CALCUTTA HIGH COURT UPHOLDS PROCEDURAL INTEGRITY IN PATENT EXAMINATION: ORAMED LTD. V. CONTROLLER OF PATENTS
- Kirti Sabharwal and Shubha Sharma
- Aug 4
- 6 min read
Introduction
In a significant ruling reinforcing the importance of procedural fairness and proper adjudication in Indian Patent Law, the Hon’ble Calcutta High Court (“the Hon’ble Court”) in Oramed Ltd. v. The Controller General of Patents and Designs & Anr. (IPDPTA/8/2022), allowed the Appeal vide judgement dated July 4, 2025, and set aside the refusal order passed by Learned Controller of Patents and Designs, in respect of the Oramed Ltd.’s (hereinafter referred to as ‘the Appellant’) patent application (Application No. 3996/KOLNP/2010). The Hon’ble Court by way of a detailed order directed the Appellant’s patent application to be considered afresh by a different hearing officer, and provided critical insights into how courts scrutinize both procedural and substantive lapses in Patent Office decisions.
Background
The Appellant, filed a national phase application derived from PCT/IL2009/000223, claiming priority from a US application dated March 26, 2008, for an invention relating to oral pharmaceutical compositions for protein administration. The invention specifically discloses an oral pharmaceutical composition comprising insulin as the active protein component along with two protease inhibitors (Aprotinin and SBTI) that prevent enzymatic degradation during oral administration. The composition may additionally include EDTA derivatives and Omega-3 fatty acids to enhance bioavailability.
The invention addresses the limitations of conventional insulin delivery via injection, aiming to improve patient compliance and mimic physiological insulin delivery more closely.
The Application was refused by the Indian Patent Office under Sections 2(1)(ja) (lack of inventive step) and Section 3(e) of the Patents Act, 1970, prompting the Appellant to file an Appeal under Section 117A.
It is worth mentioning that it is not the first occasion when the Appellant approached the Hon’ble Calcutta High Court in connection with the said Patent Application. The Appellant’s Patent Application was earlier refused vide order dated April 18, 2017, which was challenged before the Intellectual Property Appellate Board (IPAB) in appeal and simultaneously the Appellant had also preferred a writ petition, WP/9575/2019, seeking suitable directions from the court to set aside the refusal order. The Hon’ble Court vide order dated June 18, 2019 had set aside the refusal order and remanded the matter back for a fresh hearing on the Appellant’s patent application. It is then that the matter again reached before the Learned Controller of Patents for fresh consideration but the patent application was listed before the same Controller who had refused the application in the first instance, and upon fresh consideration as well the Learned Controller again refused the patent application.
Consequently, the Appellant challenged the second refusal order before the Hon’ble Calcutta High Court and the Court passed the aforesaid Judgement directing the application to be decided by a different Controller.
Key Issues
The key legal issues included whether the alteration of the prior art combinations without prior intimation was procedurally improper, whether adequate consideration was given to the expert evidence and technical data submitted, and whether the application of Section 3(d) criteria during examination under Section 3(e) of the Act was legally tenable.
Observations and Findings of the Hon’ble Court
Prior Art Combination and Obviousness Analysis
The Appellant contended that the impugned order contained glaring infirmities, particularly noting that while the hearing notice referenced prior arts D1 to D4, but the final order relied solely on D1 and D4 without providing notice to the Appellant. The Appellant argued that this arbitrary change was fatal as it altered the case of obviousness they had to address.
It was strongly asserted that the Learned Controller has neither referred nor dealt with the data with reference to the figures and specifications as furnished in the written submissions. Also, there was no reference to the expert evidence in the impugned order which dealt with both inventive step and synergistic effect, necessary in determining the patentability of the invention.
The Respondent authorities fairly submitted that “the impugned order does not deal with the expert evidence or the scientific technical materials which had been furnished by the appellant”, particularly disregarding the expert evidence of Miriam Kidron.
