Criteria for pharmaceutical term extensions clarified

To compensate patent owners for the time it takes to obtain regulatory and marketing approval for new drugs, the Australian Patents Act provides for patent term extensions of up to five years. However, in order to have an extension of term granted, a number of requirements need to be satisfied. One of these requirements is

Australia’s pharmaceuticals patents under review

The Australian Government has announced a review of the pharmaceutical patents system to establish whether it is “effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry” and, in particular, whether the system “is being used to extend pharmaceutical monopolies at the expense of new market entrants”.