Study Finds Rise In Use Of India’s Section 3(d) Against Pharma Primary Patents

Access to affordable medicines is one of the most pressing policy issues globally. India has played a prominent role as “pharmacy of the developing world” with its generic medicine industry; however, the interpretation and implementation of a particular section of the law can significantly affect this role, according to a recent study.

Authors Bhaven Sampat (Associate Professor in the Department of Health Policy and Management at Columbia University) and Kenneth Shadlen (Professor of Development Studies at the London School of Economics and Political Science) conducted an empirical study on the use and functioning of Section 3(d) of the Indian Patent Act 1970.

Controversial since 2005, when India had to give effect to its obligations under the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, this section was intended to prevent evergreening of patents. The section does not allow patents to be granted for inventions involving new forms of known substances unless they differ significantly in their properties or efficacy.

The authors noted a sharp growth in the use of Section 3(d) and found evidence that the Indian Patent Office is using it to try and reject almost everything, in the first examination report at least. However, the section was rarely used alone, but rather in conjunction with other ways of rejecting applications, especially objections concerning novelty and inventive step.

Originally intended to prevent only secondary patents, Section 3(d) is being used against primary patents as well, the authors found. This has met with criticism from patent applicants. The concern here is an examiner’s assessments of what constitutes a new compound versus a new form of a known compound.

Consequently, the authors interpret that if Section 3(d) reduces primary patents, this will make Indian generic production and distribution of new drugs easier. If, instead, Section 3(d) is focused on secondary patents, Indian generic production and distribution will not be possible until later in the lifecycle of most new drugs, after their primary patents expire.

Image Credits: Sampat and Shadlen