Manu Chaudhary Vs Controller of Patents

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"). The invention pertains to an oral herbal pain killer composition for peripheral pains, comprising effective amounts of selected herbal components (specific plant parts with defined chemical constituents) in predefined ratios to achieve synergistic pharmacodynamic effects. It also includes a simplified, reproducible process for preparing these compositions while preserving safety, efficacy, and stability. The objective was to offer herbal alternatives to existing pain relief medications with reduced 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

The application was filed on **30.12.2017**, published on **02.08.2019**, and examined after a request for examination on **08.12.2021**. The **First Examination Report (FER)** issued on **22.12.2021** found the claims novel and industrially applicable but raised objections on lack of inventive step (citing prior arts D1-D7), non-patentability under **Sections 3(d), 3(e), and 3(p)** of the Patents Act, and absence of NBA permission under **Section 10(4)(ii)(D)**. The Appellant responded on **21.06.2022**, amending claims from 1-10 to 1-7 to address issues. A hearing notice dated **30.08.2023** limited objections to NBA approval and **Section 3(p)** (implying other grounds were waived). The Appellant attended the hearing on **09.10.2023** via an authorized representative, filed written submissions explaining technical glitches in Form 3 filing and pending NBA approval (evidenced by an email on **28.12.2023** intimating NBA acknowledgment). Despite this, the Controller refused the application under **Section 15** on **22.02.2024**. NBA approval was eventually granted on **04.07.2024**, post-refusal. The Appellant challenged this refusal via appeal under **Section 117A(2)**, seeking revival.

### Reasoning and Decision of Court

The Court, presided over by **Justice Jyoti Singh**, identified three refusal grounds: (i) lack of timely NBA approval; (ii) non-patentability under **Section 3(p)** (mere new use of known herbal medicines without technical advancement); and (iii) 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 Detail**  

**Title:** Manu Chaudhary Vs Controller of Patents and Designs  

**Date of Order:** 7th February, 2026  

**Case Number:** C.A.(COMM.IPD-PAT) 36/2024  

**Neutral Citation:** 2026:DHC:1095 (or as per official notation 2026:DHC:xxxxx based on court records)  

**Name of Court:** High Court of Delhi at New Delhi  

**Name of Hon'ble Judge:** Hon'ble Ms. Justice Jyoti Singh  

**Disclaimer:** Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation  

**Written By:** Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi  

**Suggested Titles:**  

1. Delhi High Court Sets Aside Patent Refusal: NBA Approval Pendency Not Ground for Immediate Rejection in Biological Material Cases  

2. Balancing Biodiversity Compliance and Patent Prosecution: Delhi HC Remands Herbal Painkiller Application for Re-Examination  

3. No Automatic Refusal for Delayed NBA Approval – Landmark Clarity from Delhi High Court in Patents Involving Indian Biological Resources  

4. Procedural Fairness in Patent Appeals: Delhi HC Emphasizes Controller's Discretion Under Section 15 When NBA Permission is Awaited  

**Suggested Tags:** #DelhiHighCourt #PatentsAct1970 #NBAApproval #BiologicalDiversityAct #Section104iiD #Section15PatentsAct #HerbalPharmaceuticals #TraditionalKnowledge #PatentAppeal #IPLitigation #BiodiversityAccess #Section3p #InventiveStep #PatentProsecutionIndia  

**Headnote:** Delhi High Court sets aside Controller's refusal of patent application for oral herbal pain killer composition under Section 15 of Patents Act, 1970, holding that pending NBA approval (applied for and acknowledged before refusal) warranted deferral rather than outright rejection; Controller must exercise discretion to await pre-grant NBA permission in biological material cases; matter remanded for fresh examination within two months post-hearing with proper representation; merits under Section 3(p) left open.

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**Brief and Compact Summary**

In this appeal under Section 117A(2) of the Patents Act, 1970, Manu Chaudhary challenged the Controller's refusal dated 22.02.2024 of patent application IN 201711047431, which claimed an oral herbal pain killer composition using specific Indian herbal components in predefined ratios for synergistic pharmacodynamic effect along with a reproducible preparation process aimed at reducing side effects compared to conventional analgesics. The application was filed on 30.12.2017, published in 2019, examined after request in 2021, and FER issued on 22.12.2021 raising objections on inventive step, Sections 3(d), (e), (p), and lack of NBA approval under Section 10(4)(ii)(D). The applicant responded by amending claims, but the hearing notice in 2023 restricted objections to NBA approval and Section 3(p). Despite the applicant informing the Controller via email on 28.12.2023 of pending NBA application (acknowledgement received) and attending hearing through authorized representative, the application was refused under Section 15. NBA approval was eventually granted on 04.07.2024 post-refusal. The Delhi High Court held that the Controller erred in not deferring the refusal order despite proof of NBA application pendency, as neither the Patents Act nor the Biological Diversity Act, 2002 mandates rejection for delayed submission when the applicant has diligently applied and cannot control NBA timelines; Section 6(1A) requires approval only before grant, and relevant Guidelines (paras 19 & 22) prohibit grant without permission but do not compel pre-hearing rejection. The Court further found that Section 15 confers discretion to await compliance rather than refuse mechanically, especially when novelty was accepted. Representation by authorized representative was also not fatal without prior objection. Merits under Section 3(p) were not examined. The refusal was set aside, the matter remanded for fresh examination within two months after hearing (with proper Patent Agent/Advocate representation), considering NBA approval (no other new material permitted).

**Points of Law Settled**

- Absence of NBA approval at the time of examination/hearing does not warrant automatic refusal of a patent application if the applicant has applied for approval in time and informed the Controller of its pendency; the requirement under Section 6(1A) of the Biological Diversity Act, 2002 is mandatory only before grant of patent. (Para 14, 16; read with Paras 9, 10)

- The Controller must exercise discretion under Section 15 of the Patents Act, 1970 to defer the final order and await submission of NBA permission when the applicant has taken diligent steps and delay is attributable to NBA processing, rather than mechanically refusing the application. (Para 15, 14)

- Guidelines for Processing of Patent Applications relating to Traditional Knowledge and Biological Material (paras 19 & 22) prohibit grant of patent without NBA permission but do not provide for rejection of the application merely because approval is awaited despite proof of application having been made. (Para 14, 7)

- Where an applicant attends hearing through an authorized representative instead of a registered Patent Agent/Advocate, the Controller should raise objection and defer hearing to allow compliance rather than proceed and refuse on that ground. (Para 11, implied in 16)

**Case Details**  

**Case Title:** Manu Chaudhary vs Controller of Patents and Designs  

**Order Date:** 7th February, 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 Judge:** Hon'ble Ms. Justice Jyoti Singh  

**Disclaimer:** Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation  

**Written By:** Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi  

#IPUpdate #IPCaselaw #IPCaseLaw #IPLaw #IPRNews #IPIndiaupdate #Trademark #Copyright #DesignLaw #PatentLaw #Law #Legal #IndianIPUpdate #AdvocateAjayAmitabhSuman #IPAdjutor

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