The AYUSH system comprises Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy. The Government of India has established the Ministry of Ayush to revive and promote these traditional healthcare systems, focusing on their research, education, and global propagation. These guidelines mention about the area of scope for Ayush related inventions including – product(s), equipment(s), devices used in Ayush systems and food recipes / nutraceuticals described in Ayush systems.

A few restrictions as per law:

Indian law provides strong protection for Traditional Knowledge (TK). Since TK is considered part of the public domain, it does not qualify as an invention under Section 2(1)(j) of the Patents Act, 1970. Further, Section 3(p) specifically excludes patentability of any invention that is essentially traditional knowledge or merely an aggregation of known properties of traditional components. Other provisions under Sections 3(b), (c), (d), (f), (h), (i), and (j) are also applicable to patent applications related to AYUSH systems and associated inventions.

Liabilities of Applicant(s):

Section 10(4) D of the Patents Act requires disclosure of source and geographical origin of biological material used in the invention.

As per the Patent Rules, applicants must declare if their invention uses biological material from India and submit NBA permission before grant. However, as per the Biological Diversity (BD) Act, NBA approval is required only when the invention is based on research or information from Indian biological resources – not merely for mentioning or using them. For example, a device to dispense Ayurvedic medicine doesn’t need NBA approval, but an invention derived from plant extracts sourced from India require NBA approval.

The Biological Diversity (Amendment) Act, 2023, Section 55(1), imposes a penalty of ₹1 lakh to

₹50 lakhs for violating Sections 3, 4, 6, or 7, for continuing violations, an additional penalty of up to ₹1 crore may be imposed, as decided by the adjudicating officer under Section 55A.

Guiding principles for assessment of patent applications:

The patentability criteria is checked thoroughly during the examination of Patent application. The criteria include novelty, inventive step (non-obviousness) and industrial application. For a patent application related to TK and/or biological material, a thorough search for anticipation in TK and/or other databases is performed. Various guiding principles include:

  Guiding Principle 1:

Claims for extracts, alkaloids, or active ingredients naturally present in plants are not patentable if the plant’s medicinal use is already known in AYUSH systems. However, novel processes to obtain such extracts/isolates may qualify for patents if they show novelty and inventive step.

Example: A claim for Chamaemeloside (from chamomile) for treating various diseases lacks inventiveness since chamomile’s use for the same purposes is already disclosed in Ayurveda and Unani. The isolation process (if claimed) could still be patentable.

Example: An improved process for extracting berberine from Coscinium fenestratum leaves, giving higher yield and purity with minimal chemicals and low temperature, is inventive and patentable compared to prior art using stems.

  Guiding Principle 2:

If a formulation combines known plant, mineral, or animal ingredients already used in Traditional Knowledge for the same disease, it is considered obvious due to their additive effect. However, unique ratios that produce an unexpected technical effect may establish non-obviousness.

Example: A composition of Calendula officinalis, Aloe vera, and Centella asiatica for wound healing is considered obvious since each plant is already known for this use, and their combination would be expected to have an additive effect. Non-obviousness may be claimed only if an unexpected synergistic effect is demonstrated.

Example: A topical anti-acne composition combining specific extracts in defined ratios shows inventive step because, although individual ingredients are known, the exact combination and ratios produce a synergistic effect proven by experimental data, making it non-obvious over prior art.

Note: Synergism occurs when the combined effect of ingredients exceeds the sum of their individual effects.

 Guiding Principle 3: If an ingredient is already known for treating a disease, combining it with others is generally considered obvious. Non-obviousness can be established only if the combination produces an unexpected technical effect.

Example: A combination of two constituents of Cucumis melo with Citrus aurantifolia for vitiligo is considered obvious since Cucumis melo alone is already known for this use. Without a surprising or superior effect, inventive step cannot be recognized.

Example: A combination of Maghz-e-Karanjwa, Gaozaban, and Kasni for worm infestation and anemia shows unexpected synergistic effects. This data supports inventive step, distinguishing it from traditional knowledge.

 Guiding Principle 4: Finding a range of traditionally known ingredients in which it shows its best results by regular experiments is not inventive as it is within the knowledge of person skilled in the art.

Example: A formulation combining extracts of Pongamia pinnata, Lawsonia alba, Dhatura alba, and Cocos nucifera for ulcers and wound management is considered obvious, as prior TK already teaches similar plant combinations. Specified ingredient ratios are seen as routine optimizations by a skilled person and do not establish inventiveness.

 Guiding Principle 5: As per TK, if multiple ingredients are known to exhibit similar therapeutic activity, taking one component out of them cannot be considered inventive.

Example: A claim for Zingiber zerumbet extract for inflammation and asthma is considered obvious, as prior TK already uses it in multi-ingredient formulations for the same purposes. Isolating it as a single component would be expected, lacking inventive step.

 Guiding Principle 6: If invention is AYUSH system-based device / equipment, it is patentable, if it is novel and inventive.

Example: A claim for an automated device for Therapeutic Emesis (Vamana Karma) with sensors for pH, temperature, and volume is patentable, as prior Ayurveda texts describe the procedure but do not disclose such a device or method for hygienic, sensor-based execution.

Conclusion:

In summary, AYUSH patent applications are evaluated for novelty, inventiveness, and practical use. While known traditional ingredients limit patentability, new processes, synergistic combinations, or innovative devices can be patented. Compliance with biological material laws is mandatory, and inventive contributions beyond existing traditional knowledge are eligible for protection.