Naomi Pearce Archives | Page 15 of 16

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...

Preliminary discovery not justified by fear of a future product launch

by Naomi Pearce | Dec 1, 2020 | Blog, Naomi Pearce

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®...

TGA Approves Second Registered Medicinal Cannabis Product

by Naomi Pearce | Oct 1, 2020 | Blog, Naomi Pearce

The TGA has approved GW Pharma’s Epidyolex® (cannabidiol) as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients over 2 years of age. Epidyolex® was developed by GW Pharma in partnership with Chiesi...

Pharmaceutical patentees beware – the Australian Patent Office lays down the law on patent term extensions!

by Jacinta Flattery-O'Brien PhD, Naomi Pearce | Sep 18, 2020 | Blog, Jacinta Flattery O’Brien PhD, Naomi Pearce

The Australian Patent Office, in Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, has emphatically confirmed that a patent term extension (PTE) request must be based on the first regulatory approval of a product covered by the claims, even if it is a competitor...

IP Australia Increases Patent and Trade Mark Fees from 01 October 2020

by Naomi Pearce | Aug 11, 2020 | Blog, Naomi Pearce

Commencing 1 October 2020, IP rights in Australia will come with a slightly higher price tag. The new fees are not global but are selective across all types of IP rights. As outlined by IP Australia, these increases are seen as recovering administration costs....

New Thinking for New Science- Biopharmaceutical Patent Disputes in Australia

by Naomi Pearce | Jun 30, 2020 | Blog, Naomi Pearce

First published as: Pearce et al, ‘New Thinking for New Science – Biopharmaceutical Patent Disputes in Australia’ (2020) 120 Intellectual Property Forum 33. As we consider the future of pharmaceuticals (“pharma”), we sharpen our focus on biologics in...