Section 3(i) and Drug Composition Claims: Commentary on Medilabo RFP Inc v Controller of Patents (2025 DHC 10362)

Clarifying Section 3(i) for Drug Composition Claims and the Duty to Consider Amended Claims: Commentary on Medilabo RFP Inc v. Controller of Patents, 2025 DHC 10362

1. Introduction

The Delhi High Court’s judgment in Medilabo RFP Inc v. The Controller of Patents (C.A. (COMM.IPD-PAT) 16/2024, decided on 24 November 2025, “Medilabo”) continues the court’s recent line of decisions refining the interpretation of Section 3(i) of the Patents Act, 1970, as it applies to pharmaceutical inventions.

The appeal under Section 117A challenged an order of the Assistant Controller refusing Patent Application No. 202117034705, titled “PROPHYLACTIC OR THERAPEUTIC DRUG FOR NEURODEGENERATIVE DISEASES”, on the ground that the claims were hit by Section 3(i) (methods of treatment).

The invention concerns a prophylactic/therapeutic pharmaceutical composition involving rifampicin and resveratrol (including acceptable derivatives), in defined weight ratios, designed to treat or prevent neurodegenerative diseases while reducing adverse side effects of long-term rifampicin use.

The key issues before the Court were:

  • Whether the claims, properly construed, were directed to a product/composition or a prohibited method of treatment under Section 3(i);
  • Whether the Controller erred by:
    • failing to decide the application on the basis of the amended claims filed after the hearing, and
    • refusing the application solely under Section 3(i) without addressing other pending objections (novelty, inventive step, Section 3(d), and Section 59) raised earlier;
  • How Section 10(4)(c) (scope determined by the claims) interacts with Section 3(i)’s exclusion of treatment methods.

The judgment sits at the intersection of three doctrinal themes in Indian patent law:

  1. The boundary between patentable drug compositions and excluded therapeutic methods under Section 3(i);
  2. The centrality of claim language (Section 10(4)(c)) in defining patent scope, as distinct from working examples and end-use; and
  3. The procedural obligation of Controllers to:
    • consider amended claims actually on record at the time of decision, and
    • return findings on all grounds of objection, not just one.

2. Summary of the Judgment

2.1 Procedural Outcome

Justice Tejas Karia allowed the appeal, set aside the impugned refusal order dated 21.12.2023, and remanded the subject application to the Controller for:

  • fresh consideration of the application including the post-hearing amended claims filed on 06.10.2023;
  • examination on all outstanding grounds (including those under Sections 2(1)(ja), 3(d), and 59), not merely Section 3(i);
  • decision within six months, after granting the appellant a fresh hearing.

The Court expressly clarified that it was not adjudicating the substantive merits of patentability (novelty, inventive step, etc.), and that the Controller must decide those issues independently, uninfluenced by any observations in the judgment.

2.2 Key Holdings and Directions

While not granting the patent, the Court laid down several important principles:

  1. Composition vs. method of treatment:
    • The subject-matter of independent Claim 1, as amended post-hearing, is a pharmaceutical composition, not a method of treatment.
    • Section 3(i) applies to process/method claims for treatment, not to product/composition claims per se, even when such compositions are for prophylactic or therapeutic use.
  2. Scope determined by claims (Section 10(4)(c)):
    The Controller erred in:
    • basing the Section 3(i) objection on the original (pre‑amendment) claims and on working examples, and
    • not assessing the amended Claim 1, which had removed references to the specific route (“transnasal”) and dosage regimen.
    The Court reiterated that the scope of the invention is defined by the claims, construed in light of the specification; working examples and end-use do not expand the claim into a method of treatment where the claim itself is to a composition.
  3. Reliance on prior decisions and Manual:
    Building on Bayer Pharma Aktiengesellschaft v. Controller of Patents, Societe Des Produits Nestle SA v. Controller of Patents, and University of Miami v. Controller of General Patent, and guided by the Manual of Patent Office Practice and Procedure (2019), the Court reaffirmed that:
    • Claims to a composition with prophylactic/therapeutic effect are not barred by Section 3(i);
    • Section 3(i) bars processes of medicinal/surgical/therapeutic/prophylactic treatment, but not drug products or compositions.
  4. Duty to decide all issues:
    Referring to Adama Makhteshim Ltd v. Controller of Patents & Designs, the Court criticised the Controller’s approach of refusing the application exclusively on Section 3(i) and not addressing other objections that had been raised in the First Examination Report (FER) and hearing notice.

