Introduction Medicinal cannabis is now widely available in Australia. However, the vast majority of medicinal cannabis products are not registered on the Australian Register of...
21 Apr 22 | AU | Australia’s TGA granted orphan drug designation to Roche’s glofitamab. The TGA also provided approval for Roche to apply for registration using the provisional...
14 Apr 22 | CA | BIOJAMP announced the launch of SIMLANDI™/AVT02 (high-concentration, low volume, citrate-free biosimilar adalimumab) in Canada. JAMP Pharma has exclusive...
We recently reported on the decision in Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92 in which the Federal Court found certain batches of Juno’s generic parecoxib...
Commissioner of Patents v Thaler [2022] FCAFC 62Date:Court:Judges:13 April 2022Full Court of the Federal Court of AustraliaAllsop CJ, Nicholas, Yates, Moshinsky and Burley...
11 Apr 22 | CA | Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada. Yuflyma® is approved...
An enlarged bench of the Full Court of the Federal Court has overturned a first instance decision, reported here, by confirming that artificial intelligence (AI) cannot be named...
In the first such judgment since the 1980s, Justice Moshinsky has granted an interlocutory injunction to prevent TMA from threatening patent infringement proceedings against...
Thank you to all our clients who participated in the inaugural 2022 Pearce IP “We Hear You” survey. The responses we received included clients providing over 45% of Pearce IP’s...
31 March 22 | Fresenius Kabi announced that it has bought a majority stake (55%) in mAbxience, a company specialising in biosimilars, for an upfront EUR 495 million plus...
Novartis AG v Pharmacor Pty Ltd [2022] FCAFC 58 Date:Court:Judges:4 April 2022Full Federal Court of AustraliaYates, Beach and Moshinsky JJBackground Primary proceedings...
The Full Court’s refusal of leave to appeal today in Novartis AG v Pharmacor Pty Limited [2022] FCAFC 58 is good news for the cost of patent litigation in Australia: it may have...
In the quest for a more sustainable future, not least of all in response to the pressing issues of climate change and global population growth, innovative agri-technology and...
In its 2022-23 Budget, the Coalition Government has stated that it will continue to fund litigation against originator pharmaceutical companies that prevent generic versions of...
28 Mar 22 | Aurobindo announced that it will acquire certain business assets from Veritaz (the supplier of branded generic formulations and other health care products) for Rs 171...
The Australian treasurer, Josh Frydenberg used his budget speech yesterday to make several announcements in relation to new pharmaceuticals to be listed in the Australian...
In the Coalition Government’s Budget for the financial year 2022-23, it sets out the investments that it would make should the Coalition remain in power after the next election,...
19 Mar 22 | US | Amgen and Pfizer settled their pegfilgrastim (Neulasta®) dispute Amgen Inc v Hospira Inc (D. Del., No. 20-201) which has been on foot since February 2020. No...
Commissioner of Patents v Ono Pharmaceutical Co. Ltd & Anr [2022] FCAFC 39 Date:Court:Judges:18 March 2022Full Federal Court of AustraliaAllsop CJ, Yates and Burley...
Merck Sharp & Dohme & Anor v Sandoz Pty Ltd [2022] FCAFC 40 Date:Court:Judges:18 March 2022Full Federal Court of AustraliaAllsop CJ, Yates and Burley JJBackground...
14 Mar 22 | OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar Solutions Inc. to create a contract biosimilars...
Introduction Pharmacia LLC and Pfizer Australia Pty Ltd (together, Pharmacia) have partially succeeded at first instance in their claim against Juno Pharmaceuticals Pty Ltd...
Introduction The decision of the High Court in H. Lundbeck A/S v Sandoz Pty Ltd [2022] HCA 4 (Lundbeck) last week concerning allegations of patent infringement in respect of...
On 18 March 2022, the Full Court gave highly awaited judgments in two cases[1] concerning the validity of patent term extensions (PTEs) in Australia. Together, these judgments...
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