The recent judgment, ITC Limited vs. The Controller of Patents, clarifies how Section 3(b) of the Patents Act should be applied. The provision excludes inventions whose “primary or intended use” is contrary to public order, morality, or causes “serious prejudice” to human, animal, or plant life or health.
The case concerned a non-electronic nicotine delivery device that used a chemical reaction to generate aerosol without any electronics or heating elements. The Patent Office (IPO) rejected the application under Sec 3(b), citing nicotine’s health risks and regulatory restrictions under the Drugs and Cosmetics Act. The rejection framed the invention as an Electronic Nicotine Delivery System (ENDS), akin to e-cigarettes banned under Indian law.
How the IPO applied Sec 3(b):
Rather than evaluating the claimed mechanism, a non-combustion, chemical delivery system, IPO focused on the broader regulatory environment and potential health impacts of nicotine. The rejection was based on downstream effects and public policy concerns, without assessing whether the invention’s primary use, as claimed, caused serious prejudice. This approach diverged from Sec 3(b)’s legal threshold, which hinges on intended use, not assumed consequences.
What the Court Emphasized Instead:
The Court acknowledged the applicant’s reliance on IPO’s internal training guidance, which distinguishes inventions excluded under Sec 3(b), such as biological weapons or gambling devices, from those involving regulated substances like nicotine. It noted that IPO failed to assess the technical design on its own terms, including its chemical (not electronic) mode of delivery. This aligned with the principle that Sec 3(b) must assess what the invention is intended to do, not what it might resemble.
Regulatory Bans vs. Patentability:
While the Court remanded the matter for fresh examination primarily due to procedural lapses (including failure to share relied-upon documents), it also referenced TRIPS Article 27.2 and Paris Convention Article 4quater. These obligations support that patentability must not be conflated with domestic commercialization bans. The Court’s reasoning reinforces the separation between patent examination and public policy regulation, already reflected in Section 83 of the Patents Act.
The judgment clarifies that Sec 3(b) is not a proxy for public health enforcement. IPO must assess the technical intent of an invention, not its broader associations or assumed risks.
Takeaway for applicants in highly regulated sectors: frame the invention’s purpose clearly.
