Active Agrochemical Ingredient Chlorantraniliprole Patent Litigation

Chlorantraniliprole Patent Litigation Outcome – Best Agrolife Ltd. & Natco to become First Indian Companies to launch Indigenously Manufactured Chlorantraniliprole (CTPR)

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Best Agrolife Ltd. & Natco to become the First Indian Company to launch Indigenously Manufactured Best Agrolife Ltd

FMC VS Natco&BestAgro

Chlorantraniliprole CTPR technology is compounded into broad-spectrum insecticides that are used to control pests in a variety of crops.

Recently, two independent decisions of the Delhi high court have made it clear that Best Agrolife Ltd. & Natco to become the First Indian Company to launch Indigenously Manufactured Best Agrolife Ltd.

Earlier FMC is continuously trying to stop the generic launch of Chlorantraniliprole by reclaiming process patent infringement. In one of the recent decisions of the Hon’ble High Court of Delhi – Natco Pharma Limited received an order from the Hon’ble High Court of Delhi stating that NATCO is permitted to launch Chlorantraniliprole (CTPR) and its formulations using their non-infringing technology.

Similarly, the Hon’ble High Court of Delhi dines FMC for an injunction to stop Best Agrolife Ltd to launch the Best Agrolife Ltd products CITIGEN (Chlorantraniliprole 18.5 percent W/W SC) and VISTARA (chlorantraniliprole 0.4 percent GR).

Best Agrolife Ltd., a major player in the Indian Agri inputs market, has announced the introduction of two new CTPR-based formulations, CITIGEN and VISTARA.

CITIGEN (Chlorantraniliprole 18.5 percent W/W SC) is a broad-spectrum insecticide with exceptional insecticide efficacy, longer rain fastness, and low mammalian toxicity. Other than sugarcane and rice CITIGEN is highly recommended for controlling pests of cabbage, cotton, tomato, chili, soybean, brinjal, pigeon pea, Bengal gram, black gram, bitter gourd, okra, maize, and groundnut crop. It acts on Ball worm, stem borer, fruit borer, gram pod borer, stem fly, tobacco caterpillar, and pod borer.

VISTARA (chlorantraniliprole 0.4 percent GR) prevents the build-up of shoot borer and stem borer populations in paddy and sugarcane and protects growers from incurring losses due to low crop yield and thereby maximizing output. Due to its low dosage, it is also safe for the environment.

Natco Pharma Limited received an order from the Hon’ble High Court of Delhi stating that NATCO is permitted to launch Chlorantraniliprole (CTPR) and its formulations using their non-infringing technology.

NATCO is India’s first company to get registration clearance from the Central Insecticide Board and Registration Committee (CIB&RC) for indigenous manufacture of Chlorantraniliprole (CTPR) Technical 93.00% w/w min.

NATCO believes that the existing market for CTPR-containing products in India is worth more than Rs2,000 crore. The company intends to release its products very soon.

Case Summary: FMC Vs Natco (THE HIGH COURT OF DELHI – CS(COMM) 349/2022 & I.A. 8132/2022, 9519/2022, 10886/2022 – Decision dated 19/09/2022) – – Doctrine of Equivalents

      • The patent in suit IN 298645 (expiry date: 6.12.2025) is related to the process for the preparation of Chlorantraniliprole (CTPR), which is used as an insecticide.
      • In earlier litigation, the injunction was granted in favour of FMC for the product patent IN201307 (IN’307) and its process patent IN213332. Both the patents expired on 13.08.2022.
        Mainly this case involves the issue of the “Doctrine of Equivalents” (DoE) for process patents. There was no literal infringement.
      • The Honorable court noted that “in a process claim, the monopoly is restricted to the method by which the product is manufactured and if the same product is manufactured through a different process/method, the patentee cannot extend its monopoly to the different process.”
      • Claim 1 of the IN 298645 is a process of combining (1) a carboxylic acid compound, (2) an aniline compound, and (3) a sulfonyl chloride, to manufacture CTPR. (refer the decision for exact claims). Natco process contains the use of Acid + Amide, however, in place of sulfonyl chloride, Natco has used thionyl chloride.
      • Further, it was also noted that the Acid and Amide intermediates are known compounds and were disclosed in the patent which expired on 13.08.2022.
      • The Honorable court prima facie concluded that (1) sulfonyl chloride is an essential element of the suit patent and (2) thionyl chloride used as a reagent in the Natco process, differs from sulfonyl chloride in its physical and chemical properties. Additionally, thionyl chloride is used as a chlorinating agent in Natco’s process wherein the patented process uses sulfonyl chloride as a coupling agent.
      • Considering the facts, and inputs of the Scientific Advisors, the court concluded that the suit patent process and the Natco process are distinct and different and Natco was permitted to launch the CTRP product with some conditions.
      • Importance of opinion of Scientific Advisors in technical analysis.
      • Analysis of DOE in process claims (if the substituted element in the product does the same task, in substantially the same way, to accomplish substantially the same result, and also apply purposive Construction)

Best Agrolife Ltd. (BAL) is a research-based organization that serves the farmer community across the globe by bringing in world-class and cost-effective farm solutions in the form of novel agrochemical formulations.

The company offers more than 70 formulations of insecticides, fungicides, herbicides, and PGRs and retains an unrivaled portfolio of 360+ formulations and more than 80 technical manufacturing licenses.

Other than experiencing tremendous success with its newly launched productsRonfen, AxeMan, Warden, Tombo, and Reveal BAL also recently became the first Indian agrochemical company that holds the registration for the indigenous manufacturing of the crucial herbicide Pyroxasulfone.

Earlier News: Chlorantraniliprole Patent Litigation Update: FMC Corporation Granted Interim Injunction Against Natco

Patent Services: ChemRobotics offers all kinds of IP consultancy services, already serving many Pharma (API as well as Formulation) and Agrochemical / Fine chemical companies.

For more updates on Patent Litigation and other important FMC patents on Chlorantraniliprole CTPR Process and Formulations, user can get full product landscape, please Sign in to Websites for Agrochemical & Pharmaceutical Databases.

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