Cassiopea S.P.A v. Controller General of Patents and Designs & Ors.

High Court of Delhi at New Delhi, Single Judge | Date of Decision: 31.08.2026 Case Number: C.A.(COMM.IPD-PAT) 30/2024 & I.A. 11051/2024 (CNR No. DLHC010282532024) Bench: Hon’ble Ms. Justice Jyoti Singh

BACKGROUND

The Appellant, Cassiopea S.P.A., is an Italian pharmaceutical company engaged in manufacturing, marketing and selling novel pharmaceutical drugs for skin treatment, including for alopecia (hair loss). To protect a novel formulation, the Appellant filed Indian National Phase Application No. 201717044286 on 29.11.2017, originating from PCT Application No. PCT/IB2016/053662 (international filing date 20.06.2016), claiming priority from a US provisional application (No. 62/182,988) and a European application (No. 15173860.6). The invention, titled “High Concentration Formulation,” relates to a topical pharmaceutical formulation comprising fully solubilised cortexolone-17-α-propionate, containing less than 5% water by weight, pharmaceutically acceptable solvents (a polyol, a polyol ether, and/or ethanol), and pharmaceutically acceptable additives including the emulsifier polysorbate 80 and the antioxidant ascorbyl palmitate – said to promote hair growth and overcome deficiencies of the only two marketed products (Minoxidil and Finasteride) approved for treating androgenetic alopecia (AGA).

At National Phase entry, the Appellant filed 97 claims; the application was published in Patent Journal No. 11/2018 dated 16.03.2018. Two pre-grant oppositions were filed under Section 25(1) of the Patents Act, 1970: the first on 30.07.2019 (Appellant’s reply filed 11.08.2019) and the second on 08.06.2020 (Appellant’s reply filed 12.02.2021), raising objections of lack of novelty, lack of inventive step, non-patentability, insufficiency of disclosure, and lack of clarity/conciseness. The Controller issued a First Examination Report (FER) on 24.05.2021 raising similar objections, to which the Appellant responded on 04.08.2021. After a final hearing on 07.07.2023, the Appellant filed post-hearing written submissions on 20.07.2023, in the course of which the claims were progressively amended — first from 97 to 23, and then to 9 — to address the objections raised, including a notice dated 07.06.2023 objecting, among other things, to lack of clarity/conciseness in the terms “emulsifier and antioxidant” in Claim 1.

By the impugned order dated 29.08.2023, the Controller (Respondent No. 1) refused the patent application and allowed the pre-grant oppositions, sustaining the objections of lack of novelty (Section 2(1)(j)), lack of inventive step (Section 2(1)(ja)), and non-patentability under Section 3(e) (mere admixture of known ingredients), while waiving the objections of non-patentability under Section 3(i) and insufficiency of disclosure under Sections 10 and 8(1)/(2). The Controller’s reasoning was that the compound/active ingredient (cortexolone-17-α-propionate at various claimed percentages), the solvents (ethanol, Transcutol, propylene glycol), and the additives (polyol, polyol ether, emulsifier, antioxidant) were all known from the prior art cited by the opposers, principally document ITMI20132157 (published one day prior to the priority date of the Appellant’s application). The present appeal was filed under Section 117A of the Patents Act, 1970, challenging this refusal both on grounds of procedural/natural-justice violation and, in the alternative, on the merits, though the Appellant’s arguments before the Court were essentially confined to the procedural grounds, making out a case for remand.

ISSUES FOR DETERMINATION

1. Whether the impugned order dated 29.08.2023 is a reasoned and speaking order, or whether it is vitiated for being cryptic, non-speaking, and a mechanical reiteration of the objections raised without engaging with the Appellant’s responses and the applicable law.
2. Whether the Controller erred in declining to allow the Appellant’s request to amend its claims (reduced progressively from 97 to 23 to 9) to overcome the objections raised, particularly in light of the Controller’s own acknowledgment that an opportunity to lead counter-evidence ought to have been given, followed by an internally inconsistent finding that no further evidence was required.
3. Whether the Controller’s findings on lack of novelty, lack of inventive step, and non-patentability under Section 3(e) of the Patents Act, 1970 were properly reasoned, including whether the Controller had adequately discussed, analysed, and compared the teachings and disclosures of the cited prior art documents against the features of the claimed invention.
4. Whether the matter warranted remand to the Controller for fresh consideration, in light of the above deficiencies.

