Frimline Private Limited & Anr. v. K-SMATCO Lifesciences Private Limited & Ors.

1. The captioned application under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908 [‘CPC’], has been filed by the Plaintiffs seeking ad-interim injunction against the Defendants, thereby restraining the Defendants from making, using, offering for sale, selling, distributing, advertising, marketing, exporting, importing or in any manner, directly or indirectly, the product ‘FERROTOK PLUS’ and/or the composition as claimed in the suit patent i.e., IN 382949 and/or any other ad-mixture/ combination/ formulation products containing the composition as claimed in the suit patent, during the subsistence of the suit patent.

2. Issue notice.

3. Mr. Santosh Kumar, Advocate accepts notice on behalf of Defendant Nos. 1, 3 and 4 and waives off formal service of notice.

4. The present suit concerns infringement of Indian Patent No. 382949 titled “A Pharmaceutical Composition for Anaemia” [‘Suit Patent’] as well as copyright of Plaintiff No. 2’s website [‘Suit Copyright’].

CASE SETUP BY THE PLAINTIFF IN THE PLAINT

5. Mr. Dayan Krishnan, learned senior counsel for Plaintiffs, has presented the following facts and contentions: - 5.[1] Plaintiff No. 1 is a company engaged in, inter alia, the manufacturing and sale of medicines as well as health supplements. Plaintiff No. 1 is the wholly owned subsidiary of the parent i.e., Plaintiff No. 2 herein. Plaintiffs have large number of marketed products and large patent portfolio, currently 402 patent applications globally. 5.[2] The Suit Patent is owned by Plaintiff No. 1 and the same is licensed to Plaintiff No. 2 vide license agreement dated 20.12.2017. The Plaintiffs jointly and separately manufacture and market various products covering the Suit Patent. 5.[3] The Plaintiff No. 1 filed Suit Patent - IN 382949 [hereinafter referred to as IN’949] titled “A Pharmaceutical Composition for Anaemia” on 09.03.2018 and the Suit Patent was granted to Plaintiff No. 1 on 29.11.2021. The twenty-year [20] term of the Suit Patent is set to expire on 09.03.2038. The bibliographic details of the said Suit Patent are as follows: - Indian Patent number 382949 Patent application number 201821008809 Applicant/Patentee Frimline Private Limited Title A Pharmaceutical Composition For Anaemia Indian Application Date 09/03/2018 Priority date 09/03/2018 Type of Application Ordinary Application Indian Publication date 18/10/2019 Date of Grant 29/11/2021 Date of Expiry 09/03/2038 5.[4] The Suit Patent discloses and claims a pharmaceutical composition, which is a synergistic combination of ‘Lactoferrin’ [‘LF’] and one or more ‘Guanosine Nucleotide’ or a pharmaceutically acceptable salt thereof for the treatment of Iron deficiency Anaemia [‘IDA’], Anaemia of Inflammation [‘AOI’] and Neuro-degenerative disorders. 5.[5] The Suit Patent comprises 15 granted claims, where Claim 1 is for a pharmaceutical composition and Claims 2-15 are dependent on Claim 1. Claim 14 discloses the process for preparation of composition, as claimed in Claim 1. 5.[6] Purpose of the Suit Patent, which is a formulation with natural ingredients, is not limited to reducing the side effects caused by the iron supplements but to also maintain Iron homeostasis by hepcidin regulation and hence, will provide a natural treatment for IDA and AOI. 5.[7] In line of the mandate of Section 83 of the Patents Act, 1970 [‘Act of 1970’], the Plaintiffs have commercialised the product claimed via the Suit Patent since June of 2018. The Plaintiff’s first commercial product was launched in June, 2018 incorporating the claimed subject matter of IN’949 under the brand name FERRONOMIC. The FERRONOMIC contains 100 mg Lactoferrin and 10 mg of Disodium Guanosine 5-Monophosphate. 5.[8] Further, the Plaintiffs have developed various products incorporating the claimed subject matter of IN’949. The product FERRONEMIA PLUS sold by the Plaintiffs currently constitutes the following for 556 mg Tablet. The said tablet contains 50 mg Lactoferrin, 5 mg Disodium Guanosine 5- Monophosphate and 19 mg Elemental Iron [FBG-Ferrous Bisglycinate]. 5.[9] The Plaintiffs have obtained trademark registrations in class 05 for its products ‘FERRONEMIA’ and ‘FERRONOMIC’. Further, the Plaintiffs also sell products under the brand ‘FERRONEMIA PLUS’ and ‘FERRONOMIC PLUS’. It is stated that since 2018, the Plaintiffs have earned around Rs. 331 Crores in revenue from sale of the said products globally.

