Hindustan Unilever Limited Vs. Reckitt Benckiser

Case Title: Hindustan Unilever Limited Vs. Reckitt Benckiser India Private Limited & Another  

Order Date: 07 October 2025  

Case Number: A.No.3024 of 2025 in C.S.No.132 of 2025  

Neutral Citation: 2025:MHC:110  

Name of Court: High Court of Judicature at Madras  

Name of Hon'ble Judge: Hon’ble Mr. Justice K. Kumaresh Babu  

Fact

The dispute centres on an advertising conflict between Hindustan Unilever Limited (HUL), a well-known consumer goods company, and Reckitt Benckiser India Private Limited, another large player in the fast-moving consumer goods sector. HUL advertised certain products with the claim that they provide “12 hours protection” or a “protective shield.” Reckitt Benckiser questioned the accuracy and veracity of these claims and complained to the Advertising Standards Council of India (ASCI), which then directed HUL to withdraw or modify its advertisements. These ads were telecast in different languages, including Hindi, Tamil, and English, targeting various regions in India, including Tamil Nadu.

HUL, aggrieved by ASCI's directions (instigated by Reckitt Benckiser), approached the Madras High Court. The legal journey started when HUL received leave (permission) from the Madras High Court to file a suit challenging the ASCI directions. However, Reckitt Benckiser filed the present application seeking to revoke the leave granted to HUL, arguing that Madras High Court lacked territorial jurisdiction as the relevant cause of action did not arise in its jurisdiction[1].

Procedural Detail

The proceedings began with HUL’s suit in the Madras High Court, after obtaining leave under Clause 12 of the Letters Patent, contesting ASCI’s decision. Reckitt Benckiser responded by filing an application to revoke this leave, claiming improper jurisdiction. Both sides were heard by the Court. Counsel for Reckitt Benckiser contended that no part of the cause of action arose in Tamil Nadu as all relevant actions—ASCI's order, the expert reports, and the language of the contentious advertisements (primarily Hindi)—were linked to Mumbai or outside Tamil Nadu. On the other side, HUL’s counsel maintained that challenged advertisements were also published and telecast in other languages such as Tamil and English, reaching the audience within the jurisdiction of the Madras High Court. This, they argued, justified the forum's jurisdiction to decide the issue[1].

Dispute

The dispute was specifically about whether the Madras High Court had jurisdiction to entertain the suit filed by HUL against Reckitt Benckiser and ASCI. Reckitt Benckiser argued that since the ASCI decision, the expert reports, and the main dissatisfaction related to advertisements in Hindi televised elsewhere, no part of the cause of action happened within Chennai or Tamil Nadu. Therefore, leave granted by the Madras High Court should be revoked, and the matter should be heard elsewhere—particularly Mumbai, where HUL’s registered office is based, and where the ASCI took its decision.

On the contrary, HUL claimed that the cause of action indeed arose at least in part within Tamil Nadu since the same “12 hours protection” claim was being made through advertisements telecast within the Madras High Court’s jurisdiction in Tamil and English. They stressed that jurisdiction could be invoked if even a fractional cause of action arises within that Court’s reach[1].

Reasoning and Judgement

The Court first considered the legal provision—Clause 12 of the Letters Patent—allowing a party to institute proceedings if a part of the cause of action arises within the Court’s jurisdiction. Reckitt Benckiser’s arguments heavily relied on case law such as Madanlal Jalan vs. Madanlal and Ors. (AIR 1949 Cal 495), emphasizing the doctrine of forum conveniens and contesting so-called “forum shopping.” They also cited the Full Bench judgement in Ms. Duro Flex Pvt. Limited vs. Ms. Duroflex Sittings System (2014 5 LW 673), which clarified that merely having a registry at a particular place does not automatically confer jurisdiction: the factual bundle leading to the cause of action is the test.

Additionally, reference was made to a Supreme Court decision, Ahmed Abdulla Ahmed Al Ghurair vs. Star Health Allied Insurance Co., Ltd. (2019 13 SCC 259), which pointed out that granting leave under Clause 12 is discretionary, to be exercised according to fairness and convenience of the parties, i.e., applying the principle of forum conveniens.

HUL’s response was that the pleadings in the plaint alone should fix jurisdiction for the present stage. They highlighted that the 12 hours claim was not restricted to Hindi—similar advertisements ran in Tamil and English within the State of Tamil Nadu, falling squarely inside the Madras High Court’s jurisdiction. They also pointed out that the Court had granted leave after acknowledging these averments and that the impugned ASCI order affected their ability to advertise in Tamil Nadu. Citing the decision of the Division Bench in O.S.A.Nos.242 & 243 of 2023, it was contended that when a part of the cause of action occurs within the Court's territory, the Court can assume jurisdiction[1].

