Frimline v. K-SMATCO: Delhi HC Rules Firmly in Pharmaceutical Patent Infringement Case

Prescription medicine bottles and tablets placed on a courtroom bench, symbolizing a pharmaceutical patent dispute and legal ruling. Featured image for article: Frimline v. K-SMATCO: Delhi HC Rules Firmly in Pharmaceutical Patent Infringement Case

Summary

In Frimline v. K-SMATCO, the Delhi High Court granted interim relief to Frimline, finding a strong prima facie case of pharmaceutical patent infringement. The order reinforced the inclusive nature of the term “comprising” in patent claims.

Background

Frimline Private Limited and its parent company (hereinafter as “Frimline”) filed a suit alleging infringement of Indian Patent No. 382949, titled “A Pharmaceutical Composition for Anaemia”, and copyright infringement of its website. The patent discloses a synergistic composition of Lactoferrin and Guanosine Nucleotide (or its salts) for treating iron deficiency and inflammatory anaemia. Frimline had commercialised the invention since 2018 under the brands FERRONEMIA and FERRONOMIC. In July 2025, Frimline discovered that the defendants (hereinafter as “K-smatco”) were manufacturing and selling FERROTOK PLUS, which allegedly contained the same composition, and had also copied substantial content from Frimline’s website.

Issues Before the Court

-Whether K-smatco’s product FERROTOK PLUS infringed Frimline’s patent.

-Whether the patent claims, particularly the term “comprising”, covered salts such as Disodium Guanosine 5-Monophosphate (Claim 1 referred to “guanosine nucleotide,” and Claim 2 narrowed it to Guanosine Monophosphate (GMP) and DGMP was not expressly claimed, but was disclosed in the detailed description and example of the specification).

-Whether Frimline established a prima facie case warranting grant of an interim injunction.

-Whether copying content from Frimline’s website constituted copyright infringement.

Frimline’s Contentions

Frimline contended that K-SMATCO’s FERROTOK PLUS was identical to its patented formulation and clearly within the scope of IN 382949. The specification expressly disclosed Disodium Guanosine 5-Monophosphate (DGMP), a salt of GMP, covered under Claim 1, which uses the inclusive term “comprising.” All objections on novelty, inventive step, and Section 3(e) were overcome before the patent was granted in 2021. Relying on F. Hoffmann-La Roche v. Cipla and Terrell on the Law of Patents, Frimline argued that “comprising” extends protection to salts and minor variations. Frimline supported its arguments by producing Claim mapping and lab analysis to confirm ingredient-wise similarity. Frimline also alleged copyright infringement of its website content under Section 13(1)(a) of the Copyright Act.

K-smatco’s Contentions

K-smatco contended that the patent lacked novelty and inventive step, as similar compositions were already available in the market. K-smatco alleged that Frimline had not produced certified copies of the amended claims and that the composition tested by Frimline might fall outside the claimed range. K-smatco further submitted that they had withdrawn the product and taken down the infringing website, expressing regret and claiming they would not relaunch until further verification.

Court’s Analysis

Placing reliance on Guala Closures SPA v. AGI Greenpac Ltd. (2024 SCC OnLine Del 3510) and Mold Tek Packaging Ltd. v. Pronton Plast Pack (P) Ltd (2025 SCC OnLine Del 4883 (DB)), the Court stated that, under Section 10(4)(c) of the Patents Act, claims determined the scope of protection, and infringement must be assessed through proper claim construction and mapping. The Court accepted Frimline’s arguments that the term “comprising” was non-restrictive and extended protection to minor variants such as salts. Referring to the detailed description and examples in the complete specification, the Court observed that Disodium Guanosine 5-Monophosphate was expressly disclosed and therefore covered under the claims. The Court further observed that K-smatco failed to produce any documentary evidence to rebut Frimline’s analysis or to justify adoption of the same formulation. The Court opined that Frimline had a strong prima facie case and that the balance of convenience was in its favour, and affirmed that the sale of the infringing formulation could cause irreparable commercial and public harm.

Decision

The Court granted an interim injunction restraining K-smatco, their partners, and distributors from manufacturing, selling, or marketing any product infringing IN 382949 during the patent term. K-smatco’s undertaking to withdraw the infringing website content was recorded, and interim protection was also granted for Frimline’s copyright.

Key Takeaway

The Court reaffirmed the importance of using the term “comprising” in patent claims, holding that it was inclusive and enabling rather than restrictive.

Citation: CS(COMM) 808/2025

Link: https://indiankanoon.org/doc/85349301/

Article review and accessibility review: Mr. Gaurav Mishra

Author: Sowmya S Murthy

Sowmya S Murthy is an Indian Patent agent and a Managing Associate with BananaIP Counsels, a reputed IP firm and specializes in patent prosecution and drafting for electronics and software-related inventions. She also regularly contributes to blog posts on case laws and other topics related to patent practice. The views expressed in his articles and posts on Intellepedia are personal and do not represent those of BananaIP Counsels or its members.

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