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  • Delhi HC Rejects FMC...

Delhi HC Rejects FMC Plea, Clears Natco to Launch Cyantraniliprole Ahead of Patent Expiry

Written By : Susmita Roy Published On 2025-11-21T16:18:43+05:30  |  Updated On 21 Nov 2025 4:18 PM IST
Delhi HC Rejects FMC Plea, Clears Natco to Launch Cyantraniliprole Ahead of Patent Expiry

Delhi High Court

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New Delhi: Strengthening India's stance on fair market competition in agriculture, the Delhi High Court has denied FMC Corporation's attempt to restrain Natco Pharma from launching its Cyantraniliprole formulation, holding that Natco had "cleared the way" legally and commercially and that FMC's patent, set to expire shortly, no longer justified emergency market protection.

The dispute centers on FMC's Indian Patent No. 298645 (IN’645), particularly Claim 12, which covers a chemical intermediate used in producing the insecticide Cyantraniliprole 10.26% OD. Natco has launched a similar formulation, prompting FMC to seek an injunction restraining production.

Multiple suits and appeals regarding FMC’s patents on similar molecules have been fought since 2019. Natco first filed a revocation petition challenging Claim 12 in 2023, and obtained regulatory approvals before commercialization in 2025.

Natco argued it had “cleared the way” by approaching authorities and courts before launching its product—an increasingly recognized defense in patent disputes.

FMC claimed Natco’s formulation uses the same patented intermediate and the infringement would irreparably harm FMC’s rights, especially as only three months remained before patent expiry. FMC insisted its invention was novel, scientifically validated, and had survived 18 years without challenge.

Also Read: Delhi HC Dismisses Roche Appeal, Allows Natco to Continue Selling Generic Risdiplam for Spinal Muscular Atrophy

It accused Natco of a mala fide launch of the product during an ongoing argument, calling it inequitable conduct.

Natco countered that Claim 12 lacked novelty, citing prior claiming and asserting a credible challenge to patent validity. It said FMC’s patent counterpart in China had already been revoked and argued FMC delayed suing despite clear disclosures. It also emphasized that millions had already been invested in commercial production since April 2025, making the injunction economically destructive.

The Court found:

  • Natco successfully demonstrated a prima facie vulnerability of the patent.
  • FMC’s injuries, if proven, are monetary, not irreparable.
  • Only two months remained before patent expiry.
  • Natco had taken deliberate legal and regulatory steps to “clear the way”.

The Court categorically held:

“Accordingly, the plaintiffs have failed to make out a prima facie case for grant of interim injunction… this Court is not inclined to grant an injunction to the plaintiffs.”

The Court allowed Natco to continue selling its product but directed it to disclose data on quantities and revenues earned.

Also Read: Natco Pharma acquires 35.75% stake in Adcock Ingram for USD 226 million

To view the court order, click the link below:

https://medicaldialogues.in/pdf_upload/fmccorporationorsvsnatcopharmalimitedon17november2025-309789.pdf
Delhi High CourtFMC Indianatconatco pharmainsecticidespatentCyantraniliprole
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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