A familiar question arises whenever a herbal product takes off, “Our tonic is inspired by Ayurveda, but refined in the lab. Can we patent it?” Indian headlines and courtrooms have repeatedly shown why the answer depends on precise law and evidence. The famous turmeric and neem disputes, where patents abroad were struck down using Indian traditional knowledge, illustrate how quickly claims fall if the subject is already known. The USPTO revoked the turmeric wound-healing patent in 1997 after CSIR’s re-examination proved prior traditional use, and the EPO revoked a neem fungicide patent in 2005. These episodes are exactly why India built the Traditional Knowledge Digital Library, which patent offices search to block claims on age-old knowledge.
Closer home, the Madras High Court in 2024 dealt with a “panchagavya” lamp application. The Court held that combining traditionally known ingredients and relying on their known properties falls within Section 3(p)’s bar on patenting traditional knowledge. Merely aggregating known effects is not enough.
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.
Courts have started clarifying the test. In Zero Brand Zone Pvt Ltd v Controller of Patents (Madras HC, 5 July 2024), the Court said Section 3(p) gives defensive protection to TK, and claims stay out unless the product or process cannot be described, in effect, as TK. The panchagavya lamp failed because the claimed effects traced back to known properties of traditional components.
Section 3(e): mere admixtures without synergy are out
Another frequent hurdle for herbal compositions is Section 3(e), which bars patents on mere admixtures that only aggregate each component’s properties. To cross this bar, examination guidelines expect synergistic data showing a combined technical effect greater than the sum of parts. Plan comparative experiments, robust statistics, and clear claim drafting.
Section 3(i): no patents for methods of treatment
Claims to “a method of treating disease X with formulation Y” are excluded. Focus on product claims for compositions or dosage forms, not treatment methods.
Disclosure of biological material and origin, and NBA approvals
If your invention uses biological material, your specification must disclose the source and geographical origin. This is a statutory requirement under Section 10(4)(D). IP India
Separately, India’s Biological Diversity (Amendment) Act, 2023 regulates access and benefit-sharing for Indian biological resources and associated knowledge. Section 6 requires NBA approval before patent grant when an invention uses Indian biological resources or associated knowledge. Parliament amended the Act in 2023 to streamline compliance, and in April 2025 the NBA notified new regulations refining ABS calculations and timelines. Reports note a lighter regime for codified traditional knowledge, cultivated medicinal plants, and AYUSH practitioners in specific scenarios, but you must check the operative notifications for your exact use case.
Practical rule of thumb, plan to disclose origin under the Patents Act, and, where your R&D accessed Indian biological resources or associated knowledge, plan for NBA compliance well before grant.
TKDL’s real-world impact
The Traditional Knowledge Digital Library gives examiners structured access to Ayurveda, Unani, Siddha, and Sowa-Rigpa formulations. Patent offices worldwide search TKDL under access agreements, which means claims “rediscovering” known formulations are likely to be cited and refused.
When can a herbal formulation still be patented?
You need to move beyond traditional knowledge and mere admixture. In practice, patentees succeed when they can show all of the following:
Novelty and inventive step: the specific composition, structure, or process was not disclosed or obvious from classical texts or modern literature.
Synergy for Section 3(e): credible data that the combination delivers a technical effect exceeding the sum of parts, not just a re-statement of therapeutic benefits. IPO guidelines expect such proof.
Proper claim form: a product claim for a medicament, nutraceutical, extract standardised by defined markers, or a novel delivery system, rather than a treatment method barred by 3(i).
Enhanced efficacy only where relevant: if you claim a new form of a known substance, the Supreme Court in Novartis v Union of India requires therapeutic efficacy evidence under Section 3(d). Do not confuse this with synergy under 3(e), they are different tests.
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 ratios of known ingredients that deliver their known effects is still “in effect” TK under Section 3(p). You will need novelty and non-obviousness plus synergy if 3(e) is invoked.
2. “Can I claim ‘use of herb X to treat Y’?”
No, claims drafted as treatment methods fall afoul of Section 3(i). Consider composition claims, or in some cases, manufacturing processes that are genuinely novel and inventive.
3. “Do I need NBA approval to get my patent granted?”
If your invention uses Indian biological resources or associated knowledge, yes, Section 6 of the Biological Diversity Act requires NBA approval before grant. The 2023 amendment and 2025 regulations recalibrate ABS and carve out narrower exemptions, including for codified TK and certain cultivated plants, but these are fact-specific. Factor NBA timelines into your prosecution plan.
4. “Will TKDL automatically block me?”
Examiners in India and partner offices do search TKDL. If your claims read on published traditional formulations or their obvious variants, expect a novelty or obviousness objection, or a 3(p) bar. Build a prior-art map early to see if you are really adding something non-obvious.
An applicant’s mini-checklist for herbal patents in India
Screen Section 3 early: 3(p) for TK, 3(e) for mere admixture, 3(i) for methods of treatment, 3(j) for plants or parts as such. Draft around these from day one.
Plan synergy studies: design experiments and statistics that show combined technical effect, not just higher dosage or marketing claims. Tie endpoints to the claim.
Standardise and define: specify marker compounds, ranges, particle size, release profiles, or process parameters that distinguish your product.
Document origin: disclose source and geographical origin of any biological material in the specification, and prepare the NBA route where applicable.
Anticipate TKDL: chart classical texts and TKDL-like references that an examiner may cite. If you truly depart from TK, make that departure obvious in your claims and data.
Quick table: law, cases, and what you should do
Why turmeric and neem still matter
They remind applicants that fame in the marketplace is not the same as patentability. The turmeric and neem reversals abroad happened because traditional use was documented, then surfaced during examination or challenge. TKDL institutionalises that defence by giving examiners direct access to codified knowledge. If your innovation is truly new, your file must show how and why it is not “in effect” TK, and why its technical effect is more than the sum of parts.
The bottom line
You cannot patent traditional knowledge itself in India. You can patent a herbal formulation only when it is novel, non-obvious over classical sources, not a mere admixture, and claimed in a product form that avoids Section 3(i), with robust synergy data and proper disclosures. Keep an eye on biodiversity approvals and the evolving ABS rules. The jurisprudence, from Novartis on enhanced efficacy to the panchagavya decision on traditional knowledge, rewards careful science and careful drafting, not repackaging of the old.
If you are unsure whether your concept crosses the Section 3 thresholds, begin with a TKDL-style prior art sweep, design synergy studies, and shape claims to the technical effect you can prove. That is how herbal innovations make the cut under Indian patent law.
