Name of author: Vibha Patel (III Year B.Com LL.B. student at Tamil Nadu National Law University, Tiruchirappalli)
Name of author: K. Surya Kailash (III Year B.Com LL.B. student at Tamil Nadu National Law University, Tiruchirappalli)
An important turning point in India’s intellectual property laws was the Patent Act of 1970, which gave inventors exclusive rights and protected patentees’ inventions while promoting scientific research. For a limited period, it grants the exclusive right to stop third parties from stealing or using the idea without permission while also giving inventors credit for their inventions.
Section 3(b) has frequently been a central concern among its provisions because of its open wording leading to increased rejection of patent applications.
“An invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.”
Against this backdrop, this article undertakes a case analysis of the recent Calcutta High Court judgment in ITC Ltd. v. Controller of Patents. By examining how the Court interpreted Section 3(b) in this case, it explores the challenges of balancing innovation with public interest, highlights problems in the current framework, and offers recommendations to better align India’s patent regime with global standards.
CASE SUMMARY: ITC LIMITED V. CONTROLLER OF PATENTS
The Applicant, ITC Ltd., has approached the Controller of Patents for its invention titled “A Heater Assembly to Generate Aerosol”, designed to provide a uniform heat distribution system throughout the aerosol-forming substrate present with an aerosol-generating article.
Although the Controller acknowledged that the invention involved an inventive step, the application was rejected under Section 3(b) of the Patent Act, citing potential harm to public health, order, and morality. Reliance was also placed on Article 47 of the Constitution and the Prohibition of Electronic Cigarettes Act, 2019.
On appeal, the Calcutta High Court in May 2025 set aside the rejection. The Court held that the Controller had misinterpreted Section 3(b), failed to establish a nexus between the invention and the alleged harm, and overstepped by invoking extraneous statutes. It emphasized that the primary intention behind the invention must first be determined, and only then should any assessment of potential harm to public order, morality, or health follow. Since the Controller had provided no adequate reasoning and had relied on the “harm principle” without evidentiary support, the impugned order was found unsustainable.
Accordingly, the Court remanded the matter back to the Controller for fresh consideration, directing that the decision be made after granting a fair hearing to all parties and in line with the statutory framework.
CRITICAL ANALYSIS
THE CONTROLLER’S OVERREACH: MORALITY V. EVIDENCE
The Controller’s rejection of ITC’s patent application, citing section 3(b) demonstrates how administrative discretion, when exercised without a proper framework, can undermine the main objective of the Patents Act. Section 3(b) is intended to act as a safeguard against socially deleterious inventions, not as a carte blanche for bringing moral or health factors into the technical factors.
Yet, in this case, the controller equated the mere possibility of the invention being used with tobacco substrates with an inevitable health hazard, overlooking that the heater assembly itself was technologically neutral and not inherently tethered to tobacco.[1] Such reasoning disregards the doctrinal discipline required in patent examination: the “primary or intended use” must be derived from the claims and specification, not speculative assumptions about downstream market practices.
This overreach was compounded by reliance on Article 47 of the Constitution and the Prohibition of Electronic Cigarettes Act, 2019. Both were considered by the controller as if they constituted binding patent-ability criteria, when in fact they regulate matters of public health policy and market conduct. As the Delhi High Court discussed in Hindustan Lever Ltd.v. Lalit Wadhwa, a patent merely confers an exclusionary right and does not entitle its holder to market the invention without separate regulatory clearance. Merging these spheres not only undermines legal clarity but also risks transforming the Patent Office into a quasi-public health regulator, a role it is neither institutionally designed nor statutorily empowered to play.
Further, the Controller failed to substantiate claims of “serious prejudice” with scientific or technical evidence. As seen in Harvard Oncomouse case, rejecting patents on the grounds of generalized moral anxiety without proper evidence is detrimental to the core objective of the Act. By presuming harm without proof, the Controller abandoned the evidentiary threshold necessary to apply Section 3(b).
This creates a precedent where inventions may be refused not on their inherent attributes, but on broad policy generalizations. Such a pattern would definitely hinder the innovation in sensitive fields and would bring a decline in the investment in technologies that, while sensitive, may also yield socially useful outcomes (e.g., nicotine gums, etc).
