F. Hoffmann-La Roche AG & Anr. Vs. Zydus Lifesciences Limited

Section 104A of Patent Act 1970 and Disclosure Challenges in Biologic Patent Litigation

Introduction: The case of F. Hoffmann-La Roche AG & Anr. versus Zydus Lifesciences Limited represents a significant patent infringement dispute in the realm of biological drugs, specifically concerning the monoclonal antibody Pertuzumab, used in treating breast cancer. 

This case, adjudicated by the High Court of Delhi, centers on the plaintiffs’ attempt to protect two Indian patents related to Pertuzumab’s formulation and manufacturing process against alleged infringement by the defendant’s similar biologic product. The core issue revolves around the plaintiffs’ application for the constitution of a confidentiality club to access the defendant’s manufacturing process, invoking provisions of the Patents Act, 1970, and the Commercial Courts Act, 2015. 

Factual Background: The plaintiffs, F. Hoffmann-La Roche AG and its affiliate, hold two Indian patents relevant to this dispute. The first, Indian Patent No. IN 268632, titled “Pharmaceutical Formulation Comprising HER2 Antibody,” is a product patent covering an aqueous pharmaceutical formulation of Pertuzumab with specific excipients, including sucrose and a histidine acetate buffer, maintaining a pH between 5.5 and 6.5. The second, Indian Patent No. IN 464646, titled “Pertuzumab Variants and Evaluation Thereof,” is a process patent detailing a method for producing a composition comprising Pertuzumab and its variants, such as unpaired cysteine variants and low- or high-molecular-weight species. These patents underpin the plaintiffs’ commercial product, Perjeta, a prescription medicine approved in the United States in 2012 and India in 2014 for treating early-stage and metastatic breast cancer by inhibiting HER2 receptor dimerization. 

The defendant, Zydus Lifesciences Limited, an Indian pharmaceutical company, sought regulatory approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell a similar biologic, ZRC-3277, using the plaintiffs’ Perjeta as the reference biologic in its clinical trial application filed on September 9, 2021. 

The plaintiffs, upon discovering this through CDSCO’s Subject Expert Committee recommendations in January 2024 and a Clinical Trial Registry of India document, filed a quia timet suit, apprehending that the defendant’s product would infringe their patents. The defendant countered that Pertuzumab itself is not patented, as it was disclosed in prior art (WO/2001/00245) and that their product, using an arginine citrate buffer, differs from the plaintiffs’ formulation and process.

Procedural Background: The suit, filed as CS(COMM) 159/2024, was accompanied by multiple interlocutory applications, including I.A. 4196/2024 and I.A. 33509/2024 for interim injunctions, and I.A. 5827/2024, the focus of this case study, seeking the constitution of a confidentiality club to access the defendant’s manufacturing process. Summons and notice were issued on February 23, 2024, when the court directed the plaintiffs to conduct claim mapping for the product patent (IN 632) against the defendant’s patent application. 

The defendant filed its manufacturing process under a sealed cover on March 22, 2024. The plaintiffs’ application for interim injunction (I.A. 33509/2024) was dismissed on October 9, 2024, but this was overturned by a division bench on October 16, 2024, remanding the matter back to the single judge. The defendant challenged this via a Special Leave Petition before the Supreme Court, leading to the lapse of an ad interim injunction on November 21, 2024. The plaintiffs subsequently chose not to press the interim injunction applications, focusing instead on I.A. 5827/2024. 

Core Dispute:The central issue in this case was whether the plaintiffs were entitled to access the defendant’s manufacturing process for their similar biologic, ZRC-3277, through a confidentiality club to determine if it infringed the plaintiffs’ process patent (IN 646)? The plaintiffs argued that the defendant’s designation of Perjeta as the reference biologic in its CDSCO application implied that their product and process were substantially similar, necessitating disclosure to map the claims of IN 646. They contended that Section 104A of the Patents Act, which shifts the burden of proof in process patent infringement cases, was inapplicable at this stage and that discovery provisions under the Commercial Courts Act, 2015, should govern. 

The defendant countered that Section 104A’s prerequisites—proving that the products are identical and that the patented process likely produces the defendant’s product—must be met before disclosure could be ordered. They argued that their product, a similar biologic, was not identical to the plaintiffs’ product (Pertuzumab plus variants) and that their process, using a different buffer, did not infringe IN 646. The dispute thus hinged on the interpretation of Section 104A, the nature of biologics, and the balance between discovery rights and proprietary protections.

Discussion on Judgments: Several judgments were cited by the parties to support their positions, each contextualized within the arguments over disclosure and Section 104A’s applicability. 

The plaintiffs relied on F. Hoffmann-La Roche v. Drugs Controller General of India (2025 SCC OnLine Del 934), where a coordinate bench allowed discovery under the Commercial Courts Act, 2015, noting that Section 104A was irrelevant because the patents in that case had expired. The court in the present case distinguished this, emphasizing that IN 646 was valid, making Section 104A applicable. The plaintiffs also referenced Roche Products v. Drugs Controller General of India (2016 SCC OnLine Del 2358), which clarified that biologics cannot be identical due to their synthesis by living organisms, arguing that Section 104A’s “identical product” requirement was impractical for biologics. The court rejected this, noting that the 2016 case did not address Section 104A directly. 

The defendant cited Natural Remedies Pvt. Ltd. v. Indian Herbs Research and Supply Co. Ltd. (O.S. No. 1 of 2004, Karnataka High Court, dated December 9, 2011), where the court held that Section 104A requires proof of identical products before compelling disclosure, and disclosure is not warranted at the pleading or evidence stage unless the patent’s validity and product identity are established. The court in the present case endorsed this, applying it to deny premature disclosure. The defendant also relied on Bristol-Myers (unspecified citation, referenced in the context of an interim injunction appeal), which supported the application of Section 104A at interlocutory stages, reinforcing the need for plaintiffs to meet statutory thresholds. Additionally, the defendant cited Telefoniaktiebolaget LM Ericsson (PUBL) v. Competition Commission of India , which established that the Patents Act, as a special statute, prevails over general laws like the Commercial Courts Act, supporting the primacy of Section 104A. Finally, the defendant referenced Pfizer Ireland Pharmaceuticals v. Samsung Bioepis (MANU/AUF/0847/2017, Federal Court of Australia), which held that similarity in biologics does not imply identical processes, bolstering their argument that their similar biologic did not necessarily infringe IN 646.

Reasoning and Analysis of the Judge : Court focused on the applicability and scope of Section 104A of the Patents Act, which allows courts to shift the burden of proof to the defendant in process patent infringement suits if the plaintiff proves that the defendant’s product is identical to the product of the patented process and that the process is either novel or substantially likely to have been used. The court emphasized that Section 104A is a statutory exception to the general evidentiary principle that the plaintiff bears the burden of proof, but it is not automatic and requires fulfilling specific conditions. 

The court rejected the plaintiffs’ argument that Section 104A applies only at the final adjudication stage, citing Natural Remedies and Bristol-Myers to affirm its relevance at interlocutory stages. The court further held that disclosure of the defendant’s process is integral to Section 104A, as sub-section (2) explicitly protects against unreasonable disclosure of trade secrets, indicating that disclosure requests fall within its ambit. 

The plaintiffs’ reliance on the Commercial Courts Act’s discovery provisions (Order XI Rules 1(7), 1(12), and 5) was dismissed, as the court, citing Ericsson, ruled that the Patents Act, as a special statute, prevails over general laws. Regarding biologics, the court acknowledged the plaintiffs’ argument, supported by Roche Products, that biologics cannot be identical due to their complex synthesis, but held that Section 104A’s “identical product” requirement is a deliberate legislative choice that cannot be diluted. The court analyzed the Guidelines on Similar Biologics, 2016, noting that a similar biologic requires only comparable safety, efficacy, and quality, not identical processes, and cited Pfizer to reinforce that similarity does not imply process infringement. 

The court found that the plaintiffs failed to prove that the defendant’s product, ZRC-3277, was identical to the product of IN 646 (Pertuzumab plus variants), as the defendant’s CDSCO application referenced Perjeta, which the plaintiffs admitted was prior art, not the patented composition. The plaintiffs’ claim mapping for IN 632 showed differences (arginine citrate vs. histidine acetate buffer), further undermining their case. Thus, the court concluded that the plaintiffs did not meet Section 104A’s prerequisites, precluding disclosure.

Final Decision: The court dismissed the plaintiffs’ application (I.A. 5827/2024) for the constitution of a confidentiality club and disclosure of the defendant’s manufacturing process, finding no merit in the request. The court clarified that its observations were limited to the application and would not affect the suit’s final adjudication. 

