Summary
In the case of Oramed Ltd. v. Controller General of Patents & Designs, the Calcutta High Court examined the refusal of a patent for an oral insulin composition. The Patent Office had rejected the application citing lack of inventive step and Section 3(e) of the Patents Act. The Court held that inventive step cannot be determined by arbitrary combination of prior art and clarified that Section 3(e) does not require proof of therapeutic efficacy, and remanded the matter for fresh consideration.
Background
Oramed Ltd. filed a patent application in India for an oral insulin composition comprising insulin, two protease inhibitors, EDTA or its salts, and an Omega-3 fatty acid. The application aimed to overcome challenges in oral delivery of insulin by protecting it from enzymatic degradation.
The Patent Office rejected the application in 2020 on two primary grounds:
(i) lack of inventive step, and
(ii) non-patentability under Section 3(e) of the Patents Act, 1970.
Oramed appealed to the Calcutta High Court.
Issue of Inventive Step
The Deputy Controller relied on prior art documents to conclude that the invention lacked inventive step. The hearing notice had cited four documents (D1 to D4). However, in the final order, reliance was placed only on D1 and D4.
The High Court observed that such a change of reliance altered the entire foundation of the obviousness analysis. The appellant ought to have been given an opportunity to address the new basis. Failure to do so, in the court’s view, amounted to denial of a fair opportunity.
The court referred to its earlier ruling in Oppo Mobile where it was held that a combination of prior art is permissible only if there is a clear common thread linking them to the claimed invention, making the invention obvious to a person skilled in the art. Otherwise, as per the Court, mosaicing is impermissible.
The court also relied on Enercon (India) Ltd. v. Aloys Wobben, which stated that the mere presence of individual elements in prior art does not automatically render an invention obvious. There must be a clear and logical progression from the prior art to the invention. If the combination appears obvious only with hindsight, the Court stated that the requirement of inventive step is not satisfied.
On this basis, the court held that the Deputy Controller’s analysis of inventive step was flawed.
Issue under Section 3(e)
The Patent Office cited Section 3(e), and stated that the claimed composition was a mere admixture of known substances without synergy. The Deputy Controller further stated that bioavailability alone was insufficient and that therapeutic efficacy was required.
The High Court disagreed. It stated that therapeutic efficacy is a requirement under Section 3(d), not Section 3(e). According to the court, Section 3(e) is concerned with whether the claimed composition produces a synergistic effect greater than the sum of its parts.
The court observed that Oramed had submitted data and expert affidavits showing enhanced bioavailability of insulin in the claimed composition. According to the Court, these materials were relevant to demonstrate synergy under Section 3(e).
While concluding its analysis, the court also pointed out that the Patent Office Manual provides guidance on the interpretation of Sections 3(d) and 3(e). As per the Court, the Deputy Controller’s approach, which mixed standards from Section 3(d) into a Section 3(e) analysis was contrary to the statutory framework as well as the Manual.
Court’s Directions
After setting aside the refusal order, the Court directed that the matter be reconsidered by a different officer. It further stated that:
- All documents, including expert evidence and technical data, must be considered; and
- Findings must be supported with clear reasoning, particularly on inventive step and the application of Section 3(e).
Citation: Oramed Ltd. v. Controller General of Patents & Designs, IPDPTA/8/2022 (Cal. HC July 4, 2025), available at https://indiankanoon.org/doc/57730751/ (last visited Aug. 28, 2025).
Disclaimer:
The views expressed in this note are personal. Other experts may hold different views or arrive at a different understanding of the case. This note has been prepared with the assistance of an AI application and is intended solely for informational purposes.
