Novo Nordisk A/S, holder of Indian Patent No. 262697 (IN'697) granted on 5 September 2014 with priority from 18 March 2005 for acylated GLP-1 analogs including Semaglutide used in treating Type 2 diabetes and obesity, filed a suit against Dr. Reddy's Laboratories Limited alleging infringement by their manufacture and intended sale of generic Semaglutide and sought interim injunction under Order XXXIX Rules 1 & 2 CPC.
Defendants countered with revocation grounds under Sections 64(1)(a), (e), (f) of Patents Act 1970 claiming anticipation by prior claiming in plaintiff's own genus patent IN'964, prior publication, obviousness/lack of inventive step, and evergreening.
The Single Judge, after detailed analysis, held the suit patent prima facie vulnerable to revocation as the species compound Semaglutide was anticipated by claims in IN'964, obvious to a 'person in the know' (same inventor) without inventive step over prior art teachings, constituted evergreening to extend monopoly, and no other grounds favored validity.
The interim injunction application was dismissed with prima facie observations not binding trial.
In assessing obviousness under Section 64(1)(f) of the Patents Act, 1970, for a species patent derived from a prior genus patent by the same inventor, the perspective shifts from the ordinary 'person skilled in the art' to a 'person in the know' who is intimately familiar with the genus patent's details, making obviousness easier to establish. ( paras 67-70, 90)
A subsequent species patent may be invalidated for anticipation by prior claiming under Section 64(1)(a) if its claims are subsumed within the broader claims of an earlier genus patent by the same patentee, even if the specific compound is not explicitly disclosed. (paras 26-55)
Evergreening through minor modifications to extend patent monopoly without significant therapeutic enhancement renders the patent vulnerable, especially when the species lacks inventive step over the genus. (paras 89-90)
For interim injunction in patent infringement, where validity is credibly challenged on grounds like obviousness and evergreening, no prima facie case exists if the patent appears revocable; balance of convenience favors denying relief when plaintiff does not manufacture locally and damages are quantifiable. (paras 94-99)
Defendants who 'clear the way' by challenging patent validity prior to launch may avoid interim injunction, promoting timely resolution over market disruption. (paras 96-98)
Case Title: Novo Nordisk Vs. Dr. Reddys Laboratories Limited : 02 December 2025 : CS(COMM)565/2025 :2025:DHC:10820:Hon'ble Ms. Justice Manmeet Pritam Singh Arora
[Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation]
[Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi]