Introduction
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India maintains two overlapping but different frameworks when an inventor works with biological resources to develop a product for patent protection. The Patents Act, 1970 governs whether an invention qualifies for the grant of patent rights. The Biological Diversity Act, 2002 regulates who may access biological resources occurring in India and on what terms. Applicants working in the herbal medicine and nutraceutical space have sometimes read these two frameworks as mutually reinforcing, assuming that compliance with one offers some comfort within the other. The Delhi High Court put that assumption firmly to rest on June 22, 2026 in Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs case.
Hon’ble Justice Tushar Rao Gedela dismissed the appeal of Shaafi Naturcure LLP against the refusal of its herbal powder composition patent for asthma treatment, holding that approval granted by the National Biodiversity Authority carries no legal nexus with patentability. The Patents Act, the court reaffirmed, is the exclusive domain for determining whether an invention merits patent protection.
The judgment addresses post filing evidence, the internal consistency of a complete specification, the evidentiary standard for establishing synergy in a combination invention, and the reach of Section 3(p)’s traditional knowledge exclusion. Patent practitioners advising clients on herbal formulations and biodiversity based inventions will find the court’s reasoning instructive across all four areas.
Background of the Case
Shaafi Naturcure LLP filed an Indian Patent Application before the Patent Office on November 27, 2019. The application bore the title “A Herbal Powder Composition for the Treatment of Asthma” and related to a herbal powder formulation comprising six native Indian medicinal plants drawn from the Ayurvedic tradition. Those six ingredients were Tephrosia purpurea (Sarphooka), Cuscuta reflexa (Aftimoon Kasoos), Morinda citrifolia (Noni), Terminalia arjuna (Arjun Bark), Piper longum (Pipal Bari), and Piper nigrum (Kali Mirchi).
The complete specification placed Tephrosia purpurea at 25 to 60 percent by weight and each of the remaining five herbs within ranges of 1 to 30 percent by weight, with preferred and more preferred sub-ranges specified for each. The applicant also filed a process claim covering shade drying of each herb separately, mechanical grinding at ambient temperature, and blending the resulting powders in the stated proportions. The field of the invention described the composition as useful for treating asthma or similar airways conditions.
The Patent Office issued the First Examination Report (FER) on January 1, 2020. The applicant filed its response with amended claims on June 20, 2020. A hearing took place on August 28, 2020 and written submissions followed on September 11, 2020. The Assistant Controller of Patents and Designs passed the impugned order on September 16, 2020, refusing the application on three grounds. Those grounds were the failure to satisfy Section 2(1)(j) read with Section 2(1)(ja) of the Patents Act for lack of inventive step, non-patentability under Section 3(p) as traditional knowledge, and insufficient disclosure under Sections 10(4)(a) and 10(4)(b). The applicant preferred an appeal under Section 117A of the Patents Act, 1970, which the Delhi High Court registered as C.A.(COMM.IPD-PAT) 109/2022.
Prior Art Cited Against the Application
The Patent Office relied on ten prior art documents, numbered D1 through D10 in the proceedings. Documents D1, D3, D6, and D7 were citations from the Traditional Knowledge Digital Library (TKDL). The remaining documents were research publications and a patent application.
The TKDL document D1 described a single ingredient composition of Tephrosia purpurea for asthma. D2 documented the antihistaminic activity of Cuscuta reflexa and its traditional use for cough, cold, and asthma among the Gujjar and Bakerwal communities of the Baramulla district of Kashmir. D3 disclosed a composition containing Cuscuta reflexa for asthma treatment. D4 recorded the traditional use of Morinda citrifolia for allergic symptoms including bronchitis and asthma. D5 described the use of Terminalia arjuna bark in the Indian Indigenous System of Medicine for asthma, bronchitis, and cough. D6 disclosed Piper longum as a single ingredient composition for asthma. D7 described Piper nigrum for bronchitis. D8 and D9 provided additional traditional and pharmacological data on Tephrosia purpurea and Terminalia arjuna for respiratory conditions respectively. D10 was a patent application disclosing a polyherbal synergistic composition that included Piper nigrum and Piper longum.
Each of the six herbs in the claimed composition therefore appeared in at least one prior art document in the context of treating asthma or closely related respiratory conditions.
Arguments Before the Court
The Appellant
The appellant advanced a cluster of arguments covering inventive step, traditional knowledge, and the effect of NBA approval. On inventive step, the appellant contended the inventive contribution lay in selecting six specific herbs from a larger pool of plants traditionally associated with asthma treatment and determining the precise proportions for their combination. The counsel argued that multiple herbs with diverse pharmacological profiles created unpredictability in the therapeutic outcome of any given combination, and that navigating that unpredictability demanded more than routine experimentation.
The appellant also challenged the relevance of the TKDL citations D1, D3, D6, and D7, arguing each contained only skeletal disclosures without the enabling detail required to constitute prior art for inventive step purposes. On the prior art as a whole, the appellant submitted no document, whether read alone or in combination with others, taught a person skilled in the art to arrive at the specific six-ingredient combination in the claimed weight ranges.