3. Detailed Analysis

3.1 Factual and Procedural Background

3.1.1 The invention

The invention concerns a prophylactic or therapeutic drug composition for neurodegenerative diseases (including dementia), comprising:

  • a rifampicin compound (rifampicin itself, pharmaceutically acceptable derivatives with a naphthohydroquinone or naphthoquinone structure, or salts thereof); and
  • a resveratrol compound (resveratrol or certain pharmaceutically acceptable derivatives with specified derivative groups).

A key feature of Claim 1 (post‑hearing) is the defined weight ratio:

“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.”

The specification states:

  • The technical field is a medicine useful for prevention/treatment of neurodegenerative disease;
  • The first objective is a rifampicin formulation that permits long-term administration with reduced adverse side effects (para [0012]);
  • The second objective is to provide a prophylactic or therapeutic drug for neurodegenerative disease and a brain-function-improving food (para [0014]);
  • Under “Advantages of the invention”, it emphasises that combining rifampicin with resveratrol reduces rifampicin’s side effects and enables long-term administration.

Originally, the claim set included references to:

  • transnasal (intranasal) administration; and
  • dosage regimen (dose per kg per day, period of administration of one month or more).

However, crucially, in the post-hearing amendments of 06.10.2023, the patentee:

  • deleted the route-of-administration (“for transnasal administration”); and
  • narrowed the claims to:
    • Claim 1 – a drug composition as such, and
    • Claim 2 – a kit including separate rifampicin and resveratrol medicinal agents.

3.1.2 The Controller’s decision

The Assistant Controller refused the application under Section 3(i), concluding that:

“The subject-matter of claims 1 & 2 are directed to a prophylactic or therapeutic drug composition for a neurodegenerative disease… The claims 1 & 2 attract Section 3(i)… since the claims are implicitly directed to method of treatment of a disease. It can be seen from the originally filed claims that the combination is a dosage regimen given to patient in need of treatment of neurodegenerative disease like dementia for a period of one month or longer. Although the claims are worded as a prophylactic or therapeutic drug combination, the claims are intended to treat disease by nasally administering the combination in a specific range for a specific period. Therefore, claims 1 & 2 are not allowed u/s 3(i)…”

The order further stated that other objections (e.g. inventive step, Section 3(d), Section 59) raised in the hearing notice were “not addressed” since the application was non-patentable under Section 3(i).

3.1.3 The appeal and arguments

The appellant’s core submissions were:

  • Claim 1 (post-amendment) is to a composition, not a method, and therefore Section 3(i) is inapplicable;
  • Reading the claims with the complete specification shows the invention is a drug composition / formulation – not a dosage regimen;
  • The Controller wrongly relied on earlier claim versions (with transnasal and dosing language), ignoring the post-hearing amended claims that removed these features;
  • The phrase “for a neurodegenerative disease” in the preamble of the claim does not limit the claim to a treatment method; it only states intended use, consistent with international jurisprudence on claim preambles;
  • Section 3(i) must be construed in line with:
    • Bayer Pharma Aktiengesellschaft;
    • Societe Des Produits Nestle SA;
    • University of Miami;
    • and the Patent Office Manual, all of which distinguish composition claims from process-of-treatment claims.

The respondent-Controller’s counsel argued that:

  • Reading the claims in light of the description and examples, the invention remained essentially a dosage regimen for treating dementia/neurodegenerative disease;
  • The working examples are all about administration to mice (and then extrapolated to humans) in a particular dosing schedule – showing that the “technical effect” only manifested through such regimen;
  • Thus, the composition was “related to” a dosage regimen and attracted Section 3(i).

3.2 Precedents and Authorities Cited

3.2.1 Societe Des Produits Nestle SA v. Controller of Patents, 2023 SCC OnLine Del 582

This decision is central to Medilabo. In Nestle, the applicant claimed a composition containing DGLA, EPA, and DHA, intended to be used for prophylactic treatment of allergic diseases. The Patent Office refused the application under Section 3(i), treating it as a prophylactic treatment method.

The High Court reversed, holding:

  • Section 3(i) covers processes for prophylactic or therapeutic treatment;
  • The claims there were directed to a composition, not to a process of treatment;
  • Accordingly, Section 3(i) was inapplicable, and the refusal was unsustainable.

