Safiya Malik

The High Court of Delhi Single Bench of Justice Tejas Karia held that the plaintiffs were entitled to interim protection against the potential launch of a generic version of Alectinib, covered under Indian Patent No. IN 294424. The Court directed the defendant not to introduce or deal in any form of the drug Alectinib or its salts or intermediates that would infringe upon the plaintiffs’ patent. Additionally, the Court granted leave for filing supplementary documents, allowed exemption from pre-institution mediation under Section 12A of the Commercial Courts Act, and admitted the plaint as a commercial suit for further proceedings.

The matter arises from a commercial intellectual property dispute concerning infringement of a pharmaceutical patent relating to the drug Alectinib, protected under Indian Patent No. IN 294424. The plaintiffs, represented by their counsel, initiated proceedings under the Commercial Courts Act, 2015 (“CC Act”) read with relevant provisions of the Code of Civil Procedure, 1908 (“CPC”), seeking urgent injunctive reliefs against the defendant, a biosciences company, alleged to be preparing for the manufacture and market introduction of a generic version of Alectinib or its salts.

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Applications Filed by the Plaintiffs

The plaintiffs filed multiple interlocutory applications alongside the suit.

• IA No.20534/2025: The plaintiffs sought leave under Order XI Rule 1(4) CPC (as applicable to commercial suits) to place on record additional documents relevant to the dispute. The Court permitted the plaintiffs to file additional documents as per provisions of the CC Act and Delhi High Court (Original Side) Rules, 2018.

• IA No.20535/2025: An application was filed seeking exemption from instituting pre-litigation mediation as mandated under Section 12A of the CC Act. The plaintiffs relied on the urgency of interim reliefs and invoked the Supreme Court judgment in Yamini Manohar v. T.K.D. Krithi, 2023 SCC OnLine SC 1382. The Court, finding the matter to involve urgent interim measures, granted exemption from pre-institution mediation.

• IA No.20536/2025: This was a formal application seeking exemption, which was allowed subject to just exceptions.

• IA No.20537/2025: The plaintiffs moved under Order XI Rule 1 and 5 CPC read with Section 151 CPC, requesting disclosure and production of documents by the defendant. Specifically, they sought:

i) market authorization received by the defendant for generic Alectinib or related products allegedly infringing the suit patent, and

ii) details of the process employed by the defendant in manufacturing such products.
The plaintiffs submitted that this disclosure was essential to ascertain the nature of the defendant’s biosimilar manufacturing process. The Court issued notice. The defendant’s counsel, appearing on advance service, accepted notice and sought time to file a reply. The Court allowed four weeks for the reply, followed by two weeks for rejoinder, and listed the application for 9 October 2025.

• IA No.20538/2025: The plaintiffs sought leave under Section 151 CPC to place on record an unredacted affidavit of an independent investigator in a sealed cover. The Court permitted the same and disposed of the application.

Institution of the Suit

Upon considering the plaint, the Court directed registration of the matter as a suit (CS(COMM) 875/2025) and issued summons. The defendant’s counsel accepted service and sought time to file the written statement. The Court directed the defendant to file the written statement within 30 days, accompanied by an affidavit of admission/denial of plaintiffs’ documents, failing which the written statement would not be taken on record.

The Court granted liberty to the plaintiffs to file a replication, along with an affidavit of admission/denial of defendants’ documents, within 30 days of receiving the written statement. Both parties were directed to disclose documents relied upon but not in their possession, specifying source and details. Provisions were also made for inspection of documents within prescribed timelines. The matter was directed to be placed before the Joint Registrar on 15 October 2025 for completion of pleadings.

Application for Interim Injunction (IA No.20533/2025)

The plaintiffs also filed an application under Order XXXIX Rules 1 and 2 CPC read with Section 151 CPC, seeking an interim injunction. They prayed for an order restraining the defendant, its associates, employees, agents, distributors, stockists, and other connected entities from manufacturing, selling, distributing, advertising, exporting, offering for sale, or dealing in any manner in generic Alectinib or its salts, solvates, intermediates, or any other product infringing Indian Patent No. IN 294424.

Upon hearing, the Court issued notice. The defendant’s counsel, appearing on advance service, submitted that until the next date of hearing, the defendant would not launch any product involving Alectinib or its related formulations that infringes the plaintiffs’ patent. The Court recorded this undertaking and directed the defendant to file an affidavit within two weeks, placing the undertaking formally on record. Timeframes were set for filing replies and rejoinders, and the matter was listed for hearing on 9 October 2025.

