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

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

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

Best Patent Cases 2019 – Australia and New Zealand

Welcome to Shelston’s wrap-up of the most notable patent decisions in Australia and New Zealand delivered during 2019. It was a busy year for patent jurisprudence with some interesting themes emerging – in particular, it has been a banner year for decisions on the “manner of manufacture” requirement for patentable subject matter.   Read our

The distinction between repair and re-making: The Full Court clarifies the law on refurbishing a patented product

This important decision by the Full Court of the Federal Court in Calidad Pty Ltd v Seiko Epson Corporation [2019] FCAFC 115 clarifies the position on an area of law that, surprisingly, is still developing in Australia, namely the scope of the implied licence issuing from the sale of a patented product.   Re-manufacturers that

Genes, genetic applications and patent eligibility: Australia continues to be a gene-patent friendly jurisdiction

Non-invasive prenatal genetic testing based on maternal blood sampling is replacing older invasive forms of testing – a paradigm shift in prenatal medicine. The patent rights associated with these methods have been litigated in several jurisdictions, most notably to date the US, UK and Australia. This decision of Justice Beach in Sequenom, Inc. v Ariosa

Page 1 of 41234