How to use post-filing experimental data to help establish sufficiency and support
The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 was introduced in Australia with the intention of aligning Australia’s written description requirements with those in the UK and Europe. Under...
The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 was introduced in Australia with the intention of aligning Australia’s written...
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Patenting proteins: an Australian perspective
Biological molecules, including polypeptides and, in some cases, nucleic acids, can be patented under Australian law.  The level of disclosure that is required to support and enable a claim...
Biological molecules, including polypeptides and, in some cases, nucleic acids, can be patented under Australian law.  The level of...
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Switching from Biologic to Biosimilar: Australia’s Unique Approach
Switching patients from an originator biologic (the reference product) to a biosimilar version has been a topic of keen interest in recent years, both in Australia and globally, as...
Switching patients from an originator biologic (the reference product) to a biosimilar version has been a topic of keen...
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TGA transparency reforms (part 2): Early publication of major innovator prescription medicine applications
In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to provide early confidential notification to innovators of applications under evaluation...
In Part 1 of this series (available here), we examined the impact of the proposal by Australia’s Therapeutic Goods Administration (TGA) to...
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It’s good to be heard – the APO determines section 40 requirements
The Australian Patent Office’s decision in The University of British Columbia APO 15 (20 March 2020) considers how the “raised bar” requirements of support (section 40(3)), enablement (section 40(2)(a)) and...
The Australian Patent Office’s decision in The University of British Columbia APO 15 (20 March 2020) considers how the “raised...
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Coronavirus the global pandemic: a guide to patenting
COVID-19 (short for coronavirus disease 2019) is caused by Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), more commonly referred to as coronavirus. Coronavirus has dominated world headlines in 2020, leading to nationwide...
COVID-19 (short for coronavirus disease 2019) is caused by Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), more commonly referred to...
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COVID-19: mRNA vaccines – a promising approach to vaccine development
The urgent need to develop an effective vaccine to provide individuals and populations worldwide with immunity against the COVID-19 disease caused by the novel coronavirus, SARS-CoV-2, has led several...
The urgent need to develop an effective vaccine to provide individuals and populations worldwide with immunity against the COVID-19...
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Biosimilars in Australia
A ‘biosimilar medicine’ or ‘biosimilar’ is a highly similar, but not identical, version of an original biological medicine (‘reference medicine’) – a medicine comprised of large complex molecules derived...
A ‘biosimilar medicine’ or ‘biosimilar’ is a highly similar, but not identical, version of an original biological medicine (‘reference...
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Conference poster presentations as prior art for the assessment of novelty of a later patent application
Conferences are an important way for scientists and researchers to share and promote their research. They typically include poster presentation sessions where researchers present their findings. Conferences help generate interest in the scientific community...
Conferences are an important way for scientists and researchers to share and promote their research. They typically include poster presentation sessions...
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