Introduction:
Applicants seeking patent protection in India may do so either through the international route under the Patent Cooperation Treaty (PCT), which involves a National Phase (NP) entry or via a convention application. Notably, India has a distinct patent regime that imposes limitations on amendments during NP entry, permitting only straightforward claim cancellations. However, during the prosecution of a patent application in India, amendments to claims or specifications may be made either voluntarily (via Form-13) or in response to objections raised by the Indian Patent Office (IPO). These amendments are governed by Section 57, read with Section 59 of the Indian Patents Act, 1970 (‘Act’). This article extends our earlier publication, Demystifying the Scope of Amendments in Patent Claims – Indian Jurisdiction, as available here, by examining how Indian courts have interpreted Section 59 through recent case laws.
Evolution of Indian Patent Law with respect to Section 59 of the Act:
Over the years, several judgments passed by the Indian Courts and the erstwhile Appellate Body (IPAB) have helped define the scope of permissible amendments allowable under Indian Patent Law. This evolving jurisprudence has gradually shaped the boundaries of what constitutes allowable modifications to claims and specifications. In this article, the authors focus on six recent judgments that provide clarity and consistency in the interpretation of Section 59 of the Act.
1. Allergan Inc. v. Controller of Patents – Delhi High Court, 20 January 2023
The Hon’ble Delhi High Court allowed amendments made by Allergan Inc. (Appellant), where the claims originally directed to method of treatment were amended to recite a product. The Appellant had filed a Patent Application. 7039/DELNP/2012 with 20 claims primarily directed to ‘a method for treating an ocular condition comprising…….’.
The First Examination Report (FER) raised objections under Section 3(i) of the Act, which prohibits the patenting of methods of treatment. To address this, the Appellant amended the as-filed claims to recite ‘An intracameral implant’, thereby shifting the focus to a product. However, the Assistant Controller of Patents (Respondent) objected to the amended claims under Section 59 of the Act, alleging that the ‘compositions of intracameral implant’ was not supported by the originally filed claims. Following a hearing and written submissions, the application was refused on the grounds of Section 59 of the Act, prompting the Appellant to appeal to the Delhi High Court.
The Court held that (1) the amendment was permissible emphasizing that the change from method (method of treatment) to product was made to overcome the objection raised under Section 3(i), (2) the amended claims must be interpreted in light of entire specification, not in isolation, and (3) the specification contained detailed disclosures about the product (implant), including its peculiarities and characteristics. The court held that discriminating between the claims and the as-filed specification by considering the two as separate ‘would militate against the very ethos and philosophy of the Act’ paras 41-44 of (1). It concluded that since the product was fully described in the original specification, the amendment did not violate Section 59(1), and the Appellant should not be deprived of patent protection due to the nature of the amendment para 45 of (1). The matter was remanded back to IPO for reconsideration of the patentability of the amended claims.
2. Starpharma Pty Ltd v. Assistant Controller of Patents – Madras High Court, 12 October 2023
In this case, the Hon’ble Madras High Court overturned the decision of the Assistant Controller of Patents, who had rejected amended claims under Section 59 of the Act. The Appellant, Starpharma Pty Ltd, had filed Patent Application No. 10044/CHENP/2013 with 38 claims, of which claims 1-34 were directed to ‘A method of treatment or prophylaxis of bacterial vaginosis in a subject… comprising administering to the subject an effective amount of a macromolecule,,,,,.’ The remaining claims were directed to ‘use of an effective amount of macromolecule…’. To address the objection under Section 3(i) (which bars method of treatment claims), the Appellant amended the claims via Form-13 to recite a gel formulation (product). However, the Assistant Controller refused to take the amendments on record, citing non-compliance with Section 59, and maintained the objection under Section 59 of the Act. After the hearing and filing of written submissions, the Application was refused on the grounds that the as-filed claims 1-38 (method) were not allowable under Section 3(i), 2(1)(j) of the Act, and the amended claims (product) were not allowable under section 57 & Section 59 of the Act. Aggrieved by this decision, the Appellant filed an appeal at the Madras High Court.