6. On 16.07.2025, the Plaintiffs learnt the presence of Defendants’ product ‘FERROTOK PLUS’ [‘impugned product’ or ‘infringing product’] in the market through its representatives. 6.[1] It is stated that Defendant Nos. 1 and 2 are the manufacturers and Defendant Nos. 3 and 4 are the ex-employees of Plaintiff No. 2, who are employed with Defendant No. 1. Defendant Nos. 3 and 4 possibly hold senior management positions with Defendant No. 1. 6.[2] It is stated that Defendant Nos. 1 and 2’s product is available in the market. And, from the information on the package of the infringing product, Plaintiffs found the ingredients used therein clearly match the claims of the Suit Patent. According to the outer-package, the Defendant’s product contains Lactoferrin 50 mg (6.0%*), Disodium Guanosine 5-Monophosphate - 5 mg and Elemental Iron [as Ferrous Bisglycinate] 27mg. The Plaintiffs conducted a weight analysis of the infringing products of the Defendants and the certificate of analysis[1] has been filed along with the suit. 6.[3] The Claim mapping of the plaint for infringement analysis of Defendant’s infringing product with the claims of the Suit Patent, as set-out in paragraph 43 of the plaint is reproduced herein as under: - Filed as Document No. 20 in the Plaintiff’s Documents 6.[4] It is stated that upon further verification, the Plaintiffs also noted that Defendant No. 1 has blatantly copied information from Plaintiff No. 2’s website. Defendant No. 1 has adopted the contents of the Plaintiffs’ website, which is accessible from https://www.ksmatco.com/ copying all the information from Plaintiff No. 2’s website and has presented the information as their own. 6.[5] All the information regarding Plaintiff No. 2’s history, divisions, events and all information as displayed on the Plaintiffs’ website accessible at https://www.larenon.com/ is covered under the definition of ‘literary work’ as referred in Section 13(1)(a) of the Copyright Act, 1957 and are entitled to copyright protection. 6.[6] The averments in the plaint pertaining to the copyright infringement of the Plaintiffs’ website are set out at paragraph no. 55 of the plaint. The intent of the Defendants is to mislead the general public into believing the website belong to the Plaintiffs and to ensnare the public including stockists and retailers into dealing with the Defendants for the infringing products. 6.[7] It is further alarming to note that the infringing products are supposed to be used by pregnant anaemic women and if the said products are substandard, the same might even cause harm to the general public. 6.[8] On further research, the Plaintiffs obtained invoices of the Defendant’s infringing product showing that the said product is being sold in many parts of India.

CASE SETUP BY THE DEFENDANT IN REPLY

7. The Plaintiffs were directed to effect advance service on Defendant Nos. 1 to 4. Mr. Santosh Kumar, Advocate entered appearance on behalf of Defendant Nos. 1 to 4 on 11.08.2025 and sought an adjournment to address arguments. The matter was taken up on 14.08.2025, when Mr. Santosh Kumar, Advocate stated that he will address arguments on behalf of Defendant No. 1, 3 and 4. He stated that Defendant No. 2 has not given him instructions to address arguments though Defendant No. 2 is aware about the hearing scheduled on 14.08.2025.

8. Mr. Santosh Kumar, learned counsel representing the Defendant Nos. 1, 3 and 4 made the following submissions: - 8.[1] The First Examination Report [‘FER’] dated 13.02.2020[2] issued by the Indian Patent Office, while prosecuting the Suit Patent, stated that Claims 1 to 17 of the complete specification of the Suit Patent lack novelty and inventive step in light of prior art, and the Controller rejected the subject matter of the Suit Patent. 8.[2] Amended Claims 1 to 15 were filed on 24.05.2021 by the Plaintiffs as stated in the Assistant Controller’s orders, but the same is not on record. It was stated that the granted claims of Suit Patent as filed with the affidavit dated 08.08.2025 before this Court bears the date of 09.03.2018 and not 24.05.2021. 8.[3] It was contended that the Plaintiffs have not filed a certified copy of the Complete Specification; therefore, reliance cannot be placed on the downloaded copy from the IP India Website. 8.[4] There are approximately 30 to 40 different products with a similar chemical composition to that of the Defendant’s patent readily available in the market. Thus, it is a commonly available formula. Filed as Document No. 14 in Plaintiff’s Document. 8.[5] Claim 1 of IN’949 states the range of Lactoferrin between 5 to 90% by weight of the composition. However, the Plaintiffs’ contention that the Defendants’ tablet contains 6% Lactoferrin is based on an in-house report. However, the same could possibly fall outside the claimed range and therefore the said report is not admitted. 8.[6] Defendant No. 1, being a distributor, is not able to provide the details of the composition used for manufacturing the impugned product. The information regarding same is only available with Defendant No. 2, who is the manufacturer of the product and is manufacturing similar products for third parties. 8.[7] The Defendant Nos. 1, 3 and 4 were granted liberty to file written submissions, which has been filed on 21.08.2025. In these written submissions, the said Defendants have made a new disclosure, to the effect that Defendant No. 1 has stopped manufacturing and marketing the infringing product after service of the suit. The relevant portion of the written submissions reads as under: “Yet, being a Law abiding entity, after the service of present suit, Defendant No.1 has voluntarily withdrawn manufacturing order issued for the product ‘FERROTOK PLUS’ and stopped marketing/ selling the same, till they get full details of suit patent and examined their product through Government approved Lab as to weight ratio analysis. The Defendant further declares that they will not launch the product ‘FERROTOK PLUS’ in market again in any composition which will be infringing the patented rights of Plaintiffs. At present neither Defendant No.1, nor his stockists, whole sellers have any stock of ‘FERROTOK PLUS’ with them. The Defendant No.1sincerely regrets the mistake of its officials in inaccurate website description and as such they have withdrawn the website details for the time being and the same will now be uploaded after proper examination as to correctness of contents and the same shall be in full consonance of the law of the and. It is further submitted that the Defendant No.1 through its officials realized the demand of Iron related medicine, which can act as a food supplement towards the end of 2024 and then contacted Defendant No.2, who is active in the field of Drug Manufacturing since 2018. The drug composition and formulations were proposed by Defendant No.2 and based on effectiveness and pricing issues as recommended by Defendant No.2, Defendant No.1 started marketing the question product under the brand name of ‘EFRROTOK PLUS’ since February 2025.” (Emphasis Supplied)

