The Government of India, through the Ministry of AYUSH, actively promotes the traditional and indigenous systems of medicine, including Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy (AYUSH). Given the rich traditional knowledge (TK) embedded within these systems, it is crucial to strike a balance between protecting traditional knowledge and fostering innovation.
To address this, the Indian Patent Office (IPO) has issued the draft “Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions”, seeking input from stakeholders. These guidelines provide principles and illustrative examples to assess the patentability of AYUSH-related inventions. They complement the 2012 “Guidelines for Processing Patent Applications Relating to Traditional Knowledge and Biological Material”, ensuring a more refined framework for evaluating AYUSH-related patent applications.
Scope of AYUSH-Related Inventions
The guidelines outline the scope of patentability for the following categories of inventions:
- AYUSH Products and Equipment/Devices used in AYUSH systems
- Food Recipes/Nutraceuticals described in AYUSH systems
- Processes related to the above areas, subject to patentability criteria under Section 2(1)(j) and Section 3 of the Patents Act, 1970.
Existing Legal Framework for AYUSH Patent Protection
Key Sections of the Indian Patents Act, 1970:
- Section 2(1)(j): Defines “invention” as a new product or process involving an inventive step and capable of industrial application.
- Section 3(e): Mere admixtures resulting in the aggregation of properties of the components thereof or a process for producing such substance are not patentable.
- Section 3(p): Any invention that, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components is not patentable.
- Other relevant sections include Section 3(b), (c), (d), (f), (h), (i), and (j), which impose additional restrictions.
- Sections 10(4) and 10(5): Applicants must provide clear and comprehensive information about their inventions of their invention, ensuring compliance with patent filing requirements.
Key Provisions of the AYUSH Guidelines
Permission from the National Biodiversity Authority (NBA)
As per Section 10(4)(D) of the Patents Act, applicants must disclose the source and geographical origin of biological materials used. The AYUSH Guidelines clarify that NBA approval is required only if an invention is based on research involving biological resources accessed from India, not merely for using Indian biological resources. For example: NBA permission is not required for a modified device for dispensing Ayurvedic medicine. However, if the invention is an extract of certain specific plants obtained from India, Applicant shall be required to give the declaration that the invention is based on research on biological resources obtained from India and NBA permission would also be required accordingly. Non-compliance of such requirements may lead to patent refusal or opposition under the Indian Patents Act.
Biodiversity Act, 2002 (as amended in 2023)
The Biodiversity Amendment Act, 2023, effective April 1, 2024, introduces key changes in relation to use of biological resources in invention:
- Section 2(c): Expands the definition of biological resources to include plants, animals, micro-organisms or parts of their genetic material and derivatives (excluding value added products), with actual or potential use or value for humanity, but does not include human genetic material.
- Section 2(p): Defines value added products
- Section 6(1): Requires NBA approval for IP rights based on biological resources accessed from India.
- Section 55(1): Introduces penalties for violations, with fines between ₹1 lakh to ₹50 lakh for first non-compliance, extending upto ₹1 crore fir continued contravention.
Guiding Principles for Patentability Assessment under the Draft AYUSH Guidelines
Principle 1: Patentability of Extracts and Isolates
- Extracts/Alkoids and/or isolation of active ingredients that are naturally/inherently present in plants are novel and/or inventive if their use is already 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.
- Example: An extract of Withania somnifera (Ashwagandha) for treating stress lacks novelty if it is already known in Ayurveda. However, a new and inventive extraction method could be patentable.
Principle 2: Combination Formulations
- If a combination of ingredients from plants/minerals/animal origin/ existing formulations is 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.
- Example: A formulation containing Calendula officinalis, Aloe vera, and Centella asiatica for wound healing is not patentable unless synergistic data proves it is significantly more effective than individual components.
Principle 3: Known Active Ingredients in Combinations
- If one ingredient in a combination is already known for treating a disease, the combination product comprising this known active ingredient is presumed obvious for the treatment of same disease, unless it shows unexpected effects.
- Example: Maghz-e-Karanjwa is knownfor treating worm infestation. A combination of Maghz-e-Karanjwa, Gaozaban, and Kasni for treating worm infestation may be patentable only if synergistic effects are proven.
Principle 4: Optimization of Known Ingredients is not Inventive
- Discovering the optimum or workable ranges of traditionally known ingredients by routine experimentation is not inventive.
- Example: A formulation containing extracts of Pongamia pinnata (2-20%), Lawsonia alba (5-15%), Dhatura alba (2-20%), or Cocos nucifera (20-60%) for chronic ulcer management may be rendered obvious in view of prior literature documenting the use of these plants for similar purposes.
Principle 5: Isolating a Single Component from a Known Mixture is not Inventive
- Where multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, taking one component out of them cannot be considered inventive.
- Example: The claims relate to an extract of Zingiber zerumbet. Prior art shows a multi-component formulation with the same anti-bronchial asthmatic activity, so an extract of only Bitter Ginger for the same purpose may not be considered inventive.
Principle 6: AYUSH Equipment & Devices May Be Patentable
- Devices or equipment used in AYUSH therapies may be patentable if they are novel and inventive.
- Example: An automated system for Vamana Karma with pH, temperature, and volume sensors is patentable, as traditional Ayurveda does not describe such a device.
Our Analysis and Conclusion
The draft guidelines for processing patent applications in the AYUSH domain represent a thoughtful attempt to balance the preservation of traditional knowledge with the promotion of modern innovation. Legally, they provide a solid framework that aligns with existing patent statutes and biodiversity regulations, while practically, they offer clarity that can help guide innovators through a complex landscape. However, challenges remain—particularly in the areas of defining inventive thresholds, managing the evidentiary burden, and ensuring that administrative processes do not hinder innovation. For the guidelines to be truly effective, further refinements may be necessary to provide more granular definitions and streamlined procedures. This would not only benefit large organizations with robust legal resources but also ensure that smaller innovators and academic researchers have a fair chance to contribute to and benefit from advancements in the AYUSH sector.