In Medilabo, Justice Karia relies on the same reasoning:

  • The independent claim here is also to a composition (rifampicin + resveratrol in a ratio),
  • The fact that it is useful in prophylactic or therapeutic treatment does not transform it into a method/process claim.

The Court reiterates the key holding from Nestle (as quoted in the judgment):

“I conclude that the subject Patent Application is not directed towards a method or process for prophylactic treatment… I do not find merit… for refusal… on the ground that the patent was barred under Section 3(i) of the Act.”

3.2.2 Bayer Pharma Aktiengesellschaft v. Controller of Patents and Designs, 2024:DHC:2395

Bayer is invoked primarily for two propositions:

  1. The scope of an invention must be determined from the claims (Section 10(4)(c)), not from the end-use or working examples alone;
  2. Mere recitation of unit numbers/dose parameters in a composition claim does not automatically make it a method of treatment under Section 3(i).

Justice Karia quotes Bayer to reiterate:

  • Claim 1 in that case (and by analogy, in Medilabo) was “exclusively to a product rather than a process”; Section 3(i) was therefore inapplicable;
  • Working examples show feasibility and practical applicability, but “they do not define the patent’s scope”; scope is determined by claims.

This is crucial to the Court’s rejection of the Controller’s attempt to read a dosage regimen/method of treatment into a claim that, on its face and as amended, is to a composition.

3.2.3 University of Miami v. Controller of General Patent, 2020 SCC OnLine IPAB 796

The IPAB in University of Miami addressed whether the use of the phrase “composition for the treatment” in claim preambles rendered claims non-patentable under Section 3(i). It held:

  • The claims there were to a pharmaceutical composition with specified components;
  • The use of the word “treatment” in the preamble did not convert composition claims into method-of-treatment claims;
  • Such wording is simply a way to define the intended use of the composition, not a process performed by a physician.

This precedent directly supports the appellant’s position in Medilabo that:

  • phrases like “prophylactic or therapeutic drug for a neurodegenerative disease” do not, by themselves, trigger Section 3(i); and
  • composition claims remain patent-eligible (subject to other requirements) notwithstanding such language.

3.2.4 Chinese University of Hong Kong & Anr. v. Assistant Controller of Patents, 2023:MHC:4617

This Madras High Court decision, noted in Medilabo, confirms that processes for prophylactic treatment are excluded under Section 3(i). It reinforces the Section 3(i) process-based exclusion, which in turn underscores the distinction between:

  • claims to processes of prophylaxis/therapy (excluded), and
  • claims to compositions used in such prophylaxis/therapy (not automatically excluded).

3.2.5 Adama Makhteshim Ltd v. Controller of Patents & Designs, C.A. (COMM IPD-PAT) 167/2022

In Adama Makhteshim, the Delhi High Court held that:

  • Controllers must address all grounds of objection when refusing a patent, even where a preliminary objection (such as a Section 3 ground) would appear sufficient;
  • A speaking, reasoned order is required on each substantial objection.

Medilabo applies this principle to criticise the impugned order’s failure to speak to the other objections (Section 3(d), inventive step, Section 59), and uses it as a ground to remand.

3.2.6 Manual of Patent Office Practice and Procedure (2019)

The Manual is not law, but is persuasive guidance. Paragraph 09.03.05.08 lists categories explicitly excluded as “methods of treatment” under Section 3(i), for example:

  • medicinal methods (processes of administering medicines);
  • surgical methods;
  • curative and prophylactic methods (including vaccination);
  • diagnostic and therapeutic methods practiced on human/animal bodies.

Importantly, the same paragraph clarifies:

  • Instruments and apparatus for surgery/therapy are patentable;
  • Prostheses and artificial limbs (and their manufacture) are patentable;
  • Application of substances for cosmetic purposes is not therapy.

Building on Nestle, the Court in Medilabo emphasises that the Manual does not classify “pharmaceutical compositions” with therapeutic effects as falling within Section 3(i). Thus, composition claims with therapeutic/prophylactic impact are, in principle, patentable subject to satisfaction of other criteria.

3.3 The Court’s Legal Reasoning

3.3.1 Characterisation of the claimed invention

The Court engages in a careful reading of:

  • the complete specification (particularly paras [0001], [0012], [0014], and “Advantages of the Invention”);
  • the evolution of the claims: original, FER-response claims, and post-hearing amended claims.

