There is a continuous struggle between public interest and commercialisation in the context of innovations within nicotine and tobacco products. According to available information from the WHO, 8 million people die from the use of tobacco annually. The number in India resulting from the use of tobacco has reached 1.35 million. Tobacco and nicotine products damage the public's health as a whole. Over time, many new innovations concerning nicotine and tobacco, such as nicotine replacement products, have emerged, which assist a person in quitting the habit of chewing tobacco and smoking. According to Section 3b of the Patents Act, any innovation whose commercial exploitation would be prejudicial to public order, contrary to public morals, or injurious to people, animals, or the environment would not be granted a patent. As a result, inventions involving nicotine and tobacco fall within the purview of section 3(b). In this context, the Calcutta High Court in ITC Limited v. Controller of Patents reversed the decision of the Patent Officer and granted the patent application for a nicotine aerosol delivery device under section 3(b).

Brief Facts of the Case

The present case in the High Court is an appeal from the order dated 26th June 2023. The request for "A Device and Method for Generating and Delivery of a Nicotine Aerosol to a User" was rejected by the officer. That product was described as emitting a nicotine salt-based aerosol and imparting that aerosol to the consumers using no electronic part, such as a battery. The controller had refused the application by declaring that the product is against public order under section 3(b). The appellant had argued that their product is not an e-cigarette. He also complained that rejection of his invention went against the TRIPS agreement and the Paris Convention if the Controller had rejected the patent simply because commercial use is forbidden. The respondents had replied to this by stating that the invention was above the levels of nicotine as specified in the Drugs and Cosmetics Act. Emphasizing that the invention poses potential health threats to society and is capable of increasing the level of addiction to nicotine among consumers, therefore, the said product violates the public health policy

The Decision of the Court

The Calcutta High Court overturned the order given by the Patent Officer and returned the application for fresh examination. With respect to section 3 (b), the court held that this particular provision is based on the intention behind the invention and not just the health consequences that follow. Mere speculation could not be the ground for rejecting the application, some serious prejudice must be present with regard to the primary use of the product. Further, the court relied on the patent manual and Mr. Parmar's PPT. They came to the conclusion that the examples cited in the manual and PPT for section 3(b) do not include nicotine and tobacco-related inventions. The court goes on to reiterate the findings of TRIPS and the Paris Convention, saying that the patent rights and their commercialisation are two different things. The product has the possibility of getting a patent if its use can be controlled and monitored. They move on to say that just because a patent has been granted does not prohibit the government from making rules and regulations to control it and protect the public health and environmental safety.

The Patent Office's Restrictive Approach under Section 3(b)

IPO has denied patent applications pertaining to nicotine on many instances. One instance can be when IPO, while considering the application filed by Philip Morris Products S.A. had rejected their invention, which delivered nicotine to their users. The reason given was that the invention had the presumption of causing a serious harm to the public because the applicant could not demonstrate how the invention helped in preventing the nicotine addiction effect. Another application that was rejected was filed by ITC. Here too, IPO gave the reason that the invention had tobacco as its important component, hence injurious to health, as it contained harmful toxins and carcinogens.

Judicial Reassessment of Section 3(b)

However, these rejections came under scrutiny when the court in the case of Phillip Morris Products SA v. Assistant Controller Of Patents And Design allowed the appeal against the rejection of the patent application, considering the arguments of the appellants that the term “contrary to public morality” was nowhere defined, and thus was subjective in nature. Their contention was that their product aimed to reduce the harm and not encourage smoking. The appellant further highlighted the inconsistency with respect to granting patents. Traditional cigarettes were granted a patent, while e-cigarettes have now refused to be patentable. The court accepted the appeal as well as these arguments. This admission finally opened the door for a progressive and inclusive approach to nicotine-related inventions.

The Need for Evidence-Based Decision-Making

The term serious prejudice to health should be fully proven with valid evidence. The Calcutta High Court overturned the refusal of a patent application for an innovation using a syrup made from the stem of the nicotine plant, further strengthening this point of view in R.J. Reynolds Tobacco Company v. Controller General of Patents.

A progressive step

This decision of the court brings out clarity towards the nicotine-related inventions. The court has laid emphasis that just a mere presumption of harm and subjective morality can not be the sole reason to refuse to grant the patent to a product. This approach prevents the arbitrary exclusion of other scientifically backed inventions that aim to reduce the harmful effects of tobacco. Most importantly, it clarifies that the tobacco and nicotine-based products are not automatically excluded from patentability under section 3(b).

Suggestions

As it has already been mentioned, there are no set guidelines to define public morality, which has resulted in the subjective interpretation of the term according to their own whims, resulting in inconsistent evaluations of patent applications.

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The responsibility does not just lie with the parliament, but also upon the IPO to issue clear guidelines and a set of instructions while assessing the inventions to avoid any arbitrary rejection of the product. Further, the court had just reiterated the rules under TRIPS and the Paris Convention. They did not go into the intricacies of how domestic law, which allows rejections of patents if it's harmful for public health, should interact with international rules and obligations. What is needed is a more detailed analysis of how patent law should respond to public health concerns. Another issue that can be seen is that this liberal interpretation has opened the doors for more nicotine and tobacco-related products into the patent market. This highlights the need for the authorities to remain vigilant in curbing the misuse of the inventions that could lead to an increase in the consumption of nicotine and tobacco. Hence, guidelines and instructions must be formulated keeping in mind the balance between innovation and public welfare.

Way Forward

The ITC ruling is a right step in the direction that clarifies the invention related to nicotine-related products, but at the same time, more needs to be done. It is important that this new door to inclusivity is backed by stronger regulatory actions, evidence-based examination, and a defined set of rules to ensure both innovations and public health are protected.

Author :- Pragya Saigal, a Student at National Law University Odisha, Cuttack, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.