Upon weighing the submissions, the Judge observed that (1) the advertisements in question were not limited to Hindi or to areas outside Tamil Nadu; (2) “12 hours protection” claims were indeed published in different languages and telecast in Tamil Nadu as well; and (3) as a consequence, the ASCI’s order’s effect was not geographically restricted—it directly impacted HUL’s right to advertise within the Madras High Court’s jurisdiction. Thus, a part of the cause of action, as required by law, had clearly arisen within this jurisdiction[1].

The Court held that the jurisdiction question cannot be decided only on the defendant’s preferred forum or on where corporate offices are situated, but must consider the impact of the impugned action and the presence of the cause of action. The reasoning clearly spelled out that under Clause 12, if any part of the sequence of facts giving rise to the grievance happened within the Court’s territory (including, as here, through telecast and effect of advertisements), then the Court can validly grant leave and entertain the suit.

Decision

The Madras High Court upheld its own jurisdiction, refusing to revoke the leave earlier granted to HUL. It held that the advertisements and resultant harm occurred in Tamil Nadu as well, fulfilling the legal threshold for part of the cause of action within its purview. Consequently, the application seeking revocation of leave was dismissed. However, the Court made no order as to costs, keeping the focus on access to justice and fairness[1].

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

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

Dpac Ventures LLP Vs. Exotic Mile Private Limited

Case Title: Dpac Ventures LLP Vs. Exotic Mile Private Limited  

Order Date: October 3, 2025  

Case Numbers: COMAP No. 530 of 2025   

Neutral Citation: 2025:KHC:39385-DB  

Name of Court: High Court of Karnataka at Bengaluru  

Name of Hon'ble Judges: Mr. Justice B M Shyam Prasad and Mr. Justice K. V. Aravind

Fact  

This case involves a dispute over trademark rights in the gadget industry. The plaintiff, Dpac Ventures LLP, holds several registered trademarks including GOBOLD, GOJOLT, and GOVO, all registered for goods and services relating to Class 9, particularly headphones and similar electronic devices. The defendant, Exotic Mile Private Limited, began using the trademark GOBOULT in 2025 and registered it for similar classes of goods, asserting commercial success with significant turnover and marketing expenditure. The plaintiff alleged that the mark GOBOULT was deceptively similar to its own registrations and sought to restrain the defendant from its use, citing both trademark infringement and passing off. The business background and overlapping product segments made this dispute particularly relevant for Indian commercial trademark law.

Procedural Detail  

Dpac Ventures LLP brought its suit before the Commercial Court in Bengaluru, seeking an urgent injunction under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908. The plaintiff also requested dispensation with pre-institution mediation as required under Section 12-A of the Commercial Courts Act, 2015, arguing the urgency of interim relief. The Commercial Court granted an ex parte ad-interim injunction restraining Exotic Mile Private Limited from using the mark GOBOULT or any deceptively similar mark, pending disposal of the suit and the court’s application. The plaintiff was further directed to comply with procedural requirements under Order XXXIX Rule 3 of CPC and to approach the District Legal Services Authority for time-bound mediation.

The defendant challenged this order on the grounds that it held a registered trademark and that the injunction’s abrupt enforcement would cause substantial business hardship, including stress to its workforce and disruption of commercial operations. The respective parties filed cross-appeals: Exotic Mile Private Limited appealed against the injunction, while Dpac Ventures LLP appealed against the directive for pre-institution mediation.

Dispute  

The core dispute concerns whether the defendant’s use of the mark GOBOULT amounts to trademark infringement and passing off against the plaintiff’s prior registered marks GOBOLD, GOJOLT, and GOVO, all related to similar consumer gadgets. The plaintiff stressed prior registration and likelihood of confusion due to the visual and phonetic similarities of the marks. The defendant argued the benefit of its own registered mark’s prima facie validity under Section 31 of The Trade Marks Act, 1999, ongoing large-scale business activity, and absence of restraint by other courts. Additional arguments involved compliance with court processes, disclosures, and jurisdictional matters.