The Hon’ble Court observed that any change in prior art combination ought to have been communicated to the Appellant, as different combinations would “entirely change the case of obviousness which is to be answered by the appellant”. Relying on Guangdong Oppo Mobile Telecommunications Corp., Ltd.[1], the Hon’ble Court noted that “if several prior art documents are to be read in combination; there must be some common thread linking the claim with the prior art documents obvious to a person skilled in the art”.
The Hon’ble Court further referenced Enercon (India) Limited v. Aloys Wobben[2], observing that “the mere existence in the prior arts, of each of the elements in the invention, will not ipso facto mean obviousness” and emphasized that “there must be a coherent thread leading from the prior arts to the invention”.
The Hon’ble Court found the Learned Controller's exclusion of D2 and D3 to be “arbitrary, unjustified and without basis” as the common thread linking claims with D1 and D4 “has not even been discussed in the impugned order”.
Erroneous Application of Sections 3(d) and 3(e)
The Hon’ble Court observed that “the finding of the 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 criteria for adjudication under section 3(d) of the Act, it is wholly irrelevant for the purposes of interpreting section 3(e) of the Act”.
Further, the Hon’ble Court observed that the Learned Controller “has also failed to appreciate that section 3(e) is only applicable if there is an admixtures of two or more substances resulting in the additive effect of the inherent properties of each of the substances. The Controller failed to consider the description of the invention along with its specification as well as the affidavit of the expert, which recommended that the bioavailability of the composition was greatly enhanced, and such composition is peculiar having regard to the inherent properties of the individual components of the invention”.
The Hon’ble Court also noted that the Patent Office Manual[3] provides sufficient guidance regarding the scope and applicability of sections 3(d) and 3(e) of the Act (Clauses 09.03.05.04 and 09.03.05.05 of the Patent Manual of Version 3.0 dated November 26, 2019) which has been overlooked while passing the impugned order.
Moreover, the Learned Controller held that D4 teaches the use of two protease inhibitors. However, D4 does not mention the presence of double or multiple protease inhibitors. Hence, the Hon’ble Court found that the Learned Controller has erroneously interpreted prior art D4 and incorrectly applied Section 3(d) criteria while examining under Section 3(e) of the Act.
Foreign Grant not taken into consideration
The Hon’ble Court also mentioned that despite the Appellant submitting evidence that the same invention had been granted in other jurisdictions where identical prior art had been considered, the Learned Controller failed to address or even acknowledge this fact. While foreign grants are not binding on Indian authorities, they are often instructive and ought to be considered when available on record.
Failure to Consider Expert Evidence and Technical Data
Significantly, the Hon’ble Court noted that the Learned Controller failed to consider technical data and expert evidence, despite previous judicial directions to “take into consideration all materials made available and filed by the appellant”.
Hon’ble Court’s Decision
The Hon’ble Court set aside the impugned order dated June 5, 2020, and remanded the matter for fresh consideration by a different officer, directing the Learned Controller to consider all documents including expert affidavit and to furnish reasoned conclusion on patentability issues.
Conclusion
This ruling reaffirms that Controllers must assess admixture-based inventions on the basis of synergistic effect and not therapeutic efficacy. The judgment clarifies the distinct statutory frameworks under Sections 3(d) and 3(e) of the Act and emphasizes that criteria applicable to one statutory provision cannot be arbitrarily imported/ substituted into the assessment of another or misused to deny patent protection to otherwise deserving inventions.
By correcting a flawed administrative decision, the Calcutta High Court reaffirmed the judiciary’s role as a vital check on patent office practices and laid down important jurisprudential principles for the fair and reasoned adjudication of pharmaceutical patent applications.
This precedent serves as essential guidance for patent examining authorities, emphasizing that administrative efficiency cannot supersede fundamental fairness principles. The judgment reinforces that patent examination must be conducted with appropriate technical rigor, procedural transparency, and adherence to established legal frameworks.
References:
[1] Unreported decision dated 13.06.2023 in AID No. 20 of 2022
[2] ORA/08/2009/PT/CH) Order No.123 of 2013 dated June 13, 2013
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