Our experienced Biotech & Health legal team regularly publishes articles and updates - the full list of publications appears below. Allens' Focus: Health keeps you up to date with recent developments, legislative changes and important cases, while Biotech & Health News keeps you up-to-date in this important area. If you'd like to be notified when we add new biotech and health 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.
Health is an issue that pervades every sector of the community, with far-reaching implications for business. Read about our track record in biotech and health.
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Audio:
Win for gene patents in Federal Court
18 February 2013
The Federal Court has recently handed down its decision in the legal challenge by Cancer Voices Australia against a patent owned by Myriad Genetics Inc. Partner Trevor Davies speaks to BRR Media about the issues the ruling raises and how it will impact on innovators and users of Australia's medical system.
Listen - Focus:
New PBS reforms to affect pharmaceutical manufacturers
21 August 2012
The recent pricing reforms to the Pharmaceutical Benefits Scheme, which will come into effect shortly, will have implications for manufacturers of pharmaceuticals. Senior Associate Ric Morgan and Lawyer Ben Mee report.
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TGA review on packaging and labelling
07 June 2012
The Therapeutic Goods Administration has recently released the latest consultation paper in its review of packaging and labelling of medicines in Australia, which, on completion, is expected to have a significant impact on the pharmaceutical industry. Partner Richard Hamer and Lawyer Ali Ridley report
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Audio:
E-health bill to stumble post Senate inquiry
21 March 2012
The Senate has released a report on its inquiry into the Personally Controlled Electronic Health Records Bill. Senior Associate Michael Morris spoke to BRR Media about the likely privacy implications of E-health records
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US food sheriff gets greater reach
26 September 2011
Sweeping food safety reforms, including strict new requirements for importers, were passed into law by the United States Congress earlier this year. Partner Annette Hughes and Law Graduate Ali Ridley report on these new obligations
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Audio:
Senate Inquiry into gene patents
02 December 2010
A Senate committee has released its long-awaited report into gene patents. Partner Trevor Davies spoke to Boardroom Radio about the report's major findings, as well as a Private Member's Bill introduced into the Senate that could have serious consequences for the Australian biotech industry
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New code for pharmaceutical 'wholesalers'
17 November 2010
Businesses that handle, store and distribute certain medicines at the wholesale level should be aware of new standards about to be released by the Therapeutic Goods Administration. Partner Sarah Matheson, Senior Associate Ric Morgan and Lawyer Harry Evans report on the new Code of Good Wholesaling Practice for Medicines which provides additional guidance for the supply of pharmaceuticals beyond the Code of Good Manufacturing Practice
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Audio:
Kilojoules on fast food menu boards planned for NSW
09 November 2010
The New South Wales Government has announced changes to food labelling laws for fast food outlets. Partner Richard Hamer speaks to Boardroom Radio about these changes and how they differ from other food labelling laws across Australia
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Changes continue for therapeutic goods regulation
09 April 2010
Some amendments under the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (Cth), the third in a series of legislative measures affecting therapeutic goods legislation, have recently commenced, with others coming into effect on 1 July 2010. The amendments affect scheduling procedures, the inclusion of medical devices in the Australian Register of Therapeutic Goods, advice on genetically modified organisms, and advertising and labelling. Partner Sarah Matheson and Lawyer Nikki Macor report
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Extensions of term for pharmaceutical patents: the latest word
15 December 2009
The Full Federal Court's recent decision concerning the availability of extensions of term for pharmaceutical patents, particularly those claiming enantiomers, stands, following the High Court's rejection of a special leave application. Senior Associate Alexia Mayer reports
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Reforming privacy and health information
09 November 2009
The Federal Government has released the first stage of its response to the Australian Law Reform Commission's report on privacy law. Partner Catherine Parr, Special Counsel Karin Clark and Lawyer Jacqueline Goodall report on the implications for health service providers, and other bodies that handle health information
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Further changes to the regulation of therapeutic goods in Australia
09 September 2009
The regulation of therapeutic goods in Australia has been changed following amendments to the Therapeutic Goods Act 1989. This is the second of three sets of amendments to the Act, with the last set yet to pass Parliament. Senior Associate Ric Morgan and Partner Sarah Matheson report on the changes
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Changes to regulation of therapeutic goods
23 June 2009
