TRIPS AGREEMENT AND MALAYSIAN INTELLECTUAL PROPERTY LAWS: DATA EXCLUSIVITY v PATENT

Abstract

This study analyses the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement with respect to the various intellectual property protection mechanisms. The main purpose of this study is to demonstrate that Malaysia is a TRIPS compliance country and have established intellectual property laws including the incorporation of data exclusivity laws. This study also illustrates that data exclusivity and patent are two different intellectual property protection mechanisms required under the TRIPS Agreement. Moreover, this study clarifies the misconception that data exclusivity and patents are somehow related; such that data exclusivity is an extension of patent rights and that it is often regarded as a TRIPS-plus provision. The study is conducted based on qualitative research, predicated on primary sources such as the TRIPS Agreement and the various laws with respect to intellectual property in Malaysia. It is further supported by secondary sources from journals and information provided on relevant authorities’ websites. The results of the study show that Malaysia is a TRIPS compliance country and that data exclusivity is an intellectual property protection mechanism that is established pursuant to Article 39.3 of the TRIPS Agreement. Hence, this study concludes that member countries of the TRIPS Agreement that have established data exclusivity protection mechanism to protect undisclosed data submitted to their respective authorities for the purpose of marketing approval of pharmaceutical or agricultural chemical products, including Malaysia, are indeed in compliance with the obligation set under Article 39.3 of the TRIPS Agreement.