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F Hoffmann-La Roche Ltd. & Ors. V/S Drugs Controller General Of India & Ors.

The Delhi High Court in a recent judgement, recognized the doctrine of extended passing off in relation to an expired patent. F Hoffmann-LA Roche Ltd. (“Plaintiff”) filed a suit seeking a declaration that the approval granted to ‘Cadila Healthcare Limited’ (“Defendant 1”) and ‘Hetero Drugs Limited’ (“Defendant 3”) by ‘the Drugs Controller General of India’ (“Defendant 2”) for manufacturing authorization under the Drugs and Cosmetics Act, 1940, was invalid. The Plaintiff alleged that Defendant 1 and Defendant 3 were conducting clinical trials and marketing a drug purported to be biosimilar of the Plaintiffs' product. The suit specifically invoked the action for extended passing off pertaining to the characteristic, composition, and quality of a product named 'Trastuzumab', which was earlier protected under a patent that expired in 2013.

Extended passing off is a legal concept that extends protection beyond trademarked goods to protect other aspects such as the composition, characteristics, and quality of a product. In this case, the plaintiff sought to protect the reputation and goodwill associated with 'Trastuzumab' beyond the scope of the expired patent.

CS(COMM) 540/2016 F Hoffmann-La Roche Ltd. & Ors. V/S Drugs Controller General Of India & Ors., & CS(COMM) 1119/201601 Roche Product (India) Private Limited & Ors. V/S Cadila Healthcare Limited & Ors.

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