Law Settled in This Case:This case clarifies several aspects of patent law in India, particularly for process patents involving biologics. It establishes that Section 104A of the Patents Act governs disclosure requests in process patent infringement suits, requiring plaintiffs to prove that the defendant’s product is identical to the product of the patented process before compelling disclosure. The court affirmed that this requirement applies at both interlocutory and final stages, rejecting arguments that it is limited to final adjudication. The decision underscores that the Patents Act, as a special statute, prevails over general discovery provisions under the Commercial Courts Act, 2015. For biologics, the court held that the statutory threshold of “identical product” under Section 104A cannot be relaxed to “similar” despite the scientific variability of biologics, preserving the legislature’s intent. The case also highlights that regulatory filings citing a reference biologic do not automatically indicate process infringement, as similar biologics may employ different manufacturing processes.

Case Title: F. Hoffmann-La Roche AG & Anr. versus Zydus Lifesciences Limited 

Date of Order: July 23, 2025 

Case Number: CS(COMM) 159/2024 

Neutral Citation: 2025:DHC:5927: 

Name of Court: High Court of Delhi at New Delhi 

Name of Judge: Honourable 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

Chemo Healthcare Private Limited Vs. Examiner of Trademarks

Case Title: Chemo Healthcare Private Limited Vs. Examiner of Trademarks & Anr Date of Order: July 18, 2025 Case Number: R/Civil Appeal No. 142/2023 :Name of Court: High Court of Gujarat at Ahmedabad Name of Judge: Honourable Mrs. Justice Mauna M. Bhatt

Chemo Healthcare Private Limited applied for registration of the trademark 'VILDAZE' under Section 18(1) of the Trade Marks Act, 1999, for goods in Class 5, claiming use since December 12, 2019. 

The Examiner of Trade Marks issued a report raising objections under Section 11(1), citing three similar trademarks: 'VILDAZEN' (application no. 4362225, proposed to be used), 'VILDAZEN-MET' (application no. 4362262, proposed to be used), and 'VILDAZEM' (application no. 4492412, claimed use since February 29, 2020). 

The appellant responded, arguing that 'VILDAZE' was distinctive, in use since 2019 without litigation, and that prior use prevailed over the cited marks, which were either proposed or later in use. The Examiner rejected the application on May 23, 2023. 

The appellant challenged this rejection in the High Court of Gujarat under Section 91 of the Act. The court noted that Section 20 allows advertisement of a trademark despite Section 11(1) objections. Finding merit in the appellant's submissions, the court quashed the Examiner's order, directed the Trade Mark Registry to advertise the 'VILDAZE' application within three months, and stated that any opposition would be decided on its merits. The appeal was disposed of, with a copy of the order to be sent to the Trade Mark Registry.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

Bhalla Sports Pvt. Ltd. Vs. Ashutosh Bhalla

Case Title: Bhalla Sports Pvt. Ltd. Vs. Ashutosh Bhalla & Anr Date of Order: July 3, 2025 Case Number: C.O. (COMM.IPD-TM) 327/2022 Neutral Citation: 2025:DHC:5309 Name of Court: High Court of Delhi at New Delhi Name of Judge: Hon'ble Mr. Justice Saurabh Banerjee

Bhalla Sports Pvt. Ltd., a company incorporated in 1988, engaged in manufacturing and marketing sports goods, adopted the trademark 'SOFT TOUCH' in 2001 and applied for its registration in 2009, claiming usage since August 7, 2001. The company invested significantly in promoting the trademark, earning substantial profits and a strong reputation. 

The respondent, Ashutosh Bhalla, Director of Vinex Enterprises Pvt. Ltd., incorporated in 2003, registered the trademark 'SOFT-TOUCH' in 2009, claiming usage from January 9, 2003. Bhalla Sports filed a rectification petition to cancel the respondent's trademark, initially before the Intellectual Property Appellate Board, which was transferred to the Delhi High Court after the Board's abolition. 

The respondents, despite being served, did not appear or file replies, leading to their right to respond being closed, and they were proceeded ex parte. The petitioner argued prior use of 'SOFT TOUCH' since 2001, alleging the respondent's registration was fraudulent and in bad faith, as it was aware of the petitioner's prior market presence. 

The petitioner claimed the respondent's mark was identical or deceptively similar, violating Sections 9, 11, 47, and 57 of the Trade Marks Act, 1999. The court found the petitioner's claims unopposed, supported by documents like invoices and brochures proving prior use. 

The court held that the petitioner's prior use granted superior rights over the respondent's later registration, citing precedent from Neon Laboratories Ltd. v. Medical Technologies Ltd. The respondent's non-appearance suggested bad faith, constituting unfair practice. 

The court allowed the petition, directing the Registrar of Trade Marks to cancel the respondent's 'SOFT-TOUCH' trademark (application no. 1796255, Class 28) and remove it from the Register. The petition was disposed of, with an order for the Registrar to comply.

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

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

Sonu Nigam Vs. Sonu Nigam Singh

Sonu Nigam Vs. Sonu Nigam Singh & Ors.:11.07.2025:COMM IPR SUIT (L) NO.20577 OF 2025: High Court of Bomaby:Hon’ble Mr. Justice R.I. Chagla H.J.

The plaintiff, Sonu Nigam, a well-known and acclaimed singer with a successful career spanning over three decades, approached the court seeking protection against unauthorized use of his name and persona by the defendants. He submitted that the defendant no.1, whose legal name is Sonu Nigam Singh, was misusing the name "Sonu Nigam" professionally for performance and promotional purposes. The plaintiff emphasized that his name has acquired distinctiveness and is synonymous with his identity and goodwill, thus qualifying for protection under the principles of personality rights and passing off.

The plaintiff stated that despite his legal name, defendant no.1’s adoption and commercial use of the name “Sonu Nigam” was deceptive, amounting to a misrepresentation that misled the public into believing an association with the plaintiff. It was also alleged that the defendants were profiting from the plaintiff’s long-established goodwill. The plaintiff had issued a cease-and-desist notice , but the defendants failed to comply. As a result, the plaintiff initiated a suit seeking a permanent injunction and related reliefs for violation of personality rights, passing off, and misappropriation of identity.

It noted that the defendant no.1, despite bearing the legal name “Sonu Nigam Singh”, was intentionally using only the name “Sonu Nigam” for promotional and professional activities to benefit from the plaintiff’s fame. The court emphasized that every individual has an exclusive right to their personality, including control over the commercial use of their name, likeness, and reputation. The court was of the view that a mere legal coincidence of names does not justify misleading the public, especially in a professional context where confusion is likely.

The court held that the plaintiff had made out a strong prima facie case and that irreparable harm would be caused if the defendants were not restrained. It confirmed the interim injunction previously granted and directed the defendants to refrain from using the name “Sonu Nigam” or any variant thereof in a manner that creates confusion or suggests association with the plaintiff. The matter was posted for further proceedings.

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

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

Play Games 24X7 Private Limited Vs. WWW10XBETTCOM

Play Games 24X7 Private Limited Vs. WWW10XBETTCOM & Ors.:10.07.2025: CS(COMM) 657/2024:High Court of Delhi:Hon’ble Mr. Justice Saurabh Banerjee

The plaintiff, Play Games 24X7 Private Limited, is the registered proprietor of the trademark “MY11CIRCLE”, a well-known online fantasy sports gaming platform. The plaintiff had earlier secured an ex parte ad interim injunction on 07.08.2024 against 14 rogue websites engaged in infringing its trademark. The present order pertains to the plaintiff’s fresh application for impleadment of newly discovered infringing entities and for extending the earlier injunction to them.

After the earlier injunction, the plaintiff discovered that several new websites were unlawfully using its trademark “MY11CIRCLE” to lure users via dummy webpages, redirecting them to illegal betting platforms. The plaintiff therefore filed an application to implead new defendants, including additional rogue websites, domain name registrars (DNRs), and intermediaries, and sought extension of injunctive relief.

The court allowed the impleadment of Defendant Nos. 28 to 35, noting that some were running deceptive websites, others were using the plaintiff’s trademark in domain names, and the rest were domain name registrars of such infringing entities. It was found that the defendants had replicated the plaintiff’s mark and online identity to mislead users into believing in an association with the plaintiff’s brand, thereby promoting illegal betting services.

Given the seriousness of the plaintiff’s grievance and the public interest concerns involved, the court extended the original injunction order dated 07.08.2024 to cover the newly impleaded defendants. It restrained Defendant Nos. 28 to 32 from using the mark “MY11CIRCLE” or any deceptively similar trademark or domain name. 

