Naomi Pearce Archives | Page 14 of 15

How medicine repurposing could unravel the pharma industry in Australia

by Naomi Pearce | Feb 15, 2021 | Blog, Naomi Pearce

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...

Exclusive licensees: are you stuck in a “No Standing” zone?

by Naomi Pearce | Feb 11, 2021 | Blog, Naomi Pearce

Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining the identity of the patentee or exclusive licensee, the Court will look to the...

TGA seeks consultation on issues relating to the registration of off-label use of medicines: Part 1

by Naomi Pearce | Feb 9, 2021 | Blog, Naomi Pearce

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

by Naomi Pearce | Dec 23, 2020 | Blog, Naomi Pearce

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...

Biologics dominate list of costliest drugs

by Naomi Pearce | Dec 9, 2020 | Blog, Naomi Pearce

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...

Jane Halton appointed as GBMA Chair

by Naomi Pearce | Dec 9, 2020 | Blog, Naomi Pearce

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...