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Our Associate, Sandeep Gupta discusses “Astrazeneca AB & Anr. Vs. Micro labs limited”

Recently, in a patent infringement suit filed by AstraZeneca AB & Anr., the Hon’ble Delhi High Court granted an ex-parte ad-interim injunction restraining the Defendant, Micro Labs Ltd., from making commercial use of the Dapagliflozin drug.

The case of the plaintiffs is that they the owners of the patent IN 205147 (in short, ‘IN 147’), which according to the plaintiffs is the genus patent, and IN 235625 (in short, ‘IN 625’) is the species patent for the drug molecule Dapagliflozin. Plaintiffs sell the said drug under the brand name “FORXIGA”.

The grievance of the plaintiffs is that the defendant filed an Abbreviated New Drug Application (ANDA) before the US Foods and Drugs Administration seeking tentative approval to market a generic version of the plaintiffs’ drug comprising Dapagliflozin under the brand name “FARXIGA,” The defendant was granted a tentative approval from the U.S.F.D.A. on its application in respect of the generic version. The plaintiffs were also informed (on an RTI) that the defendant has been granted approval to manufacture and sell Dapagliflozin. The plaintiffs alleged that their online research revealed that the defendant had manufactured and discovered publications concerning the manufacture and development of the drug Dapagliflozin. The plaintiffs further alleged that the defendant was also approaching medical practitioners to market the impugned drug.

The plaintiffs submitted that the defendant has commenced manufacturing, selling, exporting, and listing the impugned/ infringing drug on online portals introducing as the supplier of this infringing drug in/from India. The plaintiffs further state that till the filing of the suit, no pre-grant or post-grant opposition was filed by the defendant, however, when a copy of the plaint was served on the defendant it filed for revocation of one of the plaintiffs’ patents.

The counsel of the defendant, on instructions from its client, submitted that the defendant would not be manufacturing, marketing or selling the drug Dapagliflozin till the validity of one of the plaintiffs’ patents, i.e., 2nd October 2020. The defendant’s counsel further submitted that it has not listed the drug Dapagliflozin till date on any online portal.

The Hon’ble High Court held that the plaintiffs have prima facie made out a case in their favour and in case no ex-parte ad-interim injunction is granted, the plaintiffs would suffer an irreparable loss. The balance of convenience also lies in favour of the plaintiffs. Consequently, an ex-parte ad-interim injunction was granted in favour of the plaintiffs.


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