Summary
The Delhi High Court set aside the Controller’s refusal of Medilabo’s application under Section 3(i), holding that the amended claims were directed to a pharmaceutical composition, not a method of treatment. The Court faulted the Controller for relying on unamended claims, ignoring the specification, the Patent Office Manual and precedent on composition versus treatment claims. The matter was remanded for fresh examination on all remaining grounds, including inventive step, amendments and Section 3(d).
In Medilabo Rfp Inc vs The Controller Of Patents, the Delhi High Court set aside the rejection of a patent application under Section 3(i) of the Patents Act, 1970. The Court observed that the Controller had failed to demonstrate how the claimed pharmaceutical composition fell within the ambit of a “method of treatment” and held that the refusal under Section 3(i) lacked substantive support, particularly as the amended claims had not been duly examined.
Background
Medilabo RFP Inc. (hereinafter referred to as “Medilabo”) filed Indian Application no. 202117034705, titled “Prophylactic or Therapeutic Drug for Neurodegenerative Diseases.” The invention relates to a medicine / drug composition / pharmaceutical formulation intended for the treatment of neurodegenerative diseases, formulated to reduce adverse side effects. The originally filed Claims 3 to 13 describe a prophylactic or therapeutic drug in which rifampicin and resveratrol are administered as a dosage regimen based on body weight, through trans-nasal administration over a specified period.
A First Examination Report (FER) was issued on 20 January 2023, raising objections under Section 3(i) of the Patents Act. Following the hearing notice issued on 21 September 2023, the Applicant filed written submissions along with amended claims on 6 October 2023. However, the application was rejected by the impugned order dated 21 December 2023.
Arguments by Parties
Medilabo contended that the Controller wrongly refused the application under Section 3(i), as Claim 1 clearly pertained to a composition and not a method of treatment, which was evident from a plain reading of the claims and the complete specification. Claim 2, likewise, related to a kit and included no treatment steps. They argues that the claimed subject matter was a prophylactic/therapeutic drug composition, and therefore Section 3(i) was inapplicable, as product/formulation claims are permissible under the Act.
Medilabo further submitted that the Controller’s interpretation was contrary to settled jurisprudence, including Bayer, Nestlé, and University of Miami, which establish that the scope of an invention must be determined from the claims in accordance Section 10(4)(c), and that the preamble cannot treated as a limitation unless it recites essential structure or steps or is necessary to impart meaning and vitality to the claim. Medilabo also pointed out that the Controller had improperly relied on earlier claim language referring to “trans nasal administration,” despite the fact that amended post-hearing claims had removed such references in order to make clear that the invention resided in the composition and not in the route of administration.
The Controller’s counsel contended that, despite the amendments, the claims continued to relate to a dosage regimen, as the specification and examples showed that the technical effect arose through administration over a defined period. Accordingly, the claims were implicitly directed to a method of treatment and therefore attracted Section 3(i).
Claim 1 (as amended in FER response)
- A combination of a prophylactic or therapeutic drug for a neurodegenerative disease for transnasal administration and a container for nasal administration that packs the prophylactic or therapeutic drug therein, wherein the prophylactic or therapeutic drug comprises a combination of a rifampicin compound selected from the group consisting of rifampicin, a derivative of rifampicin and a salt of rifampicin or the derivative and a resveratrol compound selected from the group consisting of resveratrol and a derivative of resveratrol, wherein the derivative of rifampicin is a derivative that has a naphthohydroquinone or naphthoquinone structure and is pharmaceutically acceptable, and the derivative of resveratrol is a derivative that is pharmaceutically acceptable and has a derivative group selected from the group consisting of N-phenylacetyl group, 4,4′-dimethoxytrityl (DMT) group, a protein, a peptide, a sugar, a lipid, a nucleic acid, polystyrene, polyethylene, polyvinyl, polyester, and an ester group.
Claim 1 (as amended in Written Submission)
“1. A prophylactic or therapeutic drug composition for a neurodegenerative disease, comprising rifampicin compound selected from the group consisting of rifampicin, a derivative of rifampicin and a salt of rifampicin or the derivative, and a resveratrol compound selected from the group consisting of resveratrol and a derivative of resveratrol, wherein the derivative of rifampicin is a derivative that has a naphthohydroquinone or naphthoquinone structure and is pharmaceutically acceptable, and the derivative of resveratrol is a derivative that is pharmaceutically acceptable and has a derivative group selected from the group consisting of N-phenylacetyl group, 4,4′-dimethoxytrityl (DMT) group, a protein, a peptide, a sugar, a lipid, a nucleic acid, polystyrene, polyethylene, polyvinyl, polyester, and an ester group; and wherein resveratrol compound is contained in an amount of 1/500 to 500 parts by weight relative to 1 part by weight of the rifampicin compound.
Court’s analysis
The Court carefully examined the subject application and noted that, when read as a whole, it related to a pharmaceutical composition for prophylactic or therapeutic use in neurodegenerative diseases, rather than a method of treatment. The Court observed that Medilabo had removed references to dosage regimen, duration of administration, and transnasal delivery in the post-hearing amended claims, clarifying that the invention resided in the composition itself.
The Court further noted that the Controller had relied on the earlier, unamended claims in the impugned order, without adequately considering the amendments, which were made to address the concerns raised under Section 3(i). The Court found that the amended claims clearly defined a pharmaceutical composition, and the removal of administration details and dosage regimen references meant the claims could not be construed as relating to a method of treatment.
The Court opined that the complete specification, including Paragraphs 1, 12, and 14, as well as the section on ‘Advantages of the Invention,’ indicated that the invention related to a pharmaceutical composition of rifampicin in combination with resveratrol for prophylactic or therapeutic use. The Court emphasized that while pharmaceutical products may have specific modes of delivery, Section 10(4)(a) of the Act requires that claims be clear and supported by the specification, and that working examples serve only to demonstrate feasibility and practical implementation without defining the claims’ scope as a method of treatment.
The Court relied on established precedents and the Patent Office Manual, noting that claims directed to pharmaceutical compositions, even if described ‘for the treatment’ of a disease, are not method of treatment claims and therefore cannot be barred under Section 3(i). The Court emphasized that claims must be interpreted based on their composition and supported specification, not on dosage or method of administration, as reinforced in prior cases.
The Court observed that the Patent Office Manual does not classify pharmaceutical compositions with therapeutic effects under Section 3(i), and the Controller could not reject the application without considering the amended claims in light of the specification. The Court further noted that the impugned order ignored other objections under Sections 2(1)(ja), 59, and 3(d), and held, that all objections must be examined prior to refusal.
Conclusion
In conclusion, the Court set aside the impugned order dated 21 December 2023 and remanded the subject application to the Controller for fresh consideration, directing that the amended claims be duly examined. The Court further ordered that the matter be decided within six months, with a fresh hearing granted to the Appellant.
Citation:
Medilabo Rfp Inc vs The Controller Of Patents (C.A.(COMM.IPD-PAT) 16/2024) (HC Delhi 24 November, 2025). Available at https://indiankanoon.org/doc/194784346/
Author: Dr. Vasundhara Paliwal
Accessibility Review: Rakesh Krishnan