The Court held that the amended claims should not have been rejected, stating that when viewed in light of the complete specification, the amendments are within the permissible scope. Importantly, the Court reaffirmed the precedent set forth by the Delhi High Court in the case of Allergan Inc. v. the Controller of Patents, reinforcing the principle that amendments must be assessed in the context of the entire specification, not just the originally filed claims para 10 of (2). The matter was remanded back to IPO for reconsideration of the amended claims.
3. Ovid Therapeutics, Inc. v. Assistant Controller of Patents and Designs – Delhi High Court, 09 February 2024
In this case, the Hon’ble Delhi High Court examined the scope of permissible amendments under Section 59 of the Act. The Appellant, Ovid Therapeutics, Inc., filed Patent Application No. 201717000025 with claims 1-28, primarily directed to ‘a method of increasing tonic inhibition of neurons in a subject’. The FER raised several objections, including lack of novelty, lack of inventive step, and non-patentability under Section 3(i) and Section 3(e) (mere admixture). To overcome these objections, the Appellant amended the as-filed claims such that the amended claims 1-10 were directed to a pharmaceutical composition (product) and the amended claims 11-20 were directed to a method of administering a pharmaceutical composition. Following further objections in the hearing notice, including an objection under Section 59, the Appellant cancelled claims 7, 8 and 11-20 (pending at the time of issuance of the Hearing Notice). Despite these amendments, the application was refused, with one key reason being that the amended claims allegedly expanded the scope of the original claims, violating Section 59 of the Act. Aggrieved by this decision, the Appellant filed an appeal at the Delhi High Court.
The Court analyzed whether the amended claims were within the scope of the original claims, and enlisted three major differences:
- Disease Limitation Removed:
The original claim 1 specified the disease being treated, while the amended claim 1 did not.
The Court held that this omission broadened the scope, making the amendment impermissible under Section 59 paras 25-26. Referring to Sulphur Mills Ltd. v. Dharmaj Corp Guard Ltd. & Anr.,2021(3A), the Court emphasized that the modification and variation can be done in the claims, as long as they are within the scope of original filed claims.
- Change in Claim Type:
The amended claims pertain to a ‘composition’ while the as-filed claims related to a ‘method’ employing a composition. The Court acknowledged that such a shift is permissible only if the amended claims remain within the scope of the original disclosure.
- New Limitations Introduced:
The amended claim 1 introduced specific dosage ranges of gaboxadol, which were not present in the original claims. The Court referred to Nippon A&L Inc. v. The Controller of Patents, 2022(3B), and clarified that so long as the amended Claim is clarificatory in nature or disclaims earlier claimed feature, they can be allowed paras 29-30 of (3B).
The court acknowledged that a claim’s scope can be modified from ‘method’ to ‘composition.’ However, it was emphasized that the amended claims must fall within the bounds of the original claims. Ultimately, the Court decided that the amended claims exceeded the original scope by removing the limitation on intended purpose (treating specific diseases) present in the original claims and thus upheld the refusal of the application. The appeal was dismissed.
4. Honeywell International Inc. v. Controller of Patents – Delhi High Court, 21 May 2024
In this case, the Hon’ble Delhi High Court addressed the scope of claim amendments under Section 59 of the Act. The Appellant, Honeywell International Inc., filed a patent application No. 3150/DELNP/2010 with claims 1-10, wherein the claims 1-3 were directed to a composition comprising an organic fluorophore (Formula I), claims 4-7 were directed to a fluorescent compound (Formulae IV or V), claim 8 was directed to an article of manufacture, and claims 9-10 were method claims.
The FER raised substantive objections under Section 2(1)(ja), and non-patentability under Sections 3(d) and 3(e) of the Act. In response, the Appellant cancelled the as-filed claims 4-7. However, the Respondent in the Hearing notice maintained the objection under Section 3(e) of the Act alleging the claims defined a mere admixture. Subsequently, the Appellant amended claims 1 to 3 to recite an organic fluorophore compound (Formula I), instead of a composition. The Respondent refused the Application stating that the amendment changed the nature of the claim from a composition comprising an organic fluorophore of formula I to an organic fluorophore compound of formula I, which allegedly exceeded the scope of the original claims.
The Appellant submitted that even though the impugned order did not cite Section 59 of the Act, the reasoning aligned with its provision. It was further submitted that the Respondent should have issued a fresh hearing notice to allow the Appellant to address the Section 59 objection, in line with principles of natural justice.
