‘A reasonable and commercial construction?’ Patent time extensions after Ono Pharmaceuticals

The Federal Court of Australia has ordered the Commissioner of Patents to grant Bristol Myer Squibb (BMS) a patent term extension (PTE) for cancer drug Opdivo until 2031, providing certainty to industry around Australia’s intellectual property regime. Background BMS and Ono Pharmaceutical sought judicial review by the Federal Court of Australia after the Australian Patents […]

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COVID-19 | TGA updates guidance for advertising of COVID-19 vaccines to Australian public

In February 2021, we provided an update on the guidance issued by the Therapeutic Goods Administration (TGA) regarding the advertising of COVID-19 vaccines to the Australian public. That update is available here: COVID-19 | TGA issues guidance for advertising of COVID-19 vaccines to Australian public. Under the previous guidance, advertisers were restricted to republishing materials […]

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FMCG Express | May 2021 Edition

2021 certainly started with a bang; we are seeing a significant boost in appetite for advice right across our FMCG client base, including a lot of M&A activity, and we are excited to see how the year ahead unfolds. In the May 2021 edition of FMCG Express, editor Hazel McDwyer and the Gadens team provide […]

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When software delivers a therapeutic benefit: regulation of digital therapeutics

Digital therapeutics are defined as evidence-based therapeutic interventions that are driven by software programs to prevent, manage or treat a medical disorder or disease. As medical technological innovation continues at pace, more software applications and devices are under development to inform, drive or replace clinical decisions or directly provide therapy to a patient. The Therapeutic […]

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COVID-19 | Medicines dispensing emergency measures extended

At the commencement of the COVID-19 pandemic, the Australian Government introduced a range of measures to take the pressure off Australia’s health care system, such as the introduction of TeleHealth and E-Prescribing. Another measure was to extend the Continued Dispensing rules to enable pharmacists to supply medicines without prescription to certain patients. These emergency measures […]

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COVID-19 | TGA issues guidance for advertising of COVID-19 vaccines to Australian public

The roll out of the COVID-19 vaccine in Australia this week brings both excitement and questions about how healthcare services may advertise or promote the vaccines to the general public. The Therapeutic Goods Administration (TGA) has issued guidance to enable vaccine providers, and the broader healthcare sector, to confidently navigate a highly regulated environment, whilst balancing […]

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Judicial review – proper, genuine and realistic consideration

A recent Federal Court decision is a timely reminder that Ministers should not rely entirely on briefing notes before making decisions – and when the decision is defended, it is the Minister who is expected to give evidence. The Federal Court recently found that a Minister had failed to “consider any comments, information or documents” […]

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