Full Court confirms relevant regulatory approval date for PTE

The Full Federal Court[1] has confirmed that the relevant regulatory approval date for requesting a pharmaceutical patent term extension (PTE) is the earliest inclusion in the Australian Register of Therapeutic Goods (ARTG) of any goods which include a pharmaceutical substance which is claimed and disclosed in the patent, regardless of whether those goods belong to …
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High Court grants special leave to Aristocrat for patentability of computer implemented inventions

Big news for patentability of computer implemented inventions in Australia: The High Court has granted special leave to appeal the decision in The Commissioner of Patents v Aristocrat Technologies Australia Pty Ltd [2021] FCAFC 202. Successful special leave applications are relatively rare, as the High Court must be satisfied the appeal involves a question of …
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High Court confirms only patentees can bring infringement proceedings during the extended term of a pharmaceutical patent

Pharmaceutical patent term extensions (PTE) are a highly litigated area of patent law.  Australia’s longest running PTE litigation relates to a patent for the antidepressant escitalopram.  The latest installment in the escitalopram saga is now available, with the High Court of Australia handing down judgement in H. Lundbeck A/S v Sandoz Pty Ltd, CNS Pharma …
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What is patent claim construction essentially about?

Anyone familiar with patents in the life sciences space will be familiar with patent claims that use terminology such as “essentially”, “therapeutic agent” and “about”. The familiarity of such terms means that they are often recited without much consideration. However, their meaning was in issue in the recent decision in Pharmacia LLC v Juno Pharmaceuticals …
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Accelerated approval achieved for CTI BioPharma

We are delighted to announce that one of our clients, CTI BioPharma, has received FDA accelerated approval for VONJO™ (pacritinib), for the treatment of adult patients with myelofibrosis and thrombocytopenia. Pacritinib is a macrocyclic small molecule oral kinase inhibitor with activity against Janus Associated Kinase2 (JAK2), mutant JAK2V617F as well as the FMS-like tyrosine kinase 3 …
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Injunctions and infringements – when is it justified?

The threat of patent infringement proceedings can be employed by a patentee as a very effective deterrent against those whose conduct brings them into potential conflict with their patent rights. However, such threats “can potentially cause substantial harm” and as a result may be actionable by a recipient or another person harmed by them. In …
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A sure footing confirmed for obvious mistakes in patent specifications

A recent decision[1] of the Federal Court has confirmed the requirements for amending a patent specification to rectify a clerical error or obvious mistake and provided a timely reminder of the importance of reviewing a patent before commencing proceedings. The amendment application was made during proceedings commenced by Surefoot IP Holdings Pty Ltd (Surefoot) against …
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Patent Box legislation introduced into Federal Parliament

Following the Federal Budget announcement in May 2021 (previously reported here), the Government has now introduced legislation to create Australia’s first Patent Box, and help Australian companies to commercialise medical and biotechnology innovation. The Treasury Laws Amendment (Tax Concession for Australian Medical Innovations) Bill 2022 was introduced into the House of Representatives on 10 February …
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Another One Bites the Dust – Patent Application Naming AI Machine DABUS as Inventor Refused in New Zealand

Last year, patent applications filed by Dr Stephen Thaler naming an artificial intelligence known as ‘Device for Autonomous Bootstrapping of Unified Sentience‘ (DABUS) as the inventor made news headlines around the world. As reported earlier, in a surprising move the Australian Federal Court recognised DABUS as an inventor. This decision is currently on appeal. In …
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