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 Strategy 300 Global Leaders. The 300...
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 Corporation and CuraTeQ Biologics announced...
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 unpatentability for five device patents for...
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 Samsung Bioepsis AU Pty Ltd (SBA) relating...
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® (biosimilar insulin glargine). 20 Dec 21 | US |...
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 speculated last week that the tide may be...
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 two new biosimilar candidates referencing...
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 requirements for a patent term extension...
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 and are at increased risk of progressing...
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 non-squamous non-small cell lung cancer and...
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. Pearce IP was also shortlisted for the...
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 non-squamous non-small cell lung cancer who...
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 health for all Australians: inquiry into...
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 (SME law) at the Lawyers Weekly Women in...
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 increased risk of progressing to severe...
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 entrant seeks to clear the way to get a...
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 target action date in December 2021....
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 on Advancing Access. The campaign seeks...
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 requirements for a patent term extension...
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 construct a new manufacturing facility...
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 FDA has approved Tecentriq® (atezolizumab)...
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 Great Patent Cliff of 2019–2024. With it...
The evolution of jurisprudence in Australia can have far reaching implications for legal practitioners in every jurisdiction. Two recent Federal Court decisions have given Australian patent applicants, and their...
05 Oct 21 | EU | Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking approval of regdanvimab for the treatment of COVID-19 in adults who do not require supplemental oxygen...
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