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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 29 July 2022: FDA approves Sandoz’s natalizumab, TGA approves Henlius/Cipla trastuzumab, Prestige/Intas bevacizumab deal, Biocon biosimilars revenue up

by Naomi Pearce | Aug 1, 2022

Significant biosimilar activities this week include: 25 Jul 22 | US | FDA accepts ABLA for natalizumab biosimilar...

Full Court dismisses Boehringer appeal on obviousness of veterinary injectable formulation

by Naomi Pearce | Jul 26, 2022

The Full Court’s decision in Boehringer Ingelheim Animal Health USA Inc., v Intervet International B.V. [2022] FCAFC...

BioBlast® w/e 22 July 2022: Hikma/Celltrion adalimumab deal, Erasca/Lilly cetuximab clinical supply agreement, Celltrion’s tocilizumab clinical trial, Alvotech denosumab study, 100mg/mL Hyrimoz® adalimumab sBLA and Novartis/Sandoz update

by Naomi Pearce | Jul 25, 2022

18 Jul 22 | MENA | Hikma and Celltrion enter into commercialisation agreement for YuflymaTM Hikma Pharmaceuticals...

“Sketchy” prior art renders Globaltech device patent not obvious

by Naomi Pearce | Jul 19, 2022

Globaltech Corporation Pty Ltd v Reflex Instruments Asia Pacific Pty Ltd [2022] FCA 797Date:Court:Judge:12 July...

BioBlast® w/e 15 July 2022: Alvotech board expansion, [vic-]trastuzumab duocarmazine BLA accepted, second Zylonta® + rituximab DLBCL trials, Polpharma natalizumab MAA and eight-year Perjeta® data

by Naomi Pearce | Jul 18, 2022

11 Jul 22 | Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL Overland ADCT BioPharma...

WTO Members endorse latest COVID IP waiver draft

by Naomi Pearce | Jul 18, 2022

The key terms of an updated draft covid IP waiver have been released by the WTO. The draft includes terms intended to...

BioBlast® w/e 8 July 2022: featuring Xbrane’s ranibizumab BLA, Viatris’ insulin glargine, Alvotech’s aflibercept study and AU’s July PBAC meeting

by Naomi Pearce | Jul 11, 2022

04 Jul 22 | US | Xbrane Biopharma provides update on ranibizumab biosimilar Xbrane Biopharma confirmed that it will...

BioBlast® w/e 01 July 22: Samsung seeks to revoke Fresenius’ AU adalimumab patent, Daiichi Sankyo’s trastuzumab deruxtecan sNDA submitted in Japan, PDS0101 Fast-tracked in US, Henlius HLX53 IND accepted

by Naomi Pearce | Jul 4, 2022

24 Jun 22 | AU | Samsung Bioepis commences AU revocation action against Fresenius Kabi adalimumab patent Samsung...

BioBlast® w/e 24 Jun 22: Alvotech dual NASDAQ listing, Samsung Bioepis/Samil ranibizumab, Formycon Q1/22 results, Daiichi Sankyo trastuzumab deruxtecan, Midas Pharma’s ranibizumab, Celltrion’s bevacizumab, Merck’s pembrolizumab, AVEO/Eli Lilly agreement, Innovent’s sintilimab

by Naomi Pearce | Jun 27, 2022

20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection) Innovent Biologics and Eli Lilly announced...

Computer–implemented method of reducing waste of unused medicines rejected by the Patent Office

by Naomi Pearce | Jun 24, 2022

Carefusion 303, Inc [2022] APO 40Date:Venue:Delegate:17 June 2022Australian Patent OfficeG PowellBackground Patent...

BioBlast® w/e 17 Jun 22: featuring Alvotech’s NASDAQ listing, Samsung Bioepis’ eculizumab, Organon/Henlius’ global biosimilars deal, Sandoz’s citrate-free adalimumab and Innovent’s bevacizumab

by Naomi Pearce | Jun 20, 2022

11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data Samsung Bioepis presented data from its Ph III trials of...

BioBlast® w/e 10 June 2022: featuring Alvotech/Stada’s adalimumab, Amgen’s rituximab, Fresenius’ tocilizumab IPR, dostarlimab study and Civica’s insulin

by Naomi Pearce | Jun 15, 2022

02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative Civica announced that is...

BioBlast® w/e 03 June 2022: featuring Outlook’s bevacizumab, Lannett’s insulin glargine, Henlius’ biosims, Novartis’ brolucizumab, Roche’s faricimab, Biogen/Samsung Byooviz™ & GBMA Biosimilars Awareness Week

by Naomi Pearce | Jun 6, 2022

24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims Shanghai...

“Method of” treating in the prior art not distinguishable from a “method for” treating

by Naomi Pearce | May 30, 2022

Astellas Pharma Inc. v Aragon Pharmaceuticals, Inc. [2022] APO 36Date:Venue:Delegate:23 May 2022Australian Patent...

BioBlast® w/e 27 May 22 : Prestige’s trastuzumab rejected by CHMP; Additional EU indications for Merck’s Keytruda; Jury trial set in BMS/AstraZeneca patent infringement suit re durvalumab; First patients dosed in Biond Biologics trials for BND-22 (SAR444881); FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim).. and more

by Naomi Pearce | May 30, 2022

20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®) Prestige’s trastuzumab...

BioBlast® w/e 20 May 22: Alvotech’s biosim ustekinumab study results, Samsung Bioepis’ biosim ranibizumab approved in KR, Teva/BioEq’s biosim ranibizumab approved in the UK; Celltrion’s PhIII clinical trial for tocilizumab biosim

by Naomi Pearce | May 25, 2022

16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)Alvotech announces study results for AVT04, biosimilar...

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