Following introduction to the Australian Parliament on 19 March 2014, the Intellectual Property Laws Amendment Bill 2014 was passed by the House of Representatives on 24 November 2014 and received its second reading in the Senate on 25 November 2014. Although the proposed changes are relatively minor compared to the changes introduced with the ‘Raising the Bar’ amendments of 2013, there are two significant changes to the Patents Act 1990.
The first is the insertion of compulsory licensing provisions to enable Australian pharmaceutical manufacturers to supply developing countries with generic versions of patented medicines. These provisions form part of Australia’s implementation of the Protocol amending the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property (‘TRIPS Protocol’) that was agreed to in 2007.
The provisions are intended to allow the Federal Court to make an order requiring the grant of a compulsory licence to exploit a patented pharmaceutical invention for manufacture and export to an eligible importing country. In addition, the court could make an order that a compulsory licence be granted if the proposed use of the pharmaceutical product is to address a public health issue in the eligible importing country:
- in a national emergency (or other extremely urgent circumstances); or
- by the public non-commercial use of the product.
IP Australia has issued an Exposure Draft Regulation which includes the above provisions. The deadline for submissions is 15 February 2015.
The second significant change relates to provisions required to implement a single trans-Tasman patent attorney regime, a single patent application process (‘SAP’) and a single examination process (‘SEP’) for Australia and New Zealand (‘the trans-Tasman initiatives’). The basis for the trans-Tasman initiatives is the Single Economic Market agenda aimed at strengthening the economic relationship between Australia and New Zealand. The concept of the trans-Tasman initiatives was initially agreed to, in principal, by the Prime Ministers of the two countries, in 2009.
At this stage, IP Australia has released a consultation paper on proposed changes to implement the trans-Tasman initiatives and has invited interested parties to make written submissions on those proposed changes. The deadline for making submissions is 15 February 2015.