The grant of a patent is governed by the complete disclosure of an invention in the complete specification. The applicant is also required to disclose the best method of working of the claimed invention. Information submitted after the priority date to support inventive step would be considered by the patent office only where the relevant technical effect is implicitly disclosed in the complete patent specification. However, this information must be timed prior to the date of priority. The Patent Office does not entertain any information/experimental results submitted after the priority date.
When Shaafi Naturcure LLP filed the patent application for grant of patent for their invention for “A Herbal Powder Composition for the Treatment of Asthma”, they failed to disclose in the specification what the essential herbs used in the composition are and what is the duration of treatment required to relieve the symptoms of asthma. The Patent Office rejected the patent application on the grounds that the invention does not meet the requirements of Section 2(1)(ja), Section 3(p) and Section 10(4)(a) and 10(4)(b) of the Patents Act, 1970. The applicant preferred an appeal against the refusal order. This patent application filed by Shaafi Naturcure suffered a setback when the Delhi High Court affirmed the order refusing the patent.
In Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs, decided on June 22, 2026, the Delhi High Court dismissed the appeal filed by Shaffi Naturcure, holding that additional experimental results submitted after the priority date to support inventive step will be considered only where the relevant technical effect is implicitly disclosed in the complete patent specification.
Appellant’s Case
Shaafi claimed that their invention relates to a novel herbal composition comprising selected herbs with medicinal value combined in a definite proportion. Appellant contended that the respondent Controller has not followed the ‘five-step process’ as enunciated in Hoffmann La Roche Ltd. vs Cipla Ltd. [2015 SCC OnLine Del 13619] and as such, the impugned order needs to be set aside, and the patent application be remanded back for reconsideration.
On Section 2(1)(ja)
The appellant submitted that the objection under Section 2(1)(ja) is erroneous, as the inventors have made extensive efforts in selecting six herbs from a pool of several herbs traditionally known to treat asthma and in optimising the ratios of each ingredient to arrive at the claimed composition. An inventor affidavit was also filed during the hearing at the IPO to demonstrate technical advancement. The appellant emphasised that the cited arts were too skeletal and could not be considered as an enabling disclosure to arrive at the claimed composition. A detailed comparison of prior art documents vis-a-vis the present invention was also submitted in support of inventive step. The appellant contended that if any evidence was developed after the patent filing, it was not excluded from consideration in understanding the full range of an invention that may not have been achieved at the time of filing the patent application.
Hence, the respondent Controller was in error in failing to consider the annexures and the inventor’s affidavit submitted to demonstrate technical advancement over the cited arts. The appellant submitted that the surprising effect demonstrated and proved in the annexures and inventor affidavit was ignored and overlooked by the respondent Controller. Therefore, the Guidelines For Processing of Patent Applications Relating To Traditional Knowledge and Biological Material, 2012 (“TK Guidelines”) were not considered in its entirety, and only certain portions were merely cherry-picked, for example, Guiding Principles Nos. 2 and 4, which caused prejudice to the appellant.
On Section 3(p)
The appellant placed reliance on the agreement entered into between the appellant and the National Biodiversity Authority (“NBA”) and argued that once such agreement was entered into and executed with the authority, the objection under Section 3(p) of the Act must either be construed to have been met with or such objection is deemed to be unsustainable.
The appellant also contended that the herbs disclosed in cited arts D1-D10 were traditionally used to treat other ailments, including asthma. The efficacy of different permutations and combinations of these herb components may result in altogether a different activity or side effects, as evidenced in the inventor affidavit. Thus, the claimed composition is not a mere aggregation of traditionally known components.
On Section 10(4)
The appellant contended that the complete specification clearly disclosed the exemplary herbal compositions and the method of preparing the same. Therefore, the basic requirement of aforesaid provisions was clearly met. Further, the inventor affidavit clearly demonstrated working examples that fall within the range claimed in the present invention. The affidavit also disclosed that a composition falling outside the claimed range would have negative effects; hence, the CS, read with the contents of the affidavit, provided complete disclosure as required.
Respondent Controller’s Reply
On Section 2(1)(ja)
The respondent Controller contended that, while deciding the inventive step of the subject application, not only was the subject patent application considered in its entirety, but the inventor’s affidavit, along with its annexures, was also considered in detail. The respondent submitted that the additional experimental results submitted by the appellant during the hearing make a blanket assertion that the claimed composition can cure all five types of asthma without any supporting experimental data or technical evidence.
The experimental results failed to disclose any specific formulation within the claimed ranges, nor did they provide any details regarding experimental methodology, comparative analysis or clinical validation. In the absence of such foundation data, the assertion made by the appellant lacked scientific substantiation. With respect to the inventor affidavit, the respondent contended that, as per the inventor affidavit, upon altering the ratios of the composition, the result was either less effective or exhibited serious side effects. As the said data contains a composition IV falling within the claimed range, it clearly demonstrated that even the compositions which were covered within the claimed ranges may not be consistently effective and, in fact, may produce undesirable effects.
Hence, the affidavit was unreliable. Regarding cited arts D1-D10, the respondent submitted that said prior arts uniformly referred to the treatment of asthma in general, whereas the appellant’s contention on five different types of asthma was based on unilateral interpretation of the inventor without submitting supporting disclosure or evidence and, as such, could not be relied upon to establish inventive step.
