Delhi High Court Allows Natco Pharma to Continue Cyantraniliprole Insecticide Sales Despite FMC Patent Dispute
核心洞察
The Delhi High Court (搜索) refused to restrain Natco Pharma from selling its Cyantraniliprole (搜索) 10.26% OD insecticide, rejecting FMC Corp (搜索)'s injunction plea citing patent infringement.
Justice Mini Pushkarna ruled that Natco had established a credible defense by demonstrating the patent's vulnerability to challenge, with the FMC patent set to expire in less than two months.
The court found that the balance of convenience favored Natco, which had invested heavily in manufacturing infrastructure and regulatory compliance since launching the product in April 2025.
The Delhi High Court (搜索) on Monday delivered a significant ruling in favor of Natco Pharma, refusing to grant an injunction sought by American agricultural sciences company FMC Corp (搜索) to halt sales of a competing insecticide formulation. The decision allows the Hyderabad-based pharmaceutical company to continue manufacturing and selling its Cyantraniliprole (搜索) 10.26% OD product despite ongoing patent infringement allegations.
Court Finds Patent Vulnerable to Challenge
Justice Mini Pushkarna ruled that Natco Pharma had "prima facie" established a credible challenge to the validity of FMC Corp (搜索)'s patent claim. The dispute centers on FMC's Indian Patent No. 298645, specifically Claim 12, which covers a chemical intermediate used in producing the insecticide. The court noted that Natco had successfully demonstrated the patent's vulnerability, with the company arguing that the claim lacked novelty and citing prior art in its defense.
FMC Corp (搜索), which claims to hold approximately 700 global patents covering various aspects of its business, had sought to prevent Natco from using what it alleged was a patented compound. However, the court found that FMC had failed to make out a prima facie case for granting an interim injunction.
Economic Considerations Favor Natco
The court emphasized that the balance of convenience lay in favor of Natco Pharma, citing the company's substantial investments in infrastructure and regulatory compliance. Natco had "invested heavily in infrastructure, regulatory compliance and commercial arrangements, with investments in its manufacturing facilities amounting to several crores," according to court submissions.
Since Natco had been manufacturing and selling the product since April 2025, the court recognized that granting an injunction would cause significant economic disruption to the Indian company's established operations. The court noted that Natco had taken deliberate legal and regulatory steps to "clear the way" before launching its product, approaching authorities and courts as an increasingly recognized defense in patent disputes.
Patent Expiry Timeline Influences Decision
A crucial factor in the court's decision was the imminent expiration of FMC's patent, with less than two months remaining before the patent expires. Justice Pushkarna observed that any injury caused to FMC would be "purely monetary in nature and could be adequately compensated by damages" given the short remaining patent term.
This timeline consideration significantly weakened FMC's position, as the court determined that the potential harm to the American company was not irreparable and could be addressed through monetary compensation rather than an injunction that would halt Natco's operations.
Ongoing Legal Battle and Regulatory Compliance
The current dispute is part of a broader legal battle, with multiple suits and appeals regarding FMC's patents on similar molecules ongoing since 2019. Natco first filed a revocation petition challenging Claim 12 in 2023 and obtained necessary regulatory approvals before commercializing the product in 2025.
FMC had accused Natco of "mala fide launch" during ongoing litigation, calling it inequitable conduct. The American company insisted its invention was novel and scientifically validated, having survived 18 years without challenge. However, Natco countered that FMC's patent counterpart in China had already been revoked and argued that FMC had delayed legal action despite clear product disclosures.
Court Orders Disclosure Requirements
While allowing Natco to continue sales, the court imposed specific disclosure requirements on the Indian pharmaceutical company. Natco must submit detailed information regarding the quantity and value of the product it has manufactured and sold, providing transparency into the commercial impact of its operations during the patent dispute period.
The court's categorical holding stated: "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."