Reinforcing Section 59 Interpretation: Madras High Court Overturns Refusal Order in Akebia Therapeutics

Introduction

In Akebia Therapeutics, Inc. v. Controller of Patents and Designs, the Hon’ble Madras High Court allowed an appeal and reversed a decision of the Assistant Controller of Patents and Designs, which had rejected Akebia Therapeutics’ application (Application No. 201647000423) for a composition aimed at treating anemia. The rejection was primarily based on alleged non-compliance with Section 59 of the Patents Act, 1970 (hereinafter referred to as ‘the Act’). The Hon’ble Court has remanded the matter for reconsideration, providing crucial clarification on the interpretation of Section 59(1) of the Act.

Background

Akebia Therapeutics (hereinafter referred to as ‘the Appellant’) filed a national phase application derived from an original PCT application as required under Section 138(4) of the Act for an invention titled ‘Composition and Methods for Treating Anemia’. During the examination process, the Controller raised various objections, including lack of novelty, inventive step, and non-patentability under Sections 3(i) and 3(d) of the Act.

The Appellant in response to the objections, amended the claims by modifying an original method of treatment claim into a pharmaceutical composition. However, the Controller refused the application, asserting that this change from a method of treatment claim to a composition claim goes beyond the scope of Section 59 of the Act.

Key Issue

The pivotal question before The Hon’ble Court was whether amending claims from a ‘method for treating anemia’ to a ‘pharmaceutical composition’ is within or beyond the scope of Section 59(1) of the Act.

Observations and Findings of the Hon’ble Court

The Appellant filed an appeal against the impugned order and contended that the amendments made were within the scope of the original disclosure. Thus, the amended claims could not be rejected under Section 59 solely on the ground that a method claim was modified to a product or composition claim. The Appellant relied on Allergan Inc. v. The Controller of Patents[1], where the Hon’ble Delhi High Court held that mere modification from method claims to composition claims is not inherently impermissible if the amended claims remain within the scope of the complete specification. Conversely, the Respondent contended that this modification of claims altered the essence of the original claims, thereby violating Section 59 of the Act.

The Hon’ble Madras High Court also referred  to an earlier decision in Commonwealth Scientific & Industrial Research Organization and Another v. The Assistant Controller of Patents & Designs[2], wherein a similar principle was upheld. Concurring with the Allergan ruling supra, The Hon’ble Court observed that while the nature of the claims changed from method to composition claims, the scope remained essentially the same. The Hon’ble Court reiterated that Section 59 does not impose an absolute bar on altering claim types. It further observed that the Indian Patent Office’s rejection was primarily based on the change in claim category rather than a substantive analysis of inventive step or non-patentability, thereby warranting reconsideration.

Court's Decision

The Hon’ble Court set aside the impugned order dated November 26, 2021, and remanded the matter for reconsideration, directing the Indian Patent Office to conduct a fresh substantive examination in accordance with the principles of the Act.

Conclusion

This judgment affirms the position taken by various High Courts that Section 59 does not prohibit the modification of method claims to product or composition claims, provided the essential scope remains unchanged. The Hon’ble Court emphasized that even if the nature of claims has changed, the substantive scope remains unchanged.

A similar view was taken by the Hon’ble Madras High Court in Starpharma Pty Ltd vs The Assistant Controller Of Patents And Designs, 2023[3] as well wherein the Hon’ble Court allowed the amendment of ‘method of treatment’ claims to product claims on the basis of Allergan supra. Likewise, in Honeywell International LLC v. The Controller of Patents, 2024[4], the Hon’ble Delhi High Court emphasized that while interpreting the ‘scope of a claim’, claims have to be read along with the complete specifications, together and as a whole. Thus, this decision aligns with the jurisprudence of High Courts on the interpretation of Section 59 and establishes a consistent approach across jurisdictions, promoting a balanced approach to amendments in claims.