## Introduction
This case study analyzes a patent infringement suit filed by Frimline Private Limited and another (Plaintiffs) against K-Smatco Lifesciences Private Limited and others (Defendants) before the High Court of Delhi. The suit concerns the infringement of Indian Patent No. 382949, titled "A Pharmaceutical Composition for Anaemia," along with a claim for copyright infringement related to the Plaintiff No. 2’s website. The Plaintiffs seek interim and permanent injunctions against the Defendants for manufacturing, marketing, and selling a product allegedly infringing their patent rights.
## Factual Background
Plaintiff No. 1, Frimline Private Limited, is engaged in manufacturing and marketing pharmaceutical compositions, including a patented formulation for the treatment of Iron Deficiency Anaemia (IDA) and Anaemia of Inflammation (AOI). The product covered by Indian Patent No. 382949 is a synergistic combination of Lactoferrin and Guanosine Nucleotide derivatives. The patent was filed in March 2018 and granted in November 2021, valid until March 2038. The Plaintiffs commercialized this patented formulation under various brand names such as FERRONOMIC and FERRONEMIA, accruing significant revenue.
The Defendants launched a competing product called ‘FERROTOK PLUS’, which the Plaintiffs allege contains the patented composition as per the claims of the Suit Patent. Furthermore, Plaintiffs contend that Defendants have copied significant content from their corporate website, amounting to copyright infringement. The alleged infringing product is marketed for use by pregnant anaemic women, raising concerns about consumer safety if the product is substandard.
## Procedural Background
The Plaintiffs filed the suit and an application under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908, seeking ad-interim injunction against the Defendants to restrain further manufacturing, marketing, and sale of the impugned product during the pendency of the suit. The Defendants appeared and contested the injunction, arguing initially on patent validity and novelty grounds, citing the First Examination Report from the Indian Patent Office rejecting initial claims. They also challenged the Plaintiffs' reliance on an incomplete specification and submitted that similar compositions are common in the market.
The Plaintiffs filed replies affirming their patent’s validity, clarifying the scope of claims including use of the term “comprising” which broadens claim coverage, and provided detailed claim construction along with an affidavit affirming that the Defendants’ product falls within the patent claim scope. The Plaintiffs further submitted a certificate of analysis confirming the infringing product’s composition.
## Core Dispute
The core issue before the court was whether the Defendants' product ‘FERROTOK PLUS’ infringes upon the claims of the Plaintiffs’ Indian Patent No. 382949. Supplemental to this was the Plaintiffs’ claim of copyright infringement by the Defendants through reproduction of the Plaintiffs’ website content. Additionally, the Plaintiffs sought a recognition of the validity of their patent claims and an immediate injunction against further infringing acts to prevent commercial injury and consumer harm.
The court extensively relied on precedents interpreting patent claim construction and infringement analysis. Particularly significant was the citation of the Division Bench judgment in *F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd.*, 2015 SCC OnLine Del 13619, which clarified that the use of the word “comprising” in a patent claim is enabling and inclusive rather than restrictive. The Court further referred to *Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries*, (1979) 2 SCC 511, underscoring that claims must be read in conjunction with the complete specification for a proper understanding of the scope of protection.
Additionally, the Court referenced *Re. Guala Closures SPA v. AGI Greenpac Limited*, 2024 SCC OnLine Del 3510, which highlighted the primacy of claim construction in determining patent infringement. The judgment in *Re. Mold Tek Packaging Ltd. v. Pronton Plast Pack (P) Ltd.*, 2025 SCC OnLine Del 4883 (DB) was cited to emphasize the role of claim mapping between the patent claims and the allegedly infringing product.
Collectively, these authorities were applied to interpret the claims broadly to include minor variations, thereby supporting the Plaintiffs’ argument that Disodium Guanosine 5-Monophosphate (DGMP) in the Defendants’ product falls within the phraseology of the patent claims, even though the claim specified Guanosine Monophosphate (GMP).
Justice Manmeet Pritam Singh Arora analyzed the claim construction applying established principles that the term “comprising” in patent claims covers variations unless expressly excluded. The Court examined the complete specification and found it explicitly discloses Disodium Guanosine Monophosphate as a preferred embodiment, reinforced by the detailed example provided in the specification.
Upon review of the Plaintiffs’ claim mapping and evidentiary materials, the Court was convinced the Plaintiffs had made a prima facie case of infringement. The Defendants’ failure to rebut the certificate of analysis, absence of filing a certified specification copy, and Defendant No. 2’s non-appearance were pressed against them. Despite the Defendants’ contention on prior art and common formulas, the Court gave weight to the granted patent and commercial evidence presented by the Plaintiffs. The balance of convenience clearly favored the Plaintiffs, given the potential market confusion and financial loss with unchecked infringement.
Regarding the copyright infringement claim, the Defendants’ undertaking to withdraw and update the infringing website content was taken on record and an interim injunction was granted in respect of the copyright claim as well.
Final Decision
The Court granted an interim injunction restraining Defendant Nos. 1, 3, and 4 and related parties from manufacturing, marketing, selling, distributing, or dealing in any product infringing the subject matter of Indian Patent No. 382949. The injunction was extended over the copyright claim as well until final adjudication. Defendant No. 2 was restrained for the time being until the next hearing. The Plaintiffs were ordered to provide certified patent specification copies to the Defendants. The Defendants were directed to file their written statement and relevant affidavits within stipulated timelines. Further procedural directions were issued for inspection, admissions, and cost consequences following unjustified denial of documents.
The judgment reiterates fundamental principles of patent claim construction, affirming that the use of the term “comprising” broadens the claim scope to include variants not explicitly enumerated but covered within adoption. Complete specifications must be considered alongside claims for infringement assessment. The case highlights the weight of commercial evidence, certificates of analysis, and the importance of timely procedural compliance in defending patent infringement suits. Furthermore, the judgment confirms that interim injunctions are appropriate when a strong prima facie case of patent infringement is demonstrated and the balance of convenience favours protection of patent rights. The Court also emphasized the remedies available for copyright infringement in the context of misleading use of website content.
Frimline Private Limited & Anr Vs K-Smatco Lifesciences Private Limited & Ors : August 29, 2025 :CS(COMM) 808/2025 :2025:DHC:7535: Justice Manmeet Pritam Singh Arora
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
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