Federal Parliament is changing the regulation of therapeutic goods. The first of three Bills before Parliament, the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008, received Royal Assent on 17 June 2009, and the others are likely to be passed during the next sitting. Partner Sarah Matheson and Senior Associate Ric Morgan report
Read More - Biotech & Health News
19 June 2008
Senior Associate Sarah Bryden and Law Graduate Leesa Vanmali examine the recent decision in Selim v Lele, where the Full Federal Court of Australia dismissed a constitutional challenge to the validity of the Professional Services Review Scheme
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Health, Aged Care & Retirement
16 January 2008
We examine the latest chapter in a case involving workers exposed to traumatic events; New South Wales planning policy changes for housing for senior and disabled people; and recent Australian Taxation Office rulings regarding the GST and retirement villages
Read More - Biotech News
13 December 2007
In this edition: Partner Dr Trevor Davies and Law Student Elizabeth Sarofim report on the recent decisions of the New South Wales and Victorian governments to lift their four-year moratoria on the commercial cultivation of GM canola
Read More - Biotech News
26 November 2007
In this edition: Partner Dr Trevor Davies provides an overview of the proposed changes to the patent rules governing the prosecution of patent applications in the United States, and of the recent legal challenge to the implementation of the rule changes
Read More - Biotech News
08 November 2007
In this edition: Since early 2005, Allens Biotech News has been closely monitoring the Advisory Council on Intellectual Property's recommendation regarding patents and experimental use in Australia. Partner Dr Trevor Davies and Lawyer Ollie Evans provide a further overview of the proposed amendments to the Patent Act 1990 (Cth) to include an experimental use exemption
Read More - Biotech News
26 October 2007
In this edition: Lawyer Rachel Darvey reports on the recent introduction of the Therapeutic Goods Amendment Act 2007 and how it impacts on the transition period for medical devices
Read More - Biotech News
28 September 2007
In this edition: Patent attorney and lawyer, Dr Rob Silberstein, provides an overview of contributory infringement in relation to patents in Australia, including a historical jurisprudential and legislative account of the issues raised by this vexed area of law
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Health
05 September 2007
We look at a case of anti-competitive conduct by doctors; the first set of standards issued by the Queensland Health Quality and Complaints Commission; and a question of discrimination in the provision of medical services
Read More - Biotech News
30 August 2007
In this edition: Partner Sarah Matheson and Articled Clerk Adel Mohamed provide a brief overview of follow-on biologics and the regulatory frameworks in the United States of America, Europe and Australia established to regulate this emerging class of therapeutic products
Read More - Biotech News
16 August 2007
In this edition: Senior Associate Matt Ireland and Law Graduate Pat Crisp examine due diligence as it relates to the biotech industry
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01 August 2007
In this edition: Partner Dr Trevor Davies and Trade Mark Lawyer Lara Gun outline the issues for trade mark adoption and protection
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19 July 2007
In this edition: Technical Assistant Dr John Landells provides an overview of recently released Federal Government policy requiring all government agencies to establish and implement plans for the management of intellectual property
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06 July 2007
In this edition: Lawyer Jacqueline Goodall reports on the outcome of three recent decisions by the federal Privacy Commissioner on the protection of health information under privacy law
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07 June 2007
In this edition: Lawyer Adrian Coras provides an overview of some of the commercialisation strategies available to biotechnology companies
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Health
05 June 2007
We report on the duty owed by employers where workers are exposed to traumatic events; the right to access one's own health information; the meaning of 'exceptional circumstances' when applying the 80/20 rule; the extent of the duty to warn patients pre-surgery; and when a surgical procedure amounts to battery
Read More - Biotech News
28 May 2007
In this edition: Partner Dr Robert Smyth, of US law firm Morgan Lewis & Bockius LLP, and Allens Arthur Robinson Patent Attorney Dr Kathryn Sunn provide an overview of a recent US Patent and Trademark Office notice on restriction requirements in patent applications containing nucleotide sequences
Read More - Biotech News
11 May 2007
In this edition: Patent Attorney and Lawyer Dr Rob Silberstein provides an overview of the grace period provisions under the patent laws of various Australian and overseas jurisdictions and discusses a range of related patents issues
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Health - A review of the exposure draft of the Therapeutic Products Bill 2007 (Cth)
30 April 2007
In late March 2007, the Department of Health and Aging released an exposure draft of the Therapeutic Products Bill 2007 (Cth). This is the first in a series of new laws that will significantly change the way therapeutic products are regulated in Australia and New Zealand by setting up a joint trans-Tasman scheme. Lawyer Przemek Kucharski summarises key aspects of the Scheme and the Bill
Read More - Biotech News
12 April 2007
