Brief Legal News Write-Up
Shaafi Naturcure LLP Vs Assistant Controller of Patents and Designs:22.06.2026 : C.A.(COMM.IPD-PAT) 109/2022 : 2026:DHC:5157:Tushar Rao Gedela
The Court considered a dispute concerning the patentability of a herbal powder composition claimed to be useful for the treatment of asthma. The case arose from allegations that the Patent Controller had wrongly refused Patent Application No. 201911048481 titled “A Herbal Powder Composition for the Treatment of Asthma” on the grounds of lack of invention, absence of inventive step, traditional knowledge exclusion, and insufficient disclosure under the Patents Act, 1970.
The principal question before the Court was whether a composition comprising six herbs allegedly capable of treating asthma constituted a patentable invention and whether post-filing evidence could be relied upon to establish inventive step and technical advancement.
After examining the material on record and the submissions of the parties, court observed that all six ingredients forming part of the claimed composition were already known in traditional medicine for treatment of asthma and related respiratory ailments. The Court further found that the applicant's attempt to establish novelty, synergy, efficacy, and treatment of five types of asthma through an affidavit and additional data was unsupported by the original specification and therefore could not be relied upon.
The Court held that post-filing evidence cannot be used to establish a technical effect for the first time and can only confirm an effect already disclosed or embedded in the patent specification. The Court emphasized that a combination of traditionally known ingredients for the same therapeutic purpose, coupled with routine optimization of proportions, falls within the exclusion contained in Section 3(p) of the Patents Act.
Accordingly, the Court dismissed the appeal and upheld the refusal of the patent application, holding that the invention lacked novelty and inventive step, constituted an aggregation of traditional knowledge, and failed to satisfy the disclosure requirements under Sections 10(4)(a) and 10(4)(b) of the Patents Act.
Disclaimer: Readers are advised not treat this as a substitute for legal advise as it is based on limited information and is intended solely for general informational purposes.
Comprehensive Analytical Legal Article
Biological Diversity Act and the Patents Act operate in distinct spheres
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 judgment 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 innovators, pharmaceutical companies, herbal medicine manufacturers, patent professionals, and researchers seeking patent protection for formulations derived from traditional knowledge. The judgment reinforces the principle that merely combining known traditional ingredients and optimizing 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, and 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 and inventive step, represented an aggregation of traditional knowledge, and 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, and 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.
Dispute Before the Court
The principal dispute before the Court concerned whether the claimed herbal composition satisfied the requirements of patentability under Indian law.
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 invention demonstrated unexpected synergy and that the Patent Controller failed to properly appreciate the inventor's affidavit and supporting data. It was also argued that approval obtained from the National Biodiversity Authority under the Biological Diversity Act supported the patentability of the invention.
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 that the claimed invention merely combined known traditional ingredients and represented routine experimentation rather than genuine innovation.
The respondent also submitted that the affidavit sought to introduce entirely new technical features and claims that were absent from the original specification and therefore could not be considered.
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 utilization of biological resources. It does not authorize 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.
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.
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.
The Court further scrutinized 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.
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.
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).
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.
Point of Law Settled
The judgment 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 inventive step for the first time.
Third, combining multiple traditionally known ingredients already recognized for treatment of the same disease is ordinarily regarded as an obvious combination and may fall within the exclusion under Section 3(p).
Fourth, routine optimization 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.
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 Hon'ble 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 Judgement and that the same are for illustrative purpose only. Readers are advised not to treat this as substitute for legal advice as it may contain errors in perception, interpretation, and presentation.
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Headnote of the Judgment
Shaafi Naturcure LLP Vs. Assistant Controller of Patents and Designs, decided by the Delhi High Court in C.A.(COMM.IPD-PAT) 109/2022, concerned an appeal challenging refusal of a patent application relating to a herbal powder composition for treatment of asthma. The Patent Controller had rejected the application under Sections 2(1)(j), 2(1)(ja), 3(p), 10(4)(a) and 10(4)(b) of the Patents Act, 1970. The Court held that the claimed six-herb formulation consisted of ingredients already traditionally known for treatment of asthma and that alleged synergy and technical advancement were not established in the original specification. The Court further ruled that post-filing affidavits and experimental data cannot be used to introduce new technical effects. Holding that the invention amounted to an aggregation of traditional knowledge and lacked inventive step, the Court dismissed the appeal and upheld the patent refusal.
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