In this 55 minute Masterclass, a panel of award winning senior Pearce IP lawyers and patent attorneys discussed the strategic options available to challenge patent rights in Australia, and the ideal circumstances in which each option might be deployed.
03 Mar 22 | US | FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable...
As a female led boutique firm, Pearce IP celebrates the successes of its high achieving women on International Women’s Day. Each of Pearce IP’s CEO, and heads of litigation and...
We previously wrote that, from 24 March 2022, individuals, businesses and organisations with an Australian presence will be able to apply to register a domain name of their...
18 Feb 22 | Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab). Celltrion reported that switching from IV to SC infliximab leads...
In this Boutique Lawyer Show podcast, Pearce IP’s CEO and Executive Naomi Pearce speaks candidly with Lawyers Weekly’s Jerome Doraisamy.
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...
We have previously reported on a number of Federal Court decisions in 2021 invalidating patent term extensions (PTEs) in Australia: Biogen International GmbH v Pharmacor Pty Ltd...
07 Feb 22 | The International Generic and Biosimilar medicines Association (IGBA) announced that it has established a CEO Advisory Committee. Committee members represent Amneal...
01 Feb 22 | JAMP Pharma announced the creation of a new division BIOJAMP™ dedicated to biosimilars. The creation of this division was primarily made possible through JAMP’s...
Last week we alerted you to the release of a draft new National Medicines Policy (NMP) for public comment. The draft NMP was released by the National Medicines Policy Review...
On 2 February a draft of a new National Medicines Policy (NMP) was made available for public comment. The draft NMP was released by the National Medicines Policy Review...
18 Jan 22 | Alvotech announced $21 million in additional commitments for private placement (PIPE) of Oaktree II common stock. Alvotech and Oaktree Acquisition Corp. II...
Pearce IP is proud to announce that Founding Principal and Executive Lawyer, Patent & Trade Mark Attorney, Naomi Pearce, has again been listed in the 2022 edition of IAM...
10 Jan 22 | CA | Alvotech and JAMP Pharma announced that Health Canada has approved Simlandi (high-concentration, citrate-free biosimilar adalimumab). 11 Jan 22 | EU | Orion...
30 Dec 21 | US | Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the US Patent and Trademark Appeal Board’s decisions of...
Shortly before Christmas, the judgment handed down by Justice Burley on 18 November 2021 on a second preliminary discovery application made by Pfizer seeking documents from...
20 Dec 21 | US | Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab. 20 Dec 21 | US | The FDA approved Eli Lilly’s Rezvlogar®...
Newly appointed Justice Rofe delivered an early Christmas gift for generic and biosimilar companies in Australia in the Biogen v Pharmacor reasons delivered yesterday. We...
11 Dec 21 | Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study. 13 Dec 21 | Xbrane Biopharma announced it is developing...
In early November Pearce IP reported on a number of Federal Court decisions which appear to indicate flaws in the Australian Patent Office’s interpretation of the eligibility...
06 Dec 21 | AU | Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen...
01 Dec 21 | CN | Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the treatment of patients with advanced, metastatic or recurrent...
It is our great privilege to share that Pearce IP was honoured as “Intellectual Property Team of the Year” at the Lawyers Weekly Australian Law Awards (2021) on 2nd December. ...
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