The case of ITC Limited Vs. The Controller of Patents, Designs & Trademark represents a significant clash between intellectual property rights and public health considerations in India. At its core, the dispute revolves around the rejection of a patent application for a novel nicotine aerosol delivery device, which ITC Limited claimed was distinct from electronic nicotine delivery systems (ENDS) like e-cigarettes. The Calcutta High Court, in its judgment, grappled with issues of procedural fairness, statutory interpretation, and the balance between innovation and public policy. This case study delves into the intricate details of the case, analyzing the factual and procedural background, the arguments presented, the judicial reasoning, and the broader implications for patent law in India.

• Detailed Factual Background:
  • ITC Limited filed Indian Patent Application No. 685/KOL/2015 on June 10, 2015, for “A Device and Method for Generating and Delivery of a Nicotine Aerosol to a User.”
  • The device used a non-electronic system comprising two components: one with nicotine or alkaloids, and the other with pyruvic acid.
  • Upon inhalation, the two components reacted chemically to produce a nicotine salt-based aerosol.
  • ITC asserted that the device did not rely on electronic heating, distinguishing it from e-cigarettes or ENDS.
  • The Controller of Patents and Designs rejected the application on June 26, 2023, citing Section 3(b) of the Patents Act, 1970.
  • The rejection cited health risks associated with nicotine delivery and referenced an ICMR White Paper, statutes, and a newspaper article.
  • ITC challenged the rejection in the Calcutta High Court, alleging procedural irregularities and legal misapplication.
• Detailed Procedural Background:
  • Application filed in 2015; FER did not reference Section 3(b).
  • Hearing notice dated May 1, 2023, introduced new documents including the ICMR White Paper and newspaper articles.
  • ITC attended the hearing on May 30, 2023, and submitted a reply on June 14, 2023.
  • Order dated June 26, 2023, relied on additional undisclosed statutes including the Prohibition of Electronic Cigarettes Act, 2019.
  • ITC appealed under Section 117A of the Patents Act before the Commercial Division of the Calcutta High Court.
  • The judgment was delivered by Justice Krishna Rao on April 30, 2025.
• Key Issues Raised:
  • Whether the Controller’s reliance on undisclosed documents violated principles of natural justice?
  • Whether the invention fell under Section 3(b) as causing serious prejudice to health?
  • Whether the classification of the device as an e-cigarette or ENDS was valid?
• ITC Limited’s Submissions:
  • Claimed the device used a novel chemical process and not electronic heating, differentiating it from ENDS.
  • Described the configuration and dosage levels, arguing they were within safe limits.
  • Asserted that speculative health risks did not meet the “serious prejudice” standard under Section 3(b).
  • Highlighted procedural lapses and cited Ssangyong Engineering to argue for procedural fairness.
  • Referenced statutory interpretation from Balsinor Nagrik Co-op. Bank and arbitrary treatment from Manganese Ore.
  • Invoked international obligations under TRIPS and the Paris Convention.
• Controller’s Submissions:
  • Claimed the device fell under NRT not approved under the Drugs and Cosmetics Act.
  • Cited health risks from nicotine and ICMR findings linking ENDS to lung diseases.
  • Argued device’s similarity to e-cigarettes warranted rejection under Section 3(b).
  • Defended procedure as fair, stating documents were publicly available and referenced in the hearing notice.
  • Invoked Article 47 of the Constitution and prior case law (Basawaraj and Fuljit Kaur) to argue against relief.
• Discussion on Judgments Cited:
  • Ssangyong Engineering: Used by ITC to show denial of fair hearing due to undisclosed materials.
  • Balsinor Nagrik Co-op. Bank: Argued that Section 3(b) should consider intended use.
  • Manganese Ore: Highlighted inconsistency in prior patent grants as arbitrary.
  • Basawaraj: Controller’s argument that past mistakes don’t justify future relief.
  • Fuljit Kaur: Used by Controller to argue against legal rights based on previous erroneous decisions.
• Judicial Reasoning and Analysis:
  • Court emphasized procedural fairness, finding the Controller’s reliance on undisclosed documents violated natural justice.
  • Held that public availability did not substitute the duty to disclose materials before reliance.
  • Rejected classification of the device as an e-cigarette due to lack of electrical component and improper notice.
  • Criticized broad application of Section 3(b) and noted international obligations discouraging rejection on domestic policy grounds.
  • Referenced Section 83(d) & (e) of the Patents Act to distinguish patentability from commercial exploitation.
• Final Decision:
  • Calcutta High Court allowed ITC’s appeal (IPDPTA No. 121 of 2023).
  • Set aside the Controller’s order dated June 26, 2023.
  • Directed reconsideration of the application in accordance with procedural fairness and patent law standards.

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: ajayamitabhsuman@gmail.com, Ph no: 9990389539