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Review your IP arrangements: IP exemption from competition laws soon to be repealed
Insight 12 Mar 2019

Section 51(3) of the Competition and Consumer Act 2010 (CCA), which currently exempts conditional licensing or assignment of IP rights from most of the prohibitions on anti-competitive conduct in the CCA, will be repealed. ...

Faster TGA disclosure - what it means for pharmaceutical patent litigation
Insight 23 Apr 2019

The TGA has consulted on whether it should disclose earlier that a prescription medicine is under evaluation and what types of prescription medicines should be published. ...

What do the Swiss and artificial sweetener have to do with patents?
Insight 18 Apr 2019

The recent Federal Court decision in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2019] FCA 28 deals with fascinating issues for patentees seeking to enforce Swiss-style claims against makers of bioequivalent products. ...

Major new proposals for regulating personalised medical devices
Insight 14 Mar 2019

Proposed amendments to the regulation of personalised medical devices, which introduce a set of new internationally haromised definitions will have a significant impact on the industry ...

Data deal - mandatory data breach notification laws to be introduced as trade-off for controversial metadata retention regime
Insight 05 Mar 2015

The Federal Government in a surprising and highly significant move for companies in Australia has committed to enacting a mandatory data breach notification scheme before the end of 2015 which will apply to all Australian companies currently subject to the Privacy Act The proposal is not limited to ...

APRA information paper targets shared computing arrangements
Insight 17 Jul 2015

In response to its concerns about the potential risks associated with shared computing services including cloud computing APRA has issued an information paper that sets out prudential considerations and key principles for APRA-regulated entities using such services Partner Michael Morris Senior ...

Should you pay a cyber criminal's ransom?
Insight 22 Jan 2018

With ransomware attacks affecting six out of 10 Australian organisations1 businesses are being forced to decide whether to concede to the ransom demands of cyber criminals in order to regain access to critical data However with no guarantee that payment of a ransom will release their data businesses ...

Mandatory data breach notification scheme passed
Insight 13 Feb 2017

The Federal Parliament has today passed the Privacy Amendment Notifiable Data Breaches Bill 2016 which will amend the Privacy Act 1988 Cth to introduce a mandatory data breach notification scheme ...

Assessment of biosimilars - Is Australia leading, following or going its own way?
Insight 26 Oct 2016

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 ...

Insuring against cyber-risks: a changing landscape
Insight 23 Jul 2015

As cyber-attacks on Australian businesses increase many companies are discovering they are not adequately prepared or insured to handle a cyber-attack ...

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