TGA transparency reforms (part 2): Early publication of major innovator prescription medicine applications

In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to provide early confidential notification to innovators of applications under evaluation for generic and biosimilar product registration. In this Part 2, we focus on the TGA’s other proposed reform, the earlier publication of applications

TGA transparency reforms (part 1): Notification of generic and biosimilar medicines to impact pharmaceutical patent disputes in Australia

Regulatory changes recently approved by the Australian Government are likely to impact the way in which pharmaceutical patent litigation is conducted in Australia. The Therapeutic Goods Administration (TGA) is currently seeking feedback on options for implementing the proposed Prescription Medicines Transparency Measures by 9 June 2020. The reforms are directed at:   1. Early publication

Growth for Start-ups/SMEs begins with IP

Recent figures show that 70 per cent of local intellectual property (IP) protection filings (patent, trade marks, registered designs) in Australia come from SMEs.    These figures were presented by IP Australia Director General Patricia Kelly during a recent seminar Intellectual Property – your business here and abroad, hosted by IP Australia and InnovationAus. It’s