Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92Pharmacia LLC v Juno Pharmaceuticals Pty Ltd (No 2) [2022]...
Establishing infringement of representative batches may be insufficient to establish liability
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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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BioBlast® w/e 30 Sep 22: Biogen’s tocilizumab, Celltrion’s bevacizumab, Samsung Bioepis’ aflibercept and ranibizumab, Merck’s pembrolizumab, Intas’ ranibizumab, Pfizer/BioNTech/Moderna COVID vaccine patents, biosimilars executive order
Significant biosimilar activities this week include: 30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA Biogen...
Amgen’s five PCSK9 mAb patents upheld in opposition
Sanofi v Amgen Inc. [2022] APO 67Date:Venue:Delegate:26 September 2022Australian Patent OfficeSophina...
Jayne Jagot appointed to Australia’s High Court bench – a new era for diversity and for patent law
The Australian High Court will have an experienced intellectual property judge on its bench, with the appointment of...
BioBlast® w/e 23 Sep 22: Stada/Alvotech’s adalimumab launch, AZ/Merck olaparib PRC approval, AVEO’s ficlatuzumab US fast-tracked, Sandoz’s denosumab, interchangeability in the EU, Coherus’ US ranibizumab launch, Celltrion invalidates Rituxan® patent, Formycon’s pembrolizumab, Celltrion’s bevacizumab
Significant biosimilar activities this week include: 22 Sep 22 | CH | STADA launches Alvotech’s Hukyndra® (100mg/mL...
BioBlast® w/e 16 Sep 22: Celltrion ustekinumab Ph III trials, Genentech/Samsung Bioepis’ US Avastin® settlement, Biogen natalizumab suit ats Sandoz/Polpharma, Lupin etanercept Rymti® CA approval, Prestige’s bevacizumab withdrawal, Apotex’s tocilizumab IPR (Regeneron), STADA/Xbrane ranibizumab approval; Biosimilars PiPCast®
Significant biosimilar activities this week include: 07 Sep 22 | Celltrion’s ustekinumab biosimilar Ph III trials...
PiPCast™ | Biosimilars – strategies for AU market entry
In this PiPCast®, Naomi Pearce walks through the key IP strategies biosimilars companies are using to enable market entry globally, and canvas biosimilar litigation in Australian courts. They also discuss recent litigation settlement activity and lessons learnt.
BioBlast® w/e 09 Sep 22: Lupin & I’rom’s denosumab, Lupin & DKSH to supply Alvotech products, Cipla/Alvotech’s AU biosimilar adalimumab approved, Formycon half year results, Celltrion’s tocilizumab IPRs instituted, Regeneron aflibercept studies, Organon’s AU biosimilars roadmap
Significant biosimilar activities this week include: 25 Aug 22 | JP | Lupin and I’rom sign licence for denosumab in...
BioBlast® w/e 02 Sep 22: Teva’s skinny label case, Merck’s Keytruda® data, Outlook’s ophthalmic bevacizumab, Biocon FDA observations, Alvotech and STADA financial results, Fresenius Kabi’s Stimufend® FDA approved
Significant biosimilar activities this week include: 12 Aug 22 | US | Alvotech, Mylan & others file amicus curiae...
BioBlast® w/e 26 Aug 22: Novartis to spin off Sandoz, Moderna sues Pfizer and BioNTech over COVID vaccine, Amgen’s eculizumab, Alvotech’s denosumab, Samsung Bioepis’ ranibizumab, Formycon’s ranibizumab, JAMP’s CA win against AbbVie
Significant biosimilar activities this week include: 23 Aug 22 | Amgen announces the results of Ph III eculizumab...
High Court has a bet each way on electronic gaming machine patent
Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2022] HCA 29Date:Court:Judges:17 June 2022High...
High Court has a bet each way on electronic gaming machine patent
Even the High Court of Australia could not come to a majority decision on the thorny question of the patentability of...
BioBlast® w/e 19 August 2022: J&J Remicade decline, ALX evorpacept, FDA approves 100mg/mL Hadlima™, Formycon Ph III ustekinumab trials, Beovu® additional indication, EC approves Vegzelma™, Fresenius Kabi tocilizumab, Cipla pegfilgrastim, Merck/Orna Therapeutics collaboration
Significant biosimilar activities this week include: 11 Aug 22 | ALX Oncology initiates Ph II trials of evorpacept in...
BioBlast® w/e 12 August 2022: Mylan Eylea® IPR, Daiichi Sankyo trastuzumab deruxtecan, Alvotech Icelandic listing move, Opthea funding for OPT-302, Merck Keytruda® clinical trials, Qila denosumab study
Significant biosimilar activities this week include: 27 Jul 22 | CN | Ph III trial shows Qila’s denosumab biosimilar...
BioBlast® w/e 05 August 2022: Viatris’ etanercept; Celltrion’s seeks IC for Yuflyma®; Samsung Bioepis’ 3rd AU suit against Fresenius Kabi; AbbVie’s patent thicket; New Stelara® indication; Fresenius Kabi’s tocilizumab; Coherus’ ranibizumab US approved with IC; Regeneron sues Viatris (aflibercept); Coherus’ high concentration adalimumab
Significant biosimilar activities this week include: 27 Jul 22 | AU | Viatris (Mylan) seeks PBS listing for etanercept...
PiPCast™ | PTE in Australia
Pearce IP’s Naomi Pearce speaks about the hot topic in Australian patent law: Patent Term Extension (PTE) in Australia