Summary
In Cassiopea S.P.A. v. Controller General of Patents and Designs & Ors., the Delhi High Court set aside the refusal of a patent application for a high concentration topical formulation containing cortexolone-17-α-propionate, intended to treat androgenetic alopecia, a form of hair loss. The Court found that the Controller had failed to analyse the prior art, explain the objection under Section 3(e), and properly address proposed claim amendments. It directed fresh consideration within four months, without expressing any opinion on patentability.
The Formulation and Its Refusal
Cassiopea sought a patent for an invention titled “High Concentration Formulation”. The application concerned a topical pharmaceutical formulation in which cortexolone-17-α-propionate was fully solubilised. It included less than 5 percent water by weight, solvents selected from a polyol, a polyol ether and ethanol, and specified additives including polysorbate 80 and ascorbyl palmitate.
According to Cassiopea, the formulation was intended to promote hair growth and treat androgenetic alopecia. Its case was that a stable, high concentration formulation could overcome shortcomings of existing treatments. These were the applicant’s claims about the invention; the Court did not determine its therapeutic benefits.
The Indian national phase application was filed on 29 November 2017 and faced two pre-grant oppositions. During examination and opposition proceedings, Cassiopea sought to reduce its claims from 97 to 23 and finally to nine. On 29 August 2023, the Controller refused the application and allowed the oppositions, sustaining objections of lack of novelty, lack of inventive step and non-patentability under Section 3(e). Cassiopea appealed under Section 117A of the Patents Act, 1970.
Questions Before the Court
- Had the Controller adequately explained the refusal on novelty, inventive step and Section 3(e)?
- Had the proposed claim amendments and the opportunity to produce counter-evidence been properly addressed?
- Did the defects in the decision require fresh consideration of the application?
Arguments Presented by the Parties
Cassiopea
- The refusal largely reproduced submissions and objections without explaining why the applicant’s responses were unacceptable or comparing the cited prior art with the claims.
- The proposed amendments were intended to overcome examination objections, but were refused without adequate reasons. Although the Controller acknowledged the need to permit counter-evidence, no opportunity was provided.
- The Section 3(e) objection failed to consider the results produced by the formulation. Cassiopea argued that the claimed concentration of a single active ingredient did not constitute a mere admixture.
The respondents
- The Controller’s counsel maintained that the order was reasoned, pointing out that objections found to be baseless had been waived.
- According to the respondents, Cassiopea had failed to establish novelty, inventive step and patentability. Respondent No. 2, one of the pre-grant opposers, supported the refusal.
Court Analysis
Recording submissions does not explain a decision
The Court began by examining whether the Controller’s order explained the refusal. Although Cassiopea had challenged both the procedure and the merits, the Court recorded that the arguments were essentially directed towards procedural defects and a remand. The immediate question was therefore whether the application had received a reasoned examination that could be reviewed in appeal.
On reading the order, the Court found that much of it recounted the opposition grounds, the applicant’s submissions, examination guidelines and statutory provisions. The Controller’s own observations appeared towards the end, but did not engage with Cassiopea’s detailed responses. According to the Court, reasons allow an applicant to understand what led to the decision and enable an appellate court to examine it. The length of the material reproduced in the order could not supply the missing explanation. The Court then examined how this defect affected each ground of refusal.
Prior art required comparison with the claims
For novelty and inventive step, the missing explanation concerned the relationship between the prior art and the claimed formulation. The Controller referred to the active ingredient, its concentrations, solvents and additives, and stated that these were known from the opposers’ citations. However, the order did not examine what those references disclosed or how their teachings compared with the features of Cassiopea’s claims.
The Court found this omission particularly difficult to reconcile with the Controller’s statement that detailing the citations was unnecessary for brevity. A conclusion that the invention lacked novelty or inventive step required an examination of the relevant similarities and differences. Without that comparison, the order did not disclose how the Controller had reached either conclusion. This was a defect in the assessment underlying the refusal; the Court did not itself undertake that assessment and resolve patentability.
The Section 3(e) objection lacked analysis
The same absence of reasoning affected the objection that the formulation was a mere admixture. Section 3(e) excludes a substance obtained by mere admixture where the result is only an aggregation of the components’ properties, as well as a process for producing such a substance. In the opposition, the objection was that the known ingredients performed their expected functions and that no synergistic effect had been demonstrated.
Cassiopea disputed that characterisation. It relied on the results of the formulation and argued that Claims 1 to 9 concerned a single active ingredient at a concentration of 5 to 15 weight percent. The Controller therefore had to consider the application of Section 3(e) in light of that submission. The Court found that the order contained no explanation of how the exclusion applied and no determination addressing the applicant’s position.
The Court’s finding was thus that the Section 3(e) objection had not been examined in accordance with law. It did not hold that a formulation containing one active ingredient necessarily falls outside the provision, or that Cassiopea had established a patentable formulation. Those questions remained for fresh consideration along with the other objections.