It notes that:

  • The technical field paragraph itself defines the invention as a “medicine useful for prevention or treatment of a neurodegenerative disease”;
  • The stated objective is to provide a rifampicin formulation which permits long-term administration with reduced side-effects, and a prophylactic/therapeutic drug for neurodegenerative disease;
  • The “Advantages” section makes clear that the technical contribution lies in a combination preparation (formulation) of rifampicin with resveratrol.

On that basis, the Court concludes that:

  • The invention is fundamentally a pharmaceutical formulation / composition;
  • The Controller’s assertion that the “complete specification discusses the method of treatment” is not borne out by a holistic reading of the specification.

3.3.2 The significance of claim amendments and claim comparison

A critical part of the reasoning is the comparison of:

  1. Originally filed claims;
  2. Amended claims in response to FER (10.07.2023);
  3. Post-hearing amended claims (06.10.2023).

The Court reproduces this comparison in a tabular form. The evolution is instructive:

  • The original and FER-response claims explicitly referred to:
    • “for transnasal administration”; and
    • doses per kg/day, and period of administration of 1 month or longer.
  • The post-hearing amended Claim 1 removes:
    • the reference to transnasal administration, and
    • all explicit dosage regimen features.

After the amendment, Claim 1 is simply:

“A prophylactic or therapeutic drug composition for a neurodegenerative disease, comprising… [rifampicin compound] and [resveratrol compound]… 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.”

Thus:

  • The claim is to a composition as such, defined by its components and their relative proportions;
  • No procedural steps (e.g. “administering to a subject in need…”; “for a period of at least X days”; “via intranasal route”) remain as positive limitations.

Yet, the Controller’s order continues to rely on the statement:

“It can be seen from the originally filed claims that the combination is a dosage regimen…”

and speaks of “nasally administering the combination in a specific range for a specific period”.

The Court holds this approach to be erroneous because:

  • Patentability must be assessed on the basis of the claims as finally amended, not on an earlier version that is no longer in force;
  • By ignoring the post-hearing amendments, the Controller effectively applied Section 3(i) to a claim formulation that the applicant had already abandoned.

3.3.3 Section 3(i) and the composition–method distinction

Applying Nestle, Bayer, and the Manual, the Court reiterates:

  • Section 3(i) excludes “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals…”;
  • The exclusion is about processes/methods, not products or compositions “per se”;
  • Pharmaceutical compositions, even when specifically designed “for the prevention/treatment of X”, are fundamentally products and are not automatically barred by Section 3(i).

The Court implicitly adopts the following interpretive line:

  • Where a claim:
    • defines a drug composition by its ingredients, derivatives, salts, excipients, and ratios, and
    • does not recite steps of administering that composition to a patient, nor define a treatment protocol (timing, intervals, sequence of doses, etc.),
    it is a composition claim and not hit by Section 3(i).
  • Conversely, where a claim is framed as:
    • “A method for treating disease X comprising administering compound Y in dose Z for period T…”,
    • it squarely falls within Section 3(i)’s exclusion as a process of therapeutic/prophylactic treatment.

In the present case, once the claim was cleaned of procedural language (route, dosage regimen), the Controller’s reliance on the original claims and working examples to treat it as a method of treatment becomes legally untenable.

3.3.4 Role of Section 10(4)(a) and (c): description, working examples, and claim scope

Section 10(4) requires the complete specification to:

  • “fully and particularly describe the invention and its operation or use and the method by which it is to be performed” (Section 10(4)(a)); and
  • “end with a claim or claims defining the scope of the invention” (Section 10(4)(c)).

Justice Karia, following Bayer, clarifies the distinction between:

  • Description / working examples (which show feasibility, enablement, and preferred embodiments); and
  • Claims (which define the legal metes and bounds of protection).

The Court emphasises:

  • Working examples “are intended to show that the invention is feasible and workable”, but “they do not define the patent’s scope”;
  • The Controller cannot convert a composition claim into a method-of-treatment claim by importing from the examples the details of how the composition happens to be used in animal or clinical studies.

This is particularly important where dosage, duration, and route of administration appear only in examples, not in the claim language as positive steps of a process. To apply Section 3(i) in such circumstances would be to penalise the applicant for providing detailed working examples – contrary to the enablement objective of Section 10(4)(a).