Additionally, Defendant Nos. 33 to 35, being DNRs, were directed to block and suspend the infringing domains and to disclose subscriber and account registration details in a sealed cover. Internet intermediaries were also directed to immediately block access to the infringing websites, including any other John Doe entities misusing the plaintiff’s mark.

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

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

M and B Engineering Ltd. Vs. Laxman D. Nagare DBA Swaraj Roofing Solutions:

M and B Engineering Ltd. Vs. Laxman D. Nagare DBA Swaraj Roofing Solutions: 17.07.2025: CS(COMM) 495/2025: High Court of Delhi:Hon’ble Mr. Justice Saurabh Banerjee

The plaintiff, M and B Engineering Limited, is a company engaged in the business of manufacturing and selling various roofing products across India and globally since 2001. The plaintiff is the proprietor of the trademark ‘PROFLEX’ and its associated label marks, holding multiple registrations in Class 19 and claiming copyright over the associated trade dress. The plaintiff promotes its products through its official website and third-party platforms, and its trademarks have acquired considerable goodwill and reputation.

The plaintiff discovered in early 2023 that Defendant No. 1, Mr. Laxman D. Nagare, was using the mark ‘Proflex Roofing System’ in relation to similar roofing products. A cease-and-desist notice was issued on 18.12.2023, followed by a reminder on 27.03.2024. Although Defendant No. 1 assured discontinuation of use, the plaintiff found that the infringing usage resumed in April 2025 through the defendant’s website and e-commerce platforms operated by Defendant Nos. 2 and 3.

The plaintiff filed the suit seeking permanent injunction, damages, and other reliefs for infringement, passing off, and copyright violation. The court noted that the impugned mark adopted by Defendant No. 1 prominently used the word ‘PROFLEX’, a coined term already registered in the name of the plaintiff. The addition of the words ‘Roofing System’ was found to be insufficient to distinguish the infringing mark from the plaintiff’s trademarks. The court observed that the defendants were operating in the same industry, through similar trade channels, and targeting the same customer base, thereby enhancing the likelihood of confusion.

The court found that Defendant No. 1’s actions appeared to be aimed at exploiting the goodwill associated with the plaintiff’s trademarks. The similarity was so close that an average consumer with imperfect recollection could easily be misled. It was also considered that the continued unauthorized use would result in irreparable harm to the plaintiff and deceive the public.

The court concluded that the plaintiff had established a prima facie case and granted an ad interim ex parte injunction restraining Defendant No. 1 from manufacturing, marketing, selling, or advertising any roofing products using the mark ‘PROFLEX’ or any deceptively similar mark. 

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

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

G4S Limited Vs G S 4 Security Management Pvt. Ltd.

G4S Limited Vs  G S 4 Security Management Pvt. Ltd.: 15.07.2025: CS(COMM) 698/2025: High Court of Delhi:Saurabh Banerjee, H.J.

The plaintiffs, G4S Limited and its Indian affiliate, filed a commercial suit before the High Court of Delhi seeking permanent injunction, passing off, declaration of their trademark as a well-known mark, rectification of the defendants’ tradename, and damages. The plaintiffs are globally recognized providers of integrated security services and have been operating under the trademark “G4S” and its stylized forms since 1989. Their registrations cover multiple classes including Classes 9, 35, 37, 38, 39, and 42, and they operate websites under the domains www.g4s.com and https://www.g4s.com/en-in.

The plaintiffs became aware in March 2025 that the defendants were offering identical security services under the deceptively similar mark “GS4” and the tradename “G S 4 Security Management Private Limited”. The defendants were also operating a domain name www.gs4security.in and actively promoting themselves on social media using the impugned mark. Despite a cease-and-desist notice issued on 17.04.2025, the defendants refused to comply and continued their infringing activities.

The plaintiffs alleged that the defendants had adopted the mark “GS4” by merely rearranging the characters in “G4S”, and used similar font, color, and style in an effort to mislead the public and trade into believing an association with the plaintiffs. The mark “G4S” being coined, distinct and globally reputed, any such mimicry posed a serious risk of deception and confusion among consumers, especially since the services concerned public safety and security.

Upon hearing the plaintiffs, the court noted that the impugned mark “GS4” was structurally, phonetically, and visually similar to “G4S”. The court further observed that such minimal modifications were hardly noticeable to an average consumer with imperfect recollection, and that the defendants had attempted to come deceptively close to the plaintiffs' well-known brand. The court underscored the significance of preventing public confusion in services related to security, where trust in the brand is paramount.

The court held that the plaintiffs had made out a prima facie case and that the balance of convenience lay in their favour. In view of the potential irreparable harm to the plaintiffs and the risk of public deception, the court granted an ex parte ad interim injunction restraining the defendants from using the impugned mark or any deceptively similar mark in connection with their security services until the next date of hearing.

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

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

Dr. Reddy's Lab Ltd. Vs. Ms. Sarita Trading as Vensia Herbals

Dr. Reddy's Lab Ltd. Vs. Ms. Sarita Trading as Vensia Herbals :10.07.2025:CS(COMM) 678/2025: High Court of Delhi:Saurabh Banerjee,H.J.

The plaintiff, Dr. Reddy’s Laboratories Limited, a well-established pharmaceutical and cosmetic products manufacturer incorporated in 1985, filed a suit seeking permanent injunction and other reliefs including passing off, dilution, tarnishment, damages, rendition of accounts, and delivery up against Ms. Sarita trading as Vensia Herbals and other related entities. The plaintiff has been marketing its skincare products under the coined and registered trademark ‘VENUSIA’ since 2002 (Class 5) and 2018 (Class 3), which has gained wide recognition in India and abroad. It also runs a dedicated website under the domain www.drreddysvenusia.com.

In January 2025, the plaintiff discovered that Defendant No. 1, a proprietorship firm, and Defendant No. 2, operating the website www.vensiaherbals.com, were selling skin care products under the deceptively similar mark ‘VENSIA’. They had also applied for registration of the impugned marks under Class 3 and 5. The plaintiff claimed that the infringing mark was visually, structurally, and phonetically similar to ‘VENUSIA’, with only a minor modification by omitting the letter ‘U’. The plaintiff asserted that this act was deliberate to deceive consumers and implied a connection with the plaintiff’s established brand.

The matter was brought before the court through an application seeking urgent ad interim relief on grounds of infringement. The court noted that the defendant’s mark ‘VENSIA’ was deceptively similar to the plaintiff’s ‘VENUSIA’, especially since both marks were used for similar categories of pharmaceutical products meant for human use. The court emphasized that such deceptive similarity could cause irreparable harm to both the plaintiff and the general public due to the sensitive nature of the products.

After examining the pleadings, documents, and comparative product images, the court held that the plaintiff had made a prima facie case for infringement. The balance of convenience favored the plaintiff, and there was a serious risk of public deception.

Consequently, the court granted an ad interim injunction restraining Defendant Nos. 1 and 2, and all persons acting on their behalf, from manufacturing, selling, advertising, or offering for sale any goods under the impugned mark ‘VENSIA’. The court further directed the relevant domain registrar and online platforms to block access, de-index, or take down infringing content and listings, and directed the defendants to disclose all platforms where the infringing products were listed. The matter was renotified for further proceedings.

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

Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.

Harmohini Sarna Vs. Govt of NCT of Delhi

Case Title: Harmohini Sarna Vs. Govt of NCT of Delhi Case No.: W.P.(C) 9445/2017 Date of Order: 28th January 2019 Court: High Court of Delhi Judge: Hon’ble Mr. Justice Vibhu Bakhru Neutral Citation: 2019:DHC:547

The petitioners, relatives residing in Delhi, sought to register a General Power of Attorney (GPA) in favor of Ms. Anjali Sarna for a property located in Haryana. The property’s location was outside the jurisdiction of the Sub-Registrar where the petitioners sought registration. The petitioners contended that since they resided in Delhi, they should be permitted to register the GPA there.

Procedural History:

The Sub-Registrar declined to register the GPA, citing jurisdictional limitations, and the petitioners appealed under Section 72 of the Registration Act, 1908. The appellate authority upheld the refusal, emphasizing that only a Special Power of Attorney (SPA) could be registered under the Minutes of Meeting held on 13.06.2005. The petitioners then challenged these orders before the High Court.

Issue:

Whether the petitioners, residing in Delhi, could register a General Power of Attorney for a property located in Haryana outside the jurisdiction of the Sub-Registrar where the registration was sought, given the provisions of the Registration Act and related circulars?

Decision:

The High Court allowed the petition, observing that the registration was permissible since the petitioners resided in Delhi, and there was no legal bar to registering a GPA there, especially one not creating interest or transferring title. The Court noted that the Registration Act, 1908, permitted registration of Power of Attorney where the principal resided, and existing circulars clarified that such registration could be done in the principal’s jurisdiction, regardless of the property’s location.

Mongia Steel Limited Vs. Saluja Steel and Power Private Limited

Conditional Leave to Withdraw the Suit and Its Legal Consequences

Introduction:The case of Mongia Steel Limited Vs. Saluja Steel and Power Private Limited, decided by the High Court of Jharkhand at Ranchi on 17 July 2025, revolves around a trademark and copyright dispute that highlights the importance of procedural compliance, conditional withdrawal of suits, and the boundaries of initiating fresh litigation. This case underscores the judiciary’s emphasis on enforcing procedural rigour to prevent the misuse of legal processes and also addresses the limitation on reinserting causes of action that were previously abandoned. The decision also explores the intersection of intellectual property law with civil procedure, particularly in the context of claims for trademark and copyright infringement.

Factual Background:Mongia Steel Limited (formerly Mongia Hi-Tech Pvt. Ltd., later Mongia Steel Pvt. Ltd., and ultimately Mongia Steel Ltd.) is a well-established company engaged in the business of manufacturing and marketing various metal products, including TMT Bars, Joist, Channels, and related materials. Since its incorporation in 1995, the company claimed to have adopted and continuously used a series of trademarks and artistic works prominently featuring the word “MONGIA” and a photo device of its director, Mr. Gunwant Singh Mongia, colloquially referred to as the “Device of Sardarji”. The marks were used extensively in advertisements and had gained significant goodwill in the market.

In contrast, Saluja Steel and Power Pvt. Ltd. was incorporated in 2004 by Amarjeet Singh Saluja (brother of Mr. Gunwant Singh Mongia) and his sons. While the company initially did not manufacture TMT Bars, it later entered the market and began using the mark “SALUJA GOLD with Device of Sardarji”, including a bust photograph of Mr. Amarjeet Singh Saluja, which Mongia Steel alleged was deceptively similar to their established mark and get-up. Mongia Steel claimed this imitation led to confusion among the public and amounted to trademark infringement, copyright violation, and passing off.

Procedural Background: The initial suit was filed in 2015 as Title Suit No. 6 of 2015, later renumbered as Commercial Case No. 06 of 2015, before the Commercial Court, Ranchi. Originally, it was a composite suit including claims for trademark infringement, copyright infringement, and passing off. However, the plaintiff later filed an application under Order VI Rule 17 CPC, which was allowed on 03.09.2015, permitting deletion of the copyright claims (Sections 51 and 62 of the Copyright Act, 1957) from the plaint.

Subsequently, Mongia Steel sought to withdraw the suit under Order XXIII Rule 1(3) CPC citing formal defects and inadequacies in prayer formulation. The Commercial Court granted leave to withdraw the suit via order dated 29.09.2020, imposing three explicit conditions: (i) no new or fresh cause of action should be introduced, (ii) no documents issued after the original suit date may be relied upon, and (iii) reliefs must be limited to those contemplated in Paragraph 5 of the withdrawal application.

Pursuant to this, Mongia Steel filed Commercial Case No. 63 of 2020 incorporating claims for trademark infringement, passing off, and notably, copyright infringement — the very claim it had earlier abandoned. The defendant, Saluja Steel, filed an application under Order VII Rule 11 CPC seeking rejection of the plaint on grounds of deviation from the permitted scope. The Commercial Court allowed this application and rejected the plaint on 15.03.2022, concluding that the inclusion of copyright claims constituted a new cause of action. The present appeal was filed against this rejection.

Core Dispute: The crux of the legal controversy was whether Mongia Steel, having voluntarily abandoned its copyright infringement claims in the earlier suit and having received conditional leave to file a fresh suit, could reintroduce those very claims in the new suit? The matter hinged on whether such reintroduction violated the court-imposed conditions and whether it constituted a new cause of action contrary to the bar under Order XXIII Rule 1(3) CPC?

Discussion on Judgments:The appellant relied on the premise that the inclusion of copyright claims was part of a continuous cause of action flowing from the same transactional relationship and, thus, was not “new” in the legal sense. It was argued that the intent to seek such relief was always present but was inadequately pleaded in the earlier suit due to the inefficiency of their earlier counsel.

The respondent cited the order passed by the Commercial Court on 03.09.2015 allowing deletion of copyright claims and the withdrawal order dated 29.09.2020, emphasizing that the leave was explicitly limited and could not be used as a carte blanche to reintroduce previously deleted claims. They also pointed to the potential violation of the limitation period under Article 57 of the Limitation Act, 1963, arguing that reintroduction of copyright claims in 2020 for acts from 2014 was time-barred.

The High Court examined the legal principles laid down by the Supreme Court in V. Rajendran & Anr. v. Annasamy Pandian (Dead) through LRs, (2017) 5 SCC 63, where it was held that withdrawal of a suit under Order XXIII Rule 1(3) CPC requires the court’s satisfaction that the suit suffers from a formal defect or that there are other sufficient grounds, and that the leave must be limited and conditional to avoid abuse. Similarly, Pirgonda Hongonda Patil v. Kalgonda Shidgonda Patil, AIR 1957 SC 363, was referred to affirm the principle that amendments or fresh suits cannot be used to introduce time-barred claims or bypass procedural mandates.

The doctrine of “relation back” was discussed, citing Siddalingamma v. Mamtha Shenoy, (2001) 8 SCC 561, but the Court clarified that this doctrine is not of universal application and can be denied where allowing such relation back would defeat substantive legal defenses, such as limitation.

Reasoning and Analysis of the Judge: The Bench held that the permission to file a fresh suit was granted on clearly stipulated terms, including a prohibition against introducing new causes of action. By deleting the copyright claims through a judicial amendment order in 2015, the plaintiff had effectively confined the original suit to trademark infringement. Consequently, the subsequent inclusion of copyright claims in the fresh suit constituted a clear deviation and amounted to a new cause of action.

The Court emphasized that even if paragraph 5 of the withdrawal application broadly referenced copyright claims, the effect of the prior amendment was that such claims were no longer part of the subject matter of the suit at the time of withdrawal. Allowing reintroduction would violate not only procedural safeguards but also defeat the statutory bar of limitation, since more than three years had passed since the alleged copyright violations.

The Court also rejected the appellant’s argument that the mistake of previous counsel justified the reintroduction. It held that procedural indulgence cannot be used to evade statutory consequences or judicial orders, particularly when the party had knowingly and voluntarily opted to delete certain claims.

Final Decision:The High Court dismissed the appeal and upheld the Commercial Court’s rejection of the plaint. It held that the inclusion of copyright infringement claims in the fresh suit violated the conditions imposed in the order dated 29.09.2020 and amounted to a fresh cause of action. Accordingly, the plaint was correctly rejected under Order VII Rule 11(d) CPC. The Court also observed that allowing such procedural circumvention would create a dangerous precedent and undermine the integrity of judicial orders and the limitation framework.

Law Settled in This Case: This case affirms that when a suit is withdrawn under Order XXIII Rule 1(3) CPC with conditions, those conditions are binding and enforceable. A party cannot, in a subsequent suit, expand the scope of reliefs or reintroduce claims previously deleted or abandoned. Courts will not permit procedural devices to circumvent limitation laws or judicial directions. The decision also reinforces that the inclusion of previously deleted claims after expiry of limitation, even under the guise of procedural correction, constitutes a barred and impermissible cause of action.

Case Title: Mongia Steel Limited vs. Saluja Steel and Power Private Limited

Date of Order: 17 July 2025

Case Number: Commercial Appeal No. 08 of 2023

Neutral Citation: 2024:JHHC:26916-DB

Name of Court: High Court of Jharkhand at Ranchi

Name of Judge: Hon’ble Mr. Justice Sujit Narayan Prasad and Hon’ble Mr. Justice Rajesh Kumar

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

Puja Agarwal Vs. Pravesh Narula

Introduction: The case of Puja Agarwal v. Pravesh Narula before the Delhi High Court involved a challenge under Article 227 of the Constitution of India to an order permitting amendment of a plaint in a commercial intellectual property suit. The dispute centers on whether the inclusion of a trademark infringement plea—post-registration of the trademark during the pendency of the suit—amounts to a change in the nature of the original suit, which had been filed solely for copyright infringement.

Factual Background: The respondent/plaintiff, Pravesh Narula, originally filed CS (COMM) No. 2732/2021 seeking relief in respect of copyright infringement involving a logo bearing the term “RD SPECIAL.” At the time the suit was instituted, the plaintiff had applied for registration of the said mark but the registration had not yet been granted. In paragraphs 3 and 4 of the plaint, the plaintiff detailed the adoption of the trademark/logo “RD SPECIAL” in 1994 and disclosed the pendency of his trademark application under No. 4242962 in Class 25 for goods including socks.

