidelines are designed to complement the existing Guidelines for Processing Patent Applications Relating to Traditional Knowledge and Biological Material, 2012. They do not replace the earlier guidelines but provide more clarity on filing and examining patents related specifically to AYUSH-based innovations.
The primary aim is to create a robust intellectual property framework that acknowledges India’s vast repository of traditional medicinal knowledge while nurturing new inventions that build upon it. The draft Guidelines aim to foster a robust IP system for AYUSH-related inventions, aligning with international frameworks such as the World Intellectual Property Organization (WIPO) Inter-Governmental Committee (IGC) and the United Nations Convention on Biological Diversity (CBD). By establishing these procedures, the guidelines seek to ensure that innovations in the AYUSH sector are adequately protected, promoting both national and international collaboration in research and development.
Criteria under the Patents Act, 1970
The scope of the draft Guidelines covers various AYUSH-related inventions, including Ayush products and equipment/devices used in Ayush systems, and food recipes or nutraceuticals described in Ayush systems. The draft guidelines highlight several key sections of the Indian Patents Act, 1970, that are pertinent to the protection of traditional knowledge. For any invention to be patentable, it must meet the criteria set under the Patents Act, 1970, which requires an invention to be novel, involve an inventive step, and have industrial applicability.
Additionally, Section 3 of the Act specifies the categories of inventions that are not patentable, including discoveries of scientific principles, new forms of known substances without enhanced efficacy, and inventions that merely aggregate the properties of traditionally known components. These provisions have been put in place in order to prevent the unjustified monopolisation of traditional remedies that have been widely known and practised in India for centuries.
Patent Procedure for AYUSH-Related Inventions
The process of obtaining a patent for AYUSH-related inventions shall follow the standard Manual of Patent Office Practice and Procedure. Applications can be filed online or at the designated Indian Patent Offices. Once filed, such applications shall undergo a rigorous screening process where they would be categorised as Traditional Knowledge (TK) and assigned to the relevant classification group, such as pharmaceuticals, biotechnology, microbiology, or food science.
Under Section 10 of the Patents Act, 1970, applicants must fully disclose their invention, including its operation, method of use, and best-known method of performance. If the invention involves biological resources, the applicant must also disclose its source and geographical origin. Any failure to do so can result in the rejection of the application.
During the examination phase, patent examiners shall assess whether the invention meets the criteria of novelty, inventive step, and industrial applicability. To verify the originality of the invention, examiners shall refer to various traditional knowledge databases, including the AYUSH Research Portal, Database of Ayurvedic, Unani, Siddha and Sowarigpa Formulations, Foundation for Revitalisation of Local Health Traditions (FRLHT) Indian Medicinal Plant Database, and the Tribal Digital Document Repository by Ministry of Tribal Affairs. If prior art is detected, a First Examination Report (FER) shall be issued, giving the applicant an opportunity to address any objections before a final decision is made.
Permission from the National Biodiversity Authority (NBA)
The draft Guidelines also address the requirements under the provisions of the Biodiversity Act, 2002, as amended by the Biological Diversity (Amendment) Act, 2023, regarding the use of biological resources in inventions. The Biological Diversity (Amendment) Act, 2023, which came into effect on April 1, 2024, strengthens the regulations surrounding the use of biological resources in inventions. The Act explicitly defines biological resources to include plants, animals, microorganisms, and their derivatives while excluding human genetic material.
If an invention is based on any research or information on a biological resource which is accessed from India, including those deposited in repositories outside India or traditional knowledge associated with it, then the applicant shall register with the National Biodiversity Authority (NBA).
Further, for any invention based on any research or information on a biological resource which is accessed from India, including those deposited in repositories outside India or associated traditional knowledge, the inventor shall obtain prior approval from the NBA at the time of commercialisation. Failure to comply with these provisions may result in penalties ranging from INR 1-50 lakh, with the possibility of penalties extending up to INR 1 crore in cases of severe violations.
Guiding Principles for Assessment of Patent Applications
The draft Guidelines highlight the need for a synergistic effect between ingredients in combinations while evaluating their patentability. Synergistic effect means the interaction of two or more substances yielding a combined effect that is significantly greater than the simple sum of their individual effects. This concept is particularly relevant in fields such as pharmaceuticals, agriculture, and chemistry, where the efficacy of combinations can lead to innovative solutions. To facilitate a thorough assessment of synergism and maintain fairness and consistency in assessing patent applications, the guidelines provide six guiding principles.
First, extracts/alkaloids and/or isolation of active ingredients of plants naturally/inherently present in plants that are pre-known in Ayush systems are not considered novel unless they involve a new and inventive process. However, if an applicant develops a new extraction technique that significantly improves bioavailability, such an innovation may be considered for patent protection.
Second, when a combination of ingredients derived from plants, minerals, animals, or existing formulations is already known in traditional knowledge for the treatment of a particular disease, it is generally evident that a product comprising these known ingredients, along with additional ingredients of similar origin and therapeutic properties, would exhibit an additive effect. To establish the non-obviousness of such a combination, it would be essential to demonstrate a specific ratio or proportion of the ingredients that leads to an unexpected technical effect beyond what is already known or anticipated from traditional knowledge. Simply combining known ingredients with the same therapeutic effect without demonstrating an unexpected result would not be considered inventive.
The third principle states that if a particular ingredient is already recognised for its efficacy in treating a disease, there would be an inherent presumption of obviousness that any combination product incorporating the known active ingredient would also be effective for the treatment of the same disease. However, in cases where the combination exhibits an unexpected and synergistic effect, such an invention may be considered non-obvious and, therefore, eligible for patent protection.
The fourth principle asserts that identifying the optimal or workable ranges of traditionally known ingredients through routine experimentation would not constitute an inventive step.
The fifth principle emphasises that when multiple ingredients are recognised as per traditional knowledge for exhibiting the same therapeutic activity, merely selecting one ingredient from the known set and formulating it independently would not be considered an inventive contribution.
The final principle states that if the claimed invention pertains to equipment or devices used within the AYUSH systems, such inventions may be eligible for patent protection, provided that they are both novel and inventive in comparison to prior art. If the equipment or device introduces a new and non-obvious technical feature that enhances its functionality, improves treatment efficacy, or provides a novel approach to AYUSH practices, it may be considered patentable.
In Conclusion
The draft Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions provide a balanced approach to protection in the AYUSH sector. The draft Guidelines encourage genuine innovation while preventing the privatisation of India’s traditional knowledge. By adhering to these principles, inventors and researchers for AYUSH systems and related inventions would be able to navigate the patent system effectively while upholding the integrity of India’s rich heritage in traditional medicine. The draft Guidelines not only align with global intellectual property norms but also safeguard the interests of traditional practitioners and communities who have preserved this knowledge for generations.
The official notice regarding the Guidelines can be accessed here: Suggestions invited on “The draft guidelines for processing patent applications of AYUSH systems and related inventions.”
