A familiar question arises whenever a herbal product starts to gain traction: "Our tonic is inspired by Ayurveda, but refined in the lab. Can we patent it?" Indian courtrooms, and a few well-known international disputes before them, have repeatedly shown that the answer depends on precise law and solid evidence, not on how novel the product feels in the market. The turmeric and neem disputes, where patents granted abroad were struck down using Indian traditional knowledge, illustrate how quickly a claim can fall once the underlying subject matter is shown to already be known. The USPTO revoked a turmeric wound-healing patent in 1997 after CSIR's re-examination proved prior traditional use, and the European Patent Office revoked a neem-based fungicide patent in 2005. These episodes are part of why India built the Traditional Knowledge Digital Library, which patent offices around the world now search to screen out claims on age-old knowledge before they are ever granted.
Closer to home, the Madras High Court dealt with this question directly in 2024, in a dispute concerning a "panchagavya" lamp application. The Court held that combining traditionally known ingredients and relying on their already-known properties falls squarely within Section 3(p)'s bar on patenting traditional knowledge. Merely aggregating known effects, however cleverly packaged, is not enough to cross the threshold into patentability.
What Indian Law Actually Says, in Plain Terms
Section 3(p): Traditional Knowledge Cannot Be Patented
The Patents Act explicitly excludes "an invention which, in effect, is traditional knowledge or an aggregation or duplication of known properties of traditionally known components." If your formulation is, in substance, a codified remedy or a routine mix of known ingredients doing what they have always done, it is not an invention under Indian law, regardless of how it is marketed or how much research went into confirming what traditional practitioners already knew.
Courts have started clarifying exactly how this test is applied. In Zero Brand Zone Pvt Ltd v. Controller of Patents (Madras High Court, 5 July 2024), the Court held that Section 3(p) gives defensive protection to traditional knowledge, and that claims stay excluded unless the product or process cannot be described, in effect, as traditional knowledge. The panchagavya lamp application failed because the claimed effects traced directly back to the known properties of its traditional components, with no genuine technical departure shown.
Section 3(e): Mere Admixtures Without Synergy Are Excluded
Another frequent hurdle for herbal compositions is Section 3(e), which bars patents on mere admixtures that simply aggregate each component's individual properties without producing anything more. To cross this bar, the Patent Office's examination guidelines expect synergistic data: evidence showing a combined technical effect that is genuinely greater than the sum of the individual components' known effects. This is not a formality. It means planning comparative experiments, gathering robust statistics, and drafting claims that are anchored to the demonstrated synergy, not merely to a list of ingredients and their traditional benefits restated in modern language.
Section 3(i): No Patents for Methods of Treatment
Claims framed as "a method of treating disease X with formulation Y" are excluded outright under Section 3(i). Applicants working in this space need to focus their claim strategy on product claims, covering compositions, dosage forms, or standardised extracts, rather than on treatment methods, which face an absolute statutory bar regardless of how inventive the underlying research might be.
Disclosure of Biological Material and Origin, and NBA Approvals
If your invention uses biological material, your complete specification must disclose the source and geographical origin of that material. This is a statutory requirement under Section 10(4)(D) of the Patents Act, and it applies regardless of whether the material itself is common or rare.
Separately, and often overlooked until late in the process, India's Biological Diversity (Amendment) Act, 2023 regulates access and benefit-sharing for Indian biological resources and any associated traditional knowledge. Section 6 of the Biological Diversity Act requires National Biodiversity Authority (NBA) approval before patent grant whenever an invention uses Indian biological resources or associated knowledge. Parliament amended the Act in 2023 specifically to streamline this compliance process, and in April 2025 the NBA notified new regulations refining how access and benefit-sharing calculations and timelines actually work in practice. Some reports suggest a lighter compliance regime for codified traditional knowledge, cultivated medicinal plants, and certain AYUSH practitioner scenarios, but these carve-outs are fact-specific, and applicants should check the operative notifications against their exact use case rather than assuming an exemption applies.
The practical rule of thumb is straightforward: plan to disclose origin under the Patents Act as a matter of course, and wherever your R&D accessed Indian biological resources or associated traditional knowledge, plan for NBA compliance well before you expect grant, since this approval sits on the critical path and cannot be rushed at the last moment.
