India’s Draft Guidelines On AYUSH Keep Traditional Knowledge And Innovations In Harmony

The Indian Patent Office (IPO) has released “Draft Guidelines for Processing Patent Applications of AYUSH Systems and Related Inventions” (draft guidelines), which is available for comment till 28 February 2025.

The AYUSH system of medicine includes Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy. The draft guidelines seek to complement the existing “Guidelines for processing of patent applications relating to traditional knowledge and biological material, 2012.”.

The scope for AYUSH-related inventions in the draft guidelines is identified as follows:

1. AYUSH Products and Equipment/Devices used in AYUSH systems
2. Food Recipes/Nutraceuticals described in AYUSH systems

Subject to patentability criteria under Section 2(1)(j) and Section 3 of the Patents Act, 1970 (‘Patents Act’), products and processes in these areas are entitled to intellectual property protection.

Existing law and procedure

At the outset, the draft guidelines clarify and emphasise that AYUSH-related inventions must meet the same standards of patentability as laid down in the Patents Act, e.g., meet the basic criteria of patentability (novelty, inventive step, industrial applicability), and lie outside the exceptions to patentability, as contained in Section 3, including exclusion on grounds of being traditional knowledge (TK) or an aggregation of known properties of traditionally known components (3(p)). Procedural requirements of proper disclosure, etc., apply to all such applications as well.

National Biodiversity Authority (NBA) approval

The draft guidelines clarify that applicants must secure prior approval from the National Biodiversity Authority (NBA) if their invention is based on research or information pertaining to biological resources sourced from India. However, NBA permission is not required merely for a device that is used merely for handling biological resources from India. For example, if an invention is for a modified device for the storage or dispensation of Ayurvedic medicine, then NBA permission would not be required merely because Ayurvedic medicine is mentioned thus.

Declaration in patent application

According to the draft guidelines, where relevant, an applicant must submit a declaration in the patent application form that the invention uses biological material from India and that necessary permissions from the competent authority (e.g., NBA) will be submitted before the grant of the patent. Further, this declaration is required only when the invention is based on research on biological resources obtained from India and not for a device that is used to handle the biological resource, as discussed above.

Non-disclosure or wrong mention of source

Applicants must also make proper disclosures. The draft guidelines specify that non-disclosure or wrong mention of the source or geographical origin of biological material used for an invention in the complete specification forms a ground for refusal of the patent application under Section 15 of the Patents Act, pre- and post-grant oppositions, and revocation.

Guiding principles for assessment of applications

The draft guidelines provide six guiding principles to be followed while examining AYUSH-based applications, accompanied by illustrative examples.

1. Guiding Principle 1: If the claimed subject matter relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally or inherently present in plants, such claims cannot be considered novel or inventive when the use of such plants is pre-known in AYUSH systems. However, processes for obtaining such extracts/isolates may be considered patentable, subject to the requirements of novelty and inventive step. For example, if the process uses low temperatures and minimal chemicals to obtain extracts or isolates that are not disclosed in prior art, it may be considered patentable.
2. Guiding Principle 2: If a combination of ingredients from plants/minerals/animal origin/ existing formulations already known for the treatment of a disease as a part of TK, then it would be considered 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 ingredients when applied separately (additive effect). However, specific ratios leading to unexpected technical effects of such combinations may be considered to establish non-obviousness. This principle is in alignment with the requirements laid out in Section 3(e) of the Patents Act, which requires that a combination or an admixture be patentable provided that the synergistic data is provided in the complete specification through comparative data.
3. Guiding Principle 3: If 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 the same disease. However, the unexpected technical effect of such combinations may be considered to establish non-obviousness.
4. Guiding Principle 4: Discovering the optimum or workable ranges of traditionally known ingredients by routine experimentation is not inventive.
5. Guiding Principle 5: If a composition comprising multiple ingredients is known to have therapeutic activity as per TK, then a claim pertaining to one of the ingredients for the same therapeutic activity cannot be considered inventive.
6. Guiding Principle 6: If the subject matter of the claims relates to inventions regarding equipment/devices used in AYUSH systems, then such inventions may be patentable if novel and inventive over the prior art.

Conclusion

The draft guidelines aim to streamline the patent application process for AYUSH-related innovations, ensuring these meet the necessary standards for patentability by collating, summarizing, and clarifying existing principles typically used in the assessment of such applications.

While the guidelines provide some clarity regarding the processing of such applications (such as the data required to demonstrate synergy), they may potentially also create rigid structures that lack the flexibility currently available in the system. For instance, the guidelines specify that discovering the optimum or workable ranges of traditionally known ingredients through routine experimentation is not inventive. This seems to contradict the principle of selection patents.

Guidelines such as these are most relevant and useful when they make the application process clearer, easier, and more efficient. In their present version, these guidelines may potentially lead to more obstacles in the application process for AYUSH-related inventions than desirable. The IPO may consider tweaking the guidelines appropriately so that flexibility, efficiency, and ease of prosecution remain unaffected.