Ayush explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
The first three guiding principles in the Ayush Guidelines deal with the most common claims an examiner sees in this field: an extract or isolated compound of a plant already used in Ayush texts, a combination of known ingredients, and a combination that includes one known ingredient. Each principle states what the examiner will presume and what the applicant can show to answer it.
The Guidelines are the Patent Office's guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as now in force prevail. The Office revises its guidelines, so check the current version on ipindia.gov.in. For the scope of the Guidelines and the disclosure rules, see the first article in this series.
If the use of a plant is known in Ayush literature, a claim to its extract or to an isolated active ingredient is treated as not novel or not inventive, but a process of obtaining it may still be patentable. A combination of known ingredients for the same disease is presumed obvious, and so is a combination that includes one known ingredient. The way out in each case is an unexpected technical effect, such as true synergy, shown by data.
Principle 1: extracts and isolated active ingredients
The Guidelines say that claims to extracts, alkaloids or isolated active ingredients that are naturally or inherently present in plants cannot be novel or inventive when the use of the plant is known in the prior art. They explain it in two steps:
- A product claim to an extract with undefined active ingredients is not novel if the use of that plant or part is published in the Ayush systems.
- A claim to a characterised alkaloid or active principle may be novel if its structure is not in the prior art, but it lacks inventive step if no real human intellect is involved beyond the reported use. The prior art, in the Guidelines' view, motivates a skilled person to isolate individual ingredients such as alkaloids, flavonoids and phytosteroids.
- A process for obtaining an extract or isolate may be patentable, subject to the normal tests.
The Guidelines give three illustrations, summarised here in our own words. In the first, an aqueous extract of a plant used in Ayurvedic and Unani texts for stress disorders is objected to as not novel, since the texts already show that use. In the second, a glycoside isolated from chamomile is novel as a compound but obvious, since chamomile was already used for the same conditions and the prior art motivates its isolation; the Guidelines add that an isolation process, if claimed, could still be patentable. In the third, a process for extracting a compound from leaves, where the prior art used the stem, may be patentable because it gives a markedly higher yield and purity at low temperature with fewer chemicals.
What this means in practice is that the strongest claim in an extract case is often the method, supported by comparative yield and purity data, not the extract itself. If you are shaping such claims, our patent objection reply service can organise the data and amendments for a first examination reply.
Principle 2: combinations of known ingredients
The Guidelines say that if a combination of ingredients from plant, mineral or animal origin, or existing formulations, is already known for a disease as part of traditional knowledge, then a combination that adds further ingredients with the same known therapeutic effect would obviously be more effective than each alone, an additive effect. They add that specific ratios leading to an unexpected technical effect may establish non-obviousness.
Two illustrations show the line:
- A healing composition of three plants, each independently known in Ayurveda and Unani for wound treatment, is an obvious combination; it would be expected to work better together. Unexpected synergy might change that.
- A topical anti-acne composition of several named plant extracts in specified amounts is held to be inventive. The prior art disclosed the ingredients for skin disorders but not the exact combination in the claimed ratio, and the application contained synergistic data.
The Guidelines include a note defining synergism as a combined effect greater than the sum of the individual effects, and say experimental results must prove it. They point to an annexure with a brief on synergism and illustrations of synergistic data. An applicant should therefore plan the experimental design before filing, with each ingredient alone and the combination in the claimed ratio, so that the comparison is on the file.
Principle 3: a combination with one known ingredient
Where an ingredient is already known for a disease, the Guidelines say a presumption of obviousness arises that a combination containing it would be effective for the same disease, unless an unexpected technical effect is shown. In the first illustration, a two-constituent combination for vitiligo is objected to because one constituent was already known for vitiligo, and inventive step cannot be acknowledged without an unexpected effect against the known product. In the second, a three-constituent combination for worm infestation and anaemia, where one constituent was known only for worm infestation, may be considered inventive because data showed an unexpected and synergistic effect against both conditions.
What the examiner checks, what you show
| What the examiner asks | What the applicant shows | Principle |
|---|---|---|
| Is the plant's use already in the Ayush literature? | A feature that the literature does not disclose | 1 |
| Is the claim an undefined extract? | Characterised constituents, or a process claim | 1 |
| Is the compound merely isolated from a known plant? | Human intellect beyond isolation, or a new process with data | 1 |
| Are all ingredients known for the same disease? | A specific ratio with an unexpected effect | 2 |
| Is one ingredient known for the disease? | Unexpected technical effect against the known product | 3 |
| Is the synergy real? | Data showing the combined effect exceeds the sum of the parts | 2, 3 |
A worked example
Vanya Naturals Pvt Ltd files for a tablet combining turmeric extract and a second plant extract for joint comfort. The examiner objects that both plants are known in Ayurvedic texts for joint disorders, so the combination is obvious and an additive effect is expected. Vanya replies with test data comparing each extract alone and the pair at the claimed ratio, showing a combined effect greater than the sum, and it narrows the claim to that ratio. It also adds a claim to its extraction process with yield and purity figures from its own laboratory.
Common lapses
- Claiming a crude extract as if it were a new product.
- Presenting a combination without a single-ingredient comparison.
- Claiming a broad range of ratios when the data supports one.
- Asserting synergy in words with no experimental evidence.
- Leaving out a process claim that is stronger than the product claim.
Need help with a herbal or Ayush reply?
Examination replies in this field turn on data and claim drafting. If you have received an objection on an extract or combination, our patent objection reply team can help with the evidence plan and the amended claims.
Key takeaways
- A known plant use in Ayush texts defeats novelty or inventive step for its extract or isolate.
- A process for obtaining the extract or isolate may still be patentable.
- Combinations of known ingredients are presumed obvious, as are combinations containing one known ingredient.
- Unexpected technical effect, such as true synergy shown by data, rebuts the presumption.
- The Guidelines are not exhaustive and each application is judged on its merits.
Read next
- Ayush Guidelines 2025: scope, provisions and filing
- Ayush Guidelines 2025: guiding principles 4 to 6
- TK Guidelines 2012: novelty and inventive step, the six principles
- Responding to a first examination report
Disclaimer: Based on the manuals and guidelines published by the Office of the Controller General of Patents, Designs and Trade Marks that are named in the article, as consulted on 4 October 2026. They are guidance and do not have the force of law; the Patents Act, 1970 and the Patents Rules, 2003 as amended (including the 2024 amendment rules) prevail, and the current versions on ipindia.gov.in should be checked. This article is general information, not legal advice; check the official text before acting.