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...
Date: 19 November 2021Court: Full Court of the Federal Court of AustraliaJudges: Middleton, Perram and Nicholas JJ Background In 2018 the Australian Patent Office refused to...
Date: 18 November 2021Court: Federal Court of AustraliaJudge: Burley J Background In December 2016 Pfizer Ireland Pharmaceuticals (Pfizer) filed a preliminary discovery...
The speed of getting a case to trial is a key metric of any litigation system. Pharmaceutical patent litigation often plays out on the cusp of patent expiry when a new market...
09 Nov 21 | Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the...
01 Nov 21 | The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its second Global Biosimilars Week to join the Biosimilars Movement...
In the last year, two significant Federal Court decisions, reported here and here have exposed key flaws in the Australian Patent Office’s interpretation of the eligibility...
22 Oct 21 | Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue year on year. 22 Oct 21 | Chugai Pharmaceutical announced that it will...
14 Oct 21 | Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin glargine biosimilar. 15 Oct 21 | US | Roche announced that the...
Originally published in World Intellectual Property Review 3 2021 After surviving the Great Patent Cliff of 2011–2016, the pharma/biopharma industry finds itself in the Second...
The evolution of jurisprudence in Australia can have far reaching implications for legal practitioners in every jurisdiction. Two recent Federal Court decisions have given...
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