Detailed Reasoning including Judgment  

The Hon’ble Division Bench reviewed the commercial court’s order, addressing key legal issues. Firstly, the court clarified that the commercial court’s refusal to dispense with pre-institution mediation was contrary to recent Supreme Court guidance (Dhanbad Fuels Private Limited v. Union of India & Another, 2025 SCC Online SC 1129) which held that urgent interim relief applications merited dispensation from mandatory mediation, based on the urgency of relief sought. The bench thus allowed the plaintiff’s appeal, permitting them to bypass mediation procedures.

Secondly, the court analyzed the commercial court’s grant of ex parte injunction. It noted that a court must record detailed reasons for immediate relief, especially due to the potential business disruption (citing Vedant Fashions Private Limited v. Smt. Rajul Devi, W.P. Nos. 33158/2015 & 33300/2014, and Smt. Supriya Shrinate v. Ms. MRT Music ORS, Commercial Appeal No. 460/2022). The injunction order, while stating that delay would defeat the injunction’s purpose, lacked justification about the business impact and reciprocal inconvenience to the defendant, whose turnover and workforce scale were substantial. The bench held that, in such commercial matters, injunctions should not be granted in a perfunctory manner and must consider genuine hardship and commercial realities.

The court also attended to the defendant’s assertion of valid registration and ongoing business activity. Under Section 31 of the Trade Marks Act, a registered trademark enjoys prima facie validity; however, the plaintiff’s prior registrations and the apparent similarity of the marks warranted judicial scrutiny. The bench concluded that, while immediate restraint should not be enforced solely ex parte, the matter merited expedient court review.

Decision  

The Division Bench modified the commercial court’s orders. Firstly, it dispensed entirely with the requirement for pre-institution mediation and settlement, aligning with the Supreme Court’s direction for urgent remedies. Secondly, it allowed Exotic Mile Private Limited to continue its business under the GOBOULT mark in Class 9 and 35, but imposed an obligation to file weekly business accounts in the commercial court. The commercial court was directed to dispose of the pending application for interim injunction expeditiously—no later than November 10, 2025—and both parties were instructed to cooperate for an early decision. The defendant was ordered to appear and complete pleadings on the next hearing date. This order struck a middle ground, preserving both parties’ interests until the Commercial Court’s final ruling, balancing urgency, business continuity, and judicial scrutiny.

Citations and Key Legal Provisions Discussed  

Section 12-A, Commercial Courts Act, 2015 (pre-institution mediation)  

Order XXXIX Rules 1 and 2, Code of Civil Procedure, 1908 (temporary injunction)  

Section 31, Trade Marks Act, 1999 (prima facie validity of registered trademark)  

Dhanbad Fuels Private Limited v. Union of India & Another, 2025 SCC Online SC 1129 (Supreme Court guidance on mediation)  

Vedant Fashions Private Limited v. Smt. Rajul Devi and Smt. Supriya Shrinate v. Ms. MRT Music ORS (high court precedents on injunction reasoning)

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and 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 for Publication  

1. Balancing Trademark Rights with Business Interests: Analysis of Dpac Ventures LLP v. Exotic Mile Private Limited  

2. Mediation and Urgent Interim Relief in Trademark Disputes: Lessons from the Karnataka High Court  

3. Commercial Injunctions in Trademark Law: Judicial Reasoning Made Simple  

4. Prima Facie Validity Versus Prior Registration: The GOBOULT-GOBOLD Trademark Conflict  

5. Judicial Treatment of Business Hardship in Commercial Trademark Litigation

Alkem Laboratories Ltd. Vs. Alchem International Pvt. Ltd.

Phonetic Similarity and Likelihood of Confusion

Fact: The plaintiff, Alkem Laboratories Ltd., is a pharmaceutical company incorporated in 1973, engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The plaintiff owns the registered trademark "ALKEM," and has been using it continuously since 1973. The defendant, Alchem International Pvt. Ltd., incorporated in 1982, provides plant-derived active ingredients and Ayurvedic extracts, selling products under the mark "ALCHEM." The defendant has been using this mark since 1985, primarily in export markets until it started retailing in India in 2006. The plaintiff sent a cease-and-desist notice in 2005 after discovering the defendant's expanded use of the mark, leading to the filing of the present suit in 2018 for trademark infringement, passing off, and related reliefs.

Procedural Details: The suit seeks permanent injunction restraining the defendant from infringing the plaintiff's trademark "ALKEM." The plaintiff filed interim injunction applications starting in 2018 to maintain status quo on the defendant's use and advertising of the mark "ALCHEM." The defendant filed an application to vacate the interim order. The parties were referred to unsuccessful mediation in 2022. The suit and related applications were heard on multiple dates with the judgment reserved on July 11, 2025, and pronounced on October 10, 2025.

