Local working of pharmaceutical patents in India: an empirical exploration into its determinants

The local working of a patent ensures that technology associated with the working of the patent is passed on to the locals, which results in flexible and quick responses to their needs. In the specific case of pharmaceuticals, local working of the patent aids the availability and accessibility of the drug, thereby contributing to the public health considerations based on the needs of a nation. In this context, this article discusses the determinants of the local working of pharmaceutical patents in India. This article analyses the working status of a patent (worked and not worked) through patent quality indicators (PQIs) and the reasons for not working on a pharmaceutical patent in India. By using a Poisson regression model on a sample of 681 pharmaceutical patents from 2012 to 2019, this study establishes that the percentage of local working of pharmaceutical patents in India as a proportion of the total sample is very low for both Indian and foreign patentees. However, Indian patentees have a stronger likelihood of being worked as compared to foreign patentees. This study also reveals that one of the main reasons for not working on the patent is the need for further ‘Research and Development’ before the drug can be introduced in the market. Other major reasons include ‘attempts being made’ and ‘not under development’, all of which show a significant and strong impact on the likelihood of non-working of the patent. Among the PQIs, patents that are licenced and opposed, and the patents routed through the Divisional Convention Application type were more likely to be worked. Not working on a patent results in adverse effects on public health, due to the inaccessibility to drugs that are required by the general public in a developing country like India. As a result of weak local production, and a strong correlation of worked patents with their licencing and opposition, this article suggests strengthening legal remedies to deal with patentees who do not work on their inventions.