In a decision that may shape the future of innovation and regulatory clarity in India, the Calcutta High Court recently delivered a pivotal judgment in the case of ITC Limited vs. Controller of Patents[1] (April 30, 2025). The case revolved around ITC’s patent application for a smoking article, which was rejected by the Controller of Patents on two primary grounds: first, that the product was already commercially available, and second, that it was deemed “injurious to health,” thus invoking the public policy exclusion under Section 3(b) of the Indian Patents Act, 1970.
The High Court categorically overruled both objections, issuing a clear and structured verdict that has been welcomed across legal and innovation circles. On the first ground, the Court clarified that the commercial availability of a product does not in itself negate patentability. The core criteria for patent eligibility, as established under Indian law, remain novelty, inventive step, and industrial applicability. The presence of a product in the market, without more, does not strip it of its eligibility for patent protection.
More importantly, the Court delivered a firm message regarding the interpretation of Section 3(b). It held that invoking public health concerns as a reason for patent rejection, when the product is lawfully sold and subject to regulatory oversight, is legally unsound. Moral or health-based objections cannot override explicit statutory criteria unless supported by clear legal reasoning. The Court emphasized that subjective judgments about health risks or morality must not replace the objective standards laid out by patent law. This ruling reinforces the principle that patent examinations must be grounded in law and technical merit, not personal or societal opinions.
This decision sends a crucial message to patent examiners: regulatory and statutory mechanisms that no discretionary interpretations should guide patentability assessments. While public health is a legitimate concern, it must be addressed through the proper legal and regulatory frameworks rather than serving as a blanket basis for patent rejection. For industries operating in regulated spaces like tobacco, pharmaceuticals, and food technology, this ruling brings much-needed clarity and confidence.
In an additional and equally significant aspect of the ruling, the Court tackled the issue of how early commercial activity affects the novelty of an invention. It concluded that commercial sales or disclosures made in confidence, such as to distributors or partners, do not constitute prior art if they are not publicly accessible or enabling. Confidential or limited-access transactions do not automatically negate an invention’s novelty. For a disclosure to count as prior art, it must be both public and enabling, providing sufficient information for a skilled person to reproduce the invention.
This finding offers vital reassurance to innovators, especially startups and R&D-led organizations. Early market testing, pilot launches, or distributor engagement, when properly safeguarded by confidentiality agreements, will not necessarily undermine a patent’s validity. This reaffirms the importance of strategic IP planning and emphasizes the role of legal safeguards like non-disclosure agreements (NDAs) and distribution contracts.
For intellectual property professionals and business leaders alike, this judgment highlights the best practices that can help preserve innovation rights. Ensuring strict confidentiality in the early stages of commercialization, aligning product launch strategies with IP timelines, and embedding legal protections into distribution models are all critical takeaways from this case.
In conclusion, the ITC Limited vs. Controller of Patents ruling marks a significant milestone in India’s patent jurisprudence. It clarifies longstanding ambiguities around public health exclusions and commercial disclosure, while firmly anchoring the examination process in the statutory framework. By balancing regulatory interests with legal integrity, the Calcutta High Court has reaffirmed India’s commitment to fostering a robust, innovation-friendly intellectual property environment.
Therefore, the Court is to be commended for delivering a well-reasoned and jurisprudentially sound judgment that not only clarifies the legal interpretation of Section 3(b)[i] of the Patents Act but also reinforces the necessity for objective, statutory compliance in patent examination, striking an appropriate balance between public policy considerations and the constitutional mandate to promote scientific innovation under Article 51A(h)[ii] of the Indian Constitution.
[1] ITC Limited vs. The Controller of Patents, Calcutta High Court, Judgment dated April 30, 2025. Available at: Indian Kanoon
[i] Section 3(b), Indian Patents Act, 1970: “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.
[ii] Article 51A(h), Constitution of India: “It shall be the duty of every citizen of India — to develop the scientific temper, humanism and the spirit of inquiry and reform.
Author: Aastha Sharma is a Registered Indian Patent Agent, Trademark Agent, and Advocate.
