When Patent Law Meets Morality: Lessons from The ITC E-Cigarette Case

Introduction: The Bargain and The Barrier

Patent law operates on a bargain: innovators disclose their inventions in exchange for a time-bound exclusivity. Yet, not all innovations qualify for this bargain. Section 3(b) of the Patents Act, 1970  (Hereafter referred to as ‘The Act’) carves out an exception for inventions which are not patentable. At first glance, the provision seems straightforward; the difficulty, however, lies in evaluating whether the harm is real or merely speculative, absent the scientific evidence. It raises an obvious concern: “Can patentability be contingent upon an innovation’s speculative harms premised on morality that may never materialize?”  

This question was the heart of the recent decision by the Calcutta High Court in the matter of ITC Ltd. v. Controller of Patents, Designs & Trademarks, where the court interpreted Section 3(b) of the Patents Act 1970. Standing at the crossroads was ITC’s patent titled “A Heater Assembly to Generate Aerosol”, developed in response to the demand for handheld aerosol-generating devices with a uniform heat distribution system. The Controller’s rejection order not only placed misplaced reliance on Section 3(b) of the Act but also aggravated the grievance by failing to provide the appellants with the documents it relied upon.

The impugned order further reflected a subtle confusion between the potential commercial uses of the patented product and the actual purpose the invention seeks to serve.  If one ventures beyond the obvious and filters out the nicotine from the case, the ruling triggers a broader debate as to whether the patent office should be acting as a moral gatekeeper in the absence of clear scientific evidence.

Morality as A Limiting Principle in Patent Law

John Locke believed that resources are shared, for when they are intertwined and put to use by humans, they become labor. Ownership arises when labor adds value to the natural resources. This concept is the basis of understanding IP laws. The intersection of law and morality has been a discourse existing in society since time immemorial. In patent law, different jurisdictions follow different approaches to morality. For instance, the European Union, China, and India follow the principle of ‘Ordre Public and Morality’ while the USA has no such criteria. Judiciary all around the globe has been making an attempt to balance the see-saw of innovation and morality. In the case of Harvard Coll. v. British Union for the Abolition of Vivisection, the court permitted claims related to transgenic mice but declined to extend protection to rodents as a whole, striking a balance between advancing medical treatments for humans and minimizing animal suffering by preventing the unchecked spread of undesirable genetic traits. In Molecular Pathology v. Myriad Genetics, the U.S.

Supreme Court ruled that naturally occurring DNA cannot be patented. The Court clarified that while the Patent Act allows patents for any new and useful composition of matter, this protection does not extend to laws of nature, natural phenomena, or abstract ideas, which remain outside the scope of patentability.

Section 3(B) And the Misapplication of Morality Standards

Section 3(b) disqualifies inventions from patent protection if their primary use is contrary to public order or morality, or causes serious prejudice to life, health, or the environment. Prima facie, the use of semantics would disclose the subjectivity of the section. However, the purpose behind the section was never to put innovation at the mercy of the Controller, thereby granting him arbitrary powers in the guise of discretion. In Novartis Ag. V UOI, the court observed that the object of patent law is not to open its perusal for lawyers who seek to claim infringement, but to value the intrinsic work of the invention. It further observed that as the patent regime in India is still at a stage of infancy, its scope should not vitiate the purpose of the act by creating a vacuum between coverage under patent and its disclosure.  

This purpose was challenged in ITC’s E-cigarettes case, where the controller pursued a narrow application of 3(b), relying on  Article 47 of the Indian Constitution, a DPSP, which was irrelevant to the case. The rejection of the impugned patent ignored the fact that the intended use of the innovation was not limited to substrates containing tobacco. This raises the uncomfortable possibility that inventions with dual-use potential could be “nipped in the bud”, not because they are inherently harmful, but because they could be misused in the future.  Building on this reasoning, the Calcutta High Court set aside the Controller’s order and drew a line between what a patent protects and what it permits. It referred to the case of Hindustan Lever Ltd. v. Lalit Wadhwa, which clarified the scope of a patent as a shield, not a free pass. It gives the right to stop others from using the invention, but it does not override the gatekeeping role of other regulatory bodies. Just as holding a drug patent does not guarantee approval from the drug authorities, the existence of a tobacco-related patent cannot, in itself, be read as approval for its use.

Domestic and International Reference Points

Parallel legislations in this regard are the European Patent Convention, TRIPS, and the Paris Convention, which prescribes that patents shall not be rejected on grounds of public order and morality merely because it is prohibited by law. This stance is further supported by the recommendation of the 161st report of the Parliamentary Standing Committee on commerce, stating that 3(b) must be amended to avoid the arbitrary exercise of power by the controller and that a check and balance mechanism be inserted. It further mentioned that, “ Hence, the widely worded provision of Section 3(b) is without any sufficient guidance or safeguards against arbitrary exercise of power by the Controller. It, therefore, may lead to refusal of socially useful inventions under patent protection.” Therefore, the assumption that a grant of a patent would lead to commercialisation and a subsequent denial on the grounds of public morality is erroneous in the fact of patent law, as also affirmed by the Calcutta HC.

Conclusion

"Proprietarianism has infiltrated the development and direction of intellectual property law and policy."

Public morality, rooted in health, safety, welfare, and ethics, must guide but not suffocate innovation. In developing economies, patents should encourage technological growth while ensuring fair access. The ITC e-cigarette case reopened the portal of the risk of misreading Section 3(b), stifling inventions before they can prove their worth. The Calcutta High Court rightly clarified that patents confer rights, not automatic market entry, and that misuse is a matter for regulatory control, not premature rejection. As India’s patent jurisprudence matures, Section 3(b) must remain a safeguard against harms that carry substance in them, so that innovation and public interest move forward in tandem.

Author: Rimjim Khera, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at  Khurana & Khurana, Advocates and IP Attorney.

REFERENCES

1.     ITC Ltd. v. Controller of Patents, Designs & Trademarks, 2025 SCC OnLine Cal 4479,¶4.

2.     Novartis AG v. Union of India, (2013) 6 SCC 1, ¶134.

3.     Hindustan Lever Ltd. v. Lalit Wadhwa, (2007) 1 SCC 1.

4.     Harvard Coll. v. British Union for the Abolition of Vivisection (Transgenic Animals/HARVARD), Case T-0315/03-3.3.08, Eur. Pat. Off. Tech. Bd. App. (July 6, 2004).

5.     Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013).

6.     European Patent Convention, art. 53(a).

7.     Agreement on Trade-Related Aspects of Intellectual Property Rights art. 27, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, 1869 U.N.T.S. 299.

8.     Paris Convention for the Protection of Industrial Property art. 4, Mar. 20, 1883, as revised July 14, 1967, 21 U.S.T. 1583.

9.     161st Report of the Department-Related Parliamentary Standing Committee on Commerce on the Review of the Intellectual Property Rights Regime in India, Rajya Sabha Secretariat (2021).