Section 3(b) of the Patents Act, 1970, excludes from patentability any invention whose primary or intended use or commercial exploitation could be contrary to public order or morality, or which causes serious prejudice to human, animal, or plant life, health, or the environment.

In the case of R J Reynolds Tobacco Company vs The Controller General of Patents [IPDPTA/31/2023], the Calcutta High Court addressed an appeal against refusal of patent application number 1940/KOLNP/2013, entitled “A Method of Preparing a Sugar Containing Syrup from the Stalk of a Plant of the Nicotiana Species”, on the ground of non-patentability under Section 3(b) of the Patents Act, 1970.

The Appellant submitted before the Court that the claimed invention was patentable and had been wrongly refused solely on the basis of a generalized and unsubstantiated assumption that all tobacco-related inventions are inherently harmful to human health and are therefore not eligible for patent protection under Section 3(b). It was contended that the Controller failed to consider the merits of the invention and disregarded the evidence submitted in support of patentability, including scientific data, details of a corresponding foreign grant, and a list of similar patents previously granted in India.

In its analysis, the Court found that the only reason assigned in the impugned order for refusing the subject application was a preconceived notion that tobacco products are seriously harmful to human health.

The Court noted that “Section 3(b) focuses on the primary or intended use or commercial exploitation of an invention. The underlying interest being ethical considerations”. The Court noted that the impugned order lacked a reasoned analysis of the evidence submitted by the Appellant. The Court further emphasized that if the Controller concluded that the claimed invention posed a risk to human health, such a conclusion should have been substantiated with specific reasons and supporting evidence.

The Court further drew attention to Article 53(a) of the European Patent Convention (EPC) 2000, which similarly restricts the grant of patents for inventions whose exploitation would be contrary to public order or morality. The Court also referred to the 161st Report of the Parliamentary Standing Committee on Commerce, which recorded that Section 3(b) is broadly worded and lacks sufficient guidance or safeguards against arbitrary exercise of power by the Controller. The Committee observed that this lack of clarity may lead to the unjust refusal of socially beneficial inventions, including those with potential health benefits like nicotine chewing gums, which are used for de-addiction to smoking. The Committee recommended that Section 3(b) be amended to introduce a safeguard mechanism, ensuring that patent exclusions are limited to inventions that are explicitly prohibited under any law in force.

In conclusion, the Court set aside the impugned order and remanded the matter to the Controller for fresh consideration.