Archives for: ‘Kim O’Connell’

The future is now: Gene therapy lands in the United States

The United States Food and Drug Authority (FDA) has just given the green light to America’s first ever gene therapy treatment. It’s called Kymriah and it’s a genetically-modified autologous T-cell immunotherapy (CAR-T cell therapy).  For the layman: individually customised, cancer-killing white blood cells. This is why it’s a big deal, and what the future could hold for us here in …

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Here’s the drill: The Full Federal Court clarifies the requirement that patents disclose the ‘best method’ of performing the invention

The Full Federal Court recently drilled down on the ‘best method’ requirement in Australia in Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138. Under Section 40(2)(aa) of the Patents Act 1990 (Cth) a ‘complete specification must … disclose the best method known to the applicant of performing the invention’. This requirement has been …

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Drugs in the fast lane: provisional drug registration and other proposed changes to the Therapeutic Goods Act

Following the Australian Government’s Response to the Review of Medicines and Medical Devices Regulation in 2016, the government recently released exposure drafts for a set of significant reforms to the Therapeutic Goods Act 1989 (Cth). The proposed changes include modifications to the regulation of complementary medicines, and a new class of “provisionally registered goods”.  This new class provides an opportunity …

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Threats Muddy Waters: unjustified threats of infringement in the Full Federal Court of Australia

A decision in March of the Full Federal Court in Australian Mud Company Pty Ltd v Coretell Pty Ltd [2017] FCAFC 44 concerning unjustified threats of infringement will have some lawyers as happy as pigs in mud. Dishing the Dirt Australian Mud Company Pty Ltd (AMC) is the owner of an innovation patent related to core sampling. In November 2006, it …

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‘Essential’ telecom patents: How to win FRANDs and influence people

The UK High Court’s 150+ page epic on fair, reasonable and non-discriminatory (FRAND) licence terms in Unwired Planet v Huawei has stirred up a lot of commentary in the tech nerd space and the international patent community (across which there is probably a fair bit of overlap). The decision goes some way to standardising the terms under which mobile phone …

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Off to a running start? Federal Court of Australia permits generic manufacturer to make PBS application before patent expiry

Can a manufacturer apply for Pharmaceutical Benefits Scheme (PBS) approval for a generic drug before the patent has expired? Justice Nicholas held in February in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 that the answer was “Yes”, and his Honour’s decision was recently affirmed by the Full Federal Court in Warner-Lambert Company LLC v Apotex …

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Don’t you wanna dance with me? US Supreme Court to hear Amgen v Sandoz biosimilars case

The US Supreme Court has granted petitions for certiorari in Amgen v. Sandoz confirming that the Court will examine the operation of the “patent dance” regime under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as well as clarifying when notice of commercial marketing can be given. Biosimilar boffins and patent pedants will be (justifiably) excited. Who Dances …

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Full Court warns against dangerous affliction of parameteritis (and confirms invalidity of aripiprazole patent)

On Wednesday the Full Court of the Federal Court of Australia handed down a decision in which it upheld Justice Yates’ findings that Otsuka’s patent relating to aripiprazole, a drug used in the treatment of schizophrenia, is invalid for want of novelty and inventive step.  Otsuka had alleged that Generic Health’s aripiprazole products, which were registered for the treatment of schizophrenia, …

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Same same but different? Federal Court finds Reckitt Benckiser’s/Nurofen’s marketing of the ‘specific pain relief’ range constitutes misleading and deceptive conduct

Last week Justice Edelman delivered judgment in the Federal Court, finding that Reckitt Benckiser (Australia)’s packaging and website descriptions of the Nurofen ‘Specific Pain Range’ constituted misleading or deceptive conduct under section 18 of the Australian Consumer Law (‘ACL’). Reckitt Benckiser was found to have represented that the four products in the Nurofen Specific Pain Range were each specifically formulated …

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