An empirical analysis of primary and secondary pharmaceutical patents in Chile.

María José Abud,Bronwyn Hall,Christian Helmers,L Michel Espinoza-Fonseca

doi:10.1371/journal.pone.0124257

Abstract

We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between “primary” (active ingredient) and “secondary” patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate “older” therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents.

Highlights

Pharmaceutical patents are among the most controversially debated issues with regard to intellectual property (IP) protection, especially in developing countries
We provide a number of descriptive findings that show that pharmaceutical patents associated with drugs that have received market approval are almost exclusively the domain of foreign originator companies
We find that only a subset of drugs with market approval is protected by patents, a much larger number of products are protected by trademarks

Summary

Introduction

Pharmaceutical patents are among the most controversially debated issues with regard to intellectual property (IP) protection, especially in developing countries. During the negotiations of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, pharmaceutical product patents represented one of the most divisive issues, being opposed by developing countries because of concerns that stronger patent protection would hinder access to drugs and prevent the development of a domestic pharmaceutical industry. The TRIPS agreement forced developing country members of the World Trade Organization (WTO) to grant patents with a statutory lifetime of 20 years from the patent application to pharmaceutical compounds. Almost two decades after TRIPS, the empirical evidence on its effect on developing countries is at best mixed [1,2,3].

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