3.3.5 Preamble language and its (non-)limiting effect

The appellant relied on US Federal Circuit case law (e.g., Pitney Bowes v. Hewlett‑Packard, Catalina Marketing v. Coolsavings.com) and the Manual’s commentary on claim structure, to argue that:

  • The preamble “A prophylactic or therapeutic drug composition for a neurodegenerative disease” is not limiting unless it imparts essential structure or is necessary to give “life, meaning and vitality” to the claim;
  • If the phrase “for a neurodegenerative disease” is deleted, the claim still defines a complete, intelligible composition (rifampicin compound + resveratrol compound in specified ratio).

The Court notes:

  • The Manual describes claims as consisting of preamble, transitional phrase, and body;
  • The preamble typically identifies the category of invention and sometimes its purpose/function.

While the judgment does not undertake a full, explicit doctrinal analysis of preamble-limiting effect, it effectively accepts the appellant’s position by:

  • treating the preamble as not converting the composition claim into a method-of-treatment claim; and
  • focusing on the substantive body of the claim (chemical composition and ratios) to classify it as a product claim.

3.3.6 Obligation to consider all grounds of objection

The Court takes explicit issue with the Controller’s statement:

“The other objections in hearing notice are not addressed as the present application is not patentable under Section 3(i) of the act…”

Referring to Adama Makhteshim, the Court notes:

  • Controllers cannot truncate their reasoning by deciding only one ground (such as 3(i)) and leaving other substantial and independent objections unresolved;
  • This approach undermines both procedural fairness and judicial economy, as it necessitates remand and further rounds of litigation even where the application may ultimately fail on other grounds.

Accordingly, the Court directs the Controller, on remand, to:

  • address objections under Sections 2(1)(ja) (inventive step), 3(d) (enhancement of known efficacy), 59 (permissibility of amendments), etc.;
  • issue a reasoned order after hearing the applicant, within six months.

4. Complex Concepts Explained in Simple Terms

4.1 Section 3(i): What is actually excluded?

Section 3(i) says that the following is not an invention:

“any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings… or animals…”

In practice, this means:

  • You cannot patent:
    • a surgical technique or procedure;
    • a method of administering a drug (e.g., “administer 5 mg/kg daily for 3 months”);
    • a vaccination protocol; or
    • a protocol for diagnosing a disease in a patient’s body.
  • You can patent (subject to other criteria):
    • drugs and pharmaceutical compositions as products;
    • medical devices, surgical instruments;
    • diagnostic kits and reagents (as products), provided the claim is not to the diagnostic process practiced on the body.

The critical distinction is between:

  • a product (e.g., a new pill, injection, formulation, kit); and
  • a process or method applied to a patient (e.g., a treatment protocol).

4.2 Composition claim vs. method-of-treatment claim

A composition claim typically looks like:

“A pharmaceutical composition comprising [ingredient A] and [ingredient B], wherein [A] and [B] are present in ratio X:Y and optionally a pharmaceutically acceptable carrier.”

A method-of-treatment claim typically looks like:

“A method of treating [disease] in a subject in need thereof, comprising administering to the subject an effective amount of [ingredient A] at a dose of at least X mg/kg per day for a period of Y days.”

Under Indian law (unlike some other jurisdictions that allow such methods), the second type is excluded by Section 3(i); the first type is generally admissible subject to novelty, inventive step, and other requirements.

4.3 Preamble, transitional phrase, and body

As the Manual explains, a typical patent claim has three parts:

  1. Preamble – identifies the general category and sometimes intended use, e.g., “A pharmaceutical composition for treating cancer…”;
  2. Transitional phrase – e.g., “comprising”, “consisting of”, which has implications for breadth of the claim;
  3. Body – the structural and compositional features that actually define the invention.

In most cases, it is the body that truly defines the invention, while the preamble serves more as context or intended use. Courts may treat the preamble as non-limiting unless it recites essential elements or is necessary to understand the claim.

4.4 Dosage regimen vs. dosage range in a composition

A dosage regimen usually refers to a structured treatment plan:

  • how much of the drug is given;
  • how often (frequency);
  • for how long (duration); and
  • by which route (oral, intravenous, nasal, etc.).

This is typically part of a method-of-treatment claim.

In contrast, a dosage range within a composition might specify that:

  • the composition contains between X and Y mg/ml of a component, or
  • one component is present in a particular weight ratio to another.

These are formulation parameters, not procedural treatment steps. In Medilabo, once explicit regimen features (daily dose/kg, period of at least one month) were removed from the claims, what remained were composition-defining ratios – which the Court did not treat as dosage regimens under Section 3(i).

