Bayer Pharma Aktiengesellschaft [2022] APO 7Date:Venue:Delegate:7 February 2022Australian Patent OfficeKeith WraggBackground In our 2021 Patent Case summary, we reported on a...
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...
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
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...
Date: 29 January 2021 Court: Federal Court of Australia Judge: McKerracher J Date: 08 December 2021 Court: Full Court of the Federal Court of Australia Judges: Perram, Nicholas...
Date: 08 December 2021Court: Full Court of the Federal Court of AustraliaJudges: Nicholas, Yates and O'Bryan JJ Background Australian Patent Application 2013213708 (708...
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. ...
21 Nov 21 | CN | Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar) combined with chemotherapy in patients with EGFR-mutated...
In the last sitting of Parliament for 2021, the House of Representatives delivered the long-awaited Zimmerman Report, more formally entitled “The new frontier—delivering better...
Pearce IP is proud to announce that Founding Principal and Executive Lawyer, Patent & Trade Mark Attorney, Naomi Pearce, was awarded the title of 2021 Partner of the Year...
Date: 25 November 2021Court: Federal Court of AustraliaJudge: Besanko J Background This appeal from a decision of the Australian Patent Office concerned the allowability of...
15 Nov 21 | EU | Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at...
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