As per the provision of 1 Section 3 and subsection (b) of the Patent Act, "inventions of 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" are non-patentable. The non-patentability objection under the provision of Section 3(b) is not common due to which the said provision is not familiar to many as compared to other subsections of Section 3. However, over the past few years, some of the applications have started receiving non-patentability objections regarding Section 3(b). Based on the provision of Section 3(b), recently two patents were rejected by the Indian Patent Office (IPO) in which the patent claim applications were related to nicotine delivery devices.
The first rejection was faced by the application number 7127/DELNP/2011 dated 16th September 2011 filed by Phillip Morris Products S.A., a tobacco company. The application specifically disclosed a device for delivering nicotine to a subject, wherein the device comprises a housing compartment consisting of an inlet and an outlet in communication with each other and adapted so that a gaseous carrier may pass into the housing through the inlet.
Further, the said application was also objected under 2 Section 3(i), wherein the objection was raised to the method and device of delivery of nicotine which is considered as a therapeutic substance and hence falls under the category of non-patentable subject matter as it is a method for treatment of human body. The Controller assigned to the application noted that the applicant had failed to elaborate how the nicotine delivery device prevents nicotine's addictive effect which can pose risk to the human health. Based on the said grounds, the Controller rejected the patent stating that the device can cause serious prejudice to health.
The second application that was rejected under Section 3(b) was filed by ITC Limited with application number 1098/KOL/2010 dated 30th September 2010. The application was rejected for the use of tobacco as an essential feature in a device similar to the Philip Morrison application. Other than section 3(b) objection, the application was also objected under 3 Section 6(1) of the Biological Diversity Act, 2002, stating that the Applicant did not take permission from the National Biodiversity Authority for the use of tobacco leaves which is a biological material procured from India. Based on the combined objection under section 3(b) and section 6(1), the patent claim was rejected by the Controller.
The main concern raised with the above-mentioned rejections under Section 3(b) is whether the patent applications were also injurious to health as the tobacco products. Section 3(b) is often considered as a vaguely worded provision offering wide and varied interpretation of the term "public order", morality and "serious prejudice". It should be taken into consideration that harmful impact of tobacco on human health is proven, however, without any adequate reasoning as to how a tobacco-based invention poses a serious prejudice to human health is not known and the same impacts the Applicant owning the patents related to tobacco devices.
It is important to note that though there are several restrictions related to sale, purchase, packaging and labelling of a tobacco products, however the sale and consumption of tobacco is not prohibited. Therefore, rejecting a patent related to tobacco delivering device or method merely based on the fact that they use nicotine/ tobacco is clearly an overreach by the IPO to regulate an industry that is not its concern.
Footnotes
1 https://ipindia.gov.in/writereaddata/Portal/ev/sections/ps3.html
2 https://ipindia.gov.in/writereaddata/Portal/ev/sections/ps3.html
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