20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection) Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT®...
Computer–implemented method of reducing waste of unused medicines rejected by the Patent Office
Carefusion 303, Inc [2022] APO 40Date:Venue:Delegate:17 June 2022Australian Patent OfficeG PowellBackground Patent Application 2014268829 was filed by Carefusion 303, Inc on 16...
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
11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal...
Pearce named as finalist for the 2022 Lawyers Weekly Partner of the Year Awards (IP)
Congratulations to CEO and Executive Naomi Pearce for being named as a finalist for the Lawyers Weekly Partners of the Year Awards 2022 in the category of Intellectual Property....
BioBlast® w/e 10 June 2022: featuring Alvotech/Stada’s adalimumab, Amgen’s rituximab, Fresenius’ tocilizumab IPR, dostarlimab study and Civica’s insulin
02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative Civica announced that is has selected Profil as its clinical trial partner to...
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
24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims Shanghai Henlius Biotech announced that it has entered into a...
“Method of” treating in the prior art not distinguishable from a “method for” treating
Astellas Pharma Inc. v Aragon Pharmaceuticals, Inc. [2022] APO 36Date:Venue:Delegate:23 May 2022Australian Patent OfficeF WhiteBackground Australian Patent Application 2018206695...
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
20 May 22 | EU | Prestige Biopharma (Roche/Genentech) | HD201, trastuzumab (Herceptin®) Prestige’s trastuzumab rejected by CHMP The CHMP recommended refusing the marketing...
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
16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)Alvotech announces study results for AVT04, biosimilar ustekinumab Alvotech announced positive top-line results...
Intervet inventive step in a veterinary injectable formulation holds on appeal from patent office
Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. [2022] FCAFC 88Date:Court:Judges:18 May 2022Full Federal Court of AustraliaPerram, Nicholas and Burley...
Pearce IP practitioners prominent in WIPR Leaders 2022
Pearce IP is proud to announce that four patent practitioners and three trade marks practitioners are ranked amongst the world’s best by WIPR Leaders 2022. Among the 47 patent...
Multiple interlocutory decisions in long-running mining systems infringement cases
Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd & Ors (No 2) [2022] FCA 88(experimental evidence) Australian Mud Company Pty Ltd & Anr...
Experimental Use Exception Clarified
Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 Date:Court:Judge:16 May 2022Federal Court of AustraliaRofe JBackground Jusand Nominees Pty Ltd (Jusand)...
Medicinal Cannabis in Australia | Part 5: Making therapeutic claims: advertising and labelling of medicinal cannabis products
Introduction The promotion of medicinal cannabis products presents some specific challenges given that very few such products are approved therapeutic goods on the Australian...
Pearce IP BioBlast® w/e 13 May 2022
04 May 22 | Amneal published its Q1 2022 financial results, reporting a 1% increase YoY in net revenue. Amneal announced that it plans to expand into high growth areas including...
Too late to challenge amendments once infringement proceedings commenced
Illinois Tool Works Inc v Airco Fasteners Pty Ltd [2022] FCA 495 Date:Court:Judge:5 May 2022Federal Court of AustraliaRofe JBackground Illinois Tool Works Inc (ITW) is the owner...
Medicinal Cannabis in Australia | Part 4: Protecting plant-related innovation in Australia
Innovation developed from plants and plant-derived material can be substantial and includes biotech crops, food production, feed, fibres, fuel and pharmaceuticals. However, as...
When supply of a staple commercial product is not infringement
Hood v Down Under Enterprises International Pty Ltd [2022] FCAFC 69Date:Court:Judges:4 May 2022Full Federal Court of AustraliaYates, Moshinsky and Rofe JJBackground Mr Hood, the...
Medicinal Cannabis in Australia | Part 3: Beyond PBR – IP rights and medicinal cannabis
As medicinal cannabis (MC) becomes more established in the medicinal sector due to regulatory and attitudinal changes, there has been a corresponding worldwide increase in...
Medicinal Cannabis in Australia | Part 2: Patient access via the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways
Introduction As noted in part 1 of our blog series, the vast majority of medicinal cannabis products are not registered on the Australian Register of Therapeutic Goods (ARTG). ...
Pearce IP BioBlast® w/e 06 May 2022
29 Apr 22 | Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent,...
Pearce IP leaders ranked by MIP in 2022
Pearce IP congratulates two of its patent leaders for being recognised by Managing IP (MIP) in its 2022 IP Stars ranking. Two Pearce IP leaders Naomi Pearce and Jacinta...
Prototype demonstrations invalidate competitor’s patent
Rakman International Pty Ltd v Boss Fire & Safety Pty Ltd [2022] FCA 464Date:Court:Judge:29 April 2022Federal Court of AustraliaYates JBackground This judgment deals with...
Psychedelic Medicines Part 1
Depression, anxiety and related disorders are serious conditions whose treatment is - in many cases - not adequately addressed by existing psychiatric or psychological...
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