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24 June 2022

The Patent Linkage Scheme for Pharmaceuticals in Singapore: Assessment and Suggestions for Reform

Edwin Neo Xuan Hao & Lee Kwang Chian

Published on e-First 24 June 2022

Abstract:
Since 2004, Singapore adopted the patent linkage scheme from the US to meet its obligations under the US–Singapore Free Trade Agreement. The patent linkage scheme requires a generic drug manufacturer that wishes to obtain a licence from the Health Science Authority to notify the patent holder of its application. If the generic licence applicant files a Category B application, claiming invalidity or non-infringement of the patent, the patent holder may, within 45 days of being notified, initiate an infringement proceeding that will trigger a 30-month moratorium against marketing approval of the applicant’s drug. While the patent linkage scheme has generally been well received in the US, the form of the patent linkage scheme in Singapore is significantly different – Singapore has modified its version of the scheme to be more pro-patentee. Most notably, it has left out the exclusivity bounty to incentivise generic manufacturers to file Category B applications. While it is important for new medicines to be innovated, this article submits that a better balance ought to be achieved, especially since Singapore has a robust generic pharmaceuticals industry. Moreover, the patent linkage scheme in the US has its limitations, including reverse payment settlement agreements and the provision of exclusivity for unmeritorious first generic applications. This article shall explore these issues and suggest how the patent linkage scheme may be reformed.