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

Bhaven N Sampat,Kenneth C Shadlen,Joshua L Rosenbloom

doi:10.1371/journal.pone.0194714

Abstract

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.

Highlights

India began to allow pharmaceutical products to become patented in 2005, in compliance with the country’s obligations under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
As we seek to understand how the patent office functions and, the role of Section 3(d) in patent prosecution processes, we focus not just on the Indian Patent Office (IPO)’s final decisions, and examiners’ initial reports, as well as the exchanges that occur between applicants and the patent office following issuance of the initial reports
To examine the role of 3(d) over time, we focused on applications that have first examination reports (FERs)

Summary

Introduction

India began to allow pharmaceutical products to become patented in 2005, in compliance with the country’s obligations under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). To obtain a pharmaceutical patent in India, do applicants have to satisfy traditional criteria that are common across all countries, e.g. novelty and inventive step, and meet Section 3(d) requirements.

Results

Conclusion