Posted by Michael Wonder on 26 Apr 2017
Changes to pharmaceutical extension of term application procedures the latest front in the battle for savings in Australia’s health care budget
26 April 2017 - It’s no secret that the Australian Government is struggling to manage the cost of its health care obligations.
Increasingly it seems these struggles are impacting on the rights of intellectual property holders in the pharmaceutical sector. Both the courts and Government policy appear to be making life for proprietary drug companies in Australia increasingly difficult.
Originator drug companies have suffered some heavy defeats in Australia’s courts in recent times. In mid 2016, subsequent to a finding that a patent on a blockbuster product was invalid, the Full bench of the Federal Court found that there was no reason why the patentee should not reimburse A$60 million in ‘overpaid’ subsidies paid to it under Australia’s PBS.
Very recently, Nicholas J. of the Federal Court found that an application by a generic manufacturer for subsidisation of the cost of a drug under the PBS will only be an infringement of a patent if the commencement of guaranteed delivery of product required by the process will occur during the lifetime of the patent. One wonders if ‘stockpiling’ will be the next domino to fall.
