Archives for: ‘Kim O’Connell’

The Budget 2018-2019: our three key areas for intellectual property

Biotechnology companies and generic pharmaceuticals are the winners and celebrities are the Biggest Losers in some intellectual property-related measures in last night’s Australian Federal Budget.  Below, we set out the three key areas of interest from our first reading. Swap it! Boost for generic and biosimilar awareness campaigns The Budget will fund measures to increase the use of generic and biosimilar medicines; …

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Fast drugs, new drugs: new opportunities in the healthcare industry in Australia and China

Chinese and Australian businesses looking for overseas opportunities to expand in the healthcare industry should be aware of important regulatory changes that are taking place in both China and Australia. The healthcare industry in both Australia and China is undergoing significant growth that has been accompanied by rapid regulatory change. Both countries have invested significantly in the industry which increasingly …

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Second throw of the dice unsuccessful: Full Federal Court confirms Hepatitis C drug patent is invalid

The recent decision of the Full Court in Idenix Pharmaceuticals v Gilead Sciences [2017] FCAFC 196 illustrates the power of the grounds of lack of utility and lack of sufficiency under section 40 of the Patents Act when challenging the validity of a patent. The decision concerned lack of utility and lack of sufficiency as those grounds existed prior to the introduction …

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Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised as bioequivalent to, the reference …

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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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