In addition to correcting the procedural anomaly, the High Court’s intervention also dispels the notion that controllers can use 3(b) without substantial evidence. For an invention to be excluded under 3(b), there must be clear and supported links between its primary use and the purported damage.[2]
SECTION 3(b) AND THE NEED FOR RESTRAINT
The language of Section 3(b) reflects the legislature’s intention to incorporate a public interest element into the patent statute. While this may be a good idea, its ambiguity necessitates judicial and administrative prudence in its application. The Calcutta High Court’s ruling in ITC Ltd. v. Controller of Patents illustrates why section 3(b) must be interpreted as a narrow exception rather than an absolute discretionary power.
When we try to compare our legislation with that of Europe, that is EPC (European Patent Convention) under Article 53(a) of the EPC, the ordre public exclusion is confined to situations where exploitation of the invention would manifestly violate the law or incite disorder.
Likewise, TRIPS, art. 27(2) permits exclusions to protect ordre public or morality but expects states to interpret these narrowly to avoid stifling innovation. The Controller’s reliance on abstract notions of morality and unverified health risks represents precisely the kind of subjective, policy-driven application that these global frameworks caution against.
This concern is not something that is raised in this blog; in fact, the 161st Report of the Parliamentary Standing Committee on Commerce warned that Section 3(b), in its current form, lacks internal checks and can be misused to reject socially beneficial innovations, such as nicotine gums or reduced-harm smoking devices.
By rejecting patent applications solely on moral grounds and also without any concrete evidence, it risks harming technological development and further alienating India from the global technological race, in which it already lags behind. The Committee explicitly recommended that exclusions be tied to inventions that are barred under the law in force, rather than those deemed objectionable by subjective moral evaluation. Such a shift would help align Indian patent law with global norms.
The Court recognized that the invention’s “primary use” cannot be deduced from a single potential substrate (tobacco), underscoring the need to interpret 3(b) in light of the inventor’s technological disclosure. The Hon’ble Court also challenged the reliance on health legislation in relation to patent law. Patents are supposed to recognize inventions, whereas regulatory laws, like those governing health, are meant to control society. Collapsing these two spheres distorts both and risks denying patents to inventions that, while requiring oversight, nonetheless advance technological frontiers.
CONCLUSION AND RECOMMENDATIONS
The Calcutta High Court’s ruling in ITC Ltd. v. Controller of Patents highlights critical flaws in the application of Section 3(b), particularly the controller’s tendency to overstep into public health regulation and rely on unsubstantiated assumptions. This case demarcates the need for a disciplined, evidence-based approach to patent rejections, ensuring that Section 3(b) serves as a targeted safeguard rather than a barrier to innovation.
The judgement establishes that Section 3(b) required a clear link between an invention’s primary use and specific harm, supported by evidence, not speculation. It clarifies that patentability assessments should not encroach on regulatory domains, preserving the Patent Office’s role as a technical evaluator. However, the Court’s failure to define “harm” under section 3(b) leaves room for future ambiguity, risking inconsistent application.
The aspect of “commercial exploitation is crucial in the process of granting a patent” must be carefully administered, as the broad phrasing of “causes serious prejudice” could otherwise give adjudicators wide discretionary powers to reject applications prematurely. If speculative or hypothetical future uses are given undue weight, it may create serious obstacles for future innovations. For instance, as the Calcutta High Court observed, the Controller had assumed that ITC’s heater assembly would inevitably be used with tobacco substrates, thereby treating it as harmful to health. In reality, the device was technologically neutral and not limited to tobacco use. Such presumptions highlight the dangers of expanding Section 3(b) beyond evidence-based reasoning.
Building on these implications, India’s patent regime must evolve to ensure Section 3(b) fosters innovation while safeguarding public interest. To achieve this, the legislature should amend Section 3(b) to define “public order”, “morality”, and “serious prejudice”. Additionally, the Patent Office should issue mandatory guidelines mandating evidence-based rejections, requiring controllers to clearly document the invention’s primary use and specific harm. Courts should also take the opportunity in future cases to define “harm” under Section 3(b), reducing subjective interpretations and ensuring consistent application. Finally, harmonizing Section 3(b)’s application with international standards, such as the EPC and TRIPS, will position India as a competitive player in global innovation while maintaining its commitment to public welfare. These reforms will ensure Section 3(b) acts as a precise guardrail, not an arbitrary roadblock, for technological progress.
[1] ITC Ltd v Controller of Patents, Designs & Trademark (2025) SCC OnLine Cal 4479.
[2] Plant Genetic Systems/Glutamine Synthetase Inhibitors (T 356/93) [1995] OJ EPO 545