Dispute: The core dispute revolves around the alleged trademark infringement and passing off by the defendant through its use of the mark "ALCHEM," which the plaintiff claims is phonetically and visually similar to the registered mark "ALKEM." The plaintiff contends that the defendant's use causes confusion among consumers, infringing their rights. The defendant denies infringement, asserting concurrent use of its mark since 1985, bona fide adoption derived from the words "Alkaloids" and "Chemicals," and non-overlapping product lines initially limited to bulk drugs and exports. The defendant also alleges plaintiff's acquiescence and laches for delay in filing the suit.

Detailed Reasoning: The Court observed that the marks "ALKEM" and "ALCHEM" are phonetically identical and visually similar to a deceptive extent, which is undisputed. The plaintiff, having adopted and registered "ALKEM" since 1973, is the prior user and proprietor, whereas the defendant adopted "ALCHEM" in 1982 and began retail sales in India only after 2006. The defendant’s registrations remain ungranted in India.

Regarding acquiescence and delay, the Court referred to settled principles from precedent cases. Mere silence or delay by the plaintiff does not amount to acquiescence unless there is positive encouragement of the defendant’s use. The plaintiff issued cease-and-desist notices and filed oppositions against the defendant's trademark applications repeatedly, negating any acquiescence claim. The Court held that delay and laches cannot bar injunctions, especially when public interest and likelihood of confusion exist.

The defendant’s claim of honest concurrent user status was rejected. Despite the defendant’s argument of bona fide adoption due to the composite nature of the word "ALCHEM," the Court pointed out that the defendant knew of the plaintiff’s prior and registered use. The defendant’s expansion of retail activities overlapping with plaintiff’s product range post-2005 demonstrated intent to capitalize on plaintiff’s goodwill, thus negating bona fide use.

On the issue of product similarity and likelihood of confusion, the Court found that both parties dealt in overlapping pharmaceutical and nutraceutical products distributed through the same trade channels. Consumer confusion is likely especially among average consumers, medical practitioners, and pharmacists.

The defense that "ALCHEM" was used only as a source identifier was contradicted by evidence of extensive advertising, prominent display on packaging, and standalone use of the mark by the defendant. Therefore, the defendant’s use was likely to cause confusion, infringing Sections 29(5) and 29(6) of the Trade Marks Act, 1999.

The Court also considered the balance of convenience and irreparable harm. It held that allowing the defendant to continue use would cause confusion and harm to both the plaintiff and the public.

Decision: The Court granted an interim injunction restraining the defendant, its associates, and agents from using the mark "ALCHEM" or any deceptively similar mark in relation to pharmaceutical or medicinal products in India, except in respect of manufacturing and sale of Active Pharmaceutical Ingredients (APIs), where the plaintiff consented to such use. 

Case Title: Alkem Laboratories Ltd. Vs. Alchem International Pvt. Ltd.

Order Date: October 10, 2025

Case Number: CSCOMM 1050/2018

Neutral Citation: 2025:DHC:8992

Court: High Court of Delhi at New Delhi

Hon'ble Judge: Mr. Justice Amit Bansal

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

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

Sequenom Inc and Anr. Vs Controller of Patents

Case Title: Sequenom Inc and Anr. Vs Controller of Patents

Order Date: 9th October 2025

Case Number: C.A.COMM.IPD-PAT 132022 and C.A.COMM.IPD-PAT 4482022

Neutral Citation: 2025:DHC:132022

Court: High Court of Delhi at New Delhi

Hon'ble Judge: Justice Prathiba M. Singh

Fact:

Sequenom Inc., a company registered in the United States, along with its affiliate Sequenom Center for Molecular Medicine, filed two Indian patent applications related to non-invasive prenatal testing (NIPT) methods. These methods involve analyzing fetal nucleic acids present in maternal blood samples to detect fetal abnormalities such as aneuploidy (chromosomal abnormalities), sex determination, and other genetic traits without invasive procedures like amniocentesis. The applications claim methods of methylation-based enrichment of fetal DNA to isolate and analyze specific genetic markers through DNA sequencing and amplification techniques. The applications originated as early as 2011 and 2012 with U.S. priority claims and underwent multiple rounds of claim amendments during prosecution to address objections.

