The Patents Act, 1970 provides patent protection in India which is compliant with Trade-Related Aspects of Intellectual Property Rights (TRIPS) and has been adopting and implementing the provisions. To obtain a patent protection in India, apart from the patentability criteria-novelty, inventive step and industrial applicability, the invention must not fall within the ambit of Section 3 and 4 of the Act. As any digital health application works on software and a computer program, Section 3(k) of the Indian Patents Act is relevant which precludes patentability of a computer program per se. Recently, the Delhi High Court has iterated that all computer programs are not barred under Section 3(k) and when such program demonstrates a ‘technical effect’ or a ‘technical contribution’, the invention would be patentable.
Additionally, a patent may not be granted if the program or device is intended to be ‘a process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products’ under Section 3(i) of the Indian Patents Act. However, the device and process of using an in vitromechanism is considered patentable.