On 19 September 2024, the Federal Court of Australia delivered judgment ordering Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties following proceedings bought by the Department of Health in August 2021…
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Naomi Pearce
Salt in the Wound: Federal Court Dissolves Novartis’ Patent Claims and Takes Aim at Hypothetical Tasks
On 13 November 2024, Justice Yates of the Federal Court of Australia delivered his decision in the dispute between Novartis AG and Novartis Pharmaceuticals Australia Pty Limited (together, Novartis) and Pharmacor Pty Limited (Pharmacor) regarding patent AU2003206738 entitled “Pharmaceutical compositions comprising valsartan and NEP inhibitors” (the Patent).
Pearce IP BioBlast® for the week ending 13 December 2024
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 13 December 2024 are set out below:
Lundbeck-Sandoz Saga Continues: Federal Court Determines Historical Licence Scope in Long-Running Patent Litigation
Justice Jackman has delivered the latest decision in the long-running dispute between Lundbeck and Sandoz regarding Lundbeck’s Australian Patent AU1989036295 for the “(+)-enantiomer of citalopram and process for the preparation thereof”.
Pearce IP BioBlast® for the week ending 6 December 2024
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar...
Pearce IP BioBlast® for the week ending 29 November 2024
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar...
Pearce IP BioBlast® for the week ending 22 November 2024
Aflibercept 18 November 2024 | EU | Approval Alert: Samsung Bioepis/Biogen’s Aflibercept Biosimilar Approved in EU On...
Settlement Sense and Costs Consequences: Federal Court’s Latest Guidance
As patent proceedings involve substantial legal expenses, parties typically employ various mechanisms to optimise cost recovery, often by issuing Calderbank letters as well as formal Notices of Offer under the Federal Court Rules, which place the receiving party at risk of indemnity costs orders should the other party receive a more favourable judgment than the terms proposed in the offer.
Four Peptides, No Problem: Neoantigen Patent Stands Strong in Opposition Proceedings
Delegate Wagg of the Australian Patent Office has ruled in favour of Dana-Farber Cancer Institute, Inc. and The General Hospital Corporation (the Applicants) in “straw person” opposition proceedings brought by QIP Nominees Pty Ltd (QIP), a company within the QANTM intellectual property group.
Pearce IP BioBlast® for the week ending 15 November 2024
Aflibercept 15 November 2024 | EU | Sandoz Aflibercept Biosimilars EU Approved & Formycon/Klinge Biosims...
Pearce IP BioBlast® for the week ending 08 November 2024
Aflibercept 30 October 2024 | US | Amgen Launches Aflibercept in the US, Prepares to Launch Ustekinumab &...
Pearce IP BioBlast® for the week ending 01 November 2024
Benralizumab 28 October 2024 | EU | New Indication Alert: AstraZeneca’s Fasenra® (Benralizumab) EU-Approved for EGPA...
Pearce IP BioBlast® for the week ending 25 October 2024
Aflibercept 23 October 2024 | Biocon Switching Study for Aflibercept Confirms Safety & Efficacy On 23 October...
Full Court Clarifies and Recalibrates the Obviousness Test for “Pre-Raising the Bar” Patents
Sandoz has triumphed in its appeal regarding the validity of two of Bayer’s Australian Xarelto® (rivaroxaban) patents. On 23 October 2024, the Full Court unanimously overturned Justice Rofe’s decision of 2 November 2023, holding that the two Bayer patents lack an inventive step in light of the common general knowledge taken together with a prior art patent specification. The parties have been given until 4 November to propose orders giving effect to the Full Court’s decision.
Nose Dive – ResMed’s Opposition Gets a Rude Awakening
In a recent decision of the Australian Patent Office, Delegate McCaffery has ruled on opposition proceedings between ResMed Pty Ltd (ResMed) and Fisher & Paykel Healthcare Limited (Fisher & Paykel). The proceedings concerned six patent applications relating to patient interfaces for delivering breathing gases, with specific focus on nasal seals for continuous positive airway pressure (CPAP) therapy.
Pearce IP BioBlast® for the week ending 18 October 2024
Aflibercept 18 October 2024 | Regeneron Announces 3-Year Results for High Dose Eylea® (Aflibercept) On 18 October...