The Court, while analyzing the amended claims, believed that the original claim, which encompassed a composition containing the compound, was effectively narrowed down to a claim specifically directed to the compound itself. The change was made to enhance clarity, not to broaden the scope. The court also held that the compound was fully supported by the original claims and the specification. Notably, this case does not involve additional elements beyond a single compound, as the original claims centered on an organic fluorophore defined by formula I only, which was subsequently elaborated upon in formulas II, X, XI, and III.
Referring to Allergan Inc. v. The Controller of Patents, 2023, the Court reiterated that the claims must be read with the complete specification, and that amendments are disallowed only when they introduce subject matter not originally disclosed. The court also relied on Nippon (Supra)(3B) , the Court emphasized that a broader and wider permissibility for amendment of claims prior to the grant has to be given. Since the amended claim pertained to a compound that was a subset of the originally claimed composition, the amendment was held to be within the scope. Accordingly, the Court allowed the amendment under Section 59 and remanded the application to IPO for fresh consideration Paras 33-41 of (4).
5. Trustees of Columbia University in the City of New York v. Assistant Controller of Patents and Designs – Madras High Court, 13 February 2025
The Appellant (The Trustees of Columbia University in the City of New York) filed Patent Application No. 202047004043 with claims 1-30, all directed to various methods, such as claims 1-14 were directed to a method of treating an amyloid deposition disease, claims 15-22 were directed to a method of detecting the presence of amyloid deposits in a patient, claims 23-25 were directed to a method of decreasing the amount of kappa and/or lambda light chain fibril aggregate deposits, claim 26 recited a method of improving myocardial function in a patient, and claims 27-30 recited a method of treating amyloid light chain amyloidosis (ALA).
The FER raised several objections, including lack of inventive step and non-patentability under Section 3 (i) of the Act. To overcome Section 3(i) objection, the Appellant amended claims 1-19 to recite a pharmaceutical composition (product). The Respondent (Assistant Controller of Patents and Designs) issued a hearing notice with an objection to the amended claims under Section 59 of the Act. Despite detailed written submission referencing Allergan (supra)(1), and support for the amended claims from the original/as-filed claims as well as the as-filed specification, the application was refused. Aggrieved by this decision, the Appellant filed an appeal at the Madras High Court.
The Court, however, observed that the summary of the invention and other parts of the specification clearly described the invention both as compositions and methods for treating amyloid deposition diseases. The Court, placing reliance on Allergan (supra)(1), emphasized that the amendment from method to product claims was permissible, provided it fell within the scope of the complete specification. The Court, in light of Allergen (1), reiterated that amended claims must be read in conjunction with the complete specification, and cannot be solely rejected due to a change in the claim type. The Court also referred to Nippon (Supra)(3B) , noting that while said judgement emphasizes that all the conditions in Section 59 should be cumulatively fulfilled, the Respondent had, however, failed to indicate as to which condition has not been fulfilled in the case at hand Para 10 of (5).
The Court meticulously examined the submissions from both parties, annulled the Respondent’s order, and remanded the case to a new Controller for fresh evaluation.
6. Abbvie Biotherapeutics Inc & Anr. v. Assistant Controller of Patents – Delhi High Court, dated 16 April 2025
The Appellant filed Patent Application No. 201817047767 titled ‘ANTI-cMet ANTIBODY DRUG CONJUGATES AND METHODS FOR THEIR USE’ as an NP entry under the PCT, originally comprising 137 claims, all directed to methods of treatment. The FER raised objections regarding industrial applicability and patentability of methods of treatment under Section 3(i) of the Act. To overcome these objections, the Appellant amended the claims to convert the method-based claims to product-based claims, introducing new claims related to antibody-drug conjugates (ADCs) and pharmaceutical compositions. Despite these amendments and subsequent hearing, the application was refused under Sections 2(1)(j), 3(i), and 59(1) of the Act. On Appeal, the Court focused on whether the amendments were permissible under Section 59(1)para 25 of (6):
The Court analysed the amendments across four categories:
1. Transformation from Method to Product Claims: Original claims focused on treatment methods; amended claims described structural ADCs.
