Reforming Patent Term Extensions: Aligning Pharmaceutical Exclusivity with Public Health Needs

Abstract

The patent term extensions (PTEs) and supplementary protection certificates (SPCs) are meant to provide an opportunity to the pharmaceutical innovator to compensate for the delay in receiving regulatory approval to launch the pharmaceutical products into the market. It has been shown that having exclusivity through PTEs or SPCs isn’t simply about recouping investment, and that it also stops access to cheaper generic versions of the drugs. A comparison of PTEs/SPCs is presented for the major jurisdictions, namely the US, European Union, Japan, Australia, and India. A thorough study was done for the drugs Lipitor, Gleevec, Revlimid, and Humira, revealing how benefits from long patents have allowed these companies to tightly control the market and collect large profits. This article suggests a list of policy recommendations to assist PTEs/SPCs systems to align with public health goals, a 5-year global limit extension, one extension per drug, a necessary public interest review, data-based paediatric exclusivity, all-inclusive exclusivity of 15 years from the date of regulatory approval, and creation of a uniform standard by international organisation. The policy recommendations are important for ensuring there is a balance between incentives for pharmaceutical innovation and public access to affordable medicines.