A ‘new normal’ when it comes to the TGA regulation of medical devices?

Key points: In Australia responding to the urgent need for COVID-related medical devices the TGA implemented a number of emergency measures to bring medical devices to market faster. The emergency regulatory measures have proven agile, flexible and successful with the potential risks to the public well managed. The regulatory measures have potential utility beyond the … Read more

Trust on a plate: consumer confidence and food safety

Consumer confidence in the origins and safety of the food they purchase and consume is a significant aspect of food brand protection and longevity. Maintaining that confidence involves the use of many different strategies, rights and regulatory controls at national and international level. In Trust on a plate: consumer confidence and food safety, the latest briefing in our Future of Consumer series, contributors Italy, Australia, the UK, China, Indonesia and across the EU cover food trust issues including geographical indications, labelling, supply chain transparency and food crime. Read more

Doctrine of implied licence exhausted in Australia

A 4:3 majority of the High Court of Australia has today overturned the Full Federal Court’s unanimous decision in Calidad v Seiko (2019) 270 FCR 572. Today’s decision breaks with the Privy Council’s 1911 decision in Menck1 and holds that in Australia the doctrine of ‘exhaustion of rights’ should apply, not one of ‘implied licence’. Read more

Where is the balance now? Preliminary injunctions in pharmaceutical patent proceedings in 2020 and beyond

Recent decisions of the Federal Court of Australia have significantly changed the way in which parties to pharmaceutical patent litigation should analyse and approach preliminary injunction applications. While previously a patentee could generally expect to obtain a preliminary injunction if their product was facing a mandatory price drop as a result of generic or biosimilar … Read more

Takeaways from the In-N-Out and Down-N-Out burger brands battle

A series of recent Federal Court cases provides a warning to “cheeky” traders whose marketing draws too closely on the brand and reputation of their rivals. In February, the Federal Court ruled that the operators of the Down-N-Out burger chain were liable to In-N-Out Burgers for trade mark infringement, misleading or deceptive conduct, and passing … Read more

Has the Full Court ‘Rokt’ the boat

Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86 is the most recent in a string of decisions by the Full Court of the Federal Court in which the Court has yet again rejected a computer-implemented invention in this instance a digital advertising system and method as patentable subject matter. Read more

Commonwealth fails in its claim for compensation for PBS expenditure

The Federal Court’s decision in Commonwealth v Sanofi Justice Nicholas’ long-awaited decision in Commonwealth v Sanofi is an Australian first.1 Of the 4 cases in Australia in which the Commonwealth has sought compensation for losses arising from an interlocutory injunction restraining the launch of a generic drug, it is the only one to have reached judgment.2 The decision therefore … Read more