Brief Introductory Head Note Summary of Case and Factual Background
The present appeal arose before the Delhi High Court when a company named Medilabo RFP Inc challenged an order refusing its patent application for a drug composition meant for helping patients suffering from neuro-related illnesses which progressively damage the brain (neurodegenerative diseases). The invention was a combined drug formulation containing two known medical compounds—Rifampicin (including its safe pharmaceutical derivative or salt form) and Resveratrol (including its safe derivative forms). The specification highlighted that the proposed formulation helped reduce harmful side effects that normally appear when Rifampicin is taken for long periods, and that combining it with Resveratrol could make long-term use possible for improving brain conditions such as dementia. The Controller of Patents, however, rejected the application stating it was not eligible for a patent under Section 3(i) of the Patents Act, 1970, which bars patenting of methods of medical treatment.
Procedural Details
The patent request was originally filed on 2 August 2021 with the Indian Patent Office, seeking protection for "A prophylactic or therapeutic drug for neurodegenerative disease". A request for examination was submitted on 26 December 2022, following which the First Examination Report (FER) was issued on 20 January 2023. The applicant filed a detailed reply under Rule 24B(5) of the Patents Rules, 2003, and amended the claims on 10 July 2023, which included the phrase "for transnasal administration". Later, a hearing was scheduled on 21 September 2023. Written submissions and further amended claims were filed by the applicant on 6 October 2023, where specific references to mode of administration and dosage regimen were removed from the main independent claim to make it clear that the invention was only a product composition (i.e., the combined medicine itself), not a method of treatment (i.e., how a doctor administers or prescribes it). The Controller, on 21 December 2023, issued the impugned order rejecting the claims under Section 3(i) without considering the final amended claims or discussing the supporting specification.
Core Dispute
The central question before the Court was whether a patent claim which merely describes a drug composition (product) containing known pharmaceutical components with a clear technical structure can be rejected under Section 3(i) of the Patents Act, 1970, only because its earlier version or title mentioned medical use, or because working examples demonstrated experimental administration. The dispute further included whether non-discussion of post-hearing amended claims while deciding patenteligibility amounts to serious legal error resulting from overlooking the law.
Detailed Reasoning and Discussion by Court (including Citations)
The Court began by interpreting the basic framework of patent claims under Section 10(4)(c) of the Patents Act, 1970 which clearly states that “the scope of the protection is to be determined by the claims”. In patent law, this means that what matters for deciding patent rights is only what is written in the final claims, not how the product may ultimately be used in hospitals or clinics. The Court noted that the Controller incorrectly relied on older claims instead of the final amended claims. The Controller essentially objected that the product needed a specific dosage or continuous administration for a month or more, therefore it was a medical treatment method. The High Court disagreed, noting that the independent claim after hearing contained no steps of instructing how to treat a patient, but only what the drug combined composition contained, and in what ratio by weight the components were formulated (1 part Rifampicin : 1/500 to 500 parts Resveratrol). The Court clarified that merely writing “composition for a disease” or showing feasibility by giving experimental test examples does not convert a product claim into a medical procedure claim.
In support of this reasoning, the Court cited the judgment in University of Miami v. Controller of Patents High Court of Delhi, with Neutral Citation 2020:DHC:1170, where the Court held that the use of the expression "composition for treatment" in the preamble does not make the claim a “method of treatment” performed by a doctor, and therefore Section 3(i) cannot be applied to reject composition structure claims. Likewise, in Societe Des Produits Nestle SA v. Controller of Patents, this Court, with citation 2023 SCC OnLine Del 582, held that compositions that have a clearly described structure and components are not covered by the treatment-method exclusion under Section 3(i).
Further, the Court referred to the Bayer Pharma Aktiengesellschaft decision—Neutral Citation 2024:DHC:2395, wherein the Federal Circuit of the U.S. also observed that the "preamble" part of claims should not be treated as a limiting restriction unless it mentions core steps or essential technical structure of the invention. The Indian Manual of Patent Office Practice and Procedure, 2019 (Paragraph No. 09.03.05.08) was also noted, which excludes medical procedures like vaccination or administering medicine, but not actual medicine compositions or formulations or curative instrument/apparatus themselves. The Court read Section 3(i) along with the Manual to emphasize that the Patents Act only bars method/procedure of medical treatment, and is not a bar against product claims for pharmaceutical formulations which have specific technical components and are not prescribing doctor-based steps.
