Introduction
In recent years, the Indian Patent Office has adopted a stricter interpretation of Section 3(b) of the Patents Act, 1970, leading to increased rejections of patent applications. This article examines two recent judgments of the Hon’ble Calcutta High Court in appeals filed by ITC Limited under Section 117A, challenging the rejection of patent applications 685/KOL/2015 and 201731039343 on grounds of non-patentability under Section 3(b). Section 3(b) bars the patenting of ‘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’.
For refusing, in both cases, the Respondents relied on newly introduced documents for the first time in the impugned orders. The Court addressed two key issues: (i) whether these documents were properly served upon the Appellant and whether the appellant was given an opportunity to deal with the documents relied upon by the respondent, and (ii) whether the inventions fell within the scope of Section 3(b).
The Court held that the failure to serve the documents violated principles of natural justice and found the Respondents’ interpretation of Section 3(b) legally flawed. Accordingly, the impugned orders were set aside, and the matters were remanded for reconsideration. This article explores the High Court’s interpretation of Section 3(b), offering critical insight into its evolving application within India’s patent regime.
Appeal 1[1]: Application No. 685/KOL/2015
Title: A Device and Method for Generating and Delivery of a Nicotine Aerosol to a User
Following the First Examination Report (FER), the Respondent raised objections under Section 3(b), later expanded to all claims in the hearing notice, citing a new document not previously disclosed. Following a hearing and written submissions, the application was refused as the invention being unpatentable under section 3(b) for causing serious prejudice to human health, prompting an appeal under Section 117A.
High Court’s findings
The Court held that the statutory materials cited in the impugned order were not served on the Appellant, thereby denying the Appellant a fair opportunity to respond para 29 of 1.
In interpreting Section 3(b), the Court emphasized that the provision must be assessed based on the intent of the invention, not speculative effects. Referring to the Patent Office’s Manual of Practice and Procedure[2], it observed that tobacco or nicotine-related inventions are not explicitly excluded under Section 3(b). The Court also cited Article 27.2 of the TRIPS Agreement and Article 4quater of the Paris Convention, affirming that patentability cannot be denied solely due to domestic restrictions on commercial exploitation paras 37-38 of 1.
Finally, while assessing Sections 83(d) and (e) of the Patents Act, as relied upon by the Respondent, the Court reiterated that patents are intended to promote innovation and commercial application within India, while public health safeguards fall within the remit of the Central Government, independent of the patent grant process para 39 of 1. The Court found that patent grants did not in any way prohibit Central Government from taking measures to protect public health.
Appeal 2[3]: Application No. 201731039343
Title: A Heater Assembly to Generate Aerosol
The Appellant’s application was refused under Section 3(b) following the FER, hearing, and written submissions. Subsequently, an appeal was filed under Section 117A challenging the rejection.
High Court’s findings
The Court underscored that the fundamental objective of the Patents Act, 1970 is to promote scientific innovation and technological advancement in the public interest. This is achieved by granting inventors exclusive rights for a limited period, after which the invention enters the public domain. The Court emphasized the critical role of the Patent Office in administering this framework, noting that its decisions must be reasoned and aligned with the legislative intent of the Act para 7 of 3.
In its interpretation of Section 3(b), the Court adopted a structured two-step approach:
- Determination of the invention’s utility: The Court reiterated that Section 3(b) requires an assessment of the “primary or intended use or commercial exploitation” of the invention. It found that the Respondent had erroneously presumed that the invention would be used exclusively with tobacco-based substrates, thereby prejudicing human health. However, the invention was not inherently limited to such use. This mischaracterization led to an incorrect conclusion regarding its patentability para 8 of 3.
- Assessment of whether the utility contravenes public order or morality: Once the utility is established, the next step is to determine whether it is contrary to public order, morality, or causes serious harm to life, health, or the environment. The Court noted that while Section 3(b) uses the term “public order,” its interpretation may be guided by international instruments such as Article 53(a) of the European Patent Convention and the TRIPS Agreement, which refer to the concept of “ordre public”. The legislative intent, as reflected in jurisprudence and guidelines (e.g., Terrell on the Law of Patents, 19th Ed., para 2-130), is to exclude inventions likely to incite disorder, criminality, or broadly offensive conduct para 9 of 3.
