By Dr. Neeti Wilson, Partner

Introduction

The interface between intellectual property protection, traditional knowledge and biodiversity regulation continues to shape the development of Indian patent jurisprudence. While the Patents Act, 1970, seeks to incentivise innovation through the grant of exclusive rights, the Biological Diversity Act, 2002, seeks to regulate access to biological resources and ensure fair and equitable sharing of benefits arising from their utilisation. The interaction between these two frameworks becomes particularly relevant where patent applications are based on biological resources and traditional medicinal knowledge.

The recent decision of the Delhi High Court in Shaafi Naturcure LLP vs Assistant Controller of Patents and Designs [C.A.(COMM.IPD-PAT) 109/2022, decided June 22, 2026] provides important guidance on this interface. The judgment not only examines the patentability of an herbal formulation comprising traditionally known medicinal plants, but also clarifies whether approval obtained under the biodiversity framework has any bearing on the assessment of patentability under the Patents Act.

The decision is significant because it reaffirms the independent operation of the patent and biodiversity regimes while highlighting the role of Section 3(p) of the Patents Act in preventing the misappropriation of traditional knowledge through patent protection.

Factual Background

The patent application related to an herbal powder composition for the treatment of asthma comprising six medicinal plants, namely Tephrosia purpurea (Sarphooka), Cuscuta reflexa (Aftimoon Kasoos), Morinda citrifolia (Noni), Terminalia arjuna (Arjun Bark), Piper longum (Pipal Bari) and Piper nigrum (Black Pepper).

The applicant contended that although the individual ingredients were known, the specific combination and proportion of the six components produced a synergistic therapeutic effect resulting in improved treatment of asthma. The Patent Office rejected the application on the grounds that the claimed invention lacked inventive step, constituted traditional knowledge within the meaning of Section 3(p), and failed to satisfy the disclosure requirements under Section 10(4) of the Patents Act.

The applicant challenged the rejection before the Delhi High Court.

The Patentability–Biodiversity Approval Interface

A noteworthy aspect of the appeal was the reliance placed by the applicant on approval obtained from the National Biodiversity Authority (NBA) under Section 6 of the Biological Diversity Act. The applicant argued that having secured biodiversity approval and entered into a benefit-sharing arrangement, the invention should not be denied patent protection on grounds associated with traditional knowledge.

This argument brought into focus a question that has frequently arisen in practice: does compliance with biodiversity requirements strengthen the case for patentability?

The Court clarified that biodiversity approval cannot be equated with patentability.

Approval granted by the National Biodiversity Authority is intended to regulate access to biological resources and ensure compliance with related benefit-sharing obligations. Such approval does not involve an assessment of novelty, inventive step or patent eligibility. These issues continue to fall exclusively within the jurisdiction of the patent system.

The judgment therefore confirms that compliance with the Biological Diversity Act cannot overcome objections under the Patents Act. An invention involving biological resources must independently satisfy all patentability requirements regardless of whether biodiversity approval has been obtained.

This clarification is particularly relevant for applicants working with biological resources, herbal formulations and traditional medicinal products, where biodiversity compliance is often incorrectly perceived as strengthening a patent claim.

Distinct Objectives of the Two Statutes

The Court’s reasoning highlights the fundamentally different objectives of the two statutes.

The Biological Diversity Act is concerned with conservation of biodiversity, sustainable use of biological resources and equitable sharing of benefits. The Patents Act, on the other hand, is designed to identify and reward genuine technological innovation through the grant of patent rights.

Although the two statutes may operate in relation to the same biological resource, they address different policy concerns and perform different regulatory functions. Compliance with one statutory framework cannot substitute compliance with the other.

The judgment reinforces the principle that biodiversity regulation and patent examination remain distinct legal processes even where they relate to the same subject matter.

Traditional Knowledge and Section 3(p): Attention to the Statutory Exclusion

The Court focussed on Section 3(p) of the Patents Act, which excludes from patentability inventions that are in effect traditional knowledge or merely represent an aggregation or duplication of known properties of traditionally known components.

