Calico Life Sciences LLC v Joint Controller of Patents and Designs (2026)

Summary

“This appeal is filed on behalf of the Appellants under Section 117A of the Patents Act, 1970 ... laying a challenge to impugned order dated 11.07.2024, whereby Patent Application No. 202117021158 filed by the Appellant has been refused.” (para 1) “Instant application relates to claimed invention titled ‘PRODRUG MODULATORS OF THE INTEGRATED STRESS PATHWAY’ and was filed on 10.05.2021.” “After the hearing notices and scheduled hearing, Appellants filed written submissions on 14.06.2024 with amended claims 1-4. Instant application was rejected by the impugned order dated 11.07.2024 on ground of lack of inventive step under Section 2(1)(ja) and non-patentability under Section 3(d).” (para 16)

The Court found that none of the Appellants’ submissions “even find a mention in the impugned order, leave alone discussing them” (para 17); that “neither of five-steps have been followed by the Respondent” and “In the absence of this exercise the conclusion of lack of inventive step cannot be sustained” (para 18); and that on section 3(d) “It was for the first time that the Respondent identified the ‘known substance’ in the impugned order” so that the Appellants “did not get the opportunity to respond to the objection and contest the same and this is a clear violation of principles of natural justice” (para 19). It ordered: “Accordingly, this appeal is partially allowed and the impugned order dated 11.07.2024 is set aside. Respondent is directed to consider Indian Patent Application No. 202117021158 titled ‘PRODRUG MODULATORS OF THE INTEGRATED STRESS PATHWAY’ afresh in accordance with law and without being influenced by the earlier order.” (para 21)

What the court decided

1. Submissions not considered. “Court finds that none of these submissions, even find a mention in the impugned order, leave alone discussing them.” The Court recorded that in Qualcomm Incorporated v. Controller of Patents and Boehringer Ingelheim Vetmedica GMBH v. Controller of Patents it “has held that orders which do not deal with the submissions advanced by parties and are ex facie unreasoned, cannot be sustained in law and that it is incumbent on the concerned authority to deal with the submissions raised by the party, to the extent they are relevant and material. This to my mind is also a facet of principles of natural justice and as rightly flagged by the Appellants an order which is bereft of consideration of the submissions of the Appellants cannot be sustained in law.” (para 17)
2. The Roche steps. “The Division Bench of this Court in F. Hoffmann (supra), has elucidated a five-step test for determining lack of inventive step in a claimed invention and the first step requires the Controller of Patents to identify the person skilled in the art. The impugned order shows that neither of five-steps have been followed by the Respondent and the objection has been dealt with by merely referring to an observation in the judgment” (para 18). “Respondent is required to follow the test as laid down and cannot absolve itself of this duty by merely citing paragraphs from the judgement. In the absence of this exercise the conclusion of lack of inventive step cannot be sustained.” (para 18)
3. Three elements of inventive step. “This Court has consistently held that while rejecting an invention for lack of inventive step, Controller has to consider three elements: (a) invention disclosed in the prior art; (b) invention disclosed in the patent application; and (c) the manner in which subject invention would be obvious to the person skilled in the art. This means that the Controller has to analyse the existing knowledge and how the person skilled in the art would move from the existing knowledge to the subject invention” (para 18), relying on Agriboard International LLC v. Deputy Controller of Patents and Designs. (para 18)
4. Known substance under section 3(d). “As for the objection of non-patentability under Section 3(d), a bare reading of the provision shows that a mere discovery of a new form of a ‘known substance’ which does not result in the enhancement of ‘known efficacy’ of that substance or the mere discovery of any new property is not an invention. Therefore, Appellants rightly submit that the most fundamental requirement while raising an objection under Section 3(d) is to provide information to the inventor regarding the ‘known substance’ or the ‘known efficacy’ of the said ‘known substance’.” (para 19)
5. A known substance named late. “It was for the first time that the Respondent identified the ‘known substance’ in the impugned order and observed ’the said compound of Formula II is already disclosed in the cited document D1 as compound no-297 and 298’. Therefore, as rightly placed by the Appellants, they did not get the opportunity to respond to the objection and contest the same and this is a clear violation of principles of natural justice” (para 19). “Considering that the Respondent has erred in not dealing with the objection under Section 3(d) in the manner it ought to have been by first providing information of ‘known substance’ prior to passing of the impugned order, Appellants have been deprived of the opportunity to defend the objection.” (paras 19–20)
6. The Controller’s efficacy reasoning. The judgment records that “Cmax is the maximum plasma concentration of the drug and AUC is the measurement of extent of drug bioavailability” (para 8). The Court recorded that the Respondent “has refused the application on the ground that the Supreme Court in Novartis (supra) affirmed that better efficacy in pharmaceutical substance is enhanced therapeutic efficacy as also that solubility is not a factor of therapeutic efficacy” and had observed that “the Cmax and AUC values are provided for the prodrug itself, which at the most indicate bioavailability” (para 20). “Appellants have seriously contested the interpretation given by the Respondent to the judgment of the Supreme Court as also the enhanced therapeutic efficacy of the claimed invention referring to articles on the subject and the specifications of claims 1-4.” (paras 8, 20)
7. Procedure. Remand. “Accordingly, this appeal is partially allowed and the impugned order dated 11.07.2024 is set aside.” “Needless to state, while reconsidering the application, the Respondent shall grant full opportunity to the Appellants to address on the objections raised under Sections 2(1)(ja) and 3(d) of 1970 Act. All documents on record including response to FER” (“First Examination Report”) “as also written submissions and the judgments relied upon shall be taken into consideration before taking a final decision. The entire exercise will be completed within a maximum period of four months from today.” (para 21)

What the court did not decide

“As the impugned order suffers from fundamental errors of following the required tests for determining lack of inventive step under Section 2(1)(ja) as also under Section 3(d) and there are violations of principles of natural justice, I am of the view that this is a fit case for remand without entering into the merits at this stage.” (para 20) “It is made clear that this Court has not expressed any opinion on the merits of the case.” (para 21)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 16 September 2026.