Abstract
The purpose of this study is to highlight the absence of specific provisions on public health under Article 31bis of the TRIPS Agreement, that were not incorporated into the Patents Act 1983 in Malaysia. The main research question of this study is; why should Malaysia immediately amend its Patents Act 1983 to incorporate these flexibilities? Malaysia must develop effective strategies to implement policies, law and governance in managing the country’s public health system. This is to ensure a balance of rights between intellectual property owners and the public, at all times. This study employs a qualitative research methodology that is based on primary sources such as the TRIPS Agreement and the Patents Act 1983, and is further supported by secondary sources such as journals and the contents of authorities’ websites. This study is limited to the issues related to public health and patents. This study includes a discussion on the provisions related to patents and public health, proposed amendments to the Patents Act 1983 that should incorporate the provisions from Article 31bis, and a conclusion on the importance of immediately amending the Patent Act 1983 to incorporate these provisions, especially during the current Covid-19 pandemic. This study proposes that the amendments be made to Section 84 of the Patents Act 1983 in relation to Rights of Government, and not through the compulsory licence mechanism under Part X of the Patents Act 1983. Thus, this study concludes that currently, Malaysia is unable to implement the provisions under Article 31bis, unless the Patents Act 1983 is amended.
Highlights
The Agreement on Trade-Related Aspects of Intellectual Property Rights 19941 (TRIPS Agreement) was endorsed by members of the World Trade Organization (WTO), and continues to be an important international agreement that protects intellectual property rights in the current era
Malaysia must incorporate the public health flexibilities provided in Article 31bis into the Patents Act 1983 (PA) so that Malaysians can benefit from these flexibilities, and LDCs and other countries with no manufacturing capabilities of pharmaceutical products, the LDCs in ASEAN
In Paragraph 3 and 4 of the Annex to the TRIPS Agreement, Article 31bis states that member countries should exercise caution on the potential misuse of the system that may arise from these public health flexibilities
Summary
The Agreement on Trade-Related Aspects of Intellectual Property Rights 19941 (TRIPS Agreement) was endorsed by members of the World Trade Organization (WTO), and continues to be an important international agreement that protects intellectual property rights in the current era. The TRIPS Agreement outlines the minimum standards of protection on intellectual property that has been acknowledged by member countries of the WTO2. The provisions of Article 31bis enabled member countries to export production of pharmaceutical products under compulsory license (CL) to other countries, to least-developed countries (LDCs) (United Nations Conference on Trade and Development, 2018). Member countries of the TRIPS Agreement could only invoke CL under Article 31 for the purpose of using the patented product within the domestic market (Article 31(f) TRIPS Agreement, 1994) and could not be exported outside of the country. With the addition of the new provision, member countries are permitted to export the production of a patented invention, limited to only pharmaceutical products through CL that is further compliant with certain regulations. CL is granted to allow the ‘infringement of a patent to be legal’, and is subjected to certain guidelines that need to be fulfilled
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