United States FDA gets serious about biosimilars
5 September 2018
The most significant advances in medical treatments are being made with biological products.
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Suzy Madar
Fast drugs, new drugs: new opportunities in the healthcare industry in Australia and China
27 April 2018
Chinese and Australian businesses looking for overseas opportunities to expand in the healthcare industry should be aware of important regulatory changes that are taking place in both China and Australia.
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Second throw of the dice unsuccessful: Full Federal Court confirms Hepatitis C drug patent is invalid
21 December 2017
The recent decision of the Full Court in Idenix Pharmaceuticals v Gilead Sciences [2017] FCAFC 196 illustrates the power of the grounds of lack of utility and lack of sufficiency under section 40 of the Patents Act when challenging the validity of a patent.
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Biosimilars: balancing access to affordable medicines with safety
3 November 2017
Biological medicines (biologics) are agents derived from a biological source.
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Full Court warns against dangerous affliction of parameteritis (and confirms invalidity of aripiprazole patent)
26 August 2016
On Wednesday the Full Court of the Federal Court of Australia handed down a decision in which it upheld Justice Yates’ findings that Otsuka’s patent relating to aripiprazole, a drug used in the treatment of schizophrenia, is invalid for want of novelty and inventive step.
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Next steps after Australia China Free Trade Agreement – how to make the most of the opportunity
23 July 2015
The China-Australia Free Trade Agreement represents significant opportunities for Australian health and aged care providers.
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Australia signs Free Trade Agreement with China – important implications for IP owners and healthcare providers
22 June 2015
After years of negotiation and months of drafting, Australia signed the Free Trade Agreement between the Government of Australia and the Government of the People’s Republic of China (ChAFTA).
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Blindsided on prior use
24 March 2015
A recent decision of the Full Court of the Federal Court reaffirms that not every prior use of an invention will be novelty defeating (see Damorgold Pty Ltd v JAI Products Pty Ltd [2015] FCAFC 31).
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Court rejects ACCC claim against Pfizer
25 February 2015
The Federal Court has today dismissed a case brought by the Australian Competition and Consumer Commission (ACCC) against Pfizer Australia for alleged misuse of market power and exclusive dealing.
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High Court grants Application for Special Leave to Appeal in Myriad Genetics
13 February 2015
The High Court has granted Cancer Voices’ application for special leave to appeal a Full Federal Court finding that Myriad’s patent relating to the BRCA1 gene is patentable.
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