Library Header Image
LSE Research Online LSE Library Services

Indian pharmaceutical patent prosecution: the changing role of Section 3(d)

Shadlen, Kenneth C. ORCID: 0000-0003-4010-4835 and Sampat, Bhaven N. (2018) Indian pharmaceutical patent prosecution: the changing role of Section 3(d). PLOS ONE, 13 (4). ISSN 1932-6203

Text - Published Version
Download (538kB) | Preview
Identification Number: 10.1371/journal.pone.0194714


India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of “secondary” pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against secondary applications in the years immediately following its enactment, and where it was, was redundant to other aspects of the patent law, raising concerns that 3(d) was being under-utilized by the Indian Patent Office. This paper uses a novel data source, the patent office’s first examination reports, to examine changes in the use of the provision. We find a sharp increase over time in the use of Section 3(d), including on the main claims of patent applications, though it continues to be used in conjunction with other types of objections to patentability. More surprisingly, see a sharp increase in the use of the provision against primary patent applications, contrary to its intent, raising concerns about potential over-utilization.

Item Type: Article
Official URL:
Additional Information: © 2018 Sampat, Shadlen
Divisions: International Development
Subjects: R Medicine > RS Pharmacy and materia medica
Date Deposited: 11 Apr 2018 11:16
Last Modified: 15 Jun 2024 00:03
Projects: Grant ES/K010999/1
Funders: Economic and Social Research Council

Actions (login required)

View Item View Item


Downloads per month over past year

View more statistics