CASE SETUP BY THE PLAINTIFF IN REJOINDER

9. In response, Mr. Dayan Krishnan, learned senior counsel appearing on behalf of the Plaintiffs, stated that the FER issued by the Patent Office on 13.01.2020 is the initial objection from the Indian Patent Office. 9.[1] He stated that the Plaintiffs filed a response to the FER on 12.07.2020[3]. Subsequently, the Controller issued a hearing notice on 18.10.2021. Since, the Controller was satisfied with the response filed by the Plaintiffs/patentee, the patent application was granted on 29.11.2021. He stated that thus the Plaintiffs have overcome the Novelty, inventive step, and the objections under Section 3(e) of the Act of 1970, raised by the Indian Patent Office. The Suit Patent has been valid and subsisting for the past four [4] years. 9.[2] He stated that the “as granted” claims have been filed along with the Affidavit e-filed on 08.08.2025[4] [as downloaded from the Patent Office website]. He clarified before the Court that, in accordance with the practice before the Indian Patent Office, any time an amendment in claims [i.e., 24.05.2021] is filed, it is done by mentioning the priority date of the patent. 9.[3] He stated that with regard to the date of patent, and the date of Claims filed, the E-register Status Page[5] and the Certificate of Grant[6] for IN’949, Filed as Document No. 15 in Plaintiff’s Document. vide diary number E-5635238/2025 Filed as Document No. 10 in Plaintiff’s Document. Filed as Document No. 11 in Plaintiff’s Document. both clearly states the date of patent as 09.03.2018, which is the filing date of the patent. He stated that the Controller in the order dated 29.11.2021 granting the patent has also noted the following: - “… I hereby proceed to grant the instant application 201821008809 with 15 claims filed on 24th May 2021 with written submissions further under section 15 of the Patents Act.”7 9.[4] He stated that the Plaintiffs became aware of the Defendant’s product on 16.07.2025 and immediately began preparing to initiate the legal proceedings. A request for a certified copy of the granted claims was filed on 22.07.2025. However, the same has not been received yet; hence, a publicly available copy of the granted claims, as available on the Patent Office website, has been filed along with the paper-book. 9.[5] He submitted that the Plaintiffs themselves are marketing different products covering the patented composition under various brands like FERRONEMIA, FERRONEMIA PLUS, FERRONOMIC, FERRONOMIC PLUS, NEURONOMIC NEURONOMIC PLUS, IRONEMIC, IRONEMIC PLUS. 9.[6] He stated that the Plaintiff’s invention is a blockbuster formulation, and many entities have infringed the suit patent in the past; subsequently, the Plaintiffs have also sent numerous legal notices against said different infringers in the past. He states that details of the same are provided at paragraph no. 30 of the plaint. Filed as Document No. 17 in Plaintiff’s Document. 9.[7] The Plaintiff has filed its written submissions on 22.08.2025 and has separately enclosed its response to the Defendant’s oral submissions at the hearing dated 14.08.2025.

ANALYSIS AND CONCLUSION

10. According to section 10(4)(c)8 of the Act, the claims of a complete specification define the scope of a patent, and claim construction forms the foundation of a patent infringement analysis [Re. Guala Closures SPA v. AGI Greenpac Limited[9] ]. Moreover, a comparison of the claims of the Suit Patent with the impugned product further aids the infringement analysis [Re. Mold Tek Packaging Ltd. v. Pronton Plast Pack (P) Ltd.10 ]. Therefore, the claim construction and claim mapping filed by the Plaintiffs is essential for adjudicating the present application.

11. At the hearing dated 08.08.2025, upon examining the claim mapping, this Court noted that the component of independent Claim 1 of the suit patent—‘Guanosine Nucleotide’—specifically claimed in Claim 2 as ‘Guanosine Monophosphate’ (GMP), is absent in the Defendants’ product. Instead, the Defendants’ product contains Disodium Guanosine 5- Monophosphate. Consequently, the Plaintiffs were directed to file an affidavit clarifying this aspect.