Introduction
The decision in Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs is a significant addition to Indian patent jurisprudence dealing with traditional knowledge-based inventions. The judgement addresses important questions regarding the patentability of herbal formulations, the scope of inventive step in traditional medicine, the evidentiary value of post-filing experimental data, and the relationship between the Patents Act, 1970, and the Biological Diversity Act, 2002.
The ruling is particularly relevant for the following:
- Innovators
- Pharmaceutical companies
- Herbal medicine manufacturers
- Patent professionals
- Researchers seeking patent protection for formulations derived from traditional knowledge
The judgement reinforces the principle that merely combining known traditional ingredients and optimising their proportions does not automatically qualify for patent protection unless genuine technical advancement and inventive ingenuity are demonstrated.
Factual and Procedural Background
The appellant, Shaafi Naturcure LLP, filed Indian Patent Application No. 201911048481 on 27 November 2019 for an invention titled “A Herbal Powder Composition for the Treatment of Asthma”. The claimed invention related to a herbal formulation comprising six ingredients, namely:
- Tephrosia Purpurea
- Cuscuta Reflexa
- Morinda Citrifolia
- Terminalia Arjuna
- Piper Longum
- Piper Nigrum
Following examination, a first examination report was issued on 1 January 2020 raising objections under Sections 2(1)(j), 3(p), 10(4)(a), and 10(4)(b) of the Patents Act, 1970. The applicant submitted a response along with amended claims and subsequently participated in a hearing before the Patent Office.
The patent controller eventually rejected the application on 16 September 2020. The controller concluded that the claimed invention:
- Lacked novelty.
- Lacked inventive step.
- Represented an aggregation of traditional knowledge.
- Failed to sufficiently disclose the invention and its best method of performance.
Aggrieved by the refusal, the appellant preferred an appeal before the Delhi High Court under Section 117A of the Patents Act.
During the appellate proceedings, the appellant relied extensively on an inventor’s affidavit and supporting materials, claiming that the composition:
- Exhibited synergistic effects.
- Treated five categories of asthma.
- Had been tested on approximately 300 individuals with positive results.
The respondent defended the rejection order and argued that the additional material could not cure deficiencies in the original specification.
Timeline of Events
| Date | Event |
|---|---|
| 27 November 2019 | Indian Patent Application No. 201911048481 filed. |
| 1 January 2020 | The first examination report was issued, raising objections under the Patents Act, 1970. |
| 16 September 2020 | The patent controller rejected the application. |
| Thereafter | Appeal filed before the Delhi High Court under Section 117A of the Patents Act. |
Dispute Before the Court
The principal dispute before the Court concerned whether the claimed herbal composition satisfied the requirements of patentability under Indian law.
Appellant’s Contentions
The appellant contended that the invention involved a unique selection of six herbs from a large pool of medicinal plants traditionally associated with respiratory disorders. According to the appellant, the inventive contribution lay in identifying specific proportions of the ingredients which allegedly produced superior therapeutic results.
The appellant further argued that the following:
- The invention demonstrated unexpected synergy.
- The Patent Controller failed to properly appreciate the inventor’s affidavit and supporting data.
- Approval obtained from the National Biodiversity Authority under the Biological Diversity Act supported the patentability of the invention.
Respondent’s Contentions
The respondent argued that each of the six ingredients was already known in traditional medicine for treatment of asthma or related respiratory conditions.
The respondent further contended the following:
- The claimed invention merely combined known traditional ingredients.
- The formulation represented routine experimentation rather than genuine innovation.
- The affidavit sought to introduce entirely new technical features and claims that were absent from the original specification and therefore could not be considered.
Summary of the Core Dispute
| Issue | Appellant’s Position | Respondent’s Position |
|---|---|---|
| Selection of Ingredients | Unique selection of six herbs. | Ingredients already known in traditional medicine. |
| Inventive Step | Specific proportions created superior therapeutic results. | Only routine experimentation without innovation. |
| Synergistic Effect | Unexpected synergy demonstrated. | Not supported by the original specification. |
| Inventor’s Affidavit | Should be considered as supporting evidence. | Cannot cure deficiencies in the original patent specification. |
| Biological Diversity Act Approval | Supports patentability. | Does not establish patentability under the Patents Act. |
Reasoning and Analysis of the Court
The Court first examined the argument based on the Biological Diversity Act, 2002. The appellant argued that once approval had been obtained from the National Biodiversity Authority, the objection under Section 3(p) of the Patents Act should no longer survive.
The Court rejected this contention. It held that the Biological Diversity Act and the Patents Act operate in distinct spheres. The Biological Diversity Act primarily regulates access to biological resources, conservation of biodiversity, and equitable sharing of benefits arising from utilisation of biological resources. It does not authorise the National Biodiversity Authority to assess patentability.
The Court observed that approval under the Biological Diversity Act is merely a regulatory requirement and has no bearing on whether an invention satisfies the patentability standards under the Patents Act.
Analysis of the Inventor’s Affidavit
The Court then examined the inventor’s affidavit. The affidavit asserted that the invention could cure five categories of asthma and contained extensive data regarding efficacy and side effects. However, the Court found that these claims were absent from the complete specification originally filed before the Patent Office.
The Court noted that the specification did not disclose any classification of asthma into five categories, nor did it contain supporting evidence for such classification. Consequently, these assertions could not be considered during patent examination or appeal.