In support of its reasoning, the Court relied on several judicial precedents and statutory provisions:
- Negative nature of patent rights: Citing Hindustan Lever Ltd. v. Lalit Wadhwa & Anr., 2007 SCC OnLine Del 1077, the Court reaffirmed that a patent confers only a negative right—the right to exclude others—not an affirmative right to use or commercialize the invention. The patentee’s ability to exploit the invention may still be subject to other legal or regulatory constraints para 10 of 3.
- Lack of evidentiary basis: The Court found that the Respondent’s conclusion—that the invention caused serious harm to human health—was unsupported by cogent reasoning or evidence. It emphasized that tobacco-related inventions are not inherently unpatentable in India and that the impugned order failed to establish a rational nexus between the facts and the conclusion, as required under Uniworth Resorts Ltd. v. Ashok Mittal & Ors., (2008) 1 Cal LT para 11 of 3.
- Misapplication of the ‘affect’ principle: The Court criticized the Respondent’s reliance on presumed harm (the affect principle) without scientific or technical substantiation, while disregarding the intent principle—the purpose behind the invention. This approach was inconsistent with international jurisprudence, including HARVARD/Onco-mouse (T19/90), PLANT GENETIC SYSTEMS (T356/93), and Harvard/Transgenic Animals (T 315/03) para 11 of 3.
- Improper reliance on uncited statutes: The Court noted that the Prohibition of Electronic Cigarettes Act, 2019, which regulates manufacture and sale, was not cited in the impugned order. Nonetheless, the Respondent relied on it during the appeal. The Court held that administrative orders cannot be defended on grounds not stated in the order itself (ITC Ltd. v. Controller of Patents, IPDPTA No. 121 of 2023) para 12 of 3.
- Misconception regarding patent rights and ethical considerations: Addressing a fundamental error in the impugned order, the Court clarified that the grant of a patent does not imply a right to commercialize the invention. Citing R.J. Reynolds Tobacco Co. v. Controller of Patents, IPDPTA 31 of 2023, it reiterated that patent rights are exclusionary and do not confer a right to use, sell, or manufacture the invention para 13 of (2). In R.J. Reynolds, the Court emphasized the need to balance ethical considerations in interpreting Section 3(b), referencing Article 53(a) of the EPC and the 161st Report of the Parliamentary Standing Committee on Commerce. The Committee had cautioned against the broad and unguided application of Section 3(b), warning that it could lead to the denial of socially beneficial inventions, such as nicotine de-addiction aids para 13 of 3.
- Misplaced constitutional reliance: Finally, the Court found the Controller’s reliance on Article 47 of the Constitution misplaced. It held that Directive Principles of State Policy and Article 14 are not determinative in assessing patentability. The misinterpretation of Section 83(e)—assuming that patent grant equates to commercialization—further reflected a flawed understanding of both the invention and the statutory framework para 17 of 3.
Conclusion
The Calcutta High Court’s rulings in both appeals underscore the importance of procedural fairness, evidentiary rigor, and statutory interpretation in patent adjudication under Section 3(b) of the Patents Act, 1970. The Court clarified that patentability must be assessed based on the invention’s intended use, not speculative harm, and reaffirmed that patent rights are exclusionary—not affirmative rights to commercialize. It also cautioned against relying on constitutional provisions and unrelated statutes to justify patent refusals, emphasizing that patent grants may not be refused merely for reasons that the domestic law imposes prohibition on commercialization of the patented product. By remanding both matters for fresh consideration, the Court reinforced the need for reasoned, evidence-based decision-making and provided valuable judicial guidance on the interpretation of Section 3(b), particularly in the context of tobacco and nicotine-related inventions. These decisions mark a significant step toward balancing innovation incentives with public interest safeguards in India’s evolving patent landscape.
[The authors are Executive Director and Senior Patent Analyst, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys]
[1] ITC Limited v. The Controller of Patents, decided on 30 April 2025
[2] Manual of Patent Office, Practice and Procedure, 2019.
[3] ITC Limited v. The Controller of Patents, decided on 20 May 2025.
