Switching from Biologic to Biosimilar: Australia’s Unique Approach

Switching patients from an originator biologic (the reference product) to a biosimilar version has been a topic of keen interest in recent years, both in Australia and globally, as more biosimilars have emerged onto the market. This trend has flowed from the expiration of data exclusivity and patent protection for a number of important originator

It is becoming clearer when computer-implemented methods are likely, or unlikely, to be deemed patentable subject matter in Australia – Encompass, Rokt and other recent decisions

During the past decade, the patent-eligibility of computer-implemented methods has been a particularly vexing focal point for Australian patent law and practice. With computer technologies now ubiquitous and relatively mature, applying the centuries-old “manner of manufacture” test in a way that is practical and predictable in the eyes of practitioners and their clients has proven

Pilkin v Sony Australia Limited

Mr Vitaly Pilkin appealed from a Federal Court decision summarily dismissing his patent infringement proceedings against Sony Australia and refusing leave to serve Sony entities out of jurisdiction in the US and the UK (see our discussion of that earlier decision in our Best Patent Cases 2019 publication).  The Full Federal Court refused Mr Pilkin’s

It’s a scheme! Rokt overturned in Full Federal Court decision on patentable subject matter

The long-awaited decision in the appeal of Rokt Pte Ltd v Commissioner of Patents [2018] FCA 1988 has finally been handed down, with the Full Federal Court finding the application to be “a marketing scheme”, and establishing that the claimed invention is not patentable subject matter.   The Full Federal Court has handed down their

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

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