The Calcutta High Court, in a recent judgement, set aside the rejection of a nicotine device patent filed by ITC Limited. The Assistant Controller of Patents rejected the application under Section 2(1)(ja) and Section 3(b) of the Patents Act, 1970, citing concerns that granting the patent would impede the Central Government\u2019s ability to protect public health. The Court noted that the grant of a patent could not be refused merely because the sale of the patented product, or a product obtained through a patented process, was subject to restrictions or limitations under domestic law.<\/p>\n
ITC filed a patent application with the Indian Patent Office bearing number 685\/KOL\/2015. The application, titled \u201cA Device and Method for generating and delivery of a Nicotine Aerosol to a user\u201d disclosed a device designed to deliver nicotine to users without the burning or heating of tobacco and\/or nicotine.<\/p>\n
In the FER report, the Controller stated that claims 1 to 17 lacked novelty and were non-patentable under Section 3(b) of the Patents Act, 1970, without providing any supporting documents to substantiate the objection.<\/p>\n
After the hearing, the Controller issued a refusal order on 26th<\/sup> June 2023. In the order, the Controller cited a list of additional documents, including an ICMR white paper on electronic nicotine delivery system, as well as various government regulations and guidelines on tobacco control to support the objection under Section 3(b) of the Patents Act.<\/p>\n ITC challenged the refusal order on the grounds that the order violated the principles of natural justice. ITC argued that the Controller had cited several documents in the order, including the ICMR white paper, which had not been cited in the FER or the hearing notice. ITC further submitted that the invention was neither an e-cigarette nor did it fall under the category of Electronic Nicotine Delivery System (ENDS) as it did not rely on electrical, electronic, or similar sources of heat to generate aerosol. Furthermore, ITC argued that Section 3(b) should be interpreted in conjunction with the terms \u201cserious prejudice\u201d and \u201cprimary or intended use,\u201d which, the Controller failed to consider.<\/p>\n The Court primarily examined whether the Controller had served ITC with the documents cited in the impugned order. The Court observed that the hearing notice issued by the Controller did not mention the statutory provisions or indicate that reliance would be placed on information available on government websites, which were later cited in the order rejecting ITC’s patent application.<\/p>\n With regard to the technical classification of the invention, the Court concurred that the invention did not qualify as an electronic nicotine delivery system, since it generates nicotine aerosol through a chemical reaction and contains no electronic components. The Court noted that the Controller had incorrectly concluded the device as an e-cigarette based on the ICMR White Paper publication and other statutory provisions.<\/p>\n The Court further observed that the Controller’s reliance on Section 3(b) was misplaced. The Court clarified that Section 3(b) is the intent principle and not the effect or harm principle. Referring to a presentation by the former Deputy Controller of Patents and Designs, Shri DPS Parmar, the Court noted that the presentation did not include tobacco, smoking, nicotine, or related inventions among the examples of exclusions under Section 3(b). Furthermore, the “Patents Manual” similarly did not list such inventions as falling within the scope of Section 3(b) of the Patents Act.<\/p>\n Referring to the Article 27(2) of the TRIPS Agreement and Article 4quarter of the Paris Convention, the Court noted that a patent should not be refused solely because the sale of the patented product is subject to restrictions and limitations resulting from the domestic law.<\/p>\n The Court reiterated section 83(d) and (e) of the Patents Act and stated that patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay. Furthermore, the Court clarified that the grant of a patent does not restrict the Central Government from taking measures to protect public health.<\/p>\n In conclusion, the Court set aside the refusal order dated 26th<\/sup> June 2023, and remanded the matter to the Controller for fresh consideration within six months.<\/p>\nCourt\u2019s analysis<\/h5>\n
Conclusion<\/h5>\n