The argument that drew the most attention related to the NBA. The applicant had executed an agreement with the National Biodiversity Authority on January 19, 2021 under Section 6 of the Biological Diversity Act, 2002. The appellant argued the BDA and the Patents Act must be read harmoniously, and that once the NBA granted approval and executed an agreement with the applicant, the objection under Section 3(p) of the Patents Act became otiose. The submission rested on the proposition that Government policy expressed through the BDA should take precedence and that sustaining a Section 3(p) objection against an NBA-approved applicant would produce an internal inconsistency in the legislative framework.
The appellant also relied on an affidavit filed by the inventor containing a classification of asthma into five Ayurvedic categories, namely Maha shwas, Urdhva shwas, China shwas, Tamak shwas, and Kshudra shwas, with the claim the composition treated all five. The affidavit also provided data on the adverse effects arising from altered ingredient ratios and included results from a preliminary survey of 300 patients across various age groups.
The Respondent
The respondent addressed the NBA argument at the threshold. The BDA operates as a regulatory mechanism for conservation of biological diversity, benefit sharing, and sustainable use of biological resources. Section 19 of the BDA allows a person intending to apply for intellectual property rights to also file an application with the NBA, and the NBA may grant approval subject to terms including imposition of charges. However, the respondent submitted, no provision anywhere in the BDA or the Biological Diversity Rules confers on the NBA any authority to examine or determine patentability. Patentability falls exclusively within the domain of the Patents Act and the Patent Office.
On merits, the respondent pointed to Annexure B of the Biodiversity Agreement itself, which described the subject matter of the invention only as “A Herbal Powder Composition for the Treatment of Asthma” without any reference to the five-category Ayurvedic classification introduced through the affidavit. The respondent also drew the court’s attention to Formulation IV in paragraph 8 of the inventor’s affidavit. This formulation contained all six herbs of the invention in weight percentages falling within the claimed ranges under Claim 1, yet the affidavit recorded Formulation IV as producing adverse effects including an increase in kapha and tridosha. A composition falling squarely within the granted claims producing side effects according to the inventor’s own data raised a public health concern, apart from the evidential difficulties it created for the applicant.
The Court’s Analysis
The BDA Argument Falls at the First Step
Hon’ble Justice Gedela began his analysis with the NBA approval argument. After examining the Preamble and objects of the Biological Diversity Act, the court found the statute pursues four objectives, i.e., conservation of biological diversity, sustainable use of its components, fair and equitable sharing of benefits arising from the use of biological resources and associated knowledge, and connected matters. No part of those objectives involves examining the patentability of a claimed invention.
The Court conducted a cumulative reading of Sections 6, 7, and 19 of the BDA together with Rule 16 of the Biological Diversity Rules, 2024. Those provisions establish a mandatory registration and prior approval regime before any entity may seek intellectual property rights over a composition involving biological resources. The approval, once granted, takes written form as an agreement containing mutually agreed terms. The court held that neither the Act nor the Rules confer any power, authority, or jurisdiction on the NBA to conduct any inquiry into whether a claimed invention satisfies patentability requirements.
The court stated in terms that the mere grant of approval by the NBA has no rationale or remote nexus with the patentability of a claimed invention, which is the exclusive mandate of the Patents Act, 1970. The argument that NBA approval rendered Section 3(p) otiose was dismissed as legally unfounded and unsustainable. The appellant was required to independently overcome each ground of refusal raised under the Patents Act.
Post Filing Data Cannot Supply What the Specification Omits
The court’s treatment of the inventor’s affidavit forms a substantial portion of the judgment and rests on the principle applied in AstraZeneca AB & Anr. v. Alkem Laboratories Limited [CS (COMM) No. 410/2020, decided November 2, 2020]. Post-priority date evidence may only confirm a technical effect already embedded in the complete specification and capable of being understood by a person skilled in the art on the basis of common general knowledge. Post filing evidence cannot establish a technical effect for the first time.
The five-category Ayurvedic classification of asthma did not appear anywhere in the complete specification. The CS made no mention of Maha shwas, Urdhva shwas, China shwas, Tamak shwas, or Kshudra shwas, and the applicant produced no documentary evidence or scientific support for the existence of these categories as a recognised classification framework. The respondent’s counsel drew an additional point from the NBA agreement itself: Annexure B to that agreement described the invention without any sub-classification of asthma, which meant the five-category framework could not even claim support from the NBA documentation. The court found the affidavit’s introduction of this classification to be new technical material unsupported by the original disclosure, and correctly declined by the Controller.
The data on adverse effects from altered ratios encountered the same difficulty. The background section of the CS stated only that combinations of herbs were believed to produce synergistic effects and reduce possible side effects. The court found that general background statement did not constitute a disclosure, even an implicit one, of the specific adverse consequences described in the affidavit when individual ingredient ratios deviated from the preferred ranges. The court accordingly refused to accept the affidavit data as permissible post-filing support.
Formulation IV in paragraph 8 of the affidavit presented an additional and more troubling problem. That formulation contained all six herbs in weight percentages falling within the claimed ranges under Claim 1. The affidavit recorded it as producing adverse effects: an increase in kapha and tridosha. The court observed this inconsistency not merely as an evidentiary problem but as a public health concern, because a composition squarely within the scope of the patent claims was being described by the inventor’s own witness statement as causing side effects.
