The Prescription - June 2021

• High Court of Australia adopts the doctrine of exhaustion of patent rights

  By Ben Miller & Natasha Faigenbaum

  We review the High Court’s decision to adopt the doctrine of patent exhaustion and consider the implications for both patentees and purchasers of patented products.

• First detailed judicial consideration of the new support requirements for patents in Australia

  By Ben Miller & Jenny Wong

  We discuss the Federal Court’s decision in Merck v Wyeth, which is the first detailed judicial consideration of the new support requirement for Australian patents.

• Restrictive practices – Recommendations of the Royal Commission into Aged Care Quality and Safety

  By Angela Wood

  We consider the reforms for restrictive practices in aged care recommended by the Royal Commission into Aged Care.

• Federal Court dismisses Pfizer’s application for preliminary discovery regarding Sandoz’s etanercept biosimilar

  By Ben Miller & Jenny Wong

  We discuss the implications of the Federal Court’s dismissal of Pfizer’s application for preliminary discovery from Sandoz regarding its etanercept biosimilar.

• Full Court dismisses Johnson & Johnson’s appeal against findings in pelvic mesh class action

  By Angela Wood & Elizabeth Reed

  We consider the Full Court’s dismissal of Johnson & Johnson’s appeal in the representative class action regarding its transvaginal mesh products.

• Active ingredient prescribing rules rolled out

  By Steven Tang & Andrew Theodosi

  We review the new mandatory active ingredient prescribing rules and the impact on prescribers of medicines.

• Advertising therapeutic goods? Don’t forget about Australian Consumer Laws

  By Angela Wood & Sophie Vo

  Following our article regarding the TGA’s active enforcement of the therapeutic goods advertising framework during the COVID-19 pandemic, we provide an overview of the ACCC’s ability to enforce consumer protection laws over the same products.

• The new regulatory requirements for software-based medical devices

  By Aaron Kloczko & Sophie Vo

  We discuss the new Software as a Medical Device (SaMD) Framework, which offers greater clarity and reduces the regulatory burden on low-risk software.

• HRIPA and deceased persons: DSC v United Protestant Association

  By Aaron Kloczko & Katherine McNaughton

  We discuss whether a person can seek access under the Health Records and Information Privacy Act 2002 (NSW) (HRIPA) the health records of a deceased person.

• ACSQHS: National Safety and Quality Digital Mental Health Standards

  By Aaron Kloczko & Katherine McNaughton

  We review the National Safety and Quality Digital Mental Health Standards which were released on 30 November 2020.