As discussed in Part 1 of this blog series, TGA has invited submissions by 23 March 2021 on its consultation paper released last Thursday designed to facilitate indication “repurposing”. In particular, TGA has sought submissions on the potential obstacles and...
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication “repurposing”, a phrase coined by TGA to describe the Australian registration of new indications for known medicines. In particular, the TGA has...
Supply of essential oil for topical use infringes method of treatment patent claims Justice Nicholas’ 96-page judgment in John Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686 raises numerous legal issues including contributory infringement under s. 117 of the Patents Act...
On 01 December NPS Medicine Wise published its annual list of the top 10 PBS drugs by cost to the Australian government. Biologics dominated the list, taking 7 of the top 10 places, including the top 5 positions. The top product aflibercept costs the government $392...
The Generic and Biosimilar Medicines Association announced it has appointed Ms Jane Halton AO PSM as its inaugural Independent Chair. Halton will bring a wealth of experience to the role, as former head of the Department of Health (2002-2014), and Department of...
In Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648, the Federal Court of Australia declined to order preliminary discovery against Sandoz, the holder of an ARTG registration for biosimilar etanercept, that had no present intention to launch its ERELZI®...