Claim amendments and the right to be heard
The defects were not confined to the reasons supporting the substantive objections. They also extended to the process by which the Controller dealt with Cassiopea’s attempts to answer them. The applicant had sought to narrow its claims to overcome the objections, but the Controller declined the amendments without explaining why they could not be permitted. The Court found that treating the amendments as voluntary overlooked their purpose and did not justify their refusal.
The handling of evidence compounded this problem. The Controller acknowledged that an opportunity to produce counter-evidence was required, but then stated that further evidence was unnecessary. The order also relied on direct evidence said to support the opposition without identifying that evidence. According to the Court, these contradictions left the applicant without the required opportunity to be heard and made it impossible to discern the evidentiary basis for the refusal. References to pharmaceutical examination guidelines and a Bombay High Court judgment did not remedy the defect because their relevance to the application was not explained.
Repeated remands consume patent time
Taken together, the failure to compare the prior art, the unexplained Section 3(e) objection and the treatment of amendments and evidence required reconsideration by the Controller. The Court nevertheless acknowledged the cost of that course. It observed that repeated remands caused by inadequately reasoned patent decisions consume judicial time and prolong an examination process that already takes years.
The Court connected that delay to the fixed twenty-year patent term. If a patent is eventually granted, time spent on repeated examination and remand can reduce the period during which the patentee benefits from it. Although conscious that another remand would consume further time, the Court considered it unavoidable because the Controller had not made the determination required by law. It therefore set aside the refusal and imposed a four-month period for the fresh decision.
Findings of the Court
- The refusal order was non-speaking and cryptic, and did not address the applicant’s detailed submissions.
- The novelty and inventive step findings lacked an analysis comparing the prior art with the claims.
- The Section 3(e) objection had not been examined in accordance with law.
- Claim amendments were refused without legitimate reasoning, and the required opportunity to produce counter-evidence was denied.
- The application required fresh consideration. The Court expressed no opinion on the merits.
Court Order
The Court partially allowed the appeal and set aside the Controller’s order dated 29 August 2023. It directed reconsideration after giving Cassiopea and Respondent No. 2 an opportunity of hearing. The fresh decision was to be taken within four months from receipt of a copy of the Court’s order. The appeal and pending application were disposed of.
Relevant Paragraphs
The following extracts are reproduced from the order. Omissions within extracts are marked.
Paragraph 15 on reasons and submissions
It has been consistently held by Courts that reasons are the heart and soul of any order as it enables the litigant to understand what weighed with the concerned authority to come to the decision in question and also helps the Appellate Courts to examine the orders, when challenged. Appellant rightly contends that the impugned order does not deal with its detailed submissions given in response to the objections raised by the pre-grant opposers.
Paragraph 16 on comparison with prior art
There is no discussion on the cited prior arts in the context of examining the differences or similarities of the prior arts with the claims in the claimed invention. Strangely, Controller has observed that detailing of citations in the oppositions is not warranted for the sake of brevity. It is not understood how, without discussing the prior arts and their disclosures and teachings and comparing them with the features of the claimed invention, Controller reached the conclusion that the claimed invention lacks novelty and inventive step.
Paragraph 17 on claim amendments
Another glaring illegality in the order is that Appellant sought claim amendments to overcome the objections raised by reducing the claims from 97 to 23 and finally to 9, however, the amendments were not allowed and no reason is forthcoming to decline the prayer.
Paragraph 18 on Section 3(e)
As for objection under Section 3(e), there is not even a single sentence in the order showing how the Controller came to a conclusion that the claimed invention was not “invention” within the meaning of the 1970 Act.
Paragraph 19 on opportunity and examination
Appellant has been denied the opportunity to carry out amendments to the claims without any legitimate reasoning and despite the Controller noting that the opportunity was required to be given to lead counter-evidence on this aspect. […] Even on the objection under Section 3(e), the examination lacks consideration in accordance with law. Therefore, in my view, the matter deserves to be remanded back to the Controller for fresh consideration.
Paragraph 20 on delay
The inevitable consequence of remands is that even if patent is granted, Patentee is able to reap the fruits of his years of hard work for a short period since patent has a fixed span of 20 years.
Paragraph 21 on relief and merits
Accordingly, the appeal is partially allowed. Impugned order dated 29.08.2023 passed by the Controller is set aside with a direction to re-consider the patent application of the Appellant after granting opportunity of hearing to the Appellant and Respondent No. 2. The decision will be taken within four months from the date of receipt of copy of the order. It is made clear that Court has not expressed any opinion on the merits of the case.
Case Citation
Cassiopea S.P.A. v. Controller General of Patents and Designs & Ors., C.A.(COMM.IPD-PAT) 30/2024 & I.A. 11051/2024, Delhi High Court, Justice Jyoti Singh, order dated 31 August 2026.
https://indiankanoon.org/doc/8850428/
Accessed 21 September 2026.
Disclaimer
This case blog is based on the author’s understanding of the judgment. Understandings and opinions of others may differ. An AI application was used to generate parts of this case blog. Views are personal.