TKDL's Real-World Impact on Examination
The Traditional Knowledge Digital Library gives patent examiners structured, searchable access to Ayurveda, Unani, Siddha, and Sowa-Rigpa formulations drawn from classical texts. Patent offices worldwide search TKDL under formal access agreements, which means claims that effectively "rediscover" a known formulation are very likely to be cited against the application and refused, often at a fairly early stage of examination. For applicants, this means TKDL functions less like a passive archive and more like an active, standing prior art search that will run against your application whether you have prepared for it or not.
When Can a Herbal Formulation Still Be Patented?
Genuine patentability requires moving clearly beyond both traditional knowledge and mere admixture. In practice, applicants succeed when they can demonstrate all of the following together, not just one in isolation:
- Novelty and inventive step. The specific composition, structure, or process was not disclosed, and would not have been obvious, from classical texts or from modern scientific literature.
- Synergy for Section 3(e). Credible experimental data showing the combination delivers a technical effect exceeding the sum of its parts, rather than a re-statement of already-known therapeutic benefits attributed to each ingredient individually. Patent Office guidelines specifically expect this kind of proof, not a general assertion of improved wellness.
- Proper claim form. A product claim covering a medicament, a nutraceutical, an extract standardised by defined chemical markers, or a genuinely novel delivery system, rather than a treatment method that would be barred outright under Section 3(i).
- Enhanced efficacy, only where it is actually relevant. If you are claiming a new form of an already-known substance, the Supreme Court's decision in Novartis v. Union of India requires evidence of enhanced therapeutic efficacy under Section 3(d). This is a distinct legal test from the synergy requirement under Section 3(e), and the two should not be conflated in either your drafting or your experimental design.
A Quick Reference Table
| Topic | Indian Position | Leading Signal | What You Should Do |
|---|---|---|---|
| Traditional knowledge | Section 3(p) bars TK and aggregation of known properties | Zero Brand Zone v. Controller (Madras HC, 2024): combining known TK ingredients for known effects falls under 3(p) | If your concept sits within classical texts, rethink the claim toward a genuine technical departure |
| Mere admixture | Section 3(e) excludes non-synergistic mixes | Patent Office pharma examination guidelines demand synergy data | Run comparative studies and claim the demonstrated technical effect, not just the list of herbs used |
| Methods of treatment | Section 3(i) excludes treatment methods outright | Statutory bar, no exceptions for herbal subject matter | Use product claims, dosage forms, or genuinely novel processes, never "a method of treating X" |
| Biological material and ABS | Section 10(4)(D) disclosure, plus Biological Diversity Act approval before grant | 2023 Amendment and 2025 ABS regulations refine compliance | Disclose origin in the specification and plan NBA engagement early wherever your R&D accessed Indian resources or associated TK |
| TK as prior art | TKDL is used by examiners worldwide under access agreements | TKDL portal documentation on access agreements | Expect TKDL citations during examination, and draft your claims and evidence around them from the outset |
Frequently Asked Questions
1. If I tweak proportions from a classical recipe, is that patentable?
Not by itself. The Madras High Court's panchagavya decision shows that simply altering the ratios of known ingredients, where those ingredients still deliver their already-known effects, remains "in effect" traditional knowledge under Section 3(p). To move past this bar, you need genuine novelty and non-obviousness, and where Section 3(e) is invoked, credible synergy data as well.
2. Can I claim "use of herb X to treat disease Y"?
No. Claims drafted in that form fall directly afoul of Section 3(i)'s bar on methods of treatment. Consider composition claims instead, or in some cases, manufacturing process claims, provided the process itself is genuinely novel and inventive rather than a routine extraction or formulation step.
3. Do I need NBA approval to get my patent granted?
If your invention uses Indian biological resources or associated traditional knowledge, yes, Section 6 of the Biological Diversity Act requires NBA approval before grant. The 2023 amendment and the 2025 regulations have recalibrated the access and benefit-sharing framework and carved out narrower exemptions, including for codified traditional knowledge and certain cultivated plants, but these exemptions are fact-specific, and NBA timelines should be built into your overall prosecution plan from the beginning rather than addressed reactively.