There were no specific pleadings or reliefs sought in the original plaint with regard to trademark infringement or passing off. The suit was limited to copyright infringement based on the alleged unauthorized use of the logo/artistic work by the defendant.

Subsequently, during the pendency of the suit, the trademark registration was granted in favour of the plaintiff. On the basis of this new development, the plaintiff moved an application under Order VI Rule 17 of the CPC to amend the plaint and include a plea of trademark infringement.

Procedural Background: The application seeking amendment of the plaint was allowed by the learned District Judge (Commercial Courts-08), Central District, Tis Hazari, Delhi on 7th April 2025. The amendment was allowed primarily on the ground that the trademark registration had been obtained during the pendency of the suit, and that it was therefore appropriate to allow the plaintiff to amend the plaint accordingly.

The petitioner/defendant, Puja Agarwal, challenged the said order before the Delhi High Court under Article 227. The primary contention was that the amendment effectively altered the nature and character of the original suit from one of copyright infringement to a combined suit including trademark infringement, which was not permissible.

Issues Involved in the Case :The key issue for determination before the Delhi High Court was whether the amendment of the plaint to include a plea of trademark infringement—based on a trademark registration granted after the institution of the suit—amounted to a change in the nature of the suit that ought not to have been allowed? A related issue was whether the Court below had erred by passing a cryptic order that failed to consider the objections of the defendant/petitioner regarding the impermissibility of the amendment under Order VI Rule 17 CPC?

Submissions of the Parties: The petitioner/defendant contended that the Trial Court’s order was cryptic and lacked proper reasoning. It was argued that the amendment fundamentally altered the character of the suit from a copyright action to a trademark infringement suit, which should not have been allowed at such a stage, particularly when it was not pleaded in the original suit.

On the other hand, counsel for the respondent/plaintiff submitted that the only change being introduced by way of amendment was with reference to the newly obtained trademark registration. It was contended that the plaint already contained factual averments regarding adoption and use of the “RD SPECIAL” logo and the pending application for registration. Therefore, the amendment did not introduce a new cause of action but merely expanded the legal grounds of relief flowing from the same set of facts.

Judgments Cited and Their Context: The respondent/plaintiff relied upon the judgment of the Supreme Court in Rajesh Kumar Aggarwal v. K.K. Modi, (2006) 4 SCC 385. In this judgment, the Supreme Court discussed the two limbs of Order VI Rule 17 of the CPC. The first part gives discretion to the court to allow amendments, and the second part mandates that amendments necessary for determining the real question in controversy should be allowed.

The Supreme Court observed that if a cause of action arises during the pendency of a suit, an amendment should be allowed so long as it does not change the fundamental structure of the suit. In that case, it was held that amendments introducing new reliefs based on subsequent events could be permitted if they arose from the same core controversy. The Court emphasized that multiplicity of proceedings should be avoided, and procedural law must serve the ends of justice.

Applying this precedent, the respondent argued that since trademark infringement is a continuing cause of action, and since the factual matrix remained the same, the amendment should be viewed as legally permissible.

Reasoning and Analysis of the Judge:Delhi High Court agreed that the order passed by the Trial Court was indeed cryptic and did not deal with the specific submission that the amendment altered the nature of the suit. However, he proceeded to evaluate the merits of the amendment independently.

Upon review of the original plaint, the court noted that the plaintiff had included factual details about the adoption and use of the mark “RD SPECIAL,” and also disclosed that a trademark registration application was pending. Nevertheless, no relief was originally claimed under trademark law—neither under the head of infringement nor passing off.

The Court acknowledged that the registration was granted only after the suit was filed and that the new amendment sought to introduce trademark infringement as a legal cause of action based on this registration. However, given that trademark infringement is a continuing cause of action, and the suit was still at a preliminary stage (issues yet to be framed), there was no legal bar to the plaintiff instituting a fresh suit on this new basis.

Instead of encouraging multiplicity of proceedings, the Court reasoned that it was preferable to allow the amendment. The guiding principle applied was whether the amendment was necessary to resolve the real dispute between the parties. The amendment, in the Court’s view, did not radically alter the structure of the original suit, but merely added a legal claim arising from subsequent registration of an already pleaded mark.

Court emphasized that allowing such amendments is consistent with the liberal approach favoured by courts, especially when the amendment is grounded in events occurring after the suit’s institution and does not prejudice the opposite party, who retains the right to raise all defences in response to the amended plaint.

Final Decision: The Delhi High Court upheld the order passed by the Trial Court allowing the amendment. The Court clarified that by permitting the amendment, it had not gone into the merits of the case. The petitioner/defendant was given full liberty to raise all relevant defences in the written statement to the amended plaint.The petition under Article 227 was accordingly dismissed and disposed of.

Law Settled in this Case: The judgment reinforces the principle that amendments under O 6 R 17 CPC to be liberally granted when based on subsequent events and necessary for adjudicating the real dispute. The case affirms that introduction of trademark infringement relief—based on post-suit registration—does not necessarily alter the nature of a suit if the foundational facts remain consistent and if the suit is still at an early stage. It also underscores the continuing nature of causes of action in intellectual property law, especially trademark infringement, and reiterates judicial aversion to multiplicity of proceedings where a more efficient procedural route is available.

Case Title: Puja Agarwal Vs. Pravesh Narula: Date of Order: 5th May, 2025: Case No.: CM(M)-IPD 14/2025: Neutral Citation: 2025:DHC:3800: Name of Court: High Court of Delhi: Name of Judge: Hon’ble 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

Rakesh Kumar Mittal Vs. The Registrar of Trade Mark

Introduction: The case of Rakesh Kumar Mittal v. The Registrar of Trade Marks before the High Court of Delhi is a significant ruling in the domain of trademark law, particularly in relation to the mandatory procedural safeguards required before the removal of a registered trademark from the Register. It raises a critical question about the extent to which administrative agencies must comply with statutory mandates when exercising quasi-judicial powers. The case underlines the mandatory nature of notice issuance prior to cancellation of registration, ensuring procedural fairness and protecting the vested rights of proprietors under the Trade Marks Act, 1999.

Factual Background: The petitioner, Rakesh Kumar Mittal, is engaged in the business of manufacturing and trading in electronic goods, specifically amplifiers, microphones, loudspeakers, transformers, and related components. On May 6, 1994, he filed an application bearing number 627446 for registration of the trademark “MILTON” under Class 9 of the Trade Marks Act, 1999, claiming usage since September 24, 1982. The registration certificate was eventually issued on May 30, 2003, but the registration was valid only up to May 6, 2004. Due to non-filing of the renewal application within the prescribed time, the trademark was removed from the Register, as published in Trade Marks Journal No. 1442 dated October 16, 2010.

The petitioner contended that he never received the statutory Form O-3 notice under Section 25(3) of the Trade Marks Act, which is a precondition for lawful removal of a trademark. He learned about the removal only through an RTI response and thereafter initiated the present writ proceedings seeking restoration of the trademark registration and permission to file belated renewal applications.

Procedural Background:  After discovering the removal, the petitioner filed a Right to Information (RTI) application to determine whether the Registrar of Trade Marks had issued the mandatory Form O-3 notice. The response from the trademark office acknowledged that no such notice had been issued, asserting that if a trademark is registered after ten years from the date of application, Section 25(3) is inapplicable. The petitioner, through his counsel, approached the Delhi High Court by way of a writ petition under Article 226 of the Constitution of India seeking restoration and renewal of the trademark. The matter was heard and reserved on April 29, 2025, and the judgment was pronounced on May 27, 2025, by Hon’ble Mr. Justice Saurabh Banerjee.

Legal Issue: The primary legal issue in the case was whether the removal of a registered trademark from the Register of Trade Marks without issuing a mandatory notice under Section 25(3) of the Trade Marks Act, 1999, read with Rule 64(1) of the Trade Marks Rules, 2002, is valid and sustainable in law?

Discussion on Judgments: A pivotal precedent cited in this case was the judgment of the Division Bench of the Delhi High Court in Union of India v. Malhotra Book Depot, 2013 SCC OnLine Del 828, where it was held that the issuance of notice under Section 25(3) is a condition precedent before the removal of a trademark. The Court held that procedural steps outlined in the statute must be followed strictly and cannot be bypassed, even if the registration has lapsed by time.

In support of this legal stance, the petitioner also referred to the decision of the Bombay High Court in Cipla Ltd. v. Registrar of Trade Marks and Another, 2013 SCC OnLine Bom 1270, where it was reiterated that the statutory notice must be issued even if the renewal application has not been filed, and failure to do so renders the removal invalid.