The Specification’s Own Examples Contradict the Synergy Claim
Separate from the affidavit, the court found internal contradictions within the complete specification that undermined the inventive step case on their own terms. Example 6 in the CS disclosed administration of composition (f.), which contained only four herbs. The court recorded the applicant’s own words from that example: the person administered received significant relief from asthma. A four-ingredient composition within the complete specification achieving the same therapeutic outcome as the six-ingredient claim made it impossible to sustain the argument that all six herbs were necessary to produce the asserted synergistic effect.
The court further noted that Example 1 described a treatment period of three months, while the affidavit data placed the minimum treatment period at four to five months for children and longer periods for various adult patient groups. These temporal disparities between the specification and the affidavit reinforced the court’s conclusion that the post-filing data was unreliable and inconsistent with the original disclosure. The court observed that different proportions of the herbs produced the same therapeutic efficiency within the same duration across the examples in the CS, which meant the claimed synergy attributable specifically to the six-ingredient combination in the stated proportions found no support in the specification’s data.
Inventive Step, Section 3(p), and the Traditional Knowledge Guidelines
With the affidavit data excluded and the specification’s internal inconsistencies on record, the court turned to the substantive patentability questions. Prior art documents D1 through D10 collectively established each of the six herbs as individually known in traditional medicine for treating asthma, bronchitis, or related respiratory conditions. The court applied Guiding Principle 2 of the Guidelines for Processing of Patent Applications Relating to Traditional Knowledge and Biological Material, 2012, which treats a combination of plants with known therapeutic effects for treating the same disease as an obvious combination. The court also applied Guiding Principle 4, which treats the discovery of optimal or workable ranges for traditionally known ingredients through routine experimentation as non-inventive.
On the appellant’s objection that the TK Guidelines are merely guidelines and not binding law, the court applied Principles 2 and 4 without expressly resolving the question of their binding force. That question therefore remains technically open, though the court’s reasoning suggests the principles reflect the correct substantive standard regardless of their formal legal status.
Applying those principles to the facts and finding no demonstrable synergistic effect grounded in the specification itself, the court held the subject application lacked inventive step under Section 2(1)(ja) of the Patents Act and did not constitute an invention under Section 2(1)(j). The Section 3(p) refusal was upheld on the same reasoning: the claimed composition represented an aggregation of known properties of traditionally known components, each already documented for treating the same disease.
The Disclosure Objection Stands
Since the court excluded the affidavit data, the appellant could not draw on it to overcome the Section 10(4) objections. The court held the complete specification failed to fully and particularly describe the claimed invention as required under Section 10(4)(a) of the Patents Act, and also failed to disclose the best method of performing the invention as required under Section 10(4)(b). The five-category asthma framework, the synergistic effect data, and the adverse effects arising from ratio changes were all absent from the specification. Without those disclosures, the CS could not meet the standard the Act requires. The court dismissed the appeal along with all pending applications, with no order as to costs.
Also read: What if the Patent Office ignores your reply?
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Conclusion
Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs case draws a line that biodiversity-based patent applicants have periodically tried to blur. The Biological Diversity Act and the Patents Act pursue different policy goals through different institutional mechanisms. One governs access to resources and the terms on which the State and local communities share in the commercial benefits of their exploitation. The other governs the grant of exclusive rights as a reward for genuine technological innovation. Treating NBA approval as a proxy for patent eligibility would allow an authority that performs a regulatory function to influence patent examination outcomes despite having neither the mandate nor the technical framework to do so.
What concerns me about the appellant’s case is the way the complete specification was structured and how the supporting data was deployed. A specification that contains Example 6 with a four-ingredient composition achieving the same therapeutic result as a six-ingredient claim cannot support a credible synergy argument. The applicant created that contradiction within the CS itself. No post-filing affidavit could undo it. Post-filing evidence is a legitimate tool in the patent practitioner’s repertoire, but it operates only when the specification already contains at least an implicit foundation for the technical effect being demonstrated. Where that foundation is absent, as it was here, the data adds nothing to the examination record and only exposes additional inconsistencies for the court to note.
Section 3(p) of the Patents Act, read together with the Traditional Knowledge Guidelines, continues to operate as a meaningful gatekeeper for herbal combination patents. Every practitioner advising a client seeking protection for an Ayurvedic or traditional medicine based formulation must ensure the specification either demonstrates a documented synergistic effect going beyond the additive properties of the individual ingredients or establishes a therapeutic outcome that prior art does not already associate with any of those ingredients. Neither condition existed here. The court applied the law accordingly. For applicants in the herbal and biodiversity space, the lesson from this judgment is less about the outcome and more about what a complete specification must contain before the application is filed.
Case: Shaafi Naturcure LLP v. Assistant Controller of Patents and Designs, C.A.(COMM.IPD-PAT) 109/2022, Delhi High Court. Coram: Hon’ble Mr. Justice Tushar Rao Gedela.