Procedural Detail:

The Indian Patent Office issued First Examination Reports raising objections on multiple grounds, including lack of inventive step, and specifically non-patentability under Sections 3(b), 3(d), 3(i), and 3(j) of the Patents Act, 1970. The rejections were upheld in orders dated 12th December 2019 and 20th January 2020, primarily on the basis that the claimed inventions fall under the exclusion of patentability under Section 3(i), which excludes diagnostic methods from patent protection. The applicants appealed these refusals under Section 117A of the Patents Act to the Delhi High Court. Given the common issue of interpretation of Section 3(i), these appeals were heard in a batch along with other landmark cases including EMD Millipore Corporation. The proceedings included extensive submissions, including those from an appointed Amicus Curiae, and the judgment was reserved on 21st December 2024 and pronounced on 9th October 2025.

Dispute:

The central dispute revolved around the scope and application of Section 3(i) of the Indian Patents Act, 1970, relating to the exclusion from patentability of diagnostic methods. The appellants contended that their invention relates to a non-invasive screening test (NIPT) rather than a diagnostic method practiced on the human body and therefore should not fall under Section 3(i). They emphasized that the methods merely provide preliminary data and risk assessments without constituting definitive medical diagnosis or treatment. On the other hand, the Patent Office represented by the CGSC argued that the test claims to detect fetal abnormalities with high accuracy and results in clinical decisions, thus qualifying as diagnostic methods excluded from patentability. They contended that Section 3(i) does not distinguish between in vivo and in vitro methods and captures any method intended for diagnosis or treatment performed on humans or animals. The scope of exclusion includes methods practiced in laboratories on human samples having diagnostic purposes. The issue of inventive step was also raised but not primarily decided.

Detailed Reasoning:

The court undertook a detailed examination of the language of Section 3(i), which excludes from patentability "any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals." It reviewed precedents and legislative history including the amendments introduced post-TRIPS, the underlying public policy to safeguard freedom of medical practitioners from patent restrictions, and the need to balance this against incentivizing innovation.

Comparative analysis with foreign laws was undertaken with detailed references to Section 4A of the UK Patents Act 1977 and Article 53(c) of the European Patent Convention (EPC) 2000, both of which exclude methods of treatment or diagnosis practiced on the human or animal body but expressly allow patents for substances or compositions for use in such methods. The Enlarged Board of Appeal decisions of the EPO in Cases G 000104 and G 000107 were a key focus, elucidating that diagnostic methods are multi-step processes involving collecting and comparing data, followed by identifying deviations and making deductive medical evaluations. Such multi-step diagnostic methods practiced on the human or animal body require professional medical judgment and carry health risks, which justifies their exclusion.

The court clarified that the exclusions apply narrowly to processes that are core medical activities involving intellectual diagnostic decision-making performed on living bodies. Ancillary or supporting processes, especially in vitro laboratory techniques without final diagnosis or treatment steps, fall outside the exclusion and qualify for patent protection. Further, diagnostic tools, instruments, machines, and products remain patentable if they fulfill patentability criteria.

The court delved into the specifications and claims of the patent applications, noting that the inventions relate to in vitro non-invasive procedures analyzing fetal DNA from maternal blood without direct interaction with the body and without final diagnostic conclusions. The inventions primarily relate to identifying probabilities and risks, distinguishing them from definitive diagnostic processes. The court highlighted the distinction between screening tests and diagnostic tests, based on medical literature and case law, including the recent decision of the Madras High Court in Chinese University of Hong Kong v. Assistant Controller of Patents. Screening tests identify a need for further confirmatory diagnosis, whereas diagnostic tests confirm presence or absence of disease requiring clinical decision and possible treatment.

The court rejected the patent office's argument that all screening tests fall under Section 3(i) if they relate to diagnosis in a broad sense, stating that statutory interpretation demands a narrower reading. It was found that in vitro laboratory tests designed merely for data gathering or analysis supporting subsequent diagnosis by medical professionals do not constitute excluded diagnostic methods.

The court also considered the legislative history, observing that Section 3(i) was introduced with intent to harmonize Indian law with global standards while preserving medical practitioners' autonomy. It pointed out that unlike EPC and UK law that specify that the exclusion applies to diagnostic methods "practiced on the human or animal body," Indian law’s text does not contain this phrase, making in vitro diagnostic methods potentially subject to exclusion. However, the court adopted a purposive interpretation to avoid stifling innovation in biotechnological and medical research fields and not unduly broadening exclusions.

On the amendments and claims, the court noted the applications had undergone significant prosecution and claims restriction to comply with patentability standards. It emphasized that inventions providing novel technical methods of analyzing biological samples while not constituting direct diagnostic processes are patentable.

