261-270 of 348 results
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 ...
Major new proposals for regulating personalised medical devices
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 ...
Review your IP arrangements: IP exemption from competition laws soon to be