31-40 of 45 results
Changes ongoing for product liability and compliance during COVID-19
Amidst increased scrutiny by the Therapeutic Goods Administration and the ACCC, Australian businesses which manufacture personal protective equipment (PPE), detergents and hand sanitiser must remain on top of changes to product laws in the healthcare space in order to avoid potential liability. ...
PBS process proving a headache for migraine medications
Challenging a PBAC decision is not straightforward. We take a look at the available options and examine the alleged delays in listing migraine treatments Emgality and Ajovy on the PBS. ...
Linklaters Insights: Novel Coronavirus - practice guide of significant commercial and legal issues
The recent outbreak of the novel coronavirus is causing disruption across greater China and the region. This cross-practice guide from our colleagues at Linklaters highlights key issues that may affect business operations in the current environment. ...
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 ...
Healthcare trend watch 2019
The healthcare team at Allens reports on some key trends and sectors to look out for in 2020. ...
TGA guidance on the promotion of stem cells and HCT products
The Therapeutic Goods Administration has issued advertising guidance for businesses involved with stems cells and other human cell or tissue products. ...
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 ...
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 ...
Reasonable belief or a mere suspicion? Full Court lowers the bar on preliminary discovery applications
The Full Federal Court has handed down a significant decision on preliminary discovery in a result that will be welcomed by IP owners, as the court has clarified the requirements for a successful preliminary discovery application while emphasising the need for such applications to be met with brevit ...
The ending point for 'starting point'
The Full Federal Court has published its much-anticipated judgment in the AstraZeneca v Apotex appeal A bench of five judges heard the appeal in contrast to the usual three judges in order to be able to clarify or overrule if appropriate an earlier Full Court decision relating to the correct test ...