The prior art relied upon by the Patent Office demonstrated that each of the six ingredients included in the claimed composition was already known in traditional medicine for treating asthma, bronchitis, cough or related respiratory ailments. The Court observed that combining ingredients already known for the same therapeutic purpose does not automatically result in a patentable invention.

The Court also relied upon the Traditional Knowledge Guidelines, which recognise that combinations of traditionally known ingredients used for the same therapeutic purpose are generally considered obvious unless a demonstrable technical advance can be established.

The decision therefore reaffirms the continued relevance of Section 3(p) as a safeguard against the grant of patents over subject matter that essentially remains within the domain of traditional knowledge.

The Role of Traditional Knowledge Documentation in Patent Examination

The judgment also illustrates the growing importance of traditional knowledge documentation systems such as the Traditional Knowledge Digital Library (TKDL).

The development of TKDL was intended to prevent the grant of patents over existing traditional knowledge by making such knowledge available as prior art during patent examination. The present case demonstrates how documented traditional uses of medicinal plants continue to influence patentability assessments, particularly where applicants seek protection for herbal formulations.

The decision reinforces the role of traditional knowledge databases in ensuring that patents are granted only where there is an additional contribution that extends beyond existing traditional practices.

Post-Filing Evidence and Patent Disclosure

A substantial part of the applicant’s case relied upon an affidavit containing additional experimental data, information relating to efficacy, alleged side effects arising from altered ingredient ratios and observations from patient treatment. The Court refused to rely upon this material.

Referring to established jurisprudence of AstraZeneca AB & Anr. vs Alkem Laboratories Limited [CS (COMM) No.410/2020, decided on 02.11.2020], the Court held that post-filing evidence may only support a technical effect already disclosed in the specification. Such evidence cannot be used to introduce an inventive concept or establish technical advancement for the first time after filing.

The Court found that several assertions contained in the affidavit, including claims regarding different types of asthma, synergistic effects and adverse consequences of altered formulations, were absent from the complete specification.

The judgment serves as an important reminder that patent applicants must ensure that the complete specification adequately discloses all essential features supporting patentability at the time of filing.

Inventive Step and Synergy

The applicant’s principal argument was that the specific combination of six herbs generated a synergistic effect that distinguished the invention from the prior art.

However, the Court identified several inconsistencies in the specification. Certain examples disclosed therapeutic benefits even where fewer than six ingredients were present. The specification also suggested that different compositions could achieve similar outcomes within comparable treatment periods.

These disclosures weakened the argument that the claimed formulation produced an unexpected technical effect attributable to the presence of all six ingredients in the claimed proportions. Since all six ingredients of the claimed composition were previously known for treating the same disease, the claimed invention was considered as an obvious combination, and in the absence of convincing evidence demonstrating synergy within the specification itself, the Court concluded that the claimed invention lacked inventive step under Section 2(1)(ja) and did not qualify as an invention under Section 2(1)(j) of the Patents Act.

Implications for Biodiversity-Based Innovation

The judgment carries important implications for innovation involving biological resources and traditional medicinal knowledge.

First, it clarifies that biodiversity approvals and patent rights operate within separate legal frameworks and must be independently justified.

Second, it reinforces the significance of Section 3(p) in preventing patents that merely combine traditionally known ingredients without demonstrating a genuine technical advance.

Third, it underscores the importance of robust drafting and disclosure practices. Applicants seeking protection for herbal formulations and biodiversity-based inventions must clearly establish the inventive contribution within the specification itself and provide adequate support for claims relating to synergy or enhanced efficacy.

Finally, the decision strengthens India’s broader policy objective of balancing innovation incentives with the protection of traditional knowledge and biological resources.

In conclusion, the Delhi High Court’s decision in Shaafi Naturcure LLP represents an important contribution to the evolving jurisprudence at the intersection of patents, traditional knowledge and biodiversity law. The judgment draws a clear distinction between biodiversity compliance and patentability, holding that approval obtained under the Biological Diversity Act does not influence the assessment of patentability under the Patents Act.