Drugs in the fast lane: provisional drug registration and other proposed changes to the Therapeutic Goods Act

Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth). The proposed changes include modifications to the regulation of complementary medicines, and a new class of “provisionally registered goods”.  This read more...
Subjects: Patents

Off to a running start? Federal Court of Australia permits generic manufacturer to make PBS application before patent expiry

Can a manufacturer apply for Pharmaceutical Benefits Scheme (PBS) approval for a generic drug before the patent has expired? Justice Nicholas held in February in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 that the answer was “Yes”, and his Honour’s decision was recently affirmed by the Full Federal Court in read more...

High Court States the Obvious: AstraZeneca AB v Apotex Pty Ltd Appeal Decided

by Kim O’Connell, Suzy Madar and James Ellsmore In a widely anticipated decision, the High Court has upheld a decision of the Full Federal Court that AstraZeneca’s patent relating to low dosages of rosuvastatin is invalid for want of inventive step. Rosuvastatin is used in the treatment of high cholesterol and is marketed by AstraZeneca read more...

Hackers cause recall of 1.4 million cars

by Kim O’Connell, Amanda Engels and Olivia Goudal As foreshadowed in our post on cyber resilience, available here, data breaches and cybercrime are becoming increasing prevalent. These issues are well illustrated by the recent recall by Fiat Chrysler of 1.4 million cars in the United States. On Friday 24 July 2015, Fiat Chrysler issued the read more...
Subjects: Technology

Consultation period commences for China’s new draft cybersecurity law

by Rui Wang (Beijing), Martyn Huckerby, Colin Bailey and Yijia Tu (Shanghai) and Kim O’Connell (Sydney) Foreign companies doing business with Chinese entities or on their own account in China should be aware of the changing landscape for digital information. A Consultation Draft of a New PRC Cyber Security Law was posted on the National read more...
Subjects: Technology