Amendment of Patent Claims and Specification at Appellate Stage
Introduction: The judgment delivered by the Hon’ble High Court of Delhi in Société des Produits Nestlé S.A. v. Controller of Patents and Designs & Anr., decided on 3rd February 2023, marks a significant clarification in the Indian patent law regime concerning the scope of Section 3(i), the permissibility of claim amendments under Section 59, and the evidentiary thresholds for inventive step and synergistic effects under Sections 2(1)(ja) and 3(e) of the Patents Act, 1970. This case revolved around a patent application relating to a nutritional composition designed for use in the prophylaxis of allergic disease, which was rejected by the Patent Office on multiple statutory grounds. The appellant, a global food and nutrition company, challenged the refusal on legal and technical grounds, seeking judicial intervention to reinstate the patent application.
Factual Background: The appellant, Société des Produits Nestlé S.A., filed an Indian patent application numbered 201817040811 on 26th October 2018 titled “Composition for Use in the Prophylaxis of Allergic Disease”. The application claimed priority from an earlier European application and was based on a PCT application (PCT/EP2016/060007) filed on 4th May 2016. The invention related to a composition comprising DGLA (Dihomo-γ-linolenic acid) and one or more omega-3 polyunsaturated fatty acids such as DHA and EPA. The objective of the invention was to reduce the incidence of allergic diseases in the progeny when the composition is administered to a mammalian subject during pre-pregnancy, pregnancy, or lactation.
According to the applicant, the claimed composition exhibited a synergistic effect that reduced allergic manifestations in the offspring. The composition was formulated for inclusion in dietary or nutritional supplements or in infant formulas, and the claims were framed as “composition for use” or “nutritional composition for use”, intending to steer clear of prohibited subject matter under Section 3(i) of the Patents Act.
Procedural Background: The application was published on 8th February 2019 and was examined pursuant to a First Examination Report (FER) issued on 4th January 2021. The FER raised objections under Sections 3(i), 3(e), and 2(1)(ja) of the Act. In response, the applicant amended the claims and submitted supporting data. However, the Controller, vide order dated 29th December 2021, refused the application. The grounds for refusal were that the claims related to a method of treatment and hence were non-patentable under Section 3(i); that the amended claims went beyond the scope of original claims, thereby violating Section 59; and that the evidence did not establish the required synergistic effect, which attracted Sections 3(e) and 2(1)(ja). Aggrieved by this refusal, the applicant filed an appeal under Section 117A of the Patents Act before the High Court of Delhi.
Core Dispute: The principal legal questions arising in this appeal were whether the claimed subject matter fell within the prohibition under Section 3(i) as being a method of treatment; whether the amended claims violated Section 59 by broadening the scope beyond the originally filed claims; and whether the invention lacked an inventive step or was hit by Section 3(e) for being an admixture without demonstrable synergistic effect. At stake was the nuanced distinction between treatment method claims, purpose-limited product claims, and the adequacy of technical data to satisfy inventive step and non-obviousness requirements.
Discussion on Judgments: In support of its position that the claims were not barred under Section 3(i), the appellant relied upon the judgment in University of Miami v. Controller of Patents, (OA/28/2016/PT/DEL), wherein the Intellectual Property Appellate Board (IPAB) held that claims directed to "product for use" are patentable and not considered as methods of treatment. The IPAB distinguished between product claims and method claims, permitting claims to compositions that are characterized by their intended medical use.
The appellant also cited the decision of the Delhi High Court in Novartis AG v. Union of India, 2019 SCC OnLine Del 9285, which reaffirmed that therapeutic efficacy and technical advancement must be evaluated in context and not be dismissed summarily without adequate reasoning. In the present case, the data relating to synergistic effects were said to demonstrate a marked reduction in allergic symptoms in animal models, with comparative experiments supporting the technical effect claimed.
On the issue of claim amendment under Section 59, the appellant invoked the jurisprudence from the IPAB decision in Esco Corporation v. Controller of Patents, OA/66/2010/PT/KOL, where it was held that claim amendments that are supported by the original specification and merely clarify or limit the scope of claims are permissible, even if introduced during prosecution or appellate proceedings.
Finally, the reliance was also placed on European Patent Office (EPO) practices, particularly since the same invention had been granted a European patent after rigorous examination. The High Court considered such foreign prosecution outcomes to be persuasive, though not binding, in assessing inventive step and synergy.
Reasoning and Analysis of the Judge: Court held that the claims were clearly directed to compositions and not to any treatment process or method. He observed that Section 3(i) prohibits only method of treatment claims and not products per se. The Court accepted that the “composition for use” language was well-established internationally, and as long as the claims remained directed to compositions with specified purpose or use, they did not attract Section 3(i). The amended claims, being purpose-limited product claims, did not claim any treatment step and were therefore outside the mischief of Section 3(i).
On the question of claim amendments under Section 59, the Court concluded that the amendment was neither broadening the claims nor introducing any matter not originally disclosed. Rather, it clarified and narrowed the scope in response to objections. Therefore, the amended claims were held to be maintainable, even at appellate stage as there is no any bar to allow amendment at appellate stage.
Regarding the inventive step and synergistic effect, the Court found that the appellant had filed experimental data comparing allergic responses in progeny across different dietary compositions. The results indicated that only the claimed composition comprising both DGLA and omega-3 PUFAs showed the desired prophylactic effect. The comparative data established a technical advancement and unexpected results over prior art. The prior art relied on by the Controller was found to be more than twenty years old and lacked the specific combinations and concentrations used in the claimed invention. Therefore, the Court held that the invention satisfied the requirements of inventive step under Section 2(1)(ja) and was not hit by Section 3(e).
Final Decision: The High Court allowed the appeal, set aside the order of refusal dated 29th December 2021, and directed that the patent application proceed for grant on the basis of the amended claim set submitted by the appellant. The Court further directed the matter to be listed before the Controller for completion of necessary formalities.
Law Settled in This Case: This judgment settled the legal position that purpose-limited product claims, such as “composition for use in prophylaxis,” do not fall within the prohibition of Section 3(i) and are distinguishable from method of treatment claims. It reaffirmed that claim amendments under Section 59 are permissible even at appellate stage, if they are based on the original disclosure and do not broaden the claim scope. Furthermore, it laid down that properly supported experimental data showing unexpected technical effect is sufficient to establish inventive step and synergy for overcoming objections under Sections 3(e) and 2(1)(ja). The decision also recognized the persuasive value of patent grants in other jurisdictions like the EPO when examining similar claims.
Case Title: Société des Produits Nestlé S.A. Vs. Controller of Patents and Designs & Anr.
Date of Order: 3rd February 2023
Case Number: C.A. (COMM.IPD-PAT) 22/2022
Neutral Citation: 2023/DHC/000774
Name of Court: High Court of Delhi
Name of Judge: Hon’ble Mr. Justice Amit Bansal
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 Delh
