<img src="https://publish-01.obsidian.md/access/744ac39d33cabbc297b91373bfcac24d/bin/images/Malaysia_map.png" alt="Malaysia" class="page-header-sidebar-image"> Malaysia has provisions in its legislation relating to the granting of compulsory licences. These can be found in the Patents Act 1983 (Act 291). There are two main grounds to obtain a compulsory licence (all under Section 49 Patents Act 1983): - Lack or insufficiency of exploitation - After 3 years from grant or 4 years from filing (whichever later), if the patented invention is not being worked in Malaysia without legitimate reason; or worked but does not meet demand in Malaysia without legitimate reason. - Special cases (at any time after grant) - If the patented products are sold at unreasonably high prices in Malaysia; or - For pharmaceutical production in Malaysia for export to an eligible importing country facing a public-health problem. The Act also separately provides for Government use (“rights of Government”, Section 84) in the public interest, national emergency, or to remedy anti-competitive practices. More information can be found [here](https://www.myipo.gov.my/wp-content/uploads/2025/02/LAMPIRAN-D37-Patents-Act-1983-Act-291-As-at-30-June-2023-Online-version-of-updated.pdf ). ## Compulsory licences Malaysia has granted compulsory licence for: - [[Sofosbuvir]] ## Generic manufacturers Malaysia has its own generic manufacturer: [Duopharma Biotech Berhad](https://duopharmabiotech.com/ ).