‘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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New wave of litigation expected to hit Australia’s eroding shoreline

Last week, the Federal Court of Australia embarked on what is predicted to be a landmark decision, in the matter of AGL v Greenpeace Australia Pacific (Greenpeace). The case involves allegations by AGL that Greenpeace infringed its trademark rights and copyright when it featured AGL’s logo in a recent ad campaign, designed to pressure the […]

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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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Timely reminder for companies to lodge their financial reports

Recent prosecutions and convictions obtained by the corporate regulator serve as a timely reminder for companies of the importance of lodging financial reports. The Australian Securities and Investments Commission (ASIC) recently prosecuted and obtained convictions against three companies for failing to lodge annual financial reports with ASIC within the specified period after the end of […]

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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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Immunity for serious financial misconduct – ASIC’s new policy

Overview ASIC has just announced a new policy that allows individuals who think they might have been involved in market manipulation, insider trading, dishonest conduct or other contraventions of Part 7.10 of the Corporations Act 2001 (the Act) to apply for immunity from civil penalty or criminal proceedings. This policy expands ASIC’s ability to identify […]

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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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