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Introduction
The Ministry of AYUSH, India, issued the draft Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions on January 31, 2025, seeking suggestions from stakeholders. These guidelines encompass AYUSH system of medicine, including Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy. Their purpose is to clarify the processes involved in filing and processing patent applications related to these systems, complementing existing guidelines on traditional knowledge and biological materials, “Guidelines for Processing of Patent Applications Relating to Traditional Knowledge and Biological Material” issued in the year 2012.
Background
India has been at the forefront of international efforts to protect traditional knowledge (TK) within the framework of intellectual property rights (IPR). This includes initiatives by the World Intellectual Property Organization (WIPO) and agreements such as the Doha Ministerial Declaration. The guidelines are designed to establish a robust intellectual property system specifically for AYUSH systems, ensuring that stakeholders have a clear understanding of the patent filing process in India.
Scope of AYUSH Related Inventions
The draft guideline covers the areas where AYUSH-related inventions can be considered for patent protection. These include:
- AYUSH Products and Equipment/devices: This includes devices used in AYUSH practices.
- Food recipes and Nutraceuticals: under this category, food recipes and health supplements derived from traditional practices are covered.
- Processes and products in the aforementioned areas, provided they meet the patentability criteria under The Indian Patents Act, 1970.
Existing Key Provisions for Protection of Traditional Knowledge
The draft guidelines emphasize several sections of the Indian Patents Act, 1970, that are relevant to the protection of traditional knowledge, particularly, relevant to AYUSH-related inventions. Key sections of The Indian Patent Act, 1970 include:
- Section 2(1)(j): Defines an invention as a new product or process involving an inventive step and capable of industrial application.
- Section 3(p): States those inventions based on traditional knowledge or aggregations of known properties of traditionally known components are not patentable.
- Section 3(e): Excludes substances obtained by mere admixture resulting only in the aggregation of properties of components from patentability.
Additionally, the sections 3 (b), (c), (d), (f), (h), (i) and (j); sections 10 (4) (a) & (b); and Section 10 (5) are of relevance with respect to the patent applications based on AYUSH systems and related inventions.
The draft guidelines emphasize that traditional knowledge, being in the public domain, cannot be patented unless it involves a novel and inventive step that goes beyond the existing knowledge.
Biodiversity Act and NBA Permission
The present guidelines also address the requirements under the Biological Diversity Act, 2002, as amended by the Biological Diversity (Amendment) Act, 2023. Applicants must obtain prior approval from the National Biodiversity Authority (NBA) if the invention is based on research or information on biological resources accessed from India. However, NBA permission is not required merely for using biological resources from India unless the invention is based on research involving those resources. The National Biodiversity Authority (NBA) must grant permission for patents based on research involving these resources. Failure to comply can lead to refusal or revocation of patents.
Recent Amendments to Biological Diversity Act
The draft guidelines highlights the recent amendments notifies as The Biological Diversity (Amendment) Act, 2023, which comes into effect on April 1, 2024, introduces new provisions regarding the use of biological resources. Key changes include:
- Definitions of biological resources and value-added products.
- Requirements for obtaining prior approval from the NBA before applying for intellectual property rights based on Indian biological resources or traditional knowledge.
Guiding Principles for Assessment of Patent Applications
The document shapes several guiding principles for assessing the patentability of AYUSH-related inventions:
- Guiding Principle 1: If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel and/or inventive when use of such plants is pre-known in AYUSH systems. However, processes for obtaining above mentioned extracts/isolates may be considered patentable subject to the requirements of novelty and inventive step.
- Guiding Principle 2: In case combination of ingredients from plants/minerals/animal origin/ existing formulations already known for the treatment of a disease as a part of Traditional Knowledge, then it is obvious that a combination product comprising these known ingredients with further ingredients from plants/minerals/animal origin/ existing formulations with the same known therapeutic effect would be more effective than each of the ingredient when applied separately (additive effect). However, specific ratios leading to unexpected technical effect of such combinations may be considered to establish non-obviousness.
- Guiding Principle 3: In case an ingredient is already known for the treatment of a disease, then it creates a presumption of obviousness that a combination product comprising this known active ingredient would be effective for the treatment of same disease. However, unexpected technical effect of such combinations may be considered to establish non-obviousness.
- Guiding Principle 4: Discovering the optimum or Workable Ranges of Traditionally known ingredients by Routine experimentation is not inventive.
- Guiding Principle 5: In case multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, taking one component out of them cannot be considered as inventive.
- Guiding Principle 6: If the subject matter of the claims relates to inventions regarding equipment / device used in AYUSH systems, then such inventions may be patentable if novel and inventive over the prior art.
Illustrative Examples
The guidelines document includes several illustrative examples under each guiding principle to clarify their application.
Overview of patent application procedure
The guidelines provide a detailed structure of patent application procedures including filing of patent applications, screening and classification, and examination of patent applications related to AYUSH systems. Key aspects include:
- Screening and classification: All patent applications relating to AYUSH systems and related inventions are screened as “Traditional Knowledge” and routed for examination to the respective groups such as Chemistry, Pharmaceuticals, Agrochemicals, Biotechnology, Microbiology, Biochemistry, Food, Mechanical, etc.
- Novelty and Inventive Step: The invention must be new and involve an inventive step that is not obvious to a person skilled in the art.
- Industrial Application: The invention must be capable of being made or used in an industry.
- Disclosure Requirements: The complete specification must fully describe the invention, its operation, and the best method of performing it. The source and geographical origin of any biological material used in the invention must also be disclosed.
Synergism
The guidelines document emphasizes the importance of synergism in assessing the patentability of combinations of ingredients. Synergism refers to the interaction of two or more substances to produce a combined effect greater than the sum of their individual effects. The document provides illustrations that demonstrate how to assess the presence of synergism and how the synergistic data can be used to establish the inventive step of a claimed invention.
Annexures
The draft guidelines document includes several annexures:
- Annexure-I: Form-1 of the Patent Rules, 2003, for filing a patent application.
- Annexure-II: A list of databases to be referred to for AYUSH systems and traditional knowledge, including the AYUSH Research Portal and the TKDL (Traditional Knowledge Digital Library).
- Annexure-III: A brief explanation of synergism with illustrative examples.
Conclusion
The draft Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions provide a comprehensive framework for the stakeholders involved in traditional medicine practices in India. By clarifying patentability criteria and emphasizing compliance with biodiversity laws, these guidelines aim to foster innovation while protecting India’s rich heritage of traditional knowledge. With clear guiding principles and illustrative examples, the guidelines document assists the patent examiners and the applicants in piloting the complexities of patenting within AYUSH systems and related inventions. The integration of IPR with AYUSH systems is expected to enhance research, development, and commercialization efforts in this vital sector.
Author: Dhakshina Moorthy C, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at Khurana & Khurana, Advocates and IP Attorney.