2. Removal of Specific Treatment Details: Dosing schedules, patient populations, and therapeutic combinations were omitted.
3. Omission of Disease-Specific References: The amended claims no longer specified the cancer type (e.g., NSCLC).
4. Introduction of New Composition Claims: Claims 5–8 introduced pharmaceutical compositions not previously disclosed.
The Court defined a ‘disclaimer’ as a statement that typically excludes specific subject matter to narrow the scope of a claim, either to avoid prior art or to clarify what is not being claimed. Furthermore, the Court observed that the amendments in question were not explanatory in nature, as they did not clarify the existing scope but instead broadened it by removing the original treatment-related limitations. The Court emphasized that ‘corrections’ under Section 59(1) must be confined to rectifying obvious mistakes or clerical errors and cannot involve substantive changes that alter the essence of the invention. Ultimately, the Court held that the amendments constituted more than a mere disclaimer, explanation, or correction, they represented a fundamental transformation of the claim category, shifting from method-based claims to product-based claims. This shift significantly expanded the scope of the patent beyond its original disclosure Paras 26-31 of (6) but also was not supported by the original claims or specification, violating Section 59(1) of the Act Para 32 of (6). It further observed that the amendments appeared to be an attempt to circumvent Section 3(i) by recasting the methods of treatment claims into product claims that were never originally pursued Para 33 of (6). While Abbvie relied on the judgment in Allergan to justify its amendments, the Court distinguished the present case. Unlike Allergan, where the amended claims retained disease-specific references, Abbvie’s amendments removed disease-specific references entirely, unjustifiably expanding the scope Paras 36-37 of (6). Accordingly, the Court upheld the Controller’s decision, affirming that the proposed amendments exceeded the permissible scope under Section 59(1), and that the original claims were non-patentable under Section 3(i) and lacked industrial applicability under Section 2(1)(j).
Conclusion:
A consistent theme emerging from judicial interpretations of Section 59 of the Act is the strategic use of claim amendments to overcome objections, particularly those related to non-patentability under Section 3. These cases underscore the complexities faced by applicants, especially in the context of India’s distinct patentability standards, which often diverge from those in other jurisdictions. As a result, applicants entering the NP in India frequently find it necessary to substantially revise their claims to align with local legal requirements, a reality acknowledged by the Court in the Allergan decision.
However, the judgments analyzed do not recognize the conversion of ‘method of treatment’ claims into ‘product’ claims as falling within the three permissible categories of amendments, namely, disclaimer, explanation, or correction. Courts have disallowed such conversions when the amended claims are not supported by the originally filed claims or specification, or when they result in a broadening of the claim scope. This reinforces the principle that amendments must not introduce new subject matters or expand the legal protection beyond what was originally disclosed.
That said, jurisprudence leaves room for interpretation. A critical question that remains unresolved is whether such a conversion would always be permissible if the originally filed specification or claims disclosed the product per se, but not explicitly claimed. This opens the door to a nuanced understanding of Section 59, where the allowability of converting method claims to product claims may hinge on whether the product was inherently part of the original disclosure.
Moreover, an important issue yet to receive judicial clarity is whether the scope of amended claims should be assessed against the originally filed claims or the claims pending immediately prior to the amendment. A definitive ruling on this point would significantly shape the future of claim amendment practices in India and provide much-needed guidance to applicants navigating patent prosecution in India.
[The authors are Associate and Principal Associate, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys]
References:
(1) Allergan Inc. Vs. The Controller of Patents, 20 January 2023.
(2) Starpharma Pty Ltd Vs. The Assistant Controller of Patents, 12 October 2023.
(3) Ovid Therapeutics, Inc. Vs. Assistant Controller of Patents and Designs, 09 February 2024.
(3A) Sulphur Mills Ltd. v. Dharmaj Corp Guard Ltd. & Anr.,2021
(3B) Nippon A&L Inc. v. The Controller of Patents, 2022
(4) Honeywell International Inc. Vs. The Controller of Patents, 21 May 2024.
(5). The Trustees of Columbia University in the City of New York Vs. Assistant Controller of Patents and Designs, 13 February 2025.
(6) Abbvie Biotherapeutics Inc & Anr. v. Assistant Controller of Patents dated 16 April 2025.