Further, the Bombay High Court in Kleenage Products (India) Pvt. Ltd. v. Registrar of Trade Marks and Others, 2018 SCC OnLine Bom 46, emphasized that registered proprietors must be informed of impending expiry and given a fair chance to renew their trademarks. The petitioner also relied on Promoshirt SM (P) Ltd. v. Registrar of Trade Marks, 2024 SCC OnLine Del 7722; Malhotra Book Depot v. Union of India, 2011 SCC OnLine Del 5086; Gopal Ji Gupta v. Union of India, 2019 SCC OnLine Del 7670; and Ashok Bhutani v. The Registrar of Trade Marks & Anr., W.P.(C)-IPD 22/2024, all affirming that mere lapse of time does not justify cancellation unless the mandatory notice is duly served.

The decisions uniformly underscored that the removal of a trademark without issuing the prescribed notice under Section 25(3) and Rule 64(1) is a violation of statutory requirements and administrative fairness.

Reasoning and Analysis of the Judge:  The court conducted a thorough analysis of the statutory framework and the procedural mandate under the Trade Marks Act and Rules. He noted that Rule 64(1) of the Trade Marks Rules, 2002 clearly obliges the Registrar to send a written notice (Form O-3) to the registered proprietor at least one month and not more than three months before the expiry of the trademark. The Court observed that such procedural compliance is not merely directory but mandatory in nature, particularly where vested rights of individuals are at stake.

The Court further rejected the respondent’s argument that the issuance of the registration certificate after ten years from the date of application negated the applicability of Section 25(3). It held that the date of actual registration triggers the start of the renewal period and that administrative interpretations contrary to statutory provisions cannot stand in the face of judicial precedents and express legislative command.

The Court also invoked the principle laid down by the Supreme Court in E. Palanisamy v. Palanisamy, (2003) 1 SCC 123, reiterated in Sarla Goel v. Kishan Chand, (2009) 7 SCC 658, that procedural steps under a statute must be followed sequentially and cannot be bypassed. The decision reinforced that if the legislature has imposed a procedural safeguard, courts must give effect to it and not dilute it based on administrative convenience.

Final Decision:  The Delhi High Court allowed the writ petition. It directed the Registrar of Trade Marks to restore and reinstate the registration of the petitioner’s trademark “MILTON” bearing Application No. 627446 under Class 9. The Court further directed that upon the petitioner filing appropriate renewal applications and completing the prescribed formalities, the Registrar must grant renewal of the trademark for the periods 2004–2014, 2014–2024, and 2024–2034 and issue the corresponding certificates.

Law Settled in This Case:  The judgment reaffirmed the settled position that the issuance of a Form O-3 notice under Section 25(3) of the Trade Marks Act, 1999 read with Rule 64(1) of the Trade Marks Rules, 2002 is a mandatory precondition for the removal of a registered trademark from the Register. Any removal of a trademark in the absence of such notice is illegal, unsustainable, and without jurisdiction. The case underscores that administrative authorities cannot disregard statutory procedures and that procedural fairness is integral to the exercise of statutory powers under the Trade Marks Act.

Rakesh Kumar Mittal Vs. The Registrar of Trade Marks:May 27, 2025:W.P.(C)-IPD 40/2024:2025:DHC:4432:High Court of Delhi :Hon'ble Mr. Justice Saurabh Banerjee

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

E. R. Squibb and Sons, LLC & Ors. Vs. Zydus Lifesciences Limited

Quia Timet Action and Patent Protection in the Biologics Sector

Introduction:  The intersection of biopharmaceutical innovation and patent law stands at the heart of the recent judgment delivered by the Hon'ble High Court of Delhi in E. R. Squibb and Sons, LLC & Ors. v. Zydus Lifesciences Limited. This decision is significant for its detailed analysis of patent claim construction, the scope of patent infringement in biosimilar development, and the jurisprudence surrounding interim relief in quia timet actions. The matter concerns Indian Patent No. IN 340060 (hereinafter "suit patent") which claims the monoclonal antibody Nivolumab, an anti-PD-1 antibody used in cancer immunotherapy. With the defendants poised to launch a biosimilar product allegedly infringing the suit patent, the plaintiffs sought a pre-emptive injunction, prompting a thorough judicial evaluation of patent validity, claim construction, prior art, and the credibility of apprehended infringement.

Factual Background: The suit patent IN 340060 titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer” was filed as a national phase application from PCT/JP2006/309606, claiming priority from U.S. provisional applications dating back to 2005. Granted in India on 1 July 2020, the patent claims a 20-year term expiring on 2 May 2026. The invention relates to the monoclonal antibody known as Nivolumab (also referred to as 5C4), which binds to the PD-1 receptor on T-cells, thereby modulating immune responses against cancer cells.

Nivolumab is marketed globally under the brand name Opdivo® and is sold in India as Opdyta®. The patent was granted after rejection of four pre-grant oppositions, and a post-grant opposition filed by Zydus Healthcare Limited, a sister concern of the defendant, is currently pending. An Opposition Board Recommendation (OBR) dated 31 January 2023 opined that the suit patent lacked novelty and inventive step, which was subsequently set aside by the High Court of Madras. The matter was remanded to the Single Judge for fresh adjudication.

Plaintiffs became aware in April 2022 that the defendant had sought regulatory approval for clinical trials of a biosimilar to Nivolumab. Although the defendant responded by claiming protection under the Bolar exemption (Section 107A, Patents Act, 1970), further investigation revealed registration of clinical trials under the name ZRC-3276, with Opdivo® listed as the reference product.

Procedural Background: The plaintiffs issued a cease-and-desist letter in May 2022, to which the defendant responded by asserting that it was only conducting clinical trials and had not yet launched the product. Based on this assurance and the clinical trial stage of development, the plaintiffs did not pursue legal action at the time.

In April 2024, the plaintiffs received inquiries from medical professionals and distribution networks indicating that the defendant may be preparing for a commercial launch. Upon discovering that the defendant had applied for marketing authorisation for ZRC-3276, the plaintiffs initiated a quia timet suit for permanent injunction and filed I.A. 10533/2024 under Order XXXIX Rules 1 and 2 CPC seeking interim relief. On 8 May 2024, the Delhi High Court granted an ad interim injunction restraining the defendant from launching the biosimilar without court approval. The order remained in force till final adjudication of the interim application, which was decided vide judgment dated 18 July 2025.

Core Dispute: The central issue was whether the plaintiffs were entitled to an interim injunction against the defendant’s potential commercial launch of its biosimilar version of Nivolumab on grounds of patent infringement. The dispute also involved determining whether the plaintiffs had made out a prima facie case of infringement, whether the suit patent was prima facie valid despite the post-grant opposition and prior art cited, and whether the plaintiffs had approached the Court with delay, thereby disentitling them to interim relief.

Discussion on Judgments: The plaintiffs relied on Jay Switches India Pvt. Ltd. v. Sandhar Technologies Ltd., 2024 SCC OnLine Del 8434, to underscore the importance of claim construction in determining patent infringement. The Court in Jay Switches emphasised that interpreting the scope of the claims is the primary step in adjudicating infringement actions, particularly in complex technologies like antibodies.

The plaintiffs also cited Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511, where the Supreme Court stressed that the claims in a patent must be read with the complete specification, and that claim construction must be rooted in the technical disclosures of the patent.

Further, reliance was placed on Novonordisk v. Union of India, 2022 SCC OnLine Del 1944, which held that the Opposition Board Recommendation under Section 25(3) of the Patents Act is not binding on the Controller and is merely recommendatory. This case was cited to negate the defendant's reliance on the OBR recommending revocation of the patent.

The defendants countered by citing prior art documents including WO 2001/014557, WO 2002/079499, and EP 1537878 B1 (WO 2004/004771), arguing that the suit patent lacked novelty and inventive step. They further contended that the plaintiffs had admitted in foreign patent filings that Nivolumab was developed under an earlier patent family, thereby invalidating the suit patent.

Reasoning and Analysis of the Judge: The Court, on the issue of delay,  accepted the plaintiffs’ explanation that they initially refrained from filing the suit in 2022 due to the defendant’s reliance on the Bolar exemption. The Court observed that a fresh cause of action arose only in 2024 when credible information regarding imminent commercial launch surfaced.

Regarding the question of infringement, the Court held that Nivolumab (also known as 5C4 antibody) was clearly claimed in Claims 1, 3, and 7 of the suit patent, which were defined by specific amino acid sequences in the CDR regions and variable chains. Since the defendant was developing a biosimilar using the plaintiffs’ product as a reference, it was prima facie covered by the scope of the claims.

