41-50 of 83 results
High Court unanimously finds isolated genetic material not patentable
In the culmination of a hard-fought patent dispute the High Court of Australia has unanimously ruled that Myriad Genetics patent claims to isolated nucleic acid coding for the mutant or polymorphic BRCA1 polypeptide are not valid ...
Protecting innovation without patents - data exclusivity and market exclusivity
Developments in patent law and the consequential limitations on patentability for biologic medicines mean that data exclusivity and market exclusivity can be the primary protection afforded to originator biologic medicines This is most stark in the US where patent protection for biologic medicines ...
OAIC concludes investigation of Australian Red Cross data breach
OAIC concludes investigation of Australian Red Cross data breach where a one-off human error by a third party provider's employee led to a massive data breach that hit the Australian Red Cross Blood Service ...
Unexpected risks of the IoT revolution: Cyber security in medical devices
In late August 2017 the US Food and Drug Administration recalled 465000 Abbott Laboratories pacemakers due to cyber security vulnerabilities Although this was the first time that the FDA had recalled a medical device because of cyber concerns they have been alive to the significant risk that a cyber ...
Using third party brands in video games: issues and opportunities
One of the emerging battlegrounds for brand owners is video games, particularly with the growth of virtual reality applications. A recent claim made in the US illustrates how having your brand featured in a video game can be a problem - but depending on the circumstances, it could also present a com ...
What you need to know about mandatory data breach notification
In response to the rising number of cyberattacks, new legislation has been introduced that proposes a mandatory notification regime that will take effect from February next year. ...
What's in a (biosimilar) name?
Because biosimilars and their reference biologic medicine are not identical whether compared to each other or even between biosimilars it is important to know which product has been used ...
Protecting investment in biologic medicines - biological medicines, biosimilars and the challenges they pose
This series of articles is directed towards the part of biotech that is pharmaceutical rather than diagnostic or bioengineering technologies and in particular towards biologic medicines ...
ACCC's Enforcement and Compliance priorities for 2017
Criminal cartels unfair contract terms consumer guarantees and the health construction and agriculture sectors are some of the ACCCs key enforcement and compliance priorities for 2017 ACCC Chairman Rod Sims released the ACCCs 2017 Compliance and Enforcement Policy on Friday 24 February 2017 ...
Assessment of biosimilars - Is Australia leading, following or going its own way?
The ongoing lack of certainty about what is required to obtain biosimilar registration in Australia extends to three key issues - Comparability is the new product sufficiently similar to permit it to rely on the reference products safety and efficacy data Extrapolation for which of the indications ...