When a suit patent is two months from expiry, what exactly is an appellate court being asked to save? That blunt question runs through Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. [FAO(OS)(COMM) 204/2025], where a Division Bench of the Delhi High Court upheld the refusal of an interim injunction over IN’697 (Semaglutide) — and, along the way, drew one of the clearer recent maps of Section 64(1) validity grounds.
A warning about late-stage appeals
The Bench began with palpable disquiet at being asked to injunct on a patent with barely two months to run. Even a successful appellant, it noted, would win only a short-lived prima facie restraint; such appeals ought ordinarily to fail on balance of convenience and irreparable loss, regardless of merits. Appellate intervention in interim matters, it stressed, must be selective and principled — reserved for genuine urgency, irreparable harm or public interest (the Bench’s vivid examples: a patented aircraft part that could endanger lives, or counterfeit pharmaceuticals). It then confined itself to the narrow Wander v. Antox standard of appellate review of discretion.
Mapping Sections 64(1)(a), (e) and (f)
The doctrinal heart of the judgment is its disentangling of three often-blurred grounds. Section 64(1)(a) — prior claiming — is a strict claim-to-claim comparison: the invention “so far as claimed in any claim” must be identically claimed in a valid claim of earlier priority date in another Indian patent, with no role for disclosure, coverage, obviousness or novelty, and no role for a person skilled in the art; the relevant limb of Section 13 is 13(1)(b). Section 64(1)(e) — anticipation by prior publication or use — engages Sections 13(1)(a) and 13(2), with a limited PSITA role; here the Bench candidly admitted there is no settled test for when a claim is anticipated, and that the line between clauses (e) and (f) “remains ambiguous,” inviting a more authoritative exposition. Section 64(1)(f) — obviousness — is comparatively settled: the touchstone is whether a PSITA would reach the invention without inventive ingenuity.
On obviousness, the Bench endorsed the five-step test from F. Hoffmann-La Roche v. Cipla [(2016) 65 PTC 1 (DB)] as a “litmus test” at final adjudication — but cautioned against applying it exhaustively at the interlocutory stage, where the question is only whether a credible challenge to validity exists, not a mini-trial. In a notable practical move, it held that at the interim stage the judge “may himself don the mantle of a PSITA” and form a prima facie view on obviousness.
Genus, species and the “person in the know”
Applying this, the Bench parted company with the Single Judge on one point: since Semaglutide was not actually claimed in the genus patent, the genus-based reasoning belonged under Section 64(1)(f) (obviousness), not 64(1)(a) (prior claiming) — a clean illustration of why the claim-to-claim discipline matters. On the merits, once it was accepted that most structural features of Semaglutide were disclosed in the genus and the only distinguishing feature was itself flagged as a preferred option in the prior art, a skilled person would arrive at the compound without inventive effort. The Bench also invoked a “person in the know” standard where the inventors are common across the prior art and the suit patent — a stricter vantage than the ordinary PSITA. A credible Section 64(1)(f) challenge was enough to deny interim relief.
Why it matters
Two things make this judgment worth keeping. First, it is a teaching text on Section 64(1): the rigid claim-to-claim nature of prior claiming under (a), the acknowledged fuzziness of (e), and the settled-but-flexible obviousness enquiry under (f) — useful far beyond this dispute, and a neat companion to this blog’s note on revocation surviving patent expiry. Second, its candour about late-stage appeals is a quiet policy signal: as more blockbuster patents near expiry amid generic entry, courts may increasingly decline to spend appellate bandwidth on injunctions that can only ever be fleeting. For originators, the lesson is to litigate validity early and on the merits; for generics, that a credible obviousness challenge — even an inelegant one — can be decisive when the clock is already running out.
Sources & further reading: Novo Nordisk v. Dr Reddy’s (judgment); Section 64; Section 13; Wander v. Antox; F. Hoffmann-La Roche v. Cipla.
Educational note: This case summary is general information, not legal advice.