The Delhi High Court’s recent decision in Medilabo RFP Inc. vs Controller of Patents [C.A.(COMM.IPD-PAT) 16/2024] is an important reaffirmation of the principle that the Patent Office must carefully distinguish between a patentable composition and a non-patentable method of treatment under Section 3(i) of the Patents Act.

The appeal concerned patent application number 202117034705, entitled “Prophylactic or therapeutic drug for neurodegenerative diseases”, which claimed a pharmaceutical composition containing Rifampicin and Resveratrol for prophylactic or therapeutic use. The Controller had refused the application on the ground of patent ineligibility under Section 3(i) of the Patents Act, 1970, treating the invention as a dosage-dependent method of treatment rather than a drug composition. The central contest of the appeal was whether the Controller had misunderstood the nature of the claims, particularly after the Appellant had filed amended claims removing all references to administration and dosage regimen.

The Appellant’s case rested squarely on the argument that claim 1 was a composition claim, not a method of treatment. They argued that the Controller had wrongly interpreted the invention by relying on the original claim set, those containing references to intranasal administration and dosage schedules, while ignoring the post-hearing amended claims specifically filed to remove those elements. According to the Appellant, the amended claim 1 was directed entirely to a composition comprising Rifampicin (or its derivatives/salts) and Resveratrol (or its derivatives) and did not stipulate the mode of administration or the combination reference. They emphasised that Section 3(i) is inapplicable to product or formulation claims, which are recognised under the Act subject to Section 3(e). The Appellant also pointed out that claim 2 covering a “kit” containing the drug was likewise indisputably a product claim yet had been rejected without analysis. Relying on the Delhi High Court’s judgment in Bayer Pharma Aktiengesellschaft vs Controller of Patents [2024:DHC:2395], the Appellant reiterated that the scope of an invention must be determined strictly from the claims in accordance with Section 10(4)(c), not from the intended end-use or therapeutic purpose. Additionally, they argued that the Controller’s insistence on reading the phrase “for a neurodegenerative disease” from the preamble of the claim as a limiting feature was contrary to settled jurisprudence, since a preamble that merely states the purpose does not limit the scope of the claim; removing the phrase would leave the claim unchanged.

The Controller defended the refusal by insisting that the specification clearly discussed administering the composition in a dosage regimen tested on mice and extrapolated to humans. It was also argued that the claimed composition lacked technical effect independent of its dosage schedule, and, therefore, remained “implicitly” a method of treatment. Even if the Appellant had deleted references to dosage and disease condition in the amended claims, the Controller maintained that the invention was still rooted in treatment steps and therefore attracted Section 3(i). The impugned order stated that the composition does not have technical effect in its entirety of scope without a regimen specifying dose and duration, and, thus, the invention amounted to a method of treating dementia through trans-nasal delivery of Rifampicin and Resveratrol.

The Court, however, found significant merit in the Appellant’s contentions and identified several flaws in the impugned order. First, the Court noted that the amended claims removed the mode of administration and combination references, yet the Controller proceeded as though adjudicating the originally filed claims. This alone rendered the reasoning unsustainable because the Controller must decide the patentability of the invention in the light of the amended claims. Second, the Court noted that the specification expressly stated that one objective of the invention was to “provide a pharmaceutical formulation of rifampicin” and another was to provide a prophylactic or therapeutic drug, neither of which is barred under Section 3(i). The Controller failed to specify from the specification as to how the boundaries of the claim extended to a method of treatment. The Court, thus, held that the submission of the Controller that the complete specification discussed a method of treatment was not acceptable.

Notably, a claim usually consists of three parts: Preamble, Transitional phrase, and Body. The Preamble is an introductory part that identifies the category of invention and sometimes the purpose of the invention. The Court highlighted that there are many patents granted by the Patent Office in which the expression “composition for the treatment” has been used in the preamble of many claims. It is a well-established jurisprudence that the preamble of the claim must not be read as a limitation to the claim unless it recites essential structure/steps, or if it is “necessary to give life/meaning, and vitality to the claim. In the instant case, the Controller ought to have determined whether the removal of the phrase “for a neurodegenerative disease” from the preamble would change the integrity and meaning of the claim.

Importantly, the Court emphasised that every pharmaceutical composition inherently has a mode of delivery, whether oral, intravenous, sublingual, transdermal, intranasal, ocular, or otherwise. It is the requirement of the Patents Act under Section 10(4)(a) for the applicants to provide the operation or use and the method by which the invention is to be performed. Citing Bayer and University of Miami, the Court reiterated that references to treatment in the claims or examples do not attract Section 3(i) where the claim body is structurally directed to a composition. The Court also referenced the Madras High Court’s decision in Chinese University of Hong Kong, that clarified that process for prophylactic treatment of human beings is excluded under Section 3(i).

In the Court’s view, the Controller had failed to articulate how the boundaries of Claim 1 extended to a method of treatment and had instead treated the claim as non-patentable simply because the composition could be used to treat a disease. This approach, the Court observed, ignores Section 10(4)(c), which is imperative to interpret the scope of the claims, and also misreads the Patent Office Manual, which does not classify therapeutic compositions as falling within Section 3(i). The Court concluded that the refusal lacked substantive basis, particularly because it made no attempt to evaluate the amended claims or to explain why the composition as claimed involved treatment steps.

Accordingly, the Court set aside the impugned order and remanded the matter for fresh consideration, directing the Patent Office to examine the amended claim set.