5. Impact and Significance

5.1 Consolidating the Section 3(i) jurisprudence

Medilabo continues and reinforces a clear judicial line:

  • Nestle – composition for prophylaxis not hit by 3(i);
  • University of Miami – “composition for the treatment of…” wording in the preamble does not trigger 3(i);
  • Bayer – composition claims with unit numbers, but no treatment steps, are not 3(i) methods.

The Court in Medilabo applies these principles and expects the Patent Office to internalise them:

  • It is not permissible to refuse drug composition claims on Section 3(i) grounds merely because they have therapeutic or prophylactic use;
  • Controllers must distinguish carefully between:
    • claims to products containing certain amounts or ratios; and
    • claims to administering those products in particular ways to patients.

5.2 Practical implications for patent drafting and prosecution

5.2.1 For patentees

The decision sends a clear signal on drafting strategy:

  • Keep composition claims free of explicit treatment steps where possible; define only the structure, components, and ratios;
  • Therapeutic/prophylactic intent may appear in the preamble and description, but avoid embedding full treatment regimens in independent composition claims if Section 3(i) objections are to be minimized;
  • If a Section 3(i) objection arises, amending to remove route/duration/dosing steps (while keeping compositional features) is a viable path, as exemplified here.

5.2.2 For the Patent Office

The judgment demands changes in examination practice:

  • Controllers must:
    • assess the latest, operative claim set, particularly after post-hearing amendments;
    • avoid relying on superseded claim versions when deciding Section 3(i);
    • not treat working examples as expanding claim scope into prohibited methods;
    • give reasoned findings on all objections (novelty, inventive step, Section 3(d), etc.).
  • This improves transparency, reduces remands, and aligns administrative practice with judicial guidance.

5.3 Impact on pharma/biotech innovation

By clarifying that:

  • drug compositions with prophylactic or therapeutic use remain patent-eligible;
  • Section 3(i) must not be over-extended to swallow such compositions;

the judgment:

  • gives greater legal certainty to pharmaceutical innovators, especially those developing combination formulations (like rifampicin + resveratrol here);
  • supports filing and enforcing composition claims even where the principal value of the invention lies in improved tolerability, side-effect profile, or long-term usability of known drugs through novel formulations.

At the same time, Section 3(i) continues to bar attempts to monopolise:

  • treatment protocols, dosage schedules, and medical procedures applied in clinical practice.

5.4 Procedural discipline and reduction of avoidable litigation

By insisting that:

  • amended claims must be considered; and
  • all objections must be adjudicated in a reasoned order,

the Court encourages:

  • more robust first-instance examination;
  • reduced need for appellate intervention and remands;
  • faster, clearer resolution for both applicants and third parties.

6. Conclusion

Medilabo RFP Inc v. Controller of Patents is a significant addition to the growing body of Indian patent jurisprudence on Section 3(i). Its key contributions can be distilled as follows:

  1. Substantive clarification of Section 3(i):
    The case reaffirms that Section 3(i) targets processes of treatment, not pharmaceutical compositions as such. A composition aimed at prophylactic or therapeutic use stays within the realm of patent-eligible subject matter, provided it is claimed as a product and does not embody a treatment method.
  2. Centrality of claims (Section 10(4)(c)):
    The Court underscores once again that:
    • claims define the legal boundaries of the invention; and
    • Controllers must focus on the claims as amended and finally on record, not on superseded versions or on working examples.
  3. Limited effect of preamble and therapeutic wording:
    Phrases like “for a neurodegenerative disease” in a composition claim’s preamble do not, by themselves, convert the claim into a prohibited method-of-treatment claim. They chiefly express intended use or purpose.
  4. Procedural discipline:
    The Patent Office is reminded of its duty to:
    • consider post-hearing amendments in full;
    • address all pending statutory objections in a speaking order; and
    • decide remanded cases expeditiously (here, within six months).
  5. Continuity with prior case law:
    The decision harmonises and builds on Bayer, Nestle, University of Miami, and Adama Makhteshim, consolidating a coherent doctrinal framework for assessing pharmaceutical patents under Section 3(i).

While the outcome in Medilabo is a remand rather than a grant, the judgment establishes an important procedural and substantive precedent: patentability of drug formulations must be assessed as composition claims, not as veiled treatment methods, and Controllers must engage fully with the final claim set and all statutory requirements before refusing protection.

Case Details

Year: 2025
Court: Delhi High Court

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