19 Jul 21 | Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration. 19...
12 Jul 21 | Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole...
05 Jul 21 | Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone...
Although Australia has taken steps in recent years to harmonise its patent laws with those around the globe, significant differences remain. This means that patent practitioners operating in one jurisdiction need to...
27 Jun 21 | CN | Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar...
Pearce IP recently reported on the Full Court of the Federal Court decision in Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101, which confirmed that a method of detecting cell-free foetal DNA (cffDNA) in...
Pearce IP is proud to announce that our team has once again been ranked among the best patent practitioners in Australia by IAM Patent 1000. Both our litigation and prosecution teams have been recommended in the 2021...
A new report demonstrates that female-dominated inventor teams in biomedical sciences are more likely to invent female-focused inventions, but a lack of majority female inventor teams means society is missing out. Last...
Pearce IP is proud to announce that our team of patent and trademark lawyers and attorneys has been selected as a finalist for the Intellectual Property Team of the Year 2021 in the Australian Law Awards. Pearce...
23 Jun 21 | US | Genentech announced that the FDA has accepted the BLA for its Port Delivery System with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or...
Following our recent announcement that Principal Naomi Pearce (Patent Star 2021) and Associate Dr Jessica Chadbourne (Notable Practitioner 2021) were honoured with Managing IP (MIP) Patent Star 2021 awards, Pearce IP’s...
Diagnostic tests that rely on a naturally occurring phenomenon patent eligible in Australia On 18 June 2021, the Full Court of the Federal Court confirmed in Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101...
10 June 21 | The UK's NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended...
07 Jun 21 | Celltrion launched Remsima SC® (subcutaneous infliximab biosimilar) in Canada. Remsima SC® is indicated for the treatment of rheumatoid arthritis. 07 Jun 21 | Merck released new data on Keytruda®...
In September 2020, Pearce IP reported on a significant Australian Patent Office decision, which held that a patent term extension (PTE) request must be based on the first regulatory approval of a product covered by the...
Pearce IP is proud that its patent practitioners feature again in the Managing IP Awards 2021. Congratulations to Naomi Pearce, Principal Lawyer, Patent Attorney and Trade Mark Attorney honoured as an IP Star 2021,...
Pearce IP recently reported on recommendations made by an independent review into the Australian patent system to overhaul the way in which patent litigation proceeds in Australia. Overall, the Report prepared from the...
31 May 21 | Celltrion will launch Yuflyma® (biosimilar adalimumab) in the EU in June, as reported by the Korea Herald. Citing ‘industry sources’ and a Celltrion official, the Korea Herald discloses that Celltrion will...
At the end of 2020, we reported on a Government review of the Australian patent system and its accessibility for small and medium sized enterprises (SMEs). The Patent Accessibility Report prepared from the review (the...
24 May 21 | IN | Zydus Cadila announced it has launched Ujvira (trastuzumab emtansine) in India. Ujvira is an antibody drug conjugate biosimilar and is available in 100mg and 160mg vials at a considerable discount to...
12 May 21 | Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%. Celltrion announced that it is planning to complete Ph III trials of biosimilar...
11 May | US | Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to its biosimilar adalimumab, AVT02. Alvotech...
On 11 May 2021, Treasurer Josh Frydenberg announced that the 2021-2022 Australian Federal Budget would introduce a Patent Box tax break. This regime is designed to encourage domestic research and development and...
Pearce IP's Executive Lawyer and Patent Attorney Katrina Crooks has been re-listed in Doyles Guide (for 2021) as a Leading Contentious Intellectual Property Lawyer. Pearce IP's Principal Naomi Pearce says: "Katrina's...
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