Decision:

The court allowed the appeals primarily holding that the claimed inventions in both patent applications do not fall under the exclusion of Section 3(i) of the Patents Act. The inventions constitute non-invasive prenatal screening tests, involving in vitro analysis outside the human body, and do not amount to diagnostic methods involving direct diagnosis or treatment by medical professionals. Consequently, the inventions are patentable subject matter. The court directed the patent office to grant the patents after completing formalities. The court clarified that patent exclusions should be narrowly construed to protect medical practice autonomy without hindering technological innovation. The judgments provide authoritative guidance on interpreting Section 3(i), balancing between innovation incentives and public health policy.

Legal Provisions Discussed:

Section 3(i) of the Patents Act, 1970 – Exclusion of medicinal, surgical, diagnostic, therapeutic processes

Sections 21(j) and 21(ja) – Novelty and Inventive Step

Section 59 – Amendments to Patent Applications

Section 117A – Appeals to High Court against Controller decisions

Article 27.3 of TRIPS Agreement – Flexibility to exclude certain inventions from patentability

Section 4A of UK Patents Act, 1977 – Methods of treatment or diagnosis exclusion

Article 53(c) EPC 2000 – Exceptions to patentability for diagnostic methods practiced on the human or animal body

Enlarged Board of Appeal Decisions G 000104 and G 000107 – Interpretation of diagnostic and surgical methods

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and 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 for Legal Research Paper:

1. "Interpreting Section 3(i) of the Indian Patents Act: A Comprehensive Analysis of Sequenom Inc. Case"

2. "Diagnostic Methods and Patent Exclusions: Lessons from the Delhi High Court on Non-Invasive Prenatal Testing"

3. "Balancing Innovation and Medical Practice Autonomy under Indian Patent Law: The Sequenom Decision"

4. "Narrow Construction of Patent Exclusions for Diagnostic Processes: A Judicial Perspective from Delhi"

5. "Scope of Patentability in Medical Biotechnologies: Analytical Review of Sequenom vs Controller"

Natera Inc and Anr. Vs Assistant Controller of Patents and Designs

Case Title: Natera Inc and Anr. Vs Assistant Controller of Patents and Designs

Order Date: 9th October 2025

Case Number: C.A.COMM.IPD-PAT 162023

Neutral Citation: 2025:DHC:162023

Court: High Court of Delhi at New Delhi

Hon'ble Judge: Justice Prathiba M. Singh

Fact:

Natera Inc, a California-based company specializing in clinical genetics including cell-free DNA testing technology, along with UCL Business Ltd., filed an Indian patent application on 5th September 2019 titled "Methods for Lung Cancer Detection." The invention concerns a laboratory method to detect and monitor genetic mutations associated with lung cancer, specifically lung squamous cell carcinoma (a type of non-small cell lung cancer), by amplifying and sequencing tumor-derived DNA from blood samples. The method involves performing multiplex PCR amplification on nucleic acids isolated from blood or its fractions, followed by the analysis of single nucleotide variants (SNVs) associated with lung cancer. The technology is characterized by high sensitivity and the ability to detect mutations relevant for diagnosis, staging, and monitoring. The appellants claimed priority from a U.S. application dated 15th April 2016 and filed multiple amended claims through prosecution to refine the scope.

Procedural Details:

The Indian Patent Office issued a First Examination Report (FER) dated 31st August 2021 raising objections including lack of novelty and inventive step under Sections 21(j) and 21(ja), non-patentability under Sections 3(d) (improvement) and 3(i) (diagnostic exclusion), and non-compliance with formalities under Sections 104(c) and related procedural rules. The appellants responded with amended claims, reduced from 54 to 15 and finally to 8 claims. A hearing was conducted on 9th January 2023, but the application was refused by the Assistant Controller of Patents via order dated 20th March 2023 primarily on the ground that Claims 1 to 4 were excluded from patentability under Section 3(i) of the Patents Act, as the method was diagnostic for lung cancer detection. Claims 5 to 8 were held impermissible by Section 59 because they were considered beyond the scope of the original specification. The appellants challenged this refusal before the Delhi High Court under Section 117A of the Patents Act.

Dispute:

At the core lies the interpretation of Section 3(i), which excludes from patentability methods for diagnosis practiced on humans or animals. The appellant argued that the invention was a laboratory, in vitro process for detecting the presence of specific genetic variants associated with lung squamous cell carcinoma and did not itself constitute a diagnostic method practiced on the human body. They contended the claims were related to research, predisposition testing, and monitoring, not treatment or diagnosis requiring professional judgment. The respondent (Patent Office) insisted that since the complete specification described the method as improving detection, diagnosis, staging, screening, and treatment of lung cancer, the claims fell squarely within the non-patentable subject matter under Section 3(i). Further, the respondent maintained claims 5-8 were impermissible amendments beyond the original scope, violating Section 59.

