Aristocrat Technologies Australia Pty Limited v Konami Australia Pty Limited (No 3) [2022] FCA 1373 Date:Court:Judge:18 November 2022Federal Court of AustraliaNicholas...
Account of profits/damages as complex as validity/infringement
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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
Significant biosimilar activities this week include: 18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin glargine) as interchangeable The FDA approved Eli Lilly’s...
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
Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for prurigo nodularis The CHMP recommended the approval of Dupixent®...
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
Significant biosimilar activities this week include: 04 Nov 22 | New dupilumab study suggests serum dupilumab levels are not associated with treatment response or adverse effects...
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
Significant biosimilar activities this week include: 28 Oct 22 | Health Canada approves additional COVID-19 indication for Actemra® IV (tocilizumab) Roche Canada announced that...
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
Significant biosimilar activities this week include: 21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™ Spectrum Pharmaceuticals announced the US launch of 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
Significant biosimilar activities this week include: 14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable PK to Stelara® in Ph I trial BioFactura has announced...
Long-running mining systems dispute reaches the merits phase – Globaltech still infringing
Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd & Ors (No 3) [2022] FCA 1189 Date:Court:Judge:6 October 2022Federal Court of AustraliaRofe...
Pearce recognised by WIPR as a Diversity Champion in IP for 2022
We are thrilled to announce that Pearce IP’s founder Naomi Pearce, Executive Lawyer, Patent Attorney and Trade Mark Attorney has been recognised by WIPR as a Diversity Champion...
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
Significant biosimilar activities this week include: 08 Oct 22 | US | Samsung to pursue adalimumab interchangeability in the US In an interview with Managed Healthcare, Samsung...
Pearce IP shortlisted for the award of Boutique Diversity Firm of the Year at the Lawyers Weekly Women in Law Awards 2022
We are excited to announce that Pearce IP is a finalist in the Lawyers Weekly Women in Law Awards in the category of 2022 Boutique Diversity firm of the Year. The Women in Law...
Establishing infringement of representative batches may be insufficient to establish liability
Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92Pharmacia LLC v Juno Pharmaceuticals Pty Ltd (No 2) [2022] FCA 369Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [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
Significant biosimilar activities this week include: 30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA Biogen announced that the EMA has accepted the MAA for BIIB800...
Amgen’s five PCSK9 mAb patents upheld in opposition
Sanofi v Amgen Inc. [2022] APO 67Date:Venue:Delegate:26 September 2022Australian Patent OfficeSophina CalanniBackground The five patent applications the subject of these...
PiPCast™ | Expedited Patent Prosecution in Australia and New Zealand
PiPCast™ | Expedited Patent Prosecution in Australia and New Zealand
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 Justice Jayne Jagot to the bench announced on Thursday 29...
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 adalimumab) in Switzerland Alvotech and STADA announced the...
Naomi Pearce is 2022 Patent Lawyer of the Year (Asia Pacific) at the Women in Business Law Awards
Pearce IP is very proud to announce that its CEO and Executive Lawyer, Patent Attorney and Trade Mark Attorney Naomi Pearce has been honoured as the 2022 Patent Lawyer of the...
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 Yonhap News Agency reported that Celltrion’s ustekinumab...
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 Japan Lupin announced that it has entered into an exclusive...
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 briefs in support of Teva’s skinny label case Alvotech,...
PiPCast™ | The implications of recent DABUS Federal Court decisions for life sciences companies
In this PiPCast™, we discuss whether a patent inventor must be human or can include artificial intelligence systems in Australia, and look to the future legal developments in this space.
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 trials Amgen announced the results of a Ph III study evaluating...
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