Patent Act amendments - impact on biotechnology patenting


Oon Yen Yen

Following enforcement of the amended Patent Regulations, reformation of Malaysia’s IP laws continues with the new provisions and amendments proposed to the Patents Act scheduled to be tabled in Parliament in June 2011.

The Patents (Amended) Act 2011 contains many new provisions and enhancements that will be directly beneficial for the local biotechnology industry.

This is very much in line with phase II of Malaysia’s National Biotechnology Policy announced by then Prime Minister, Tun Abdullah Badawi, in 2005. In phase II (2011 to 2015), emphasis is placed on the development of human capital for the discovery and development of new drugs based on natural resources—protection of IP arising from such development is essential.

A new provision has now been proposed that allows the government to grant rights for the manufacture, export and import of generic drugs without the prior consent of patent owners. This is an expansion to the existing provisions for generic drugs in the act (e.g. compulsory licence) and is as provided for under the Doha Declaration (paragraphs 1(a) and 2(a) of the TRIPS agreement) of which Malaysia is a party.

Malaysia Patent Act