On validity, the Court found that the prior art documents relied on by the defendant did not disclose the specific amino acid sequences claimed in the suit patent. D3 (EP '878) was held to pertain only to the use of anti-PD-1 antibodies in general, not to the precise structure of Nivolumab. Further, D1 and D2 were dismissed for failing to disclose any antibody sequences. The Court relied on the Guidelines for Examination of Biotechnology Applications for Patent, 2013, which state that unless the prior art matches the claimed sequence exactly, it cannot be deemed anticipatory.

The Court also dismissed the defendant’s reliance on the Opposition Board’s adverse recommendation, noting its recommendatory nature and the pending adjudication in the Madras High Court.

Final Decision:  The High Court of Delhi granted interim relief in favour of the plaintiffs, continuing the injunction against the defendant from launching or commercially exploiting its biosimilar product ZRC-3276 without court approval until the expiry of the patent or final adjudication of the suit. The Court held that the plaintiffs had made out a strong prima facie case of infringement, that the balance of convenience lay in their favour, and that irreparable harm would be caused if the injunction was denied.

Law Settled in This Case:  This judgment reinforces the jurisprudence on quia timet actions in patent infringement suits, particularly in the biopharmaceutical context. It clarifies that the apprehension of infringement, if supported by credible evidence, can sustain an injunction even before actual launch. The case also reaffirms that prior art must disclose specific elements of the claimed invention—such as amino acid sequences in the case of biologics—for a credible challenge to novelty or inventive step. Furthermore, the judgment affirms that the recommendation of an Opposition Board is not binding and cannot by itself undermine a patent’s validity. Lastly, it underlines that reference to a patented product in biosimilar development may constitute prima facie infringement if claim mapping is established.

Case Title: E. R. Squibb and Sons, LLC & Ors. Vs. Zydus Lifesciences Limited

Date of Order: 18 July 2025

Case Number: CS(COMM) 376/2024 

Neutral Citation: 2025:DHC:5802

Name of Court: High Court of Delhi

Name of Judge: Hon’ble Ms. Justice Mini Pushkarna

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

Société des Produits Nestlé S.A. Vs. Controller of Patents and Designs

Amendment of Patent Claims and Specification at Appellate Stage

Introduction:  The judgment delivered by the Hon’ble High Court of Delhi in Société des Produits Nestlé S.A. v. Controller of Patents and Designs & Anr., decided on 3rd February 2023, marks a significant clarification in the Indian patent law regime concerning the scope of Section 3(i), the permissibility of claim amendments under Section 59, and the evidentiary thresholds for inventive step and synergistic effects under Sections 2(1)(ja) and 3(e) of the Patents Act, 1970. This case revolved around a patent application relating to a nutritional composition designed for use in the prophylaxis of allergic disease, which was rejected by the Patent Office on multiple statutory grounds. The appellant, a global food and nutrition company, challenged the refusal on legal and technical grounds, seeking judicial intervention to reinstate the patent application.

Factual Background:  The appellant, Société des Produits Nestlé S.A., filed an Indian patent application numbered 201817040811 on 26th October 2018 titled “Composition for Use in the Prophylaxis of Allergic Disease”. The application claimed priority from an earlier European application and was based on a PCT application (PCT/EP2016/060007) filed on 4th May 2016. The invention related to a composition comprising DGLA (Dihomo-γ-linolenic acid) and one or more omega-3 polyunsaturated fatty acids such as DHA and EPA. The objective of the invention was to reduce the incidence of allergic diseases in the progeny when the composition is administered to a mammalian subject during pre-pregnancy, pregnancy, or lactation.

According to the applicant, the claimed composition exhibited a synergistic effect that reduced allergic manifestations in the offspring. The composition was formulated for inclusion in dietary or nutritional supplements or in infant formulas, and the claims were framed as “composition for use” or “nutritional composition for use”, intending to steer clear of prohibited subject matter under Section 3(i) of the Patents Act.

Procedural Background:  The application was published on 8th February 2019 and was examined pursuant to a First Examination Report (FER) issued on 4th January 2021. The FER raised objections under Sections 3(i), 3(e), and 2(1)(ja) of the Act. In response, the applicant amended the claims and submitted supporting data. However, the Controller, vide order dated 29th December 2021, refused the application. The grounds for refusal were that the claims related to a method of treatment and hence were non-patentable under Section 3(i); that the amended claims went beyond the scope of original claims, thereby violating Section 59; and that the evidence did not establish the required synergistic effect, which attracted Sections 3(e) and 2(1)(ja). Aggrieved by this refusal, the applicant filed an appeal under Section 117A of the Patents Act before the High Court of Delhi.

Core Dispute:  The principal legal questions arising in this appeal were whether the claimed subject matter fell within the prohibition under Section 3(i) as being a method of treatment; whether the amended claims violated Section 59 by broadening the scope beyond the originally filed claims; and whether the invention lacked an inventive step or was hit by Section 3(e) for being an admixture without demonstrable synergistic effect. At stake was the nuanced distinction between treatment method claims, purpose-limited product claims, and the adequacy of technical data to satisfy inventive step and non-obviousness requirements.

Discussion on Judgments: In support of its position that the claims were not barred under Section 3(i), the appellant relied upon the judgment in University of Miami v. Controller of Patents, (OA/28/2016/PT/DEL), wherein the Intellectual Property Appellate Board (IPAB) held that claims directed to "product for use" are patentable and not considered as methods of treatment. The IPAB distinguished between product claims and method claims, permitting claims to compositions that are characterized by their intended medical use.

The appellant also cited the decision of the Delhi High Court in Novartis AG v. Union of India, 2019 SCC OnLine Del 9285, which reaffirmed that therapeutic efficacy and technical advancement must be evaluated in context and not be dismissed summarily without adequate reasoning. In the present case, the data relating to synergistic effects were said to demonstrate a marked reduction in allergic symptoms in animal models, with comparative experiments supporting the technical effect claimed.

On the issue of claim amendment under Section 59, the appellant invoked the jurisprudence from the IPAB decision in Esco Corporation v. Controller of Patents, OA/66/2010/PT/KOL, where it was held that claim amendments that are supported by the original specification and merely clarify or limit the scope of claims are permissible, even if introduced during prosecution or appellate proceedings.

Finally, the reliance was also placed on European Patent Office (EPO) practices, particularly since the same invention had been granted a European patent after rigorous examination. The High Court considered such foreign prosecution outcomes to be persuasive, though not binding, in assessing inventive step and synergy.

Reasoning and Analysis of the Judge:  Court held that the claims were clearly directed to compositions and not to any treatment process or method. He observed that Section 3(i) prohibits only method of treatment claims and not products per se. The Court accepted that the “composition for use” language was well-established internationally, and as long as the claims remained directed to compositions with specified purpose or use, they did not attract Section 3(i). The amended claims, being purpose-limited product claims, did not claim any treatment step and were therefore outside the mischief of Section 3(i).

On the question of claim amendments under Section 59, the Court concluded that the amendment was neither broadening the claims nor introducing any matter not originally disclosed. Rather, it clarified and narrowed the scope in response to objections. Therefore, the amended claims were held to be maintainable, even at appellate stage as there is no any bar to allow amendment at appellate stage.

Regarding the inventive step and synergistic effect, the Court found that the appellant had filed experimental data comparing allergic responses in progeny across different dietary compositions. The results indicated that only the claimed composition comprising both DGLA and omega-3 PUFAs showed the desired prophylactic effect. The comparative data established a technical advancement and unexpected results over prior art. The prior art relied on by the Controller was found to be more than twenty years old and lacked the specific combinations and concentrations used in the claimed invention. Therefore, the Court held that the invention satisfied the requirements of inventive step under Section 2(1)(ja) and was not hit by Section 3(e).

Final Decision:  The High Court allowed the appeal, set aside the order of refusal dated 29th December 2021, and directed that the patent application proceed for grant on the basis of the amended claim set submitted by the appellant. The Court further directed the matter to be listed before the Controller for completion of necessary formalities.

Law Settled in This Case:  This judgment settled the legal position that purpose-limited product claims, such as “composition for use in prophylaxis,” do not fall within the prohibition of Section 3(i) and are distinguishable from method of treatment claims. It reaffirmed that claim amendments under Section 59 are permissible even at appellate stage, if they are based on the original disclosure and do not broaden the claim scope. Furthermore, it laid down that properly supported experimental data showing unexpected technical effect is sufficient to establish inventive step and synergy for overcoming objections under Sections 3(e) and 2(1)(ja). The decision also recognized the persuasive value of patent grants in other jurisdictions like the EPO when examining similar claims.

