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

Australian Designs – Changes on the way

IP Australia has now released its proposals for implementing the recommendations of the Advisory Council on Intellectual Property’s (ACIP) to improve the Australian designs system.   For background, in 2012 ACIP was asked to investigate and improve the effectiveness of the designs system in stimulating innovation by Australian users and the impact the designs system

The Claws Come Out – A Distinctive Design

Caterpillar Inc. v Sayvest Pty Ltd [2020] ATMO 16 (5 February 2020)   Caterpillar Inc. (Opponent), the well-known US construction equipment manufacturer, was partially successful in its oppositions to registration of two trade marks (Trade Marks) IRONCAT (Word Mark) and IRONCAT TYRES logo shown below by Sayvest Pty Ltd (Applicant) for various tyres in class

Federal Court dismisses first Commonwealth damages claim against an unsuccessful pharmaceutical patentee

In an unprecedented decision, the Federal Court of Australia has considered and dismissed a claim by the Commonwealth Government for compensation from sponsors of innovator pharmaceutical products, pursuant to undertakings as to damages given in exchange for an interlocutory (preliminary) injunction restraining the launch of the first generic product: Commonwealth of Australia v Sanofi (No

Sealed Air Australia Pty Limited v Aus-Lid Enterprises Pty Ltd [2020] FCA 29

Sealed Air Australia Pty Limited v Aus-Lid Enterprises Pty Ltd [2020] FCA 29 (24 January 2020) Judge: Kenny J The Federal Court of Australia awards almost $3m in damages to the exclusive sublicensee under a patent licensing agreement.  The patent owner (licensor) was ordered to pay $1.32m for granting another licence over the patent in

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

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