Our experienced Healthcare legal team regularly publishes articles and updates – the full list of publications appears below. These publications provide a snapshot of the latest legislation, court cases, policy changes and contentious issues. If you'd like to be notified when we add new publications to the site, please go to our subscription page to sign up for email alerts or, alternatively, you can subscribe to our RSS feed.

For publications in other legal areas see our recent publications page.

Healthcare Publications

  • Paper: 3D Printing Legal Workshop - A Deeper Dive

    18 December 2018

    The Allens 3D Printing Practice recently held a workshop in Melbourne and Sydney which explored key legal issues arising from 3D printing, particularly for the healthcare industry. Our Allens panel members - Sarah Matheson, Ric Morgan, Phil O'Sullivan, Dr Tony Shaw, Tracy Lu and Rob Munro - were joined by industry leaders

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  • Client Update: Making sense of human cell and tissue products regulation

    12 September 2018

    The Therapeutic Goods Administration has released guidance on recent changes to the regulation of human cell and tissue products. Special Counsel Ric Morgan and Senior Associate Tracy Lu dissect the complex regulatory framework, particularly in relation to advertising.

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  • Paper: Assessment of biosimilars - Is Australia leading, following or going its own way?

    26 October 2016

    The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues - Comparability: is the new product sufficiently similar to permit it to rely on the reference product's safety and efficacy, data?, Extrapolation: for which of the indications of the reference biological will the biosimilar receive marking authorisation?, and Interchangeability: should the new product be substitutable for the reference product in clinical practice and, if so, in what circumstances?

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  • Paper: Protecting investment in biologic medicines - biological medicines, biosimilars and the challenges they pose

    15 September 2016

    This series of articles is directed towards the part of biotech that is 'pharmaceutical', rather than diagnostic or bioengineering technologies, and, in particular, towards biologic medicines.

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  • Paper: What's in a (biosimilar) name?

    8 September 2016

    Because biosimilars and their reference biologic medicine are not identical, whether compared to each other or even between biosimilars, it is important to know which product has been used.

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  • Paper: Costs before Caution - Australia's unique approach to the interchangeability of biosimilars

    17 August 2016

    Recent developments in Australia suggest that there has been a deliberate prioritisation of the cost benefits of facilitating biosimilar interchangeability over the safety and efficacy risks that can arise when biosimilars are used interchangeably.

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  • Discussion Paper: Biologic medicines and biosimilars in the Australian landscape - The challenges and the opportunities

    1 August 2016

    Allens is engaging with stakeholders on the challenges and opportunities presented by biosimilars. As part of this engagement, we highlight a number of key issues for discussion and comment.

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  • Client Update: Protecting innovation without patents - data exclusivity and market exclusivity

    19 July 2016

    Developments in patent law and the consequential limitations on patentability for biologic medicines mean that data exclusivity and market exclusivity can be the primary protection afforded to originator biologic medicines. This is most stark in the US where patent protection for biologic medicines can be very limited. This seems to be the reason that the US has twelve years of exclusivity, and is pressing for other nations to have similar protection. In the TPP agreement, Australia has committed to providing a comparable outcome in the market to eight years of exclusivity but is robustly resisting extending its current five years of statutory protection. Partner Sarah Matheson and Special Counsel Ric Morgan report.

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  • Special Report: Understanding the opportunities and navigating the legal frameworks of distributed ledger technology and blockchain

    17 June 2016

    Authored by a multidisciplinary team from Allens, Blockchain Reaction is designed to assist business stakeholders, decision makers and in-house counsel across a variety of sectors to understand the technology and how it is being used, as well as navigate the regulatory and legal opportunities and challenges.

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  • Focus: Predictive coding: the future of electronic document production?

    25 February 2016

    A recent decision of the English High Court may pave the way for the use of 'predictive coding' in large scale discovery and regulatory investigations in Australia. Partners Nick Rudge and Duncan Travis, Managing Associate Kate Austin and Associate Emily Giblin look at the benefits and risks of the new software.

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  • Focus: Government rejigs electronic health records system with opt-out approach

    21 October 2015

    The Federal Government's electronic health records system may have a new lease on life following the introduction of a new Bill that attempts to improve the system's effectiveness with key changes such as the transition to an 'opt-out' approach. Partner Ian McGill, Senior Associate Phil O'Sullivan and Associate Emily Cravigan report.

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  • Client Update: Not quite business as usual - IP Australia takes pragmatic view of Myriad

    19 October 2015

    IP Australia has taken a pragmatic approach to the Myriad decision that will give comfort to Australia's biotechnology industry and research organisations that they can continue to carry out biological R&D and be able to obtain patent protection for innovation in Australia. Partner Dr Trevor Davies reports.

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  • Audio: D'Arcy v Myriad: The High Court rules on gene patenting

    7 October 2015

    Allens Partner Dr Trevor Davies discusses why the High Court overturned the decision and what it means for the biotech industry.

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  • Scintilla: Intellectual Property in Review

    12 November 2014

    The Allens IP blog, Scintilla, provides regular insights and analysis on intellectual property law. We have published a selection of blog posts in a handy digest for clients. In this edition, we cover the latest issues in patents, trade marks, copyright, designs and international issues.

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  • Focus: Isolated genetic material confirmed as patentable

    12 September 2014

    In a unanimous decision, the Full Federal Court has confirmed that genetic materials in their isolated form remain patentable in Australia. The decision related to an appeal from an earlier Federal Court decision in which it was found isolated nucleic acids to be a 'manner of manufacture' as required by Australia's patent legislation and therefore patentable subject matter. The latest decision did not deal with policy, social or moral reasons as to whether nucleic acids or genes should be patentable which, as the court noted, has been considered by the Australian Law Reform Commission and the Australian Parliament. Partner Dr Trevor Davies and Associate Dr Tony Shaw provide an overview of the decision and its implications for patentees, patients, the biotechnology industry and the Australian medical research community.

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  • Focus: The ending point for 'starting point'

    1 September 2014

    The Full Federal Court has published its much-anticipated judgment in the AstraZeneca v Apotex appeal. A bench of five judges heard the appeal (in contrast to the usual three judges) in order to be able to clarify, or overrule if appropriate, an earlier Full Court decision relating to the correct test for assessing 'inventive step' - known as the 'starting point' issue. This ruling restores the tighter test for obviousness and should be welcomed by patentees. As Managing Associate Clare Young and Senior Associate Suzy Muller report, the court also provided other useful guidance on infringement of method of medical treatment claims, and on the issue of whether injunctions are always the right remedy for patent infringement.

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  • Client Update: Changes to New Zealand patent law - the deadline approaches

    10 July 2014

    Changes to New Zealand's patent legislation, which come into effect on 13 September 2014, will align it more closely to Australia's patent law. Partners Chris Bird and Trevor Davies advise on the importance of acting quickly before the stricter standards of New Zealand's new patent regime apply.

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  • Focus: TGA confirms its approach to disclosure of commercially confidential information

    21 May 2014

    The Therapeutic Goods Administration has released the final version of a document outlining its approach to the disclosure of commercially confidential information, including information provided by medicine sponsors. This follows the release of a draft version in June 2013 and a period of public and industry consultation. Partner Sarah Matheson and Senior Associate Alison Beaumer report.

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