In a recent ruling for pharmaceutical patents in India, the Calcutta High Court has overturned a decision by the Controller of Patents for erroneously conflating the legal standards under Sections 3(e) and 3(d) of the Patents Act, 1970. The judgment, delivered by Justice Ravi Krishan Kapur in Oramed Ltd. v. Controller General of Patents and Designs & Anr., (IPDPTA/8/2022), underscores long-standing concerns regarding inconsistencies in patent examination, especially in cases involving pharmaceutical compositions.

The High Court held that the Deputy Controller had committed serious errors in rejecting Oramed’s patent application (No. 3996/KOLNP/2010) relating to an oral insulin formulation. These errors ranged from selective use of prior art, misreading of technical evidence, and most crucially, a legal misapplication of Sections 3(e) and 3(d): two often-confused but legally distinct provisions in Indian patent law.

Background of the Case

Oramed Ltd., a pharmaceutical company, had sought an Indian patent for a novel oral insulin composition aimed at eliminating the need for daily insulin injections. This innovation involved the use of two protease inhibitors (Aprotinin and SBTI), EDTA or its salts, and omega-3 fatty acids to stabilize insulin and improve its bioavailability through oral delivery.

Following a complex timeline of filings, hearings, the application was eventually rejected by the Deputy Controller on June 5, 2020, citing lack of inventive step and ineligibility under Section 3(e) of the Patents Act. Oramed appealed to the Calcutta High Court under Section 117A of the Act.

Key Judicial Findings

Misapplication of Section 3(e) as Section 3(d)

The core legal error identified by the High Court was the Deputy Controller’s conflation of Section 3(e) and Section 3(d) of the Indian Patents Act, two distinct statutory provisions with separate legal thresholds. Section 3(e) bars patentability of mere admixtures, i.e., combinations of known substances where the resulting product does not demonstrate any synergistic effect beyond the sum of its individual components. In contrast, Section 3(d) involving known substances and bars patentability unless the applicant can show a significant enhancement in therapeutic efficacy. The High Court noted that the Deputy Controller wrongly applied the efficacy-based test under Section 3(d) in a matter governed by Section 3(e), which does not concern therapeutic improvement but rather the presence (or absence) of synergy in a composition. This misapplication not only led to an incorrect rejection of the patent but also raised serious procedural concerns, as it blurred the lines between two separate legal standards that serve different purposes within the Indian patent framework. The Ld. Judge emphasized that therapeutic efficacy, central to Section 3(d), has no relevance under Section 3(e). and opined:

“14. The finding of the Deputy Controller that bioavailability alone does not establish synergism and requires therapeutic efficacy for the purpose of section 3(e) is incorrect and is based on a misconception of the provisions. While the latter is a criterion for adjudication under section 3(d) of the Act, it is wholly irrelevant for the purposes of interpreting section 3(e) of the Act. The impugned order proceeds on the basis of section 3(d) of the Act while considering the application for grant of patent. On the contrary, the hearing notice was under section 3(e) read with section 2(1)(ja) of the Act. This is a serious flaw in the impugned order in as much as it brings elements of section 3(d) inter-alia enhancement of therapeutic efficacy as well as bioavailability which are wholly irrelevant and immaterial insofar as section 3(e) of the Act is concerned.

15. In passing the impugned order, the Deputy Controller has also failed to appreciate that section 3(e) is only applicable if there is an admixture of two or more substances resulting in the additive effect of the inherent properties of each of the substances….”

“The impugned order proceeds based on Section 3(d)… while the hearing notice was under Section 3(e)… This is a serious flaw,” the Court observed. In doing so, the Court reaffirmed that Section 3(e) concerns only whether a combination exhibits a mere aggregation of properties or a synergistic effect: not therapeutic enhancement, which belongs only under Section 3(d).

Improper Exclusion of Scientific and Expert Evidence

Another major shortcoming in the Controller's order was the complete disregard of expert evidence, particularly the affidavit of Dr. Miriam Kidron, the inventor, and a key witness. Her testimony, which addressed both the invention’s technical advancement and its synergistic effects, was not even referred to in the final decision. The Court held that any such omission violates procedural fairness, especially in a matter remanded by the Court with explicit directions to consider all evidence.

Arbitrary Reliance on Select Prior Art

Despite issuing a hearing notice citing four prior art documents (D1–D4), the Deputy Controller’s decision relied only on D1 and D4 a fact that materially altered the basis of the rejection without providing the appellant an opportunity to respond. Citing prior judgments including Guangdong Oppo v. Controller of Patents, the Court reiterated that mosaicing of prior art requires a clear and logical thread and that changing the combination of references at the final stage without notice undermines the applicant’s right to fair hearing.

The Role and Responsibility of Controllers

The judgment throws a spotlight on the responsibilities of Patent Controllers, particularly the duty to reason their findings and adhere strictly to the legal framework of patentability under the Act. Ld. Judge remarked that Deputy Controllers are not entitled to reframe the legal grounds arbitrarily, and that expert testimony, foreign grants, and technical data cannot be dismissed without express reasoning. This reiterates the importance of transparency, reasoned decision-making, and procedural fairness in patent prosecution.

Conclusion

In conclusion, the Calcutta High Court set aside the impugned order dated June 5, 2020, remanded the matter for fresh consideration by a different officer, directed that all expert evidence and technical submissions must be duly considered, and mandated that any conclusion on patentability be supported by cogent and reasoned findings. This decision is not merely a win for Oramed Ltd.; it serves as a direction to the Indian Patent Office to exercise greater diligence, transparency, and legal precision, particularly when navigating the complex interplay between Section 3(e), which concerns synergistic combinations, and Section 3(d), which addresses enhanced efficacy over known substances. At a time when India’s patent regime faces growing international scrutiny, such judicial interventions are critical to reinforcing procedural fairness and restoring confidence in the robustness of its patent examination framework. It is now imperative that Controllers clearly distinguish between the legal thresholds for obviousness and subject matter eligibility vis-à-vis synergy and efficacy, and apply each standard properly within its proper statutory boundary.