On 24 November 2025, the Delhi High Court issued a judgment in a major patent dispute Medilabo Rfp Inc. v. The Controller of Patents C.A. (Comm.Ipd-Pat) 16/2024, concerning the patent eligibility of a drug for neurodegenerative diseases.
Factual Background
Medilabo Rfp Inc. (hereinafter referred to as the “Applicant”) filed a patent application for a drug for the prevention and treatment of neurodegenerative diseases. The initial application included references on mode of administration and dosage regimen.
Following an examination report, the Applicant amended the claim of invention by removing the features characterizing the treatment method, retaining only the features of the composition itself (a combination of rifampicin and resveratrol, including their derivatives and ratios).
Despite this, the Controller of Patents rejected the application, citing Section 3(i) of the Indian Patents Act, 1970, which excludes methods of treatment from patentability.
The Controller of Patents position was that the technical result – safe long-term use of the drug – is achievable only by adhering to a specific dosage regimen, which, in its view, rendered the invention a method of treatment.
The Court disagreed with the conclusions of the Controller of Patents, stating that the scope of legal protection is determined solely by the claims. The regulator is obligated to assess patentability based on the final, amended claims. This confirms that the subject matter of the patent is a pharmaceutical composition within the meaning of Section 10(4)(c) of the Patents Act, 1970.
The Court also referred to a number of judicial precedents, including:
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The Bayer Pharma case, in which it was stated that an example of how a drug works (its method of use) does not define the scope of the patent;
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The University of Miami case, in which it was stated that the expression “for treatment” in the claim does not mean the invention relates to a method of treatment.
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As a result of the proceedings, the Court set aside the impugned order of the Controller of Patents and remanded the patent application for reconsideration.
Methods of Treatment in the Russian Federation
Unlike India, in the Russian Federation, methods of treatment, including methods of using drugs, can be patented as inventions provided they meet the criteria of novelty, inventive step, and industrial applicability (Article 1350 of the Civil Code of the Russian Federation).