Aadrikaa Legal Services (ALS)- Law I Litigation I Arbitration
Date: 24.10.2026
Calcutta HC: Patent Applications Cannot Be Rejected on Public Health Grounds Without Scientific Evidence
This Short Article has been prepared & written by Advocate Ravi Shekhar Jha-Delhi High Court, New Delhi. The views expressed are based on his interpretation of the law. He can be reached at his email id intelconsul@gmail.com .
The Calcutta High Court has set aside the Patent Controllerβs rejection of ITC Limitedβs application for a βHeater Assembly to Generate Aerosol,β holding that the decision under Section 3(b) of the Patents Act lacked adequate reasons, misconstrued the invention, and breached principles of natural justice.
Background of the dispute
ITCβs patent application concerns a heater assembly designed for handheld aerosol-generating devices. Its stated technical purpose is to provide uniform heat distribution across an aerosol-forming substrate. The substrate may be solid or liquid and may, but need not, contain tobacco compounds.
On 21 August 2024, the Controller of Patents rejected the application under Section 3(b) of the Patents Act, 1970. That provision excludes inventions whose primary or intended use, or commercial exploitation, would be contrary to public order or morality or seriously prejudice human, animal or plant life, health, or the environment.
The Controller treated the invention as one exclusively connected with tobacco-containing substrates and concluded that it was harmful to human life and health. ITC appealed this decision before the Intellectual Property Rights Division of the Calcutta High Court.
What the High Court decided
In its judgment dated 20 May 2025, Justice Ravi Krishan Kapur set aside the rejection order and remanded the application to the Controller for a fresh decision. The Controller must reconsider the matter in accordance with law, after giving the parties a hearing, within three months of communication of the Courtβs order.
The Court did not grant the patent or decide the applicationβs merits. Instead, it found that the earlier decision-making process and reasoning were legally deficient.
Key findings
1. Section 3(b) requires an assessment of the inventionβs actual primary or intended use
The Court emphasized that Section 3(b) focuses on the primary or intended use or commercial exploitation of the specific invention. The inquiry cannot rest on an assumption that every possible use of a product associated with tobacco necessarily makes the invention unpatentable.
The heater assembly was not limited to tobacco substrates. By treating the invention as necessarily and exclusively tobacco-based, the Controller fundamentally misunderstood its scope.
2. A patent does not give permission to commercialize an invention
A central point in the ruling is the distinction between a patent right and regulatory permission. A patent is an exclusionary or negative right: it enables the patentee to prevent others from making, using, selling, or exploiting the claimed invention without consent. It does not itself authorize the patent holder to manufacture, sell, market, or use the invention.
The Court held that the Controllerβs reasoning wrongly assumed that granting a patent would automatically permit commercialization of the product. Whether a product may lawfully be made, marketed, or sold is governed by other applicable laws and regulations, not by the patent grant alone.
3. Health and morality objections need cogent reasoning and evidence
The Court found that the conclusion that the invention caused serious prejudice to human life and health was unsupported by reasons or justification. Tobacco-related products are not, by themselves, categorically unpatentable in India.
A refusal under Section 3(b) must show a clear connection between the inventionβs actual intended use and the alleged harm, supported by cogent reasoning. The Court rejected a subjective or preconceived view that all tobacco-related products necessarily fall within the statutory exclusion, particularly where there is no independent scientific or technical evidence supporting the conclusion.
4. βPublic orderβ and βmoralityβ cannot be applied as vague objections
The Court held that the Controllerβs finding that the invention was contrary to public order and morality was cryptic and unreasoned. It noted that Section 3(b) should not become a vehicle for refusing patents based solely on broad, subjective concerns about morality, public order, or health.
In interpreting the provision, the Court referred to international patent-law concepts, including the notion of ordre public in TRIPS and the European Patent Convention. These materials indicate that the exclusion is directed at inventions likely to induce riot, public disorder, criminal conduct, or generally offensive behaviour, rather than at every invention that may raise a policy concern.
5. New materials could not be relied on without giving ITC an opportunity to respond
The Controller relied on three additional documents in the rejection order even though those documents had not been disclosed in the First Examination Report or hearing notices. ITC was therefore denied the opportunity to address them.
The Court treated this as a serious procedural defect and a violation of natural justice. A patent applicant must have a fair opportunity to respond to material relied upon in a decision against it.
6. The e-cigarette prohibition law did not justify the rejection order
During the appeal, the Controller relied on the Prohibition of Electronic Cigarettes Act, 2019. However, the Court noted that this ground was not part of the original rejection order or the pleadings.
The Court further observed that the 2019 legislation regulates activities such as production, manufacture, import, export, sale, distribution, storage, and advertising. It does not itself determine whether a patent should be granted. The Controller could not defend the rejection by adding new grounds after issuing the decision.
7. Constitutional and public-health provisions were improperly invoked
The Controller had relied on Article 47 of the Constitution, which directs the State to improve public health. The Court held that this reliance was misplaced in deciding patentability under Section 3(b). It also found that Section 83(e) of the Patents Act had been incorrectly applied on the assumption that a patent grant necessarily results in commercialization and public-health consequences.
Why the ruling matters
The decision reinforces several important limits on patent examination in India:
- Patentability must be assessed on the claimed invention, not on assumptions about a particular product category.
- Section 3(b) demands evidence-based and reasoned analysis, especially where an objection concerns health, public order, or morality.
- A patent is not a regulatory licence. Granting a patent does not authorize commercial activity prohibited or regulated under other laws.
- Procedural fairness is essential. Applicants must be informed of and allowed to answer the material used against their applications.
- Post-hoc reasons cannot repair an invalid order. The Controllerβs decision must stand or fall on the reasons contained in the order itself.
Outcome
The High Court set aside the Controllerβs rejection of ITCβs patent application and returned the matter for fresh consideration. All substantive questions remain open, meaning the Controller must now reassess the application independently, give the parties a proper hearing, and issue a reasoned decision based on the law and the record.
The ruling clarifies that Section 3(b) is a narrow, evidence-based safeguard against genuinely harmful or morally impermissible inventions, not a blanket basis for rejecting inventions merely because they may be associated with tobacco or aerosol-generating products.
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Source: Calcutta High Court
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