Introduction
The crossroads of patent law and ethical imperatives have always been fraught with uncertainty. In India, this uncomfortable coexistence is codified, inter alia, in Section 3(b) of the Patent Act, 1970, which empowers the Patent Office to refuse patent applications for inventions that are deemed to be contrary to public order, morality, or injurious to public health. For any lawyer patent professional, this provision has long been a point of debate.
In a recent judgment, the High Court at Calcutta in the case of ITC Limited v. The Controller of Patents Designs and Trademark (2025)[1] has thrown much-needed judicial light on this provision. Through the judgment, the High Court set aside the refusal order against an application for patenting a heater assembly device, drawing a clear distinction between “patent eligibility” and “regulatory approval,” and limiting the Controller’s discretion by clarifying that they cannot act as a subjective moral arbiter without empirical evidence.
Facts Of The Case
The dispute arose from a patent application filed by ITC Limited for an invention titled “A Heater Assembly to Generate Aerosol”. The device was designed with the intention to provide a uniform heat distribution system for aerosol-generating articles.
The Controller of Patents, vide an order dated 21 August 2024, rejected the application under Section 3(b) of the Act, citing that the invention in question that the invention causes ‘serious prejudice to human life, health, public order and morality’. The reasoning of the Controller seems to have been rooted in the belief that because the device could potentially be used for electronic tobacco dispersion, and as such, its use would cause serious prejudice to human life, health, and public order.
The Controller viewed the invention through the lens of tobacco harm, effectively equating the heating mechanism sought to be patented with the adverse health effects of smoking.
Submissions Of The Parties
The applicant appealed the order of refusal before the High Court, arguing that the Controller had misconstrued the scope of the invention, which works on various aerosol-producing substrates (solid or liquid) and is not predicated solely on the heating of tobacco. The applicant further argued that the impugned order was violative of principles of natural justice insofar as the order referred to, and relied on documents that were not made known to the applicant prior to passing of the order of refusal thereby denying the applicant any right to deal with the same. Lastly, the applicant contended that the reference made in the order of Article 47 of the Constitution of India was erroneous and beyond the scope of consideration of the Controller.
Per contra, it was argued on behalf of the Controller that there was no reason to interfere with the impugned order and that the same is in conformity with The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage, and Advertisement) Act, 2019.
The Opinion Of The Court
Decoding Section 3 (b) of the Patent Act, 1970
The High Court approached the problem through a two-step contextual analysis of Section 3(b) of the Patents Act, 1970. Firstly, in interpreting what amounts to “primary or intended use or commercial exploitation” the High Court held that the same is to be seen from the primary or intended use or commercial exploitation of the invention in question and that the Controller had erred in fixating on only one of the potential uses of the invention (i.e. as a tobacco heating device) and presuming that the device would only be used for “substrates comprising of active tobacco compounds and thus cause prejudice to human life and health”.
Secondly, the Court proceeded to answer the question as to whether the primary or intended use of the invention in question was contrary to public order or to morality or causes serious prejudice to human, animal, plant life to health or to the environment. The Court opined that the purpose of Section 3(b) “is to deny protection to inventions likely to induce riot or public disorder or to lead to criminal or other generally offensive behaviour”.
The Court held that since a device that potentially can be used for a harmful purpose is not automatically unpatentable if it has other legitimate uses, therefore if the invention in question is itself (the heater) distinct from the harmful substance (the tobacco), with no necessary causal nexus, the Controller had erred in disregarding the intent of the invention and relying on a subjective metric of harm to refuse the application.
In reaching the foregoing conclusion, the Court was guided by the construction of ‘public order’ under Agreement on Trade Related Aspects of Intellectual Property (TRIPS), the European Patent Convention (EPC), and the Paris Convention of 1881. The Court opined that “the interaction of patent laws and ethics is an uncomfortable relationship and has always produced difficulties. In such circumstance, section 3(b) ought not to be interpreted to deal with all subjective concerns of morality, public order or health regardless of any scientific or technical evidence or any cogent reasoning.”
Patent as a Negative Right
Another significant clarification arising out of this judgment is the reiteration of what the contours of a patent registration are. The impugned order proceeded on the fallacious understanding that granting a patent confers an affirmative right to use or commercialize the invention. The High Court corrected this misconception by citing the “Exclusionary Right” principle and reaffirming that patent is in effect, a negative right and as such, it does not, ipso facto give the patentee the right to commercially utilise their invention, but only the right to exclude others from doing so. The Court held that “Controller has erroneously interpreted section 83(e) Act, in assuming that the grant of patent would commercialize the product and would affect public health.”
Procedural Due Process and Principles of Natural Justice
Beyond the interpretation of Section 3(b), the judgment also serves as a reminder to the Patent Office of the importance of procedural fairness in adjudicating patent applications. The reliance placed by the Controller on three documents cited for the first time in the final rejection order, without any reference to the same at the examination or hearing stages was held to be a serious violation of the principles of natural justice that vitiated the validity of the order.
A Consistent Approach
The judgement of the High Court at Calcutta comes in the heels of another similar dispute adjudicated by the Madras High Court in Regeneron Pharmaceuticals Inc. v. Controller of Patents & Designs (2024), establishing a clear judicial trend.
In the Regeneron case, the Patent Office had rejected a patent for a method of modifying the genome of mice to create “chimeric mice” to be used for pharmaceutical research. The Controller refused the application under Section 3(b), on the ground that the invention caused suffering to animals without any “substantial medical benefit to mankind.”
In appeal, the Madras High Court set aside order of the Controller, noting that the applicant had explicitly stated the invention was intended to aid in the development of therapeutic antibodies, which showed a clear benefit to humanity. However, the Controller, had ignored these submissions of the applicant and asserted in absence of any empirical evidence that the suffering of the mice outweighed the potential benefits to medical research.
Both the ITC and Regeneron judgments underscore the principle that the Patent Office cannot act as a subjective moral arbiter and assert a violation of Section 3(b) based on general assumptions, and that there must be a balancing test that weighs the alleged harm against the scientific utility of the invention and evidence provided by the applicant in support of their invention.
Conclusion
The judgment, in conjunction with the Regeneron decision, reinforces a pragmatic interpretation of Section 3(b) of the Patents Act, 1970, by restraining the Patent Office from acting as a moral or policy regulator and clarifying that the scope of Section 3(b) cannot be stretched to the arbitrary biases of the Controller and the question of whether an invention is injurious to public order, morality or health must be answered with cogent, empirical evidence and not subjective assumptions.