Justice Tejas Karia, while passing the order, recorded the following judicial observations:

On the application for filing additional documents, the Court stated: “The Plaintiffs are permitted to file additional documents in accordance with the provisions of the CC Act and the Delhi High Court (Original Side) Rules, 2018.”

On exemption from pre-institution mediation, the Court observed: “As the present matter contemplates urgent interim relief, in light of the judgment of the Supreme Court in Yamini Manohar v. T.K.D. Krithi, 2023 SCC OnLine SC 1382, exemption from the requirement of pre-institution Mediation is granted.”

Regarding disclosure of defendant’s documents, the Court recorded: “The learned Counsel for the Plaintiffs submitted that the above information is essential for the Plaintiffs to determine the process employed by the Defendant to manufacture their biosimilar product.”

The Court further noted: “Issue Notice. The learned Counsel for the Defendant appearing on advance service accepts Notice and seeks time to file the Reply. Let Reply to this Application be filed within a period of four weeks from date. Rejoinder thereto, if any, be filed within a period of two weeks thereafter.”

On the filing of the investigator’s affidavit, the Court held: “For the reasons stated in the Application, the same is allowed.”

On registration of the suit and filing of pleadings, the Court recorded: “Let the Plaint be registered as a Suit. Issue Summons. Let Written Statement be filed by the Defendant within 30 days from date. Along with the Written Statement, the Defendant shall also file an Affidavit of Admission / Denial of the documents of the Plaintiffs, without which the Written Statement shall not be taken on record.”

With respect to the interim injunction sought by the plaintiffs, the Court observed: “The learned Counsel for the Defendant, on instructions, submits that till the next date of hearing, the Defendant shall not launch any product dealing with Alectinib or its salt or solvates or intermediate(s) that infringes the Plaintiffs’ patent granted vide Indian Patent No. IN 294424.”

The Court then noted: “The said statement is taken on record and Defendant is bound by the said statement. The learned Counsel for the Defendant shall file an affidavit giving the said undertaking within a period of two weeks from date.”

The High Court issued several directions.

First, it permitted the plaintiffs to place on record additional documents under Order XI Rule 1(4) CPC read with the Commercial Courts Act, clarifying that such filing shall comply with the Delhi High Court (Original Side) Rules, 2018.

Second, the Court granted exemption from the statutory requirement of pre-institution mediation under Section 12A of the Commercial Courts Act, holding that urgent interim reliefs justified bypassing the usual mandate of prior mediation.

Third, the Court issued notice on the plaintiffs’ application seeking disclosure of defendant’s market authorization and manufacturing process concerning generic Alectinib. The defendant’s counsel, having accepted notice, was directed to file a reply within four weeks, followed by a rejoinder within two weeks thereafter. The matter was posted for hearing on 9 October 2025.

Fourth, the Court allowed the plaintiffs to submit an unredacted affidavit of an independent investigator in a sealed cover, noting the reasons provided in the application.

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Fifth, the Court directed that the plaint be registered as a commercial suit (CS(COMM) 875/2025), and issued summons. The defendant was directed to file its written statement within 30 days, along with an affidavit of admission/denial of documents. Failure to comply would render the written statement inadmissible. Plaintiffs were granted liberty to file replication with similar compliance requirements. Both parties were directed to specify details and sources of documents not in their possession, and to facilitate inspection within prescribed timelines.

Sixth, the Court issued notice on the application for interim injunction under Order XXXIX Rules 1 and 2 CPC. The defendant’s counsel gave an undertaking that no product relating to Alectinib or its salts infringing Indian Patent No. IN 294424 would be launched until the next date of hearing. This undertaking was recorded, and the defendant was directed to file an affidavit affirming the same within two weeks. Replies and rejoinders were scheduled in accordance with statutory timelines, and the matter was listed for hearing on 9 October 2025.

Advocates Representing the Parties

For the Petitioners: Mr. Pravin Anand, Mr. Shrawan Chopra, Mr. Achyut Tiwari & Ms. Krisha Baweja, Advocates

For the Respondents: Ms. Amrita Majumdar & Mr. Samik Mukherjee, Advocates

Case Title: Chugai Seiyaku Kabushiki Kaisha & Anr. v. Anthem Biosciences Limited

Case Number: CS(COMM) 875/2025

Bench: Justice Tejas Karia