Judicial Analysis Court Copy Headnote Facts Arguments Court observation

2026 Supreme(Online)(Mad) 45580

1For Plaintiffs: M/s Hemant Singh Mamta Jha Arun C. Mohan Shruthi Srinivasan Aanjana Sasidharan For Defendant: M/s T.K.Ram Kumar Sumitha Vibhu

Advocates:
For the Appellants/Petitioners: Hemant Singh, Mamta Jha, Arun C. Mohan, Shruthi Srinivasan, Aanjana Sasidharan
For the Respondents: T.K.Ram Kumar, Sumitha Vibhu

The research exception for patented inventions is narrowly construed and strictly conditional. A defendant claiming this exception must provide concrete evidence that exports were made solely for regulatory approval processes, and a prior consent decree acknowledging patent validity creates an estoppel against future challenges to that patent.

Headnote:(A) Patents Act, 1970 - Sections 8, 47, 48, 53, 64, 107, 107A - Patent infringement - Term of patent - Scope of research exception (Bolar provision) - Patentee's rights - Term of patent for international applications under Patent Cooperation Treaty is twenty years from the international filing date (Para 30).

(B) Patent Infringement - Estoppel - Consent decree - A defendant who acknowledges the validity of a patent in an earlier consent decree is estopped from challenging the validity of the same patent in subsequent infringement litigation between the same parties (Para 35).

(C) Research Exception - Scope of Section 107A - The exception is not a general permit for research; it is limited to acts solely for regulatory approval and requires the defendant to discharge a substantial burden of proof, including evidence of commissioning or specific regulatory requests (Paras 68-71, 80).

(D) Burden of Proof - In an infringement action, the onus lies on the defendant to establish that its activities, which otherwise infringe the patent, fall squarely within the narrow scope of the regulatory exception (Para 68).

Facts of the case:
The plaintiffs alleged patent infringement by the defendant for manufacturing and exporting a pharmaceutical ingredient, claiming it violated their patent rights. The defendant argued that the exports were for research and development purposes, protected under the statutory regulatory exception, and also challenged the patent's validity based on non-disclosure of information.

Findings of Court:
The court held that the defendant failed to provide sufficient evidence that its manufacturing and exports were intended solely for regulatory submission. The evidence showed commercial sales by the recipients, contradicting the claim of research-only usage. The court also held the defendant estopped from challenging patent validity due to a previous consent decree.

Issues: Whether the manufacturing and export constituted patent infringement or fell under the statutory research exception, and whether the defendant could challenge the validity of the patent after a previous consent decree.

Ratio Decidendi: The court ruled that Section 107A provides a limited exception for regulatory compliance only, requiring robust documentation to prove the end-use is solely for regulatory purposes. Mere labelling of goods as 'for research' is insufficient to discharge this evidentiary burden. Additionally, consent in an earlier judicial decree precludes subsequent challenges to the validity of the same patent.

Result: Suit decreed for permanent injunction, delivery up of infringing stock, and rendition of accounts of profits with costs.

Table of Content
1. establishing standing and factual basis for patent infringement claims. (Para 1 , 2 , 3 , 4 , 5 , 8)
2. defendant asserts the bolar exception and challenges patent validity. (Para 6 , 7)
3. verification of corporate authority and locus standi of plaintiffs. (Para 24 , 25 , 26 , 27 , 28)
4. determination of patent term under the patents act. (Para 29 , 30 , 31)
5. consent decrees create issue estoppel regarding patent validity. (Para 32 , 33 , 34 , 35)
6. statutory construction of section 8 disclosure requirements and patent validity. (Para 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46)
7. legal standard and evidentiary burden for the bolar exception. (Para 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83)
8. final orders, accounting of profits, and allocation of legal costs. (Para 84 , 85 , 86)

JUDGMENT

1.The suit was filed for remedies in relation to alleged infringement of the plaintiffs’ patent in the active pharmaceutical ingredient (API), VILDAGLIPTIN, or in formulations containing VILDAGLIPTIN, by the defendant.

2. The first plaintiff is the proprietor of Indian Patent No.212815 (IN 212815) granted in relation to a new chemical entity with the international non-proprietary name “VILDAGLIPTIN”, which is prescribed for the treatment of Type 2 Diabetes Mellitus. The patent was granted with effect from December 09, 1999.

Pleadings

3. In the plaint, the plaintiffs state that the first plaintiff launched VILDAGLIPTIN globally in the year 2007 under the trademark GALVUS and VILDAGLIPTIN with metformin hydrochloride in the year 2008 under the trademarks GALVUS MET or EUCREAS. After stating that said pharmaceutical products achieved great success all over the world, including India, the plaintiffs have set out the sales figures in India and globally for several years up to the year 2017. It is also stated that the above mentioned products are best selling pharmaceutical products of the second plaintiff, which is a subsidiary of the first plaintiff and the user of the trademarks in India.

4. The plaintiffs further state that they came to know that the defendant offered the patented product VILDAGLIPTIN for sale and supply on its website:// www.nutraforlife.com/products/vildagliptin . html. Therefore, the plaintiffs filed C.S.No.329 of 2015 on a quia timet basis seeking injunctive relief. The suit was decreed on July 31, 2015 on the basis of undertakings given by the defendant on July 28, 2015. By such undertakings, the defendant acknowledged the rights of the first plaintiff in the suit patent and undertook not to manufacture, sell, supply, export, import or offer for sale VILDAGLIPTIN. The plaintiffs further state that they did not press for damages in the suit on account of the undertakings.

5. The plaintiffs state that they received information in the second week of March, 2018 that the defendant had exported very large quantities of VILDAGLIPTIN API from India to Egypt during the years 2016-17. Details of such exports are set out in paragraph 7 of the plaint. In paragraph 9, the plaintiffs have stated that the importers of VILDAGLIPTIN from the defendant, namely, Inspire Pharmaceutical Company (‘Inspire Pharma’), Mash Premiere (‘Mash Premiere’) and Eva Pharma (‘Eva Pharma’) have commercialised VILDAGLIPTIN and are selling the product in the Egyptian market. Therefore, the plaintiffs state that they issued lawyer’s notice dated March 22, 2018 to the defendant calling upon the defendant to stop any further export of VILDAGLIPTIN to Inspire Pharma , Mash Premiere and Eva Pharma. The plaintiffs also state that they engaged the services of an independent research firm, namely, Strategic Analysis (India) Private Limited to confirm whether the defendant had manufactured and exported VILDAGLIPTIN to the above mentioned entities. On the basis of the report dated April 23, 2018, it is stated that s

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2026 Supreme(Online)(Mad) 45580

1For Plaintiffs: M/s Hemant Singh Mamta Jha Arun C. Mohan Shruthi Srinivasan Aanjana Sasidharan For Defendant: M/s T.K.Ram Kumar Sumitha Vibhu

Cases Referred (3)