The Court also criticized the Controller for selectively stopping the analysis after holding the claims as non-patentable under 3(i), despite the hearing notice having other objections under Sections 2(1)(ja), 59, and 3(d). By relying on the ruling in Adama Makhteshim Ltd. v. Controller of Patents (C.A.(COMM.IPD-PAT) 167/2022), the High Court reiterated that "the Controller must consider all objections even if claims appear non-patentable on one ground". Not doing so shows lack of proper application of the law.
Decision
The Court ultimately set aside the order and sent (remanded) the matter back to the Controller for fresh decision, clearly directing that the final amended claims must be considered. The Court clarified that its present decision was not based on deciding merits of novelty or inventive step, but only on the legal question whether 3(i) was wrongly applied to refuse a composition-product claim. The Controller was directed to decide the application within six months and provide a fresh hearing to the applicant.
Concluding Note
This decision serves as an important reminder that patent law, though technical in structure, operates on simple fairness: a medicine as a thing (product) can be patented if it has a novel technical structure and meets other requirements, but a doctor’s action of prescribing or administering it cannot be patented. The High Court balanced innovation rights of applicants with safeguards for medical freedoms under the law. The ruling corrects a common misunderstanding at patent offices where medical-use phrases in titles or older claims often lead to automatic rejection without deep reading of final claims and supporting written explanations. The message is clear—read the claims carefully, read the specification fairly, and do not stop the analysis half-way.
Concluding Note for Publication—Suggested Article Titles
The Ordinary Man’s Patent and the Doctor’s Freedom: Understanding Product vs Treatment Claims; Pharmaceutical Formulation Patents and the Myth of Treatment Exclusion Under Section 3(i); Preamble Misinterpretation in Patent Claims—A Simple Guide Through Medilabo v Controller; Combination Drug Compositions—Eligible for Patent Protection in India?; When a Medicine is Patentable but its Use is not—Lessons from the Delhi High Court.
Case Title: Medilabo Rfp Inc. VS The Controller Of Patents
Order Date: 24 November 2025
Case Number: C.A.(COMM.IPD-PAT) 16/2024
Neutral Citation: 2025:DHC:2395
Name of Court: Delhi High Court
Hon'ble Judge: Justice Tejas Karia, High Court of Delhi
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
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The Delhi High Court, in the case Medilabo RFP Inc. VS The Controller of Patents, decided on 24 November 2025 in appeal number C.A.(COMM.IPD-PAT) 16/2024, delivered an important ruling through Justice Tejas Karia. The order came from the Delhi High Court, which is one of India’s constitutional courts of record. The appeal was filed by Medilabo RFP Inc., challenging the decision of the Indian Patent Office, passed by the Assistant Controller on 21 December 2023, which had refused their patent for a combined drug composition meant for the prevention and long-term treatment of brain-damaging diseases such as dementia. The refusal was made under Section 3(i) of the Patents Act, 1970, which prohibits patents on medical treatment methods. The company argued that their claim was not a treatment method but a medicine composition itself containing two known substances—Rifampicin and Resveratrol, combined in a specific, safe ratio to reduce side effects for long-term use, not explaining any steps of how doctors should treat patients.
The Court observed that patent law protects inventions based on what is finally written in the claims, not older versions or the effect it may have when eventually administered in labs or hospitals. The judge noted that the Controller had mistakenly examined older claims instead of the final amended claims filed after hearing, and had not explained from the patent’s description how the “method of treatment” boundaries extended into the claim. Relying on past rulings of Societe Des Produits Nestle SA v. The Controller of Patents and Bayer Pharma Aktiengesellschaft v. The Controller of Patents, the Court re-affirmed that pharmaceutical compositions which clearly define their components and structure are not barred by Section 3(i), even if they mention treatment or prevention in the introduction of the claim. It was also held that the Controller should decide on all pending objections and not stop the analysis only on one section ignoring others. In view of these legal mistakes, the refusal order was set aside, and the patent application was sent back (remanded) for fresh examination with an assurance of a new hearing and a time-bound decision within six months, strictly as per law without influence from the Court’s observations.
This ruling clarifies a key public-interest issue—that a medicine as a product may be eligible for a patent if it shows technical innovation, but a doctor’s act of prescribing or administering it cannot be patented. The judgement protects both innovation rights and medical freedom under the law, while correcting frequent misunderstandings in patent refusals involving pharmaceutical combination claims.
Disclaimer:This is for general information only and should not be construed as legal advice as it may contain human errors in perception and presentation: Advocate Ajay Amitabh Suman, IP Adjutor (Patent & Trademark Attorney), High Court of Delhi
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