Legal Insights
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.
The Prescription - June 2021
In this edition
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Legal Insights
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.
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Legal Insights
We consider the reforms for restrictive practices in aged care recommended by the Royal Commission into Aged Care.
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Legal Insights
We discuss the implications of the Federal Court’s dismissal of Pfizer’s application for preliminary discovery from Sandoz regarding its etanercept biosimilar.
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Legal Insights
We consider the Full Court’s dismissal of Johnson & Johnson’s appeal in the representative class action regarding its transvaginal mesh products.
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Legal Insights
We review the new mandatory active ingredient prescribing rules and the impact on prescribers of medicines.
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Legal Insights
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.
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Legal Insights
We discuss the new Software as a Medical Device (SaMD) Framework, which offers greater clarity and reduces the regulatory burden on low-risk software.
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Legal Insights
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.
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Legal Insights
We review the National Safety and Quality Digital Mental Health Standards which were released on 30 November 2020.