KEY HOLDINGS OF THE COURT

1. The Court held that the impugned order was indeed non-speaking, unreasoned and cryptic, noting that despite several prior decisions of the Court remanding patent matters with directions to pass reasoned orders, the order under challenge fell short of this standard. The Court held that reasons are “the heart and soul” of any order, both to enable the litigant to understand what weighed with the authority and to enable appellate scrutiny, and found that the impugned order’s substantial portion merely recorded the grounds of opposition, the Appellant’s submissions, applicable guidelines, and statutory provisions, without engaging with the Appellant’s detailed responses to the objections raised by the pre-grant opposers.
2. On the Controller’s brief observations under the heading “Controller observation,” the Court held that the Controller had failed to discuss the cited prior art documents in the context of examining their differences or similarities with the claimed invention, and had expressly (and, in the Court’s view, erroneously) stated that “detailing of citations in the oppositions is not warranted for the sake of brevity.” The Court held it could not discern how, without any discussion of the prior art disclosures and teachings and their comparison with the claimed invention’s features, the Controller reached the conclusion that the claimed invention lacked novelty and inventive step.
3. On the claim amendment request, the Court held that the Controller’s refusal to allow the reduction of claims (from 97 to 23 to 9), sought specifically to overcome the objections raised, was unreasoned and internally contradictory: the Controller had, on one hand, stated that in keeping with audi alteram partem, an opportunity ought to have been given to the Appellant to produce counter-evidence, but then, without explanation, stated “I see no requirement for further evidence,” and separately observed that the “voluntary amendment” to overcome the citations “failed to convince.” The Court held this reasoning legally flawed on two counts: first, it violated the right to be heard; and second, it mischaracterized the amendments as “voluntary” when they were specifically sought to overcome the objections raised, meaning the refusal on this sole ground was erroneous.
4. The Court further flagged as inexplicable the Controller’s observation that although the opposers had not filed an expert affidavit to substantiate their grounds of opposition, no such evidence was required because “direct evidence is suffice to corroborate their claim and statement” — the Court holding that it could not discern from the order what “direct evidence” had in fact been produced by the opposers to support this conclusion, since the order contained no reference to any such evidence.
5. On the Section 3(e) objection (non-patentability as a mere admixture), the Court held that the impugned order contained “not even a single sentence” explaining how the Controller concluded that the claimed invention was not an “invention” within the meaning of the Act, and that there was no determination of whether Section 3(e) was even applicable in light of the Appellant’s submission that the claims (1 to 9) related to a single active ingredient (cortexolone-17-α-propionate) at a specified concentration range (5 to 15 weight percent), which the Appellant contended was not a mere admixture.
6. The Court noted, without independently endorsing or rejecting it, the Controller’s reference to Gillette Industries Ltd. v. Yeshwant Brothers (AIR 1938 Bom 347) – for the proposition that simplicity is not necessarily an objection to patentability, though matters of ordinary skilled designing or mere workshop improvement are not inventions – observing that the relevance and applicability of this authority (and of the pharmaceutical examination guidelines also referenced) to the facts of the case was not discussed in the order.
7. Final holding and operative order: The Court held that the impugned order was non-speaking and cryptic; that the Appellant had been denied the opportunity to amend its claims without legitimate reasoning, despite the Controller’s own acknowledgment that counter-evidence should have been permitted; that the most glaring illegality was the absence of any discussion of the prior art’s teachings/disclosures or their comparison with the claimed invention, despite which a finding of lack of novelty and inventive step was reached; and that the Section 3(e) objection had similarly not been examined in accordance with law. The appeal was accordingly partially allowed, the impugned order dated 29.08.2023 was set aside, and the matter was remanded to the Controller with a direction to reconsider the patent application after granting a fresh opportunity of hearing to the Appellant and Respondent No. 2, with the decision to be taken within four months from receipt of the order. The Court expressly clarified that it had not expressed any opinion on the merits of the case.

STATUTORY PROVISIONS INVOLVED

Section 25(1) of the Patents Act, 1970, providing for pre-grant opposition to a patent application, was the provision under which the two oppositions in this case were filed by Respondent No. 2 and another opposer.

Section 2(1)(j) of the Patents Act, 1970, defining “invention” (a new product or process involving an inventive step and capable of industrial application), was the basis of the Controller’s finding of lack of novelty, which the Court held was not adequately reasoned for want of any discussion or comparison of the prior art against the claimed invention.

Section 2(1)(ja) of the Patents Act, 1970, defining “inventive step,” was similarly the basis of the Controller’s finding of lack of inventive step, held by the Court to be unreasoned for the same want of prior art analysis.

Section 3(e) of the Patents Act, 1970, excluding from patentability “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance,” was the provision under which the Controller held the claimed formulation non-patentable as a mere admixture; the Court held that the impugned order contained no reasoning or determination as to how or why this provision applied to the facts, particularly given the Appellant’s contention regarding the single active ingredient and its claimed concentration range.

Sections 3(i), 8(1), 8(2) and 10 of the Patents Act, 1970 (relating respectively to certain other non-patentability grounds, disclosure of corresponding foreign applications, and sufficiency of disclosure/clarity and conciseness of claims), were objections initially raised but ultimately waived by the Controller in the impugned order; these were not the subject of adverse findings and were not central to the Court’s remand, though the Court noted the seeming inconsistency between the Controller accepting the Appellant’s explanation on disclosure sufficiency as “well-reasoned and persuasive” while simultaneously raising concerns about non-disclosure of the status of a corresponding European patent application.

Section 15 of the Patents Act, 1970, empowering the Controller to require amendment of a patent application (or refuse it) to bring it into compliance with the Act, was referenced by the Appellant in support of its contention that its claim amendments were sought specifically to satisfy the Controller under this provision and were therefore not “voluntary” as characterized in the impugned order.

