Characterizing pharmaceuticals on data exclusivity in Malaysia

Abstract

This study analyses the occurrence and characteristics of pharmaceutical products containing new chemical entities granted data exclusivity in Malaysia since the implementation of the provision in 2011. Data for the drug products granted data exclusivity in Malaysia during March 2011 and April 2014 was obtained from the Malaysian National Pharmaceutical Control Bureau Register for granted data exclusivity. For each product, data on the type of product, the therapeutic class and the patent status in the reference country/jurisdiction and Malaysia was collected. The patent status of the drug products were sourced from international and Malaysian Patent Databases. A total of ten drug products containing new chemical entities (NCEs) were granted data exclusivity during the data period, with an average of 3.3 NCEs per year. The products were distributed among five therapeutic classes, with 50% of the products belonging to antineoplastic agents. Average effective data exclusivity period for the study sample was about 3 years. Nearly all (90%) products had at least one granted patent or patent application covering the active ingredient of the new chemical entities. Both the granted patent period and data exclusivity period run concurrently, with the former extending beyond the latter by an average of 8 years. In this study, data exclusivity was generally associated with high selling drugs. Data exclusivity was mainly used as an additional intellectual property, with the patent period longer than the data exclusivity period.