By Jigyasa Pareek

In Novo Nordisk A/S vs Dr. Reddy’s Laboratories Ltd. [FAO(OS)(COMM) 204/2025], the Division Bench of the Delhi High Court upheld the refusal of interim injunction against alleged patent infringement of IN’697 covering Semaglutide. Significantly, the Bench also cautioned against the growing tendency to prefer appeals against interim injunction orders in intellectual property disputes in the absence of demonstrable pressing urgency, irreparable harm or any element of public interest.

At the outset, the Bench expressed palpable disquiet at being called upon to adjudicate an appeal wherein the suit patent was on the verge of expiry, with barely two months remaining at the time of hearing of the appeal. In a series of pointed observations, the Bench questioned the very utility of appellate interference in such circumstances, noting that even a successful appellant would secure, at best, a short-lived, prima facie restraint. The Bench remarked that such appeals ought to be dismissed on the principles of balance of convenience and irreparable loss, de hors the merits of the case.

Placing this concern in a broader institutional context, the Court underscored that appellate scrutiny in interim matters must be selective and principled, particularly given the competing demands on judicial resources. The Bench acknowledged that intellectual property disputes may, in appropriate cases, warrant urgent intervention, such as infringement of a patent relating to an aircraft part which could endanger thousands of lives, or trade mark infringement cases involving counterfeit pharmaceutical products.

The Court however proceeded within the narrow confines of appellate review laid down in Wander vs Antox [1990 Supp SCC 727] to examine whether the decision of the Single Judge to refuse the interim injunction suffered from any infirmity in principle.

The Single Judge had held that the Defendants had raised a credible challenge to the validity of the suit patent on the grounds of Section 64(1)(a), (e), (f) and (k) of the Patents Act and concluded that the Plaintiff failed to make out a prima facie case for an interim injunction.

The Bench examined the scope of Sections 64(1)(a), (e) and (f), and the doctrinal boundaries between them.

• Regarding Section 64(1)(a) (anticipation by prior claiming), the Bench held that the provision is confined to a claim-to-claim comparison, requiring that the invention “so far as claimed in any claim” in the suit patent must be identically claimed in a valid claim of earlier priority date contained in another patent granted in India. The Bench clarified that this enquiry does not extend to issues of disclosure, or coverage, or obviousness, or “newness” or novelty. It expressly noted that a person skilled in the art (PSITA) has no role to play under Section 64(1)(a) and the relevant clause of Section 13 for the purpose of Section 64(a) is Section 13(1)(b) i.e. “anticipation by previous publication” or “anticipation by prior claim”.
• Regarding Section 64(1)(e) (lack of “newness”/anticipation by prior publication or prior usage), the Bench observed that the Act does not define the contours of either “new” or “anticipation”. The Bench noted that the relevant clauses of Section 13 for the purpose of Section 64(e) are Section 13(1)(a) and 13(2) i.e. “anticipation by publication”. The Bench observed that the statutory framework appears to proceed on the understanding that what is “anticipated by publication” cannot be regarded as “new”. It noted that the role of a PSITA under Section 64(1)(e) is very limited. However, the Bench candidly acknowledged that there is no settled or uniform test for determining when a claim is anticipated by prior publication. The Bench pointed out the Act merely enumerates situations that would not amount to anticipation, without defining what would. The Bench recognised that the distinction between clauses (e) and (f) of Section 64(1) remains ambiguous and remarked that a more authoritative exposition would be required to bring clarity to this area. However, the Bench refrained from an extensive analysis on Section 64(e), particularly since, in its view, the findings of the Single Judge made out a prima facie case of vulnerability under Section 64(1)(f).
• Regarding Section 64(1)(f) (obviousness/lack of inventive step), the Bench noted that while the Patents Act does not define “obviousness”, the legal position in this regard is now fairly settled through judicial precedents. It reiterated that the touchstone for obviousness is whether a PSITA, on the basis of prior art and existing prior knowledge, would be able to arrive at the claimed invention without the exercise of inventive ingenuity. Significantly, the Bench endorsed the five-step test laid down in F. Hoffmann-La Roche Ltd. vs Cipla Ltd. [(2016) 65 PTC 1 (DB)] as a “litmus test” for determining obviousness at the stage of final adjudication after evidence is led. However, it cautioned against an exhaustive application of this test at the interlocutory stage. In the context of interim injunctions, the enquiry is necessarily limited to assessing whether a credible challenge to validity has been raised, and not to conclusively determining inventive step through a mini-trial, thus, the Bench opined that strict adherence to the five-step test is impractical and unnecessary.  In this regard, the Bench made an important doctrinal clarification: at the interim stage, the judge may himself don the mantle of a PSITA and undertake a prima facie assessment of obviousness from such a perspective.

Applying this standard, the Bench concurred with the Single Judge’s conclusion that the suit patent was vulnerable to revocation on the grounds under Section 64(1)(e) and (f). However, it clarified that the reasoning adopted by the Single Judge in relation to the teachings of the genus patent, more appropriately fell within the domain of Section 64(1)(f), rather than Section 64(1)(a), since Semaglutide was not claimed in the genus patent.  

The Bench observed that once it is accepted that: (i) most structural features of Semaglutide were already disclosed in the genus patent; and (ii) the only distinguishing feature was itself suggested as a preferred option in the prior art, a PSITA would be led, without inventive effort, to arrive at the claimed compound. This, in the Court’s view, squarely raised a credible case of obviousness.

Further, the Bench invoked the “person in the know” standard, noting that where inventors are common across the prior art and the suit patent, the aspect of obviousness should be viewed from the perspective of a “person in the know”, rather than a PSITA. The Bench found it prima facie evident that the claimed invention lacked the requisite inventive step.

Accordingly, even though the Court disagreed with the Single Judge’s finding on anticipation by prior claiming under Section 64(1)(a), it held that the existence of a credible challenge under Section 64(1)(f) was sufficient to deny interim relief.