26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea...
BioBlast w/e 26 May 23
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Naomi Pearce
Naomi is listed in IAM Patent 1000 as one of Australia's leading patent litigators. Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from first hand experience and knowledge as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm.
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PiPCast™ | Best Method and why it is relevant to patents in Australia
PiPCast™ | Best Method and why it is relevant to patents in Australia
CHMP recommends withdrawal of MA for Novartis’s Adakveo® (crizanlizumab)
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Adakveo® (crizanlizumab) should...
Alnylam sues Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines
Alnylam commenced proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer...
MHRA announces new regulatory recognition routes with seven international partners
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory...
Beware the shifting sands of patent term extensions (PTE) in Australia
Recent Australian decisions have resulted in both new opportunities to challenge patent term extensions in Australia...
PiPCast™ | Patent oppositions & litigation – what about estoppel?
PiPCast™ | Patent oppositions & litigation – what about estoppel?
BioBlast w/e 22 May 23
22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of...
Grains of Justice | Preliminary discovery order extended to wheat product samples in CSIRO case
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.
BioBlast w/e 12 May 23
11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported...
BioBlast w/e 05 May 23
04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye...
Poor Drafting and Poor Choice of Expert Brings Calix Process Patent To Boiling Point
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.
BioBlast w/e 28 Apr 23
28 April 2023 | US | FDA advisory committee supports approval of Merck’s Lynparza® (olaparib) combination for first...
Marlow Foods edible fungi patent amended but still obvious
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.
BioBlast w/e 21 Apr 23
20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent®...
BioBlast f/e 14 Apr 23
Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding...