ALL BLOGS BY

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 16 Dec 22: Doer Biologics and Merck collaboration, expanded Dupixent® indications, Fresenius US citrate-free Idacio® (adalimumab) approval, Merck and Moderna cancer vaccine trial results, Amgen acquires Horizon, Alvotech lists on Nasdaq Iceland Main Market, Regeneron seeks expedited motion in aflibercept dispute

by Naomi Pearce | Dec 19, 2022

Significant biosimilar activities this week include: 15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials...

BioBlast w/e 09 Dec 22: Roche’s glofitamab, Paras Biopharma’s new biosimilars division, Biogen’s biosimilar tocilizumab, Alvotech/Stada’s EU Hukyndra® roll out, Biocon closes Viatris biosimilars acquisition

by Naomi Pearce | Dec 12, 2022

Significant biosimilar activities this week include: 11 Dec 22 | New study reports glofitamab is effective in diffuse...

Fall from Grace: Patent Office allows extension of time for claim to grace period but patent still found invalid

by Naomi Pearce | Dec 9, 2022

Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2 Generic Partners Pty Ltd v Neurim Pharmaceuticals...

BioBlast w/e 02 Dec 22: Janssen sues Amgen over ustekinumab, Capstone’s insulin, Erasca trials, Alvotech leadership changes, MHRA Dupixent® guidance, Merck sues JHU on Keytruda patents, Hikma and Celltrion ustekinumab deal

by Naomi Pearce | Dec 5, 2022

Significant biosimilar activities this week include: 03 Dec 22 | Alvotech announces changes to share listings and...

BioBlast w/e 25 Nov 22: AbbVie’s risankizumab, FDA investigating Prolia® (denosumab) risk, Amneal’s filgrastim launch, Junshi Biosciences’ adalimumab, US biosimilars bill, Teva and Sandoz biosimilars ramp-up

by Naomi Pearce | Nov 29, 2022

Significant biosimilar activities this week include: 23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s...

Account of profits/damages as complex as validity/infringement

by Naomi Pearce | Nov 25, 2022

Aristocrat Technologies Australia Pty Limited v Konami Australia Pty Limited (No 3) [2022] FCA 1373...

BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide

by Naomi Pearce | Nov 21, 2022

Significant biosimilar activities this week include: 18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin...

BioBlast w/e 11 Nov 22: Dupixent® recommended by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar approved, Alvotech’s adalimumab IC data, Mylan’s IPR win against Regeneron aflibercept patents, MHRA biosimilars guidance, Amgen biosimilars data, Coherus’ ranibizumab

by Naomi Pearce | Nov 14, 2022

Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for...

BioBlast w/e 04 Nov 22: dupilumab study, Accord cleans up at Global Generics and Biosimilars Awards, Amgen’s Supreme Court petition for certioriari regarding enablement granted, AU tocilizumab COVID shortage measures lifted, Bio-Thera’s secukinumab, Outlook’s ophthalmic bevacizumab, Rani Therapeutics’ oral ustekinumab

by Naomi Pearce | Nov 7, 2022

Significant biosimilar activities this week include: 04 Nov 22 | New dupilumab study suggests serum dupilumab levels...

BioBlast® w/e 28 Oct 22: Expanded indications in CA for Roche’s tocilizumab, AU PBAC outcomes, Alvotech financial results, Biogen seeks PI against Sandoz in natalizumab dispute, JSR/Similis Bio agreement, Regeneron/Mylan expedited aflibercept hearing, Genentech trade secrets sentencing

by Naomi Pearce | Oct 31, 2022

Significant biosimilar activities this week include: 28 Oct 22 | Health Canada approves additional COVID-19 indication...

BioBlast® w/e 21 Oct 22: Spectrum’s eflapegrastim, Eylea® paediatric exclusivity, Saskatchewan biosimilars switching program, AbbVie acquires DJS Antibodies, Lupin FDA observations, Alvotech and JAMP expand partnership, Alvotech/Fuji Pharma, Biocon’s ustekinumab, denosumab

by Naomi Pearce | Oct 24, 2022

Significant biosimilar activities this week include: 21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™...

BioBlast® w/e 14 Oct 22: BioFactura’s ustekinumab, Prestige’s trastuzumab, Merck/Moderna personalised cancer vaccine combo, Regeneron’s aflibercept, Jacobio Pharma/Merck’s cetuximab, Janssen’s guselkumab/golimumab, Alvotech’s aflibercept

by Naomi Pearce | Oct 17, 2022

Significant biosimilar activities this week include: 14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable...

Long-running mining systems dispute reaches the merits phase – Globaltech still infringing

by Naomi Pearce | Oct 13, 2022

Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd & Ors (No 3) [2022] FCA 1189 ...

BioBlast® w/e 07 Oct 22: Samsung Bioepis’ adalimumab interchangeability, Celltrion’s adalimumab interchangeability, FDA biosimilars program, Amneal bevacizumab launch, Medicare Part B biosimilar payment increase

by Naomi Pearce | Oct 10, 2022

Significant biosimilar activities this week include: 08 Oct 22 | US | Samsung to pursue adalimumab interchangeability...

Establishing infringement of representative batches may be insufficient to establish liability

by Naomi Pearce | Oct 5, 2022

Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92Pharmacia LLC v Juno Pharmaceuticals Pty Ltd (No 2) [2022]...

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

by Naomi Pearce | Oct 4, 2022

Significant biosimilar activities this week include: 30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA Biogen...

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