The Prescription - December 2022

• Freedom to research in Australia - exemptions to patent infringement

  By Ben Miller, Stephen Rohl & Jenny Wong

  We consider patent infringement exemptions of particular relevance to the life sciences.

• Discounting in the era of the Medicines Supply Security Guarantee

  By Steven Tang

  We review the new stockholding and discounting requirements introduced by the Strategic Agreements with the Australian Government.

• Aged Care and Other Legislation Amendment Act 2022 - what you need to know

  By Lucille Scomazzon, Angela Wood, Tamie Duncan-Bible

  This article is part one in a series where we summarise the key amendments and the relevant commencement dates.

• Is your ASX announcement advertising a therapeutic good?

  By Angela Wood

  The TGA recently released its Guidance for ASX announcements addressing the need to comply with both therapeutic goods advertising requirements and continuous disclosure obligations

• Patent settlement and licence agreements

  By Ben Miller, Stephen Rohl

  We analyse the recent high profile withdrawal of an application to the ACCC for authorisation of a patent litigation settlement by Juno and Celgene.

• Government takes steps to deliver on ‘key commitment’ of strategic agreement with Medicines Australia

  By Angela Wood, Francine Kinkade, & Laura Wood

  A reference committee has been appointed to conduct a review of the Health Technology Assessment policy and methods.

• Functional antibody claims in Australia – what will happen if the bar is raised?

  By Ben Miller, Stephen Rohl, & Katie Pryor

  We consider the Patent Office’s decision in Sanofi v Amgen and the future for functional antibody claims under the ‘Raising the Bar’ regime.

• Tribunal decisions, consent, substitute decision makers and the use of restrictive practices in residential aged care – what can we learn?

  By Lucille Scomazzon, Angela Wood, Tamie Duncan-Bible

  We summarise guidance from recent tribunal decisions on the use of restrictive practices in residential aged care services.

• Restrictive practices in aged care – an update on consent

  By Angela Wood

  We provide an update on changes to legislation regarding informed consent.

• Indemnity costs in patent cases

  By Ben Miller, Stephen Rohl & Jenny Wong

  We assess the Federal Court’s approach to indemnity costs in recent patent cases.