This breaks down the ITC Ltd. v Controller of Patents judgement. The Calcutta High Court held that a patent cannot be denied under Section 3(b) on morality or public health grounds without clear scientific or technical evidence. It found that the Controller wrongly presumed the invention—a device for generating and delivery of a Nicotine Aerosol—was related to electronic nicotine delivery systems (ENDS), despite no such reference in the patent application. The Court emphasized that assessment must be based on the invention itself, not on assumed commercial use. The process was also found to be procedurally unfair, as ITC was not given an opportunity to respond to key documents introduced for the first time in the rejection order.
In the case of ITC Limited v Controller of Patents, ITC Limited (ITC) filed an appeal under Section 117A of the Patents Act, 1970 challenging the rejection of its patent application which related to a non-electronic device designed to chemically generate and deliver aerosols of nicotine salt. The Controller of Patents, Designs & Trademarks (Controller) rejected the application primarily based on Section 3(b) of the Patents Act, which excludes inventions contrary to public order or morality or those causing serious prejudice to health or the environment.
ITC contended that their invention is neither an electronic cigarette nor an Electronic Nicotine Delivery System (ENDS), which usually causes prejudice to health or the environment; rather, it operates on a chemical reaction between nicotine and pyruvic acid to generate aerosol. Therefore, it argued that the invention should not be presumed to be dangerous or harmful to health in the same way as ENDS or vaping devices are, and it does not fall under the purview of Section 3(b).
ITC further contended that during the prosecution proceedings, the Controller relied on various documents, statutes, and government advisories that were neither cited in the First Examination Report, nor during the hearing proceedings. ITC pointed out that these documents, such as the Indian Council of Medical Research white paper on Electronic Nicotine Delivery Systems, circulars issued by various state governments, online toxicology data from PubChem, and related court judgments, were only cited during the issuance of a final rejection order. ITC argued that it was denied a fair opportunity to contest the rejection, thereby violating principles of natural justice.
The Court agreed with ITC’s contention and emphasized that Section 3(b) should be interpreted based on the intended use of the invention and not its potential health effects. In addition, the Court also suggested that patentability should not be denied solely due to commercialization restrictions.
The Controller rejected the patent application on the ground that the device delivered nicotine in quantities exceeding permissible limits under the Drugs and Cosmetics Act, 1940, and posed public health risks. However, the Court held that the decision was based on reliance upon undisclosed documents and statutes, leading to a procedurally flawed outcome. The Court determined that a grant of a patent shall not be refused on the ground that “the sale of the patented product or of a product obtained by means of a patented process is subject to restrictions and limitations resulting from the domestic law”. Additionally, the Court considered that patents are granted to encourage inventions and to secure that the inventions work in India on a commercial scale. The Court also considered that patents granted do not in any way prohibit the Central Government from taking measures to protect public health.
Based on the above interpretations, the Court set aside the Controller’s order and remanded the matter for reconsideration.
ABOUT THE AUTHOR
Revanth Diwakar K
Revanth Diwakar K is a Senior Associate with K&S Partners, bringing experience in the mechanical and design domains.
- revanth@knspartners.com