In this edition: Privacy Commissioner's biometrics recommendations in response to ALRC privacy review
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29 March 2007
In this edition: Partner Dr Trevor Davies and Law Graduate Matt Vitins provide an outline of the recent Issues Paper released by the Advisory Council on Intellectual Property on its review of the enforcement of Plant Breeder's Rights in Australia
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16 March 2007
In this edition: Partner Dr Trevor Davies and Technical Assistant Dr John Landells provide an overview of bio-prospecting of Australia's genetic heritage, including a review of Australia's new regulatory regime for controlling access to its natural resources
Read More - Biotech News
07 March 2007
In this edition: The operative provisions of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Cth) commence on 12 June 2007. Partner Sarah Matheson and Articled Clerk Adel Mohamed provide a brief overview of changes brought about by the amending legislation that affects the status of therapeutic cloning in Australia
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Health
28 February 2007
In this issue we examine the role of the Professional Services Review; final and binding determinations made under the Medical Practice Act 1994 (Vic); recent amendments to stem cell legislation; and the treatment of a child without parental consent
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Food
21 December 2006
A new food descriptors guideline issued by the Australian Competition and Consumer Commission, coupled with two recent investigations by the ACCC regarding misleading packaging of food items, highlight the need for food manufacturers to be careful of the claims made on their packaging. Partner Belinda Thompson and Lawyer Alexander Gelis report
Read More - Biotech News
14 December 2006
In this edition: Recent decisions concerning the law relating to patent term extensions for pharmaceutical patents may raise concerns for patentees. Partner Trevor Davies and Lawyer Jonathan de Ridder explain
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30 November 2006
In this edition: Partner Sarah Matheson and Lawyer Emma Stacey provide a jurisdictional comparison of the 'springboarding' exception to patent infringement
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Health - Witness immunity and other articles
29 November 2006
In this issue we look at the issue of witness immunity; a duty of care case; medical record ownership; and new or amended legislation
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15 November 2006
In this edition: Partner Peter Allen and Lawyer Sean Massingham provide an overview of the upcoming provisions for the taxation of capital gains made by foreign residents set out in the Tax Laws Amendment (2006 Measures No. 4) Bill 2006
Read More - Biotech News
02 November 2006
In this edition: Partner Trevor Davies and Technical Assistant John Landells provide a jurisdictional comparison of the patentability of methods of treating humans
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18 October 2006
In this edition: Partner Peter Allen and Paralegal Karla Drinkwater provide an outline of the Federal Government's scheme encouraging eligible Australian companies to increase their research and development activities by providing tax incentives
Read More - Biotech News
11 October 2006
In this edition: Patent Attorney and Lawyer Dr Rob Silberstein provides an outline of some of the available grants and concessions offered and/or supported by Australian State and Territory governments
Read More - Biotech News
21 September 2006
In this edition: Lawyer Dominic Nguyen provides an update on the proposed introduction of an experimental use exemption in Australia. Since early 2005, Biotech News has been closely monitoring the Advisory Council on Intellectual Property's recommendations regarding patents and experimental use in Australia and, in particular, an amendment to the Patents Act 1990 (Cth) to include an experimental use exemption. IP Australia has now released a public consultation paper on ACIP's recommendations
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06 September 2006
In this edition: Patent Attorney and Lawyer Dr Rob Silberstein provides an outline of some of the available grants and concessions offered and/or supported by the Australian Federal Government
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Health - Changes to the Queensland health system
31 August 2006
In this issue we look at changes to the Queensland health system, the Community Services Obligation funding pool for pharmaceutical wholesalers and distributors, and a case concerning a parental dispute over the appropriate disposal of their deceased daughter
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23 August 2006
In this edition: Special Counsel Karin Clark and Lawyer Andrew Ailwood provide an outline of the recent changes to the Privacy Legislation Amendment Bill 2006 (Cth) and its impact on genetic information
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10 August 2006
In this edition: Lawyer Andrew Gun provides an outline of the recent changes to the Therapeutic Goods Advertising Code 2006, and the regulation of cosmetic chemicals with regard to antibacterial skin products
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Food
24 July 2006
We look at changes to country-of-origin food labelling that could cost the Australian food industry $60 million, the mandatory introduction of iodine and folic acid fortified foods and an industry report on the fatty acid content in infant formula products
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