Case Title: Société des Produits Nestlé S.A. Vs. Controller of Patents and Designs & Anr.

Date of Order: 3rd February 2023

Case Number: C.A. (COMM.IPD-PAT) 22/2022

Neutral Citation: 2023/DHC/000774

Name of Court: High Court of Delhi

Name of Judge: Hon’ble 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 Delh

Uto Nederland B.V. Vs Tilaknagar Industries Ltd

Trademark Ownership, Goodwill and the Doctrine of Reversion

Introduction:  The dispute arises between Uto Nederland B.V., a Dutch entity, and Tilaknagar Industries Ltd., an Indian spirits manufacturer, over the trademarks 'MANSION HOUSE' and 'SAVOY CLUB'. At the heart of the conflict lies the question of whether a conditional ceding of these marks in 1987 resulted in a permanent transfer of ownership to Tilaknagar or whether the trademarks automatically reverted to UTO upon breach of conditions as stipulated in the ceding arrangement. The High Court of Bombay’s Commercial Appellate Division, in a detailed judgment delivered on 16 July 2025, adjudicated upon this multifaceted controversy, examining the doctrines of passing off, transborder reputation, and the impact of Section 31 of the Transfer of Property Act, 1882 on trademark ownership.

Factual Background:  UTO Nederland B.V. and its group companies are Dutch entities engaged in the global manufacture and distribution of alcoholic beverages. UTO originally registered the trademark 'MANSION HOUSE' in the Netherlands in 1922 and 'SAVOY CLUB' in 1967, and subsequently obtained registration in multiple jurisdictions, including India. On 7 July 1983, UTO entered into a License and Manufacturing Agreement with Tilaknagar Industries Ltd. (Tilaknagar) for the manufacture and sale of liquor under the said trademarks in India, on the condition that Tilaknagar would procure specified quantities of concentrates from UTO. In February 1987, following litigation between UTO and the Scotch Whisky Association in the Netherlands regarding misleading use of the term "Scotch", UTO conditionally ceded the trademarks to Tilaknagar via two interlinked letters dated 23 February 1987. The cession was subject to Tilaknagar’s continued compliance with procurement obligations, failing which the trademarks would revert to UTO. Although Tilaknagar continued to use the trademarks, it stopped procuring concentrates from UTO by 1994, and began using self-developed substitutes.

Procedural Background: UTO initiated Commercial Suit No. 2 of 2009 (originally Suit No. 632 of 2009) before the High Court of Bombay, seeking a permanent injunction against Tilaknagar for passing off and infringement of copyright in the artistic works associated with the trademarks 'MANSION HOUSE' and 'SAVOY CLUB'. The suit also sought mandatory relief for cancellation of registrations obtained by Tilaknagar and damages. UTO filed Notice of Motion No. 993 of 2009 for interim relief, which was dismissed by a Single Judge on 22 December 2011. UTO preferred Commercial Appeal No. 66 of 2012 challenging this order. In response, Tilaknagar filed Cross Objection No. 3 of 2012 disputing the finding that UTO enjoyed transborder reputation. 

In parallel, Tilaknagar filed Counterclaim No. 6 of 2010 with Notice of Motion No. 1287 of 2010 seeking to restrain UTO from using the marks. In 2014, UTO transferred part of its rights to Allied Blenders and Distillers (ABD), who moved Interim Application No. 16999 of 2023 seeking permission to introduce products in West Bengal under the trademark 'MANSION HOUSE'. By order dated 7 February 2025, a Single Judge rejected Tilaknagar’s motion and allowed ABD’s application. Tilaknagar then filed Commercial Appeal (L) Nos. 6617 and 6622 of 2025. All three appeals were adjudicated together in a common judgment dated 16 July 2025.

Core Dispute:The central controversy revolved around the legal status of the 1987 ceding arrangement and whether the trademarks 'MANSION HOUSE' and 'SAVOY CLUB' reverted to UTO upon breach by Tilaknagar. UTO contended that the ceding was conditional and that Tilaknagar’s failure to procure concentrates as agreed caused automatic reversion of ownership under Section 31 of the Transfer of Property Act. Conversely, Tilaknagar argued that the transfer was absolute, that any breach merely gave rise to damages, and that UTO had waived any such condition through prolonged inaction and acquiescence.

Discussion on Judgments: UTO relied heavily on judicial precedents recognizing the enforceability of superadded conditions under Section 31 of the Transfer of Property Act. These included Nagindas Ramdas v. Dalpatram Ichharam, (1974) 1 SCC 242, for the proposition that judicial admissions in pleadings are conclusive unless withdrawn or explained. It also referred to Indu Kakkar v. Haryana State Industrial Development Corp., (1999) 2 SCC 37, and Harichand & Co. v. Gosho Kabushiki Kaisha, (1925) ILR 49 Bom 25, to assert the principle of automatic extinguishment of title upon breach of a superadded condition.

To support its passing off claim, UTO invoked N.R. Dongre v. Whirlpool Corporation, (1996) 5 SCC 714, and Toyota Jidosha Kabushiki Kaisha v. Prius Auto Industries Ltd., (2018) 2 SCC 1, affirming the doctrine of transborder reputation and the ability to maintain passing off claims even in the absence of local sales.

On the contrary, Tilaknagar placed reliance on Madanlal Fakirchand Dudhediya v. Shree Changdeo Sugar Mills Ltd., 1962 (3) SCR 973, and Devendra Prasad Sukul v. Surendra Prasad Sukul, 1935 SCC OnLine PC 54, to argue that no automatic reversion can take place without a suit for declaration and that Section 31 does not displace this requirement. For the defence of delay, waiver and acquiescence, Tilaknagar cited Amritdhara Pharmacy v. Satya Deo Gupta, 1962 SCC OnLine SC 13, and Ramdev Food Products v. Arvindbhai Rambhai Patel, (2006) 8 SCC 726, asserting that UTO had sat on its rights for over a decade after the breach and thus lost entitlement to injunctive relief.

Reasoning and Analysis of the Judge:  The Division Bench of the High Court examined the 1987 ceding letters closely and concluded that the two letters formed a composite transaction. The second letter explicitly stipulated that the trademarks would revert to UTO if Tilaknagar failed to comply with the procurement obligations. The Court rejected Tilaknagar’s contention that the two letters constituted independent contracts, holding that the absence of consideration in the first letter necessitated its reading alongside the second. The judges emphasized that Section 31 of the Transfer of Property Act permits insertion of superadded conditions in transactions and enables automatic reversion on occurrence of the stipulated event.

The Bench was particularly critical of the long delay in judicial relief, but held that repeated correspondence from Tilaknagar seeking to resume procurement, along with UTO’s consistent assertions of ownership, negated the elements of waiver or abandonment. The Court reaffirmed that an owner of a mark with established transborder reputation is entitled to protect the mark against misappropriation in India, irrespective of local sales. The findings of the Single Judge in 2011 and 2025 were carefully scrutinized, with the Court concluding that the former failed to adjudicate the reversion issue adequately, while the latter rightly found in favour of UTO and ABD.

Final Decision:  The Court allowed UTO’s Commercial Appeal No. 66 of 2012, set aside the order dated 22 December 2011, and granted interim injunction restraining Tilaknagar from using the trademarks ‘MANSION HOUSE’ and ‘SAVOY CLUB’ pending the suit. It also upheld the order dated 7 February 2025 granting leave to ABD to introduce products in West Bengal. Tilaknagar’s Commercial Appeals (L) No. 6617 and 6622 of 2025 were dismissed.

Law Settled in This Case: This judgment settles several important propositions in Indian trademark law. First, a conditional transfer of trademark rights, if coupled with a superadded condition clearly embedded in the same transactional framework, can result in automatic reversion of ownership upon breach, without the need for a separate declaratory suit. Second, a claim for passing off can be sustained even by a foreign proprietor with no physical presence in India, provided transborder reputation is established. Third, long delays in asserting rights may not amount to waiver if there is continuing assertion of ownership and absence of detrimental reliance. Fourth, the scope of Section 31 of the Transfer of Property Act extends to intellectual property transactions, and if properly invoked, operates as a defeasance clause.

Case Title: Uto Nederland B.V. & Anr. v. Tilaknagar Industries Ltd. & Ors.

Date of Order: 16 July 2025

Case Number: Commercial Appeal No. 66 of 2012

Neutral Citation: 2025:BHC-OS:10958-DB

Name of Court: High Court of Bombay 

Name of Judge: Hon’ble Chief Justice Alok Aradhe and Hon’ble Mr. Justice Sandeep V. Marne

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