The Prescription - December 2021

• The COVID-19 vaccination information life cycle

  By Angela Wood & Sophie Vo

  We consider the privacy implications surrounding collection and use of COVID-19 vaccination status information.

• Patentability detected in diagnostic methods

  By Ben Miller & Jenny Wong

  We review the Full Federal Court’s decision in Ariosa v Sequenom regarding the patentability of diagnostic testing methods.

• Patent term extensions – Which product?

  By Stephen Rohl, Ben Miller

  We compare two recent decisions of the Federal Court regarding the relevant goods when applying for a patent term extension.

• Thaler and DABUS – Opening the doors for AI inventors

  By Anthony Willis & Benjamin Duff

  We consider the Federal Court’s decision in Thaler v Commissioner of Patents that artificial intelligence can be the inventor of a patent.

• Observations about the mandatory COVID-19 vaccination requirements in aged care

  By Angela Wood & Sophie Vo

  We provide an update on the mandatory COVID-19 vaccination frameworks in residential aged care.

• Provider governance – Recommendations of the Royal Commission into Aged Care Quality and Safety and changes to aged care laws

  By Angela Wood, Tamie Duncan-Bible

  We outline proposed good governance reforms to the Aged Care Act 1997 and the Aged Care Quality and Safety Act 2018 following the Royal Commission into Aged Care Quality and Safety.

• Changes to TGA regulation of personal medical devices

  By Angela Wood & Natasha Faigenbaum

  We review the Therapeutic Goods Administration’s new framework for regulating custom-made medical devices.

• Permissions for therapeutic good ‘restricted representations’ concerning COVID-19

  By Angela Wood & Sophie Vo

  We provide a summary of the Therapeutic Goods Administration’s permissions for the advertising of therapeutic goods for COVID-19.

• The pandemic isn’t over, but the emergency exemptions are – An update on PPE regulation

  By Ben Miller & Emma Woelke

  We provide an update on personal protective equipment regulation through the COVID-19 pandemic.

• The Evolution (Supplements) of TGA penalties

  By Steven Tang, Damien Wurzel

  We review the Federal Court’s decision to impose the largest ever fine for unlawfully advertising products containing therapeutic substances.

• About face on appeal in PROTOX v BOTOX dispute?

  By Brendan Coady, Shelley Einfeld & Natasha Faigenbaum

  We consider the Full Federal Court’s decision in Allergan v Self Care regarding the deceptive similarity of PROTOX to BOTOX.

• A step forward for design law in Australia

  By Ben Miller & Natasha Faigenbaum

  We outline the recent reforms to design law in Australia.

• New strategic agreement with Medicines Australia

  By Xinyu Zhang

  We discuss the Australian Government’s new strategic agreement with Medicines Australia.

• New strategic agreement with the Generic and Biosimilars Medicines Association

  By Xinyu Zhang

  We discuss the Australian Government’s new strategic agreement with the Generic and Biosimilars Medicines Association.