Case Overview
The Delhi High Court in a significant ruling has set aside the refusal of a patent application involving an oral herbal pain killer composition derived from Indian biological materials, primarily on the ground of non-submission of approval from the National Biodiversity Authority (NBA) at the time of refusal. The Court emphasized procedural fairness, discretion under Section 15 of the Patents Act, 1970, and the mandatory but timing-flexible requirement of NBA permission under the interplay of the Patents Act and the Biological Diversity Act, 2002.
Introduction
This appeal before the Delhi High Court addresses a recurring challenge in patent prosecution involving traditional knowledge and biological resources from India: the mandatory requirement of prior or pre-grant approval from the National Biodiversity Authority (NBA) when inventions utilize biological material sourced from India.
The case highlights the tension between strict compliance with biodiversity access regulations and the practical realities of administrative timelines in government bodies. It also touches upon procedural aspects like representation in hearings and the scope of Controller’s discretion to refuse or defer decisions.
The ruling promotes a balanced approach, ensuring applicants are not unduly penalized for delays beyond their control while upholding the protective intent of biodiversity laws. This decision is particularly relevant for inventors working in herbal, pharmaceutical, and traditional medicine sectors, where Indian biodiversity forms the basis of many innovations.
Factual Background
The Appellant, Manu Chaudhary, an experienced pharmaceutical researcher with over three decades in antimicrobial resistance, natural products, and drug revival technologies, filed Indian Patent Application No. IN 201711047431 (originally titled under related application 2545/DEL/2010 as “Oral Herbal Pain Killer Formulations”).
Invention Details
- An oral herbal pain killer composition for peripheral pains
- Comprising effective amounts of selected herbal components (specific plant parts with defined chemical constituents)
- Predefined ratios to achieve synergistic pharmacodynamic effects
- Simplified, reproducible preparation process
- Preservation of safety, efficacy, and stability
Objective Of The Invention
- Provide herbal alternatives to existing pain relief medications
- Reduce side effects
- Suitable even for patients with ulcers or other vulnerabilities
The application disclosed use of biological materials from India, triggering NBA approval requirements.
Procedural Background
First Examination Report (FER) Observations
| Issue | Observation |
|---|---|
| Novelty & Industrial Applicability | Claims considered novel and industrially applicable |
| Inventive Step | Objections citing prior arts D1-D7 |
| Non-Patentability | Sections 3(d), 3(e), and 3(p) |
| NBA Approval | Absence under Section 10(4)(ii)(D) |
Appellant Response
- Amended claims from 1-10 to 1-7
- Addressed technical objections
Hearing Stage
- Hearing notice limited objections to NBA approval and Section 3(p)
- Other objections treated as waived
- Appellant attended via authorized representative
- Written submissions filed explaining technical glitches in Form 3 filing
- Pending NBA approval supported by email acknowledgment
Controller Decision
- Application refused under Section 15
- NBA approval granted post-refusal
- Appeal filed under Section 117A(2) seeking revival
Reasoning and Decision of Court
The Court identified three refusal grounds:
- lack of timely NBA approval;
- non-patentability under Section 3(p) (mere new use of known herbal medicines without technical advancement); and
- improper representation by an unauthorized person at the hearing (contrary to Sections 128 and 132).
The Court focused primarily on the NBA issue, holding that while Section 10(4)(ii)(D) mandates disclosure and permission for biological material from India, neither the Patents Act nor the Biological Diversity Act, 2002 (Section 6(1A)) prescribes outright rejection for delayed submission. The relevant provision requires registration/approval before grant, not at filing or hearing stages.
Guidelines for Processing Patent Applications relating to Traditional Knowledge and Biological Material (paragraphs 19 and 22) reinforce that patents “should not be granted” without NBA permission, but do not compel refusal if approval is pending and the applicant has applied diligently.
The Appellant had applied to NBA, informed the Controller via email with acknowledgment proof before the refusal order, and could not control NBA’s processing timeline. The Court found the Controller erred by not deferring the order under discretionary powers in Section 15, which allows requiring amendments/documents and refusing only on failure to comply. Non-submission due to pending approval was not a “failure” attributable to the Applicant.
On representation, the Court noted the Controller should have objected and deferred rather than proceeding ex parte. Merits under Section 3(p) were not examined, leaving them open.
The appeal was disposed of by setting aside the refusal, remanding for re-examination post-hearing (with proper Patent Agent/Advocate representation), considering NBA approval (no new material except this), and deciding within two months.
Point of Law Settled in the Case
The judgment clarifies that while NBA approval is mandatory for patent grant in cases involving Indian biological resources, absence of approval at examination/hearing stages does not automatically warrant refusal if the applicant has applied timely and informed the Controller of pendency.
The Controller must exercise discretion under Section 15 to defer proceedings awaiting approval, rather than refusing mechanically, especially when novelty is acknowledged. This prevents hyper-technical rejections and aligns with the proviso in Section 6 of the Biological Diversity Act allowing post-filing but pre-grant approval. It reinforces procedural fairness in patent prosecution involving biodiversity access obligations.
Case Details
| Case Title | Manu Chaudhary Vs Controller of Patents and Designs |
|---|---|
| Date of Order | 07.02.2026 |
| Case Number | C.A.(COMM.IPD-PAT) 36/2024 |
| Neutral Citation | 2026:DHC:1095 |
| Name of Court | High Court of Delhi at New Delhi |
| Name of Hon’ble Judge | Hon’ble Ms. Justice Jyoti Singh |
