The Test of Inventive Step in Patent and Procedural Fairness
The Fact:This case center around a patent application for an ophthalmic delivery device. Oxular Limited filed Patent Application No. 201817034819 titled "Ophthalmic Delivery Device and Ophthalmic Drug Compositions" at the Patent Office, New Delhi, on 14 September 2018, through its authorized Patent Agent. A request for examination was timely filed on 13 March 2020, within the permissible window starting from the date of priority. The Patent Office took up the application for detailed examination and, on 27 August 2020, issued the First Examination Report (FER) raising a range of objections regarding novelty, inventive step, patentability under Section 3(d), and sufficiency of disclosure under Section 10(5) of the Patents Act, 1970.
Response by Appellant:Oxular Limited responded through its authorized agent, submitting a reply and amending the claims to reduce and clarify the claims under challenge. However, the Patent Office persisted with its objections and issued a hearing notice on 2 August 2023, which was followed by actual hearing only after several adjournments on 31 October 2023. Further written submissions along with amended claims were filed by Oxular Limited on 15 December 2023, aiming to address the outstanding objections. Despite these submissions, the Assistant Controller of Patents and Designs refused the application under Section 15 of the Patents Act by an order dated 9 January 2024. The primary ground was lack of inventive step as prescribed under Section 2(1)(ja) of the Act, referencing several prior arts.
The Core Issue:The dispute before the High Court of Delhi involved the appellant, Oxular Limited, challenging the order of the Assistant Controller. The appellant argued that the refusal order failed to properly consider the written submissions made in response to the hearing notice and did not apply the well-known judicial criteria for determining "inventive step."
The Reasoning:The Court’s analysis starts with recapping the reasons provided in the impugned order, which found that the claims did not involve an inventive step in light of documents cited as prior art (particularly D1 to D6).
The Controller reasoned that using a flexible cannula deployed from a needle to the suprachoroidal or supraciliary space was obvious, and that other choices such as the shape or semi-solid state of compositions were routine and did not show any inventive step. The Court noted that the applicant’s main argument was that the device's self-actuated deployment mechanism was a significant advancement over the cited prior art and that the written submissions with clarifications had not been duly considered.
Assessment of inventive step:The appellant also invoked two key judicial precedents regarding assessment of inventive step:
F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., 2016 (65) PTC 1 (Del) (DB)
Agriboard International LLC v. Deputy Controller of Patents & Designs, 2022 SCC OnLine Del 4786
The Hoffmann-La Roche Ltd. test involves five steps:
1. Identify who is an ordinary person skilled in the art
2. Identify the inventive concept in the patent
3. Impute what was commonly known in the field at the date of invention
4. Identify distinctions between prior art and the claimed invention
5. Determine whether those distinctions would have been obvious.
Similarly, the Agriboard International LLC case emphasizes that, in order to refuse a patent for lack of inventive step, the Controller must consider:
- The prior art
- The invention as claimed
- Whether, in light of the prior art, the invention would have been obvious to a skilled person
The Finding:The Court found that the refusal order did not reflect a reasoned application of these legal tests. It observed that the impugned order focused solely on the obviousness issue using a broad-based and generic approach, without examining whether the features unique to the applicant’s device were in fact obvious when read in the context of the technical field and the full set of prior art documents. The Court strongly reiterated, by relying on Supreme Court precedents like Assistant Commissioner v. Shukla and Brothers and Manohar v. State of Maharashtra (AIR 2013 SC 681), that a reasoned and speaking order is central to procedural fairness, a fundamental principle of natural justice.
The Conclusion:Thus, the Court concluded that the Assistant Controller had failed not only to consider the applicant’s submissions but also to pass a reasoned order as required by law. The decision was held to be non-compliant with both statutory requirements and judicial precedent laid down for patent assessments.
The Decision:Accordingly, the High Court set aside the impugned order and remanded the matter to the Patent Office for a fresh decision. The Patent Office was directed to grant a hearing to Oxular Limited and provide a reasoned order after applying the tests prescribed in F. Hoffmann-La Roche Ltd. and Agriboard International LLC. The matter was to be decided as expeditiously as possible, preferably within three months from the date of the order. The Court made it clear that no observations in this judgment should be read as an opinion on the patentability of the invention itself.
Case Title: Oxular Limited Vs. The Assistant Controller of Patents and Designs
Order Date: 11 September, 2025
Case Number: C.A.(COMM.IPD-PAT) 142024
Neutral Citation: 2025:DHC:8337
Name of Court: High Court of Delhi
Presiding Judge: Hon’ble Ms. Justice Manmeet Pritam Singh Arora
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