Detailed Reasoning:

The Court carefully examined the language of Section 3(i) of the Patents Act, 1970, which excludes from patentability "any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals..." The Court reviewed similar provisions in foreign jurisdictions, notably the UK Patents Act 1977 and Article 53(c) of the European Patent Convention (EPC), which excludes methods of diagnosis practiced on the human or animal body but allows patents on substances or compositions used in those methods.

The Court referenced the landmark Enlarged Board of Appeal decisions of the European Patent Office defining diagnostic methods as multi-step processes practiced on the body, including: collecting data, comparing this with standard values, identifying deviations, and reaching a diagnostic decision. The exclusion applies narrowly to core medical activities that require professional skill and pose health risks, ensuring medical practitioners can diagnose and treat without infringing patents.

The subject matter of the invention was found to be an in vitro laboratory technique that amplifies and sequences nucleic acids from blood samples without direct diagnostic acts on the human body. The Court observed that the method provides genetic data related to tumor mutations but does not itself perform diagnosis, treatment, or clinical decision-making. The Court also noted that distinguishing between in vivo (on the body) and in vitro (outside the body) diagnostic methods is key: Section 3(i) does not distinguish them explicitly but the context and judicial interpretation limit exclusion to processes practiced on living bodies.

The Court further examined the detailed claims and specification, finding them aimed at detecting the presence of lung squamous cell carcinoma-associated single nucleotide variants in blood samples. The invention facilitates early detection, monitoring, and research but does not make a medical diagnosis or prescribe treatment. Hence, the Court held the process qualifies for patentability under Indian law as it falls outside the exclusion of Section 3(i).

On the question of claims 5 to 8, the Court considered Section 59 of the Act restricting amendment beyond disclaimers, corrections, or explanations. The appellants argued these claims were supported by earlier PCT claims and thus should be allowable without extending original scope. The Court referenced precedents including Axcess Limited v Controller of Patents (2024) and Allergan Inc. v Controller of Patents (2023) which endorse allowance of amendments within the scope of the original application. The Court found that these claims were within the ambit of the original specification and supported by original filings, therefore rejecting the Patent Office's objection under Section 59.

The Court also reviewed the inventive step objections but clarified that these were not examined in the impugned order and were to be decided separately.

In conclusion, the Court adopted a balanced interpretation of Section 3(i), ensuring the protection of genuine medical diagnostic processes practiced on living beings from patent monopolies to safeguard public health, while protecting innovative technical methods and tools used in diagnostics outside the human body.

Decision:

The appeal was allowed. The impugned order refusing the patent application was set aside. The Court held that Claims 1 to 4 do not fall under the non-patentable exclusions of Section 3(i) as the invention constitutes an in vitro laboratory method and not a diagnostic method practiced on the human body. Claims 5 to 8 were also held to be permissible amendments under Section 59 of the Act as they did not extend beyond the original scope. The Patent Office was directed to grant the patent after completion of formalities. The Court emphasized that the ruling strikes a balance between public interest and incentive for innovation and clarified interpretation principles for Section 3(i) exclusions to aid consistent patent examination in future.

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

EMD Millipore Corporation Vs Assistant Controller of Patents and Designs

Diagnostic Processes and Patent Eligibility

Fact: The appellant, EMD Millipore Corporation, a U.S.-based corporation, filed a patent application bearing No.1026/DEL/2012 in India on 3rd April 2012 titled "Devices and Methods for Infrared (IR) Based Quantitation of Biomolecules." The invention concerns a method for the quantitative analysis of biomolecules in various types of samples including human plasma, food, cosmetics, and environmental samples using infrared spectroscopy. The appellant claimed priority from a U.S. patent application and amended the claims multiple times during prosecution, finally seeking patent protection for a technical innovation. The key object of the invention was to improve efficiency in IR spectroscopic analysis by reducing repeated calibration and enabling reuse of calibration data. Despite amendments to overcome objections, the Assistant Controller of Patents and Designs refused the application by order dated 18th February 2021 on the ground that the claims fall under the non-patentable subject matter exclusion of Section 3(i) of the Indian Patents Act, 1970, which excludes diagnostic processes from patentability.

