The Indian Patents Act, 1970, serves as the cornerstone of India’s patent regime, delineating what constitutes a patentable invention. Among the various provisions of Section 3 of the Indian Patent Act, 1970, Section 3(b) stands out as a critical determinant in assessing the patentability of inventions. This section excludes from patentability inventions that are “primarily or intended to be used” for certain purposes, such as the “commercial exploitation of which” would be detrimental to public health, the environment, or animal and plant life. The interpretation and application of this provision have been the subject of judicial scrutiny.
Section 3(b) states that
“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” is not patentable.
This provision aims to prevent patenting of inventions that, despite being novel and inventive, pose significant risks to public health, safety, or the environment. The emphasis is on the intended use and potential consequences of the invention’s commercial exploitation.
The key elements of Section 3(b) subject to interpretation would be as follows:
- Primary or Intended Use: It relates to the purpose for which the invention is intended. If the primary or intended use of the invention falls within the excluded categories, it may be deemed non-patentable under this section, even though the invention might have a secondary purpose.
- Commercial Exploitation: The potential for the invention to be commercially exploited in a manner that could harm public health, safety, or the environment is a critical consideration.
- Contrary to Public Order or Morality: In case of commercialisation, if the invention in question disrupts public order or morality, the invention is excluded from patentability.
- Serious Prejudice to Life or Health: The term “serious” is important here, and it was added during the amendment of 2002, which came into effect in 2003. Prior to the 2002 amendment, Section 3(b) did not have the word “serious”. Inventions that could cause serious harm to human, animal, or plant life, health or the environment are barred from being patented under this section.
While the interpretation and application of this provision have been subject to judicial scrutiny, two notable judgments recently have provided a clearer understanding of the section.
IPDPTA 121 of 2023
In the case of ITC Limited vs The Controller of Patents (IPDPTA 121 of 2023), the Calcutta High Court had the opportunity to provide clarity on the application of Section 3(b). The Court addressed the rejection of patent application 685/KOL/2015, titled “A device and method for generating and delivery of a Nicotine Aerosol to a user” by the Indian Patent Office, which had cited Section 3(b) as the basis for refusal.
The applicant’s advocate argued that denying patentability of an invention merely because its commercial exploitation is prohibited violates Article 27(2) of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). It was further argued that the “grant of patent” is distinct from “commercialisation” and that the grant of patent does not result in a consequential right to sell the product.
Court’s Observation on Section 3(b)
- The Court noted that Section 3(b) is an “intent principle” and not an “effect or harm principle” and referred to a PowerPoint presentation by the then Deputy Controller of Patents and Designs, which provided examples of inventions falling under Section 3(b). It was also pointed out that none of the examples discussing Section 3(b) mention tobacco, smoking or nicotine or inventions relating thereto. The “Patents Manual” also does not include tobacco/smoking/nicotine-related inventions at the time of giving examples of inventions that fall within the ambit of Section 3(b) of the Patents Act.
- The Court also referred to Article 27.2 of TRIPS and Article 4 quarter of the Paris Convention.
Critique
The appeal was allowed, and the application was remanded to the IPO for further consideration. In this matter, the Court’s emphasis on natural justice was commendable, and its treatment of Section 3(b), with particular reference to TRIPS and the Paris Convention, gave a clear idea of the Section’s interpretation.
IPDPTA 13 of 2024
In a subsequent case, the Calcutta High Court revisited Section 3(b) in the context of a patent application titled “A Heater Assembly to Generate Aerosol”. The Court’s approach in this case provided further insights into interpreting this provision.
Court’s Approach
- Intent vs Effect: The court reiterated the distinction between the intended use of an invention and its potential effects. It emphasised that the primary or intended use is the key factor in determining patentability under Section 3(b).
- TRIPS Compliance: The court considered India’s obligations under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, particularly Article 27.2, which allows members to exclude inventions from patentability to protect public health and nutrition. The court concluded that rejecting a patent solely because its sale is prohibited in another country does not align with TRIPS obligations.
- Commercialisation: The Court further pointed out that the Controller has erroneously interpreted Section 83(e) of the Act in assuming that the grant of the patent would commercialise the product and would affect public health
Analysis
This judgment reinforced the need for a nuanced understanding of Section 3(b), balancing the intended use of an invention with its potential effects. The court’s consideration of international obligations underscores the importance of aligning domestic patent laws with global standards.
Conclusion
Section 3(b) of the Patents Act, 1970, serves as a critical safeguard against the patenting of inventions that could harm public health, safety, or the environment. The judgments in IPDPTA 121 of 2023 and IPDPTA 13 of 2024 offer valuable insights into the interpretation and application of this provision. While the former emphasises procedural fairness, the latter provides a more detailed analysis of the substantive aspects of Section 3(b).
Together, these cases contribute to a more nuanced understanding of patentability under Indian law, balancing innovation with public interest considerations. A thorough read of both these judgments would give a fresh approach for interpreting Section 3(b) of the Patents Act, 1970. The particular reference made to the Patent Manual, TRIPS, Paris Convention and Section 83(e) on commercialisation of granted patents, will surely provide a stronger case while dealing with Section 3(b), particularly for cases relating to tobacco, nicotine or smoking.
Authors: Manisha Singh and Suranjana Chowdhury
First Published by: Mondaq here