Introduction
In a recent judgment dated July 4, 2025, the Calcutta High Court in Oramed Ltd. vs The Controller General of Patents 1overturned a patent refusal order for Application No. 3996/KOLNP/2010, which the Indian Patent Office had rejected on the grounds of lack of inventiveness under Section 2(1)(ja) and non-patentability under Section 3(e) of the Indian Patents Act, 1970 (“the Act”). Notably, the refusal order inappropriately invoked criteria such as therapeutic efficacy and bioavailability—parameters relevant to Section 3(d), not Section 3(e).
The Court found this misapplication to be a serious procedural flaw, noting that the hearing notice had cited objections under Section 3(e) read with Section 2(1)(ja), but the refusal order effectively applied Section 3(d) criteria, which were irrelevant to the stated grounds.
Facts
Oramed filed a patent Application No. 3996/KOLNP/2010 titled “Methods and Compositions for oral administration of proteins for treatment of diabetes”, on 25.10.2010. The Controller refused the application on the grounds that it (a) lacked an inventive step under Section 2(1)(ja), and (b) fell within the exclusion under Section 3(e) of the Act. However, while doing so, the Deputy Controller erroneously applied standards related to Section 3(d)—particularly, therapeutic efficacy and bioavailability—rather than focusing on the requirement of synergism under Section 3(e).
Oramed Ltd. appealed the refusal to the Calcutta High Court.
Issues before the Court
- What is required to overcome the rejection under Section 3(e): demonstrating therapeutic efficacy or providing synergistic data?
- Does changing the combination of cited prior art from D1–D4 (as mentioned in the hearing notice) to D1 and D4 (in the refusal order) affect the determination of inventive step?
Court’s Observation
Issue 1 – Patentability under Section 3(e)
The Court held that the Deputy Controller’s application of Section 3(d) standards—requiring therapeutic efficacy and bioavailability—to a Section 3(e) objection was fundamentally flawed.
Section 3(e) excludes from patentability “mere admixture resulting only in the aggregation of the properties of the components.” The correct test here is whether the composition exhibits synergism, not whether it shows therapeutic efficacy or bioavailability (which is relevant under Section 3(d)). However, the court noted that the while rejecting the application, the Deputy Controller cited that the bioavailability alone does not establish synergism and requires therapeutic efficacy for the purpose of Section 3(e), which is totally incorrect and is based on a misconception of the provisions. Therefore, the Deputy Controller erroneously evaluates the patent application through the lens of Section 3(d), even though the hearing notice was issued under Section 3(e) read with Section 2(1)(ja). This constitutes a serious flaw, as the hearing notice was issued under different grounds (Section 3(e) read with Section 2(1)(ja)) than those used in the refusal order as it brings elements of Section 3(d) – enhancement of therapeutic efficacy as well as bioavailability – which are wholly irrelevant and immaterial in so far as Section 3(e) of the Act is concerned.
The Court further noted that in determining the applicability of Section 3(e), the Deputy Controller failed to acknowledge that the claimed composition demonstrates enhanced bioavailability due to the unique properties of its individual components, as supported by expert evidence. Both the specification and the Patent Office Manual (Clauses 09.03.05.04 and 09.03.05.05 of Manual Version 3.0, dated November 26, 2019) provide relevant guidance on the interpretation of Sections 3(d) and 3(e), which were disregarded in the impugned order.
Issue 2 – Inventiveness
The Court noted that the Hearing Notice referred to prior arts “D1 to D4”. However, the impugned order concludes that the invention lacked inventive step on the basis of “D1 and D4”, thereby omitting D2 and D3 without providing any prior notice to the Appellant. The different combination of documents relied on in the impugned order would entirely change the case of obviousness and the Appellant was deprived of an opportunity to respond to the revised combination. The court found this decision of excluding documents D2 and D3 arbitrary, unjustified and without basis.
Any common thread linking the claim with D1 and D4 and the decision to exclude D2 and D3 was not even been discussed in the impugned order. Citing prior judgments including Guangdong Oppo v. Controller of Patents2, the Court reiterated that mosaicking 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 a fair hearing.
The Court further noted that the Deputy Controller has also not referred to nor dealt with the data with reference to the figures in the specification submitted along with the Written Submissions for determining inventive step. There is also no reference to the expert affidavit in the impugned order, though the same highlighted both inventive step and synergistic activity in dealing with Section 3(e) of the Act.
Furthermore, the Appellant had submitted records showing that the invention had been granted in other jurisdictions, where the same prior arts were considered. Despite being part of the record, this material was neither referred to nor discussed in the impugned order, further evidencing the lack of proper application of mind.
The Deputy Controller’s conclusion on obviousness, therefore, lacked both factual and legal foundation. The Calcutta High Court ultimately set aside the impugned refusal order, and remanded the matter for fresh consideration by a different Deputy Controller.
Our Analysis and Conclusion
This decision highlights the need of proper interpretation of the Sections by the Controllers while arriving at a final decision. The Court clearly distinguished Section 3(d) and Section 3(e) of the Act, by describing in detail the requirements of each Section. The Court emphasized that the requirement of Section 3(e) is synergistic data while Section 3(d) requires bioavailability and therapeutic efficacy.
This decision also serves as a reminder for the Indian Controller to carefully consider the specific requirements of each section to ensure accurate and fair decision and serve justice to the Applicant.
In addition, it emphasizes the significance of procedural fairness in patent examination by concluding that mosaicking of prior art requires a clear and logical thread, and changing the combination of references without notice to the Applicant is unfair for the Applicant. Thus, this judgment acts as a reminder for proper application of mind and consideration of relevant evidence in patent examination.