Criteria for pharmaceutical patent 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.   These requirements include: (a)

Federal Court brings generic manufacturers a step closer to a large damages payment re Escitalopram

The Federal Court of Australia has dismissed an appeal by Alphapharm and others against the Commissioner of Patents’ decision to allow a patent term extension on Lundbeck’s patent covering the antidepressant drug Escitalopram (LEXAPRO) (the Escitalopram Patent) – Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185. This decision immediately followed the High Court’s

The High Court confirms extensions of time for patent term extensions

The High Court of Australia has confirmed by a three to two majority that extensions of time under s223(2) of the Patents Act and the associated regulation permit the Commissioner of Patents to extend the time within which to apply for a pharmaceutical patent term extension under s70(1) – Alphapharm Pty Ltd v H Lundbeck