Section 117A of the Patents Act, 1970, under which the present appeal was filed before the High Court against the Controller’s order, was the jurisdictional basis for the appeal.

REASONING OF THE COURT

The Court’s reasoning proceeded by close, paragraph-by-paragraph scrutiny of the impugned order, contrasting the extensive recitation of the parties’ submissions, procedural history, and statutory framework in the earlier portions of the order with the markedly thin and internally inconsistent reasoning in the concluding “Controller observation” and “Decision” sections. The Court’s central concern, running through nearly every specific criticism it identified, was the complete absence of any comparative analysis between the cited prior art (particularly ITMI20132157) and the specific features of the claimed invention – the Court reasoned that a finding of lack of novelty or inventive step is meaningless without such a comparison, and that the Controller’s express statement that detailed discussion of the citations was unnecessary “for brevity” reflected a fundamental abdication of the adjudicatory function required for assessing patentability.

On the claim amendment issue, the Court’s reasoning drew out a direct textual self-contradiction within the order itself: the Controller had acknowledged, in one breath, that fairness (audi alteram partem) required giving the Appellant an opportunity to produce counter-evidence in light of the amended claims, yet in the very next breath declared that no further evidence was required – a contradiction the Court treated as itself sufficient evidence of non-application of mind, without needing to resolve which of the two propositions the Controller actually intended to apply. The Court reinforced this by noting the mischaracterization of the amendments as “voluntary,” reasoning that amendments made specifically in response to a notice of objections (here, the notice dated 07.06.2023) cannot properly be described as voluntary in a sense that would justify disregarding them, and that no independent finding had been made that the amendments fell outside the permissible scope of amendment (e.g., introducing new matter beyond the original disclosure), which the Court noted is normally the recognized basis for refusing an amendment request.

Similarly, on the reference to “direct evidence” allegedly corroborating the opposers’ claims (used to excuse the absence of expert affidavit evidence from the opposers), the Court’s reasoning was that a decision-maker cannot rely on evidence that is not identified, described, or discussed anywhere in the decision itself – the mere assertion that “direct evidence” existed, without any indication of what that evidence was, could not substitute for reasoned analysis and left the Court unable to assess whether the Controller’s conclusion was properly founded.

On Section 3(e), the Court’s reasoning was that non-patentability as a “mere admixture” is itself a substantive legal test requiring engagement with the specific claims and their asserted technical effect (here, the Appellant’s contention of an efficacious, high-concentration, stabilized single-active-ingredient formulation), and that the Controller’s order, by combining its reasoning on novelty, inventive step, and Section 3(e) non-patentability into a single undifferentiated paragraph listing known prior art components, failed to independently engage with any of the three distinct legal standards.

Having identified these cumulative and, in the Court’s assessment, serious deficiencies – non-engagement with prior art, self-contradictory reasoning on amendment/evidence, and absence of Section 3(e) analysis – the Court’s reasoning for ordering remand (rather than deciding the matter itself) was that these were failures of first-instance adjudicatory reasoning that only the Controller, equipped with the technical expertise and statutory mandate to examine patent applications, could properly cure; the Court expressly declined to substitute its own view on the merits, confining its intervention to the procedural/reasoning deficiencies identified. The Court closed with an observation of institutional concern – noting the recurring pattern of such unreasoned orders necessitating repeated remands, the resulting loss of judicial time, and the particular prejudice to patentees given the fixed 20-year patent term, which is further eroded by delay — though this observation did not alter the disposition, which remained a remand rather than any other relief.

DOCTRINAL SIGNIFICANCE

Within the bounds of what was actually decided, this is a procedural/administrative-law ruling in the patent context, resulting in a remand rather than any substantive determination of patentability – the Court expressly declined to express any opinion on the merits of novelty, inventive step, or Section 3(e) non-patentability. Its significance lies in its reaffirmation and application of the established requirement, articulated in a consistent line of Delhi High Court patent appeals, that orders of the Controller of Patents refusing an application must be reasoned and speaking, must engage with the specific submissions and evidence of the applicant, and must include a genuine comparative analysis of cited prior art against the claimed invention’s features – mere recitation of objections and conclusory statements of known ingredients, without such analysis, does not satisfy this standard. The judgment also illustrates a specific and recurring failure mode — internally self-contradictory reasoning on procedural fairness (acknowledging an obligation to permit counter-evidence while simultaneously declining to require it) – as an independent, freestanding ground for setting aside a Controller’s order. The Court’s closing remarks about the systemic costs of repeated remands (loss of judicial time, and the disproportionate impact of delay given the patent’s fixed 20-year term) function as an institutional observation rather than a binding holding, but signal continuing judicial concern about the quality of first-instance patent-office adjudication. As a remand order, the decision’s direct precedential weight is confined to the standard for adequacy of reasoning in patent-refusal orders and does not resolve, for future cases, the substantive questions of novelty, inventive step, or the scope of Section 3(e) as applied to pharmaceutical formulation claims.