Procedural Detail: The appellant challenged the refusal under Section 117A of the Patents Act before the High Court of Delhi. The appeal proceeded through multiple hearings from 2021 onwards. The court sought additional reports from the patent office concerning the novelty and inventive step of the claims. A significant issue considered was the correct interpretation and scope of the exclusion clause under Section 3(i) of the Act, which bars patentability of diagnostic methods. The court appointed an Amicus Curiae to assist with submissions on complexity related to the interpretation of Section 3(i). The matter involved detailed examination of foreign jurisprudence, including decisions from the European Patent Office (EPO) on exclusions for diagnostic methods. Judgment was reserved in December 2024 and pronounced in October 2025.

Dispute: The fundamental dispute centered on whether the subject invention qualifies as a diagnostic process excluded from patentability under Section 3(i) of the Patents Act or whether it qualifies as a patentable technical method. The appellant contended that the invention was an innovative technical process improving IR spectroscopic quantitation applicable across industries and should not be barred. The respondent, represented by the Assistant Controller, argued that the invention was a diagnostic method within the scope of Section 3(i) and thus non-patentable, emphasizing that the exclusion applies broadly to diagnostic methods regardless of their in vivo or in vitro nature. Issues surrounding the legislative history of Section 3(i), international obligations under TRIPS, and Indian patent policy balances between innovation and public health were debated.

Detailed Reasoning: The court undertook a comprehensive examination of the legal framework, including Indian patent law, legislative history, and international precedents. The court noted that Section 3(i) of the Patents Act excludes "any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products" from patentability. The appellate court analyzed the corresponding provisions in foreign jurisdictions like the UK's Patents Act 1977, Article 53(c) EPC 2000, and jurisprudence from the European Patent Office's Enlarged Board of Appeal (notably Case G 000104). The court emphasized that diagnostic methods excluded under these laws are typically multistep processes involving examination, data gathering, comparison, symptom detection, and clinical decision-making practiced directly on the human or animal body.

It was clarified that the exclusion's purpose was to free medical practitioners from patent constraints when applying core diagnostic procedures requiring professional judgment and bearing health risks. However, patentability is not barred for diagnostic tools, instruments, or technical processes that do not themselves constitute a diagnostic method practiced on the living body.

The court thoroughly examined the appellant's patent claims and the specification, observing that the invention was directed to an in vitro technical process using infrared spectroscopy for biomolecular quantitation on samples that could be biological fluids but also included broad categories like cosmetics, food, water, and fuels.

Conclusion: The court concluded the invention did not involve any step constituting diagnosis for curative purposes or clinical decision-making performed on or practiced on a human or animal body. The method improved the technical aspect of IR spectroscopic measurement rather than the intellectual exercise of diagnosis itself. Furthermore, the court noted the patent had been granted in jurisdictions including the United States and Europe, where comparable exclusions exist, supporting its patentability.

The role and intent of Section 3(i) were revisited in light of legislative history and international trade commitments under TRIPS. The court held that the section was intended to exclude medical procedures requiring practitioner skill and direct interaction with the patient, but not to bar patents on inventions involving technical methods or devices that facilitate analysis or diagnostics without constituting a disallowed diagnostic method.

The court also discussed the permissibility of claims amendments during appeals under Section 59 of the Act, confirming that amendments clarifying or narrowing claims within the original disclosure are allowed. The appellant's amendments were found to be within permissible limits and did not expand the scope of the invention.

Decision: The appeal was allowed. The impugned order refusing the patent application was set aside, as the claimed invention does not fall within the exclusion of Section 3(i) of the Patents Act. The court directed the patent office to proceed with the grant of the patent to the appellant after completion of formalities. The court emphasized that the exclusion applies narrowly to core diagnostic processes practiced on the human or animal body and does not extend to technical innovations or in vitro processes. Hence, the appellant's method for IR-based quantitation of biomolecules qualifies for patent protection. The court relied heavily on the Enlarged Board of Appeal, EPO decision G 000104, setting out the multi-step definitional framework for diagnostic methods and the distinction between in vivo diagnostic processes and technical methods or tools. In sum, the judgment clearly elucidates the boundary between non-patentable diagnostic processes and patentable technical innovations, guiding future patent prosecution in medical technology fields in India.

Case Title: EMD Millipore Corporation Vs Assistant Controller of Patents and Designs

Order Date: 9th October 2025

Case Number: C.A.COMM.IPD-PAT 7/2021

Neutral Citation: 2025:DHC:8928

Court: High Court of Delhi at New Delhi

Hon'ble Judge: Justice Prathiba M. Singh

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

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