In its recent decision in Akebia Therapeutics Inc. vs Controller of Patents and Designs [CMA(PT)/64/2024], the Madras High Court set aside the order passed by the Controller in national phase application number 201647000423, entitled “Composition and Methods for Treating Anemia”, and remanded the application to the Patent Office for re-consideration.

In the subject application, original claim 1 disclosed a method of treating anaemia which was subsequently amended to a pharmaceutical composition for treating anaemia. This amendment was rejected by the Controller for contravening Section 59 and the application was refused on the grounds of lack of novelty and inventive step, and non-patentability under Sections 3(i) and 3(d) of the Patents Act, 1970.

Section 59(1) states that, “no amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.”.

The Appellant assailed the impugned order asserting that the amended claim fell within the scope of the original claim and the complete specification. They pointed out that the amended composition claim was directed towards treating the same condition i.e. anemia, through the administration of the same compound in the same dosage range as specified in the original claim. In support of this position, reliance was placed on the decision in Allergan Inc. v. The Controller of Patents [2023 SCC OnLine Del 295], wherein it was held that claim amendment ought not to be disallowed under Section 59 solely on the ground that a method claim has been modified to a product or composition claim.

The Court noted that the Controller had substantially rejected the amended claim on the sole ground that it involved amendment from a method of treating anaemia to a composition claim which may be used for treating anaemia. Reaffirming the position in Allergan, the Court held that such a ground for rejection is untenable under Section 59.

Upon a comparative analysis of the original and amended claim, the Court observed that while the nature of the claim had changed from method to composition, the scope remained unchanged.

In the light of the forgoing, the Court set aside the impugned order and remanded the matter to the Patent Office for re-consideration in accordance with law.