4. Will TKDL automatically block my application?
Not automatically, but examiners in India and in partner offices abroad do actively search it. If your claims read on published traditional formulations, or on obvious variants of them, expect a novelty or obviousness objection, or a direct Section 3(p) bar. Building a prior-art map early, informed by what TKDL is likely to surface, lets you see clearly whether you are genuinely adding something non-obvious before you commit to a full filing.
5. Does standardising an extract by its active markers help with patentability?
It can, provided the standardisation itself, or the resulting product's properties, represent a genuine technical advance over what was previously known or obvious. Simply identifying and naming the active markers already present in a well-known traditional preparation, without more, is unlikely to satisfy novelty or inventive step on its own.
6. Is there a difference between the Section 3(d) efficacy requirement and the Section 3(e) synergy requirement?
Yes, and conflating them is a common and costly mistake. Section 3(d) applies specifically to new forms of known substances and asks whether therapeutic efficacy has been enhanced, following the Supreme Court's reasoning in Novartis. Section 3(e) applies to combinations and admixtures and asks whether the combination produces a technical effect greater than the sum of its parts. A formulation might need to satisfy one, the other, or both, depending on exactly how it is claimed, so each claim should be checked against both tests separately rather than assuming one covers the other.
Why Turmeric and Neem Still Matter
These two cases are cited so often for a reason: they remind applicants that fame or commercial success in the marketplace is not the same thing as patentability. The turmeric and neem reversals abroad happened because traditional use had been well documented, and that documentation surfaced during examination or a subsequent challenge, undoing patents that had already been granted. TKDL institutionalises exactly this defence, giving examiners direct, searchable access to codified traditional knowledge at the examination stage itself, rather than leaving the discovery to chance or a post-grant challenge. If your innovation is genuinely new, your filing needs to show clearly, with data, how and why it is not "in effect" traditional knowledge, and why its technical effect is demonstrably more than the sum of its known parts.
An Applicant's Checklist for Herbal Patents in India
- Screen Section 3 early. Check 3(p) for traditional knowledge, 3(e) for mere admixture, 3(i) for methods of treatment, and 3(j) for plants or plant parts as such. Draft around these exclusions from day one, not as an afterthought during prosecution.
- Plan synergy studies deliberately. Design experiments and statistical analysis that demonstrate a genuine combined technical effect, not simply a higher dosage or a repackaged marketing claim. Tie your experimental endpoints directly to the language of your claims.
- Standardise and define precisely. Specify marker compounds, concentration ranges, particle size, release profiles, or process parameters that meaningfully distinguish your product from what came before.
- Document origin carefully. Disclose the source and geographical origin of any biological material in the specification as required, and prepare the NBA compliance route well in advance wherever it applies to your R&D.
- Anticipate TKDL citations. Chart the classical texts and TKDL-type references an examiner is likely to cite against your application. If your invention genuinely departs from traditional knowledge, make that departure explicit and well-evidenced in both your claims and your data.
You cannot patent traditional knowledge itself in India, however it is repackaged or refined. You can patent a herbal formulation, but only when it is novel and non-obvious over classical sources, is not a mere admixture under Section 3(e), and is claimed in a product form that avoids the Section 3(i) bar on treatment methods, all supported by robust synergy data and proper regulatory disclosures. Keep a close eye on biodiversity approvals and the evolving access and benefit-sharing rules throughout your filing timeline, not just at the final stage. The jurisprudence in this space, from Novartis on enhanced efficacy to the panchagavya decision on traditional knowledge, consistently rewards careful science and careful drafting, not the repackaging of what has already long been known.
If you are genuinely unsure whether your concept crosses the Section 3 thresholds, the sensible starting point is a TKDL-style prior art sweep, followed by properly designed synergy studies, with claims shaped tightly around the specific technical effect you can actually prove. That combination, more than any single clever claim, is how herbal innovations make the cut under Indian patent law.
This article is for general informational purposes and reflects the author's understanding of the Indian Patents Act, 1970, the Biological Diversity (Amendment) Act, 2023, and related judicial decisions. It is not a substitute for specific legal advice on your own formulation or filing strategy.
