The intersection of patent law with ethical and moral considerations brings forth complex legal challenges, especially when evaluating inventions that may affect public health, order, or morality. Section 3(b) of the Indian Patents Act, 1970 serves as a gatekeeper by disqualifying inventions that could potentially harm human, animal, or plant life, health, or the environment, or are contrary to public order and morality. But the scope and interpretation of this section have sparked extensive debate.
The recent Calcutta High Court judgment in ITC Limited v. Controller of Patents, Designs and Trademarks (2025) has rejuvenated this discussion, offering a critical lens into the misuse of Section 3(b) and reaffirming the need for objective reasoning and due process.
Understanding Section 3(b) of the Patents Act, 1970
Section 3 of the Patents Act outlines what is not considered an invention. Section 3(b) states:
“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.”
The provision operates as a moral filter, aligning the patent regime with broader constitutional and ethical values. However, the ambiguous phrasing — particularly terms like “public order,” “morality,” and “serious prejudice” — often leads to arbitrary decisions, depending heavily on the subjective interpretation of the patent examiner.
Case Background: ITC Limited v. Controller of Patents
In this case, ITC Limited sought to patent a “Heater Assembly to Generate Aerosol,” a technology used in aerosol-generating devices which may, but not necessarily, involve tobacco substrates. Despite clearing technical hurdles such as novelty and inventive step, the patent was rejected under Section 3(b) by the Controller because it was “prejudicial to human life, health, public order and morality.”
The High Court, in its judgment dated 20 May 2025, strongly criticised the rejection, finding that the decision was:
- Bereft of adequate reasoning,
- Based on an erroneous interpretation of the invention,
- Violative of the principles of natural justice, and
- Influenced by irrelevant statutory references like Article 47 of the Constitution and the Prohibition of Electronic Cigarettes Act, 2019.
Key Legal Issues Raised
1. Nature of Patent Rights: Positive vs. Negative Rights
The Court emphasised that patents are negative or exclusionary rights, not positive rights to use or commercialise a product. Citing the decision in Hindustan Lever v. Lalit Wadhwa and scholarly commentary by Philip Grubb, the judgment clarified that a patent allows the inventor to stop others from exploiting the invention — it does not grant automatic permission to sell or distribute it.
2. Misconstruction of Section 3(b)
The Controller assumed the invention would only be used with harmful substances like tobacco. However, the Court observed that the invention was substrate-agnostic, i.e., it could be used with both tobacco and non-tobacco materials. Hence, the rejection based solely on the assumption of harmful use was found to be unsustainable.
3. Public Order and Morality – The Need for Objective Tests
The Court stressed that vague moral standards should not become a tool for arbitrary denials. In the absence of scientific or technical evidence showing actual harm or societal disruption, it is improper to invoke Section 3(b). The judgment echoed precedents from the European Patent Convention (EPC) and TRIPS Agreement to suggest that “ordre public” should only apply to inventions that pose a serious threat to public peace or ethics.
4. Violation of Natural Justice
One of the most glaring faults identified was the Controller’s reliance on documents never shared with the appellant. This procedural lapse violated the principle of audi alteram partem, a cornerstone of administrative fairness.
5. Improper Reliance on Article 47 and Directive Principles
The Controller’s invocation of Article 47 — a Directive Principle advising the State to improve public health and prohibit intoxicating substances — was deemed irrelevant. The Court clarified that directive principles cannot override specific statutory mandates like patent eligibility criteria.
Comparative Jurisprudence and Global Trends
European Patent Convention (EPC)
Article 53(a) of the EPC bars patents on inventions whose commercial exploitation would be contrary to “ordre public” or morality. However, the EPO applies this clause narrowly — only in cases of a clear threat to human dignity, animal welfare, or public order. This standard prevents arbitrary moral policing and aligns patent law with rational, evidence-based governance.
TRIPS Agreement and Paris Convention
The WTO’s TRIPS Agreement allows members to exclude inventions from patentability on grounds of public order or morality, provided the exclusion is not arbitrary and is based on clear legal principles. India, as a TRIPS-compliant jurisdiction, must ensure its patent decisions are consistent with international obligations.
Indian Parliamentary Oversight
The 161st Report of the Parliamentary Standing Committee on Commerce voiced concerns over the arbitrary use of Section 3(b). It recommended a safeguard mechanism to prevent rejection of socially useful inventions like nicotine de-addiction gums and safer smoking devices.
Implications of the Judgment
a. Clarifies Patent Office’s Role
The Court’s ruling reinforces that the Patent Office is a technical body, not a moral adjudicator. Its decisions must be grounded in law, scientific reasoning, and procedural fairness, not subjective ethics.
b. Sets Limits on Section 3(b)
The judgment serves as a precedent that Section 3(b) cannot be a blanket tool to reject innovations. It mandates proper analysis of the intended use and requires evidence of actual harm to public health, morality, or order.
c. Encourages Innovation
By curbing the misuse of Section 3(b), the decision encourages innovators to pursue patent protection without fear of arbitrary moral scrutiny, particularly in industries like biotechnology, medicine, and lifestyle devices.
d. Respects Legislative Intent
The Court rightly interpreted the Patents Act in consonance with its purpose — to promote innovation and protect inventors — without letting the broader socio-political agendas interfere in objective patent assessment.
Conclusion
Section 3(b) of the Patents Act, while designed to prevent harmful or immoral inventions from being patented, must be applied with restraint, clarity, and evidence-based reasoning. The Calcutta High Court’s 2025 judgment in ITC Limited v. Controller of Patents marks a crucial step in reining in arbitrary patent denials and upholding the rule of law in India’s intellectual property regime.
Patent law must remain a neutral and technical field. The invocation of morality or public order must be limited to truly egregious inventions — not based on assumptions or ideological overreach. As India aspires to become a global innovation hub, judgments like these ensure that our legal framework balances public interest with inventors’ rights fairly and rationally.
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