The Court also found significant inconsistencies between the specification and the affidavit. While the affidavit claimed that altering ingredient ratios could lead to adverse side effects, the original specification contained no such disclosure. More importantly, one formulation disclosed in the affidavit fell within the claimed ranges yet allegedly produced undesirable effects, undermining the applicant’s own assertions regarding efficacy and synergy.
Post-Filing Evidence and Technical Effect
The Court relied extensively on AstraZeneca AB & Anr. v. Alkem Laboratories Limited, CS (COMM) 410/2020, decided on 02.11.2020, which in turn referred to Generics (UK) Ltd. v. Yeda Research and Development Company Ltd., (2017) EWHC 2629 (Pat.). The Court reiterated the principle that post-filing evidence may only confirm a technical effect already disclosed or reasonably inferable from the specification. Such evidence cannot be used to establish a technical effect for the first time.
Applying this principle, the Court held that the affidavit attempted to introduce new technical effects and supporting data that were not disclosed in the original specification and therefore could not be relied upon.
Court Findings on Synergy and Examples
The court further scrutinised the examples contained in the specification itself. It found that certain examples demonstrated significant relief from asthma even when only four ingredients were used. This directly contradicted the applicant’s claim that the specific six-ingredient combination produced the alleged synergistic effect.
As a result, the Court concluded that the alleged synergy was not established.
Prior Art Analysis
The Court also analysed the prior art documents cited by the Patent Office. These references demonstrated that each of the six herbal ingredients had already been traditionally used for asthma, bronchitis, cough, or related respiratory ailments. The Court therefore concluded that the claimed formulation did not demonstrate any meaningful technical advancement over the existing state of knowledge.
Application of Section 3(p) of the Patents Act
The Court then considered Section 3(p) of the Patents Act, which excludes inventions that are essentially traditional knowledge or an aggregation of known properties of traditionally known components.
Particular reliance was placed on the Guidelines for Processing Patent Applications Relating to Traditional Knowledge and Biological Material, 2012. The Court referred to Guiding Principle 2, which treats combinations of plants already known for treatment of the same disease as obvious combinations. The Court also relied on Guiding Principle 4, which states that discovering optimum ranges of traditionally known ingredients through routine experimentation is not inventive.
Applying these principles, the Court held that the invention was essentially a combination of herbs already known for treating asthma and therefore fell squarely within the exclusion under Section 3(p).
Disclosure Requirements Under Section 10
The Court further held that the specification failed to fully and particularly describe the invention and failed to disclose the best method of performing it, thereby attracting objections under Sections 10(4)(a) and 10(4)(b).
Final Decision of the Court
The Court dismissed the appeal and upheld the order of the Assistant Controller of Patents and Designs refusing Patent Application No. 201911048481.
The Court concluded that the claimed invention lacked novelty and inventive step under Sections 2(1)(j) and 2(1)(ja) of the Patents Act. It further held that the invention constituted an aggregation of traditionally known ingredients and was therefore barred by Section 3(p).
The Court also held that the complete specification failed to satisfy the disclosure requirements under Sections 10(4)(a) and 10(4)(b).
Consequently, the refusal order was affirmed, and the appeal was dismissed without costs.
Summary of the Final Ruling
| Issue | Court’s Finding |
|---|---|
| Biological Diversity Act Approval | Does not establish patentability under the Patents Act. |
| Novelty | Not established. |
| Inventive Step | Not established. |
| Section 3(p) | The invention is held to be an aggregation of traditionally known ingredients. |
| Section 10(4)(a) & 10(4) (b) | Complete specification failed to meet disclosure requirements. |
| Appeal | Dismissed. |
Point of Law Settled
The judgement reinforces several important principles of Indian patent law.
- First, approval obtained under the Biological Diversity Act does not establish patentability and cannot override objections under the Patents Act.
- Second, post-filing experimental data may only corroborate a technical effect already disclosed in the patent specification. Such evidence cannot be used to introduce new technical features or establish an inventive step for the first time.
- Third, combining multiple traditionally known ingredients already recognised for the treatment of the same disease is ordinarily regarded as an obvious combination and may fall within the exclusion under Section 3(p).
- Fourth, routine optimisation of proportions or ranges of known traditional ingredients does not constitute an inventive step unless genuine technical advancement or unexpected results are clearly demonstrated.
- Finally, patent specifications must independently disclose the invention, its technical contribution, and the best method of performing it. Deficiencies in disclosure cannot be cured through later affidavits or supplementary evidence.
Key Legal Principles at a Glance
| Legal Principle | Court’s Position |
|---|---|
| Biological Diversity Act Approval | Regulatory approval only; does not determine patentability. |
| Post-Filing Evidence | Can only support an already disclosed technical effect. |
| Traditional Knowledge | Known herbal combinations for the same disease may be barred under Section 3(p). |
| Routine Optimization | Not considered an inventive step without unexpected technical advancement. |
| Patent Specification | Must independently disclose the invention and best method of performance. |
Case Details
| Title of the Case | Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs |
|---|---|
| Date of Judgment/Order | 22.06.2026 |
| Case Number | C.A. (COMM.IPD-PAT) 109/2022 |
| Neutral Citation | 2026:DHC:5157 |
| Name of Court | Delhi High Court |
| Name of the Honourable Judge | Tushar Rao Gedela |
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi.
Disclaimer: Images used herein do not reflect actual images used in the judgement, and the same are for illustrative purposes only. Readers are advised not to treat this as a substitute for legal advice, as it may contain errors in perception, interpretation, and presentation.
