The Calcutta High Court’s judgment, in ITC Limited v. The Controller General of Patents Designs and Trademarks (IPDPTA/13/2024) marked a crucial development in Indian patent law by overturning the rejection of ITC’s patent application (No. 685/KOL/2015) for “a device and method to generate and deliver a nicotine aerosol”. The case centered on Section 3(b) of the Patents Act, 1970 (the ‘Act’), which excludes inventions that are “contrary to public order or morality” or cause “serious prejudice to human, animal or plant life or health.”
Background of the Dispute
ITC’s invention aimed to create uniform heat distribution in portable devices for inhalable aerosol production. The Controller rejected the application under Section 3(b) of the Act, on the grounds that it could harm public health and violate morality. The Controller’s decision cited regulatory reports and guidance that ITC was not given an opportunity to review or respond to.
ITC challenged the rejection, arguing that their device was not covered by bans on electronic nicotine devices, and that the refusal violated principles of natural justice, since important material was withheld from them. They also asserted that patentability should be determined independently of potential regulatory bans on the product’s use.
Key Judicial Findings
A key part of the judgment was the Court’s emphasis on procedural fairness and natural justice. The High Court found that the Controller did not provide ITC with all the documents and reports used to make the decision, including regulatory guidance and white papers. By not allowing ITC to respond, the procedure violated fundamental principles of fair hearing and was legally unsound.
The Court also gave important guidance on interpreting Section 3(b), which excludes inventions that go against public order or morality or that significantly harm life or health. It reiterated that refusals must be based on clear evidence and a direct link between the invention's use and legal restrictions, rather than vague generalizations about the product category. Simply being related to nicotine or tobacco was not enough to justify exclusion.
The judgment also made a clear distinction between patent rights and commercial exploitation. The Court reaffirmed that a patent is an exclusionary right—it does not automatically allow someone to market or sell an invention. All products, even if patented, still need regulatory approval and must follow health and safety laws, such as the Prohibition of Electronic Cigarettes Act.
The Court referred to international agreements like TRIPS and the Paris Convention, stating that regulatory obstacles alone should not determine patentability. Instead, each application must be examined based on its specific facts and legal merits with careful reasoning and transparency.
The Outcome and Its Broader Impact
The Calcutta High Court set aside the Controller’s order and remanded the case for fresh consideration, instructing the Patent Office to provide all relied-upon materials to ITC and issue a reasoned decision with opportunity for hearing. The Court refrained from a categorical ruling on the patentability of nicotine-related inventions but affirmed that such inventions are not per se excluded from patent protection. Each case requires an evidence-based, fair assessment.