On Section 3(p)
The respondent contended that the permission sought by an entity or an individual under the BDA is to facilitate the extraction of natural resources. It was also emphasised that the BDA is a regulatory mechanism to ensure that no person shall undertake biodiversity-related activities without approval of the NBA. The respondent contended that other than providing a regulatory mechanism and revenue sharing, the BDA does not contemplate conducting enquiries in respect of patentability of a claimed invention. The same is clear from the bare perusal of the NBA agreement placed on record by the appellant.
The respondent argued that the appellant failed to overcome the objections under Section 3(p) of the Act and substantially relied on the NBA agreement, the inventor affidavit and annexures, which was unsustainable in facts and law. As the individual herbs are independently known for the treatment of asthma, the claimed invention was nothing but an aggregation of properties of traditionally known components without any demonstrable technical advancement or unexpected effect.
On Section 10(4)
The respondent submitted that the annexure of agreement with NBA made no reference to classification of asthma into five distinct categories or that the claimed composition could cure all such types of asthma. Similarly, the CS did not refer to any such sub-classification. The respondent contended that the differentiation into five types of asthma and the assertions made in the accompanying affidavit were new technical features introduced for the first time at the hearing stage and could not be considered. Therefore, the said post-filing material did not form part of the original disclosure in the CS, thus attracting objection under Section 10(4)(a) and (b) of the Act.
Analysis and Decision of the Court
On NBA Approval and Patentability
First, the Court observed that the primary objective of the BD Act is to conserve biological diversity by regulating the use of biological resources and associated traditional knowledge, thereby preventing their misuse or abuse. The Court further noted that the provisions of the BD Act require any person or entity seeking an intellectual property right in a composition or invention involving the extraction or use of biological resources from India to obtain prior approval from the NBA. However, the Court clarified that neither the BD Act nor the Rules confer on the NBA any power, authority, or jurisdiction to examine or determine the patentability of a claimed invention. Accordingly, NBA approval has no bearing, direct or otherwise, on the patentability of the invention, which remains governed exclusively by the Patents Act, 1970. Hence, the applicant must make necessary submissions to overcome the objection under section 3(p) of the Indian Patents Act.
On Section 2(1)(ja)
Regarding the objection under Section 2(1)(ja), the Court agrees with the observation of the respondent Controller and notes that the complete patent specification was silent about five different types of asthma as well as the negative effect of altering the ratio of constituents of the composition, as mentioned in the inventor affidavit submitted during hearing. Citing AstraZeneca AB & Anr. vs Alkem Laboratories Limited, CS (COMM) No.410/2020, decided on November 2, 2020, the Court emphasised that if the applicant has filed additional data before the Indian Patent Office to show technical effect after the priority date, such evidence would be considered only if such effect is implicitly disclosed in the complete patent specification.
Accordingly, the respondent Controller was right in rejecting the data submitted in the inventor affidavit. Even if considered relevant, the data submitted in the inventor affidavit contained exemplary formulation with only four ingredients, which also shows synergy. Therefore, the cited arts provided motivation to add two or more ingredients to arrive at the claimed composition with six ingredients. In the absence of a synergistic effect, the claimed composition lacked inventive step under Section 2(1)(ja) of the Indian Patents Act. Therefore, the invention claimed under the subject application did not constitute an invention under Section 2(1)(j) of the Act.
On Section 3(p)
With respect to the objection under Section 3(p), the Court held that the claimed composition was an obvious combination, as all six ingredients were already known for treating asthma, consistent with Traditional Knowledge Guiding Principle 2. The Court further noted that, under Traditional Knowledge Guiding Principle 4, merely identifying optimum or workable ranges of traditionally known ingredients through routine experimentation does not involve inventiveness. Applying these principles, and in view of the absence of any demonstrated synergy, the Court concluded that combining known ingredients having the same therapeutic effect would fall within the bar under Section 3(p). Accordingly, the subject application was held to be not patentable under Section 3(p) of the Act.
On Section 10(4)
Regarding the objections under Sections 10(4)(a) and 10(4)(b), the Court held that, since the additional data submitted through the inventor affidavit was inadmissible, the complete specification did not fully and particularly disclose the claimed invention as required under Section 10(4)(a) of the Act. The Court further found that the application failed to disclose the best method of performing the invention, as required under Section 10(4)(b). On these grounds, the Court dismissed the appeal.
Conclusion
This judgement is significant as it not only clarifies the role of working examples in defending the inventiveness of the claimed invention but also provides a clear demarcation between the Biological Diversity (BD) Act and the Patents Act. The Court’s finding that NBA approval does not render an objection under Section 3(p) of the Patents Act otiose appears clear. The connection between the Biological Diversity Act and the Patents Act is limited: where an invention is based on biological resources obtained from India, the applicant must obtain NBA approval before the patent is granted.
In the absence of such approval, the Controller may keep the grant pending under Section 43 of the Patents Act until approval is submitted. Since the claimed composition in this case was an herbal composition using ingredients sourced from India, NBA approval was obtained for securing intellectual property rights under Section 6 of the BD Act. Since an agreement with the NBA is part of regulatory approval, it cannot act as an instrument to overcome a patentability objection.
This case highlights the need to draft patent specifications with precision, ensuring that the scope of the invention is clear and that the claims are comprehensive and unambiguous. Where the description includes one or more working examples, they should demonstrate the invention’s workability without conflicting with the claim scope. For product or composition claims involving known medicinal herbs for specific medical use, the experimental data should establish a synergistic effect in relation to that application. The applicant is also required to disclose the best method of working of the claimed invention. Information submitted after the priority date to support inventive step would not be considered by the patent office for establishment of inventive step.
Authors: Manisha Singh and Vijaya Chaudhary