Pearce IP, an award-winning Australian boutique Intellectual Property firm, specialising in the pharma, biopharma and life sciences industries, has joined Australia’s peak body...
26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea Biomed has reported that Celltrion filed a marketing authorisation...
PiPCast™ | Best Method and why it is relevant to patents in Australia
Recent Australian decisions have resulted in both new opportunities to challenge patent term extensions in Australia and new patent prosecution practices to shield against them....
PiPCast™ | Patent oppositions & litigation – what about estoppel?
22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of Delaware has dismissed with prejudice. The parties agreed...
Pearce IP congratulates two of its leaders, Founder and CEO Naomi Pearce, and Special Counsel Jacinta Flattery-O’Brien PhD, who were honoured this week as MIP Patent stars for...
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.
11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®,...
04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye Pharma announced that it has enrolled its first subject in an...
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.
28 April 2023 | US | FDA advisory committee supports approval of Merck’s Lynparza® (olaparib) combination for first line treatment of prostate cancer Merck announced that the...
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.
20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent® (dupilumab) in children > 6 months Sanofi and Regeneron...
Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab 12...
Webinar | Pharmaceutical Patent Term Extensions The Good, The Bad and the Ugly
Significant biosimilar activities this week include: 01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023 | EU | EMA CHMP gives nod to Samsung Bioepis’ Epysqli™...
The High Court recently issued its decision in the case of Self Care IP Holdings Pty Ltd & Anor v Allergan Australia Pty Ltd & Anor [2023] HCA 8. The court surprised many...
Significant biosimilar activities this week include: 22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs re Regeneron’s key aflibercept patents 21 March 2023 | CN |...
Significant biosimilar activities this week include: 01 March 2023 | CA | Study finds nonmedical switching policy did not negatively impact patients A new study published in...
A central tenet of patent interpretation under Australian law is that the specification should be a given a purposive construction rather than a purely literal one. While this...
Significant biosimilar activities this week include: 09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics facility Novartis announced that Sandoz signed an MOU to build...
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.
Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of Humira® (adalimumab) biosimilar in India Biospectrum...
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