On 20 March 2025, the Madras High Court allowed an appeal against the refusal of a patent application concerning a pharmaceutical composition for treating anaemia. The Court\u2019s decision offered some clarity on the permissible breadth of claim amendments under Section 59 of the Patents Act, 1970.<\/p>\n
Akebia Therapeutics, Inc. (\u201cAkebia\u201d) filed a national phase application (No. 201647000423) with the Indian Patent Office (\u201cIPO\u201d \/\u201dPatent Office\u201d) claiming priority from a PCT application filed in 2014. The patent application was titled \u201cComposition and methods for treating anaemia.\u201d The initial claim in the patent application focused on a method of treatment<\/em>, involving the administration of a specific compound to patients suffering from anaemia.<\/p>\n The Patent Office issued an examination report on 8 January 2019 in which objections were raised for lack of novelty and inventive step, and non-patentability under Section 3(i) and 3(d). Following subsequent prosecution, a final refusal was issued on 26 November 2021, primarily relying on Section 59 of the Patents Act, asserting that the amended claims \u2014 now directed towards a pharmaceutical composition<\/em> \u2014 fell outside the scope of permissible amendments.<\/p>\n The Patent Office contended that the amendment from a method of treatment to a composition altered the nature of the invention beyond what is allowed under Section 59, which restricts amendments to disclaimers, corrections, or explanations that do not broaden the original disclosure.<\/p>\n Akebia argued that the amendment did not introduce new matter but merely recharacterized the claim format without departing from the invention\u2019s original disclosure. Akebia pointed out that the pharmaceutical composition was already detailed in the complete specification and supported by examples and preferred embodiments. Reliance was placed on Allergan Inc. v. Controller of Patents<\/em> decision, where similar amendments were upheld.<\/p>\n The Patent Office, in its arguments, maintained that converting a treatment method claim into a composition claim went beyond the scope of the original claims and thus violated Section 59(1).<\/p>\n Based on the decisions in Allergan case<\/em> and Commonwealth Scientific & Industrial Research Organisation v. Assistant Controller of Patents & Designs<\/em>, the Court found that the amendment did not result in any substantive addition but merely changed the claim category. Both cases had clarified that claim format changes (e.g., method to product\/composition) are not per se impermissible, provided they remain within the substantive disclosure of the original specification.<\/p>\n The Court found that the rejection was based solely, or at least substantially, on an untenable interpretation of Section 59. Since other objections concerning inventive step and non-patentable subject matter were neither addressed nor decided, the Court found it fit to remand the matter back to the Patent Office for fresh consideration.<\/p>\n This decision reiterates the flexibility afforded under Section 59 in aligning claims with the disclosed invention. It also reinforces judicial precedent supporting amendments that change the form, but not the substance, of claims. For patent applicants, particularly in the pharmaceutical domain, the case reinforces the strategic value of detailed specifications that can support alternative claim structures.<\/p>\nAkebia\u2019s arguments<\/strong><\/h2>\n
Patent Office\u2019s Arguments<\/strong><\/h2>\n
Court\u2019s Analysis <\/strong><\/h2>\n
Conclusion<\/strong><\/h2>\n