Compulsory licensing for the manufacture and export of patented pharmaceutical inventions

From 25 August 2015, Australian pharmaceutical manufacturers can apply to the Federal Court of Australia for a compulsory licence to manufacture generic versions of patented medicines to supply to developing countries in need. The manufacturers would then be able to supply drugs that would otherwise not be available, to help people in developing countries who face life-threatening illnesses such as malaria, HIV/AIDS or tuberculosis.

This reflects Australia’s role as a good international citizen, and delivers on the Australian Government’s commitment to implement the Protocol amending the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (the TRIPS Protocol).

The new scheme is implemented through Part 3 of Chapter 12 of the Patents Act 1990 and Part 2 of Chapter 12 of the Patents Regulations 1991.

 

Further information

The following Guide provides general information on compulsory licenses for the manufacture and export of patented pharmaceutical inventions to developing countries.

Further information on the supporting legislation is also available on the IP Laws Amendment Act 2015 page and the Consultation on the Intellectual Property Legislation Amendment (TRIPS Protocol and Other Measures) Regulation 2015 page.

Last updated: 
2 August 2016