Dundas lawyers advises on all aspects of the new Therapeutic Goods Advertising Code 2021 (Cth) (2021 TGA Code) that brought about several changes to the regulatory framework for advertising and manufacturing therapeutic goods. This includes advise on compliance with The Therapeutic Goods Administration (TGA) which is the regulatory body in Australia for medicines and products that are marketed as having a “therapeutic” effect.
Why choose Dundas Lawyers®?
Having exerted Blood Sweat and Years® since April 2010 we are the team you want on your side for the long term to act as the ‘bodyguard’ for your therapeutic goods business. Some of the reasons clients choose Dundas Lawyers® include:
- our Uncommon business acumen;
- our Uncommon expertise in transactional, compliance and litigious matters;
- our Uncommon expertise in advising manufacturers of therapeutic goods;
- our Uncommon customer focus;
- the fact that we don’t just know law, we know business!
- how we leverage our Uncommon Nous® to provide client centric solutions.
Considering getting a lawyer to advise your business?
For a confidential, no obligation initial telephone call to find out how we can help your business gain an uncommon advantage in therapeutic good manufacturing, please phone our team on either 1300 386 529 or 07 3221 0013.
Malcolm Burrows B.Bus.,MBA.,LL.B.,LL.M.,MQLS.
Legal Practice Director
T: +61 7 3221 0013 (preferred)
M: +61 419 726 535
E: mburrows@dundaslawyers.com.au
Legislation
Recent insights for therapeutic goods manufacturers
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Influencers now regulated when promoting therapeutic goods
The Therapeutic Goods Advertising Code 2021 (Cth) (2021 TGA Code) brings regulations for social media endorsements of therapeutic goods. Learn more about the changes and how to ensure compliance before they take effect on 1 January 2022. Read more
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Use of a competitors trade marks for comparative advertising
Comparative advertising can be a powerful tool, but it must be done within the bounds of the law. Learn more about the legal implications of comparative advertising in Australia, including the case of GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser (Australia) Pty Limited (No 2) [2018] FCA 1. Read more
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Therapeutic Goods Advertising Code 2021 update
The Therapeutic Goods Administration has released the Therapeutic Goods Advertising Code 2021 (Cth), introducing changes to distinguish between physical and online therapeutic goods, updates to medical device and medicine advertising, and more. Get the details to stay informed and ensure compliance with the new rules. Read more
Recent Federal Court decisions regarding therapeutic goods manufacturers
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Zoetis Services LLC v Boehringer Ingelheim Animal Health USA Inc [2024] FCAFC 145
PATENTS – patents for supernatant vaccine against diseases affecting pigs PATENTS – validity – best method – where antigen concentrations of vaccine disclosed as a range – whether antigen concentrations material to the advantages claimed of the invention – consideration of Firebelt Pty Ltd v Brambles Australia Ltd [2000] FCA 1689; 51 IPR 531 –…
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Sandoz AG v Bayer Intellectual Property GmbH [2024] FCAFC 135
PATENTS – whether skilled person could be reasonably expected to have ascertained international patent publication – where patent database would have been one of the databases searched by person skilled in the art – where expert provided with search results which formed a subset of larger set of search results which would have been derived…
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Glass Hardware Australia Pty Ltd v TCT Group Pty Ltd [2024] FCAFC 95
PATENTS – innovation patent relating to hinges – infringement – validity – whether primary judge erred in the proper construction of the invention disclosed PATENTS – validity – lack of clear and complete description – classical sufficiency – “relevant range” – s 40(2)(a) of the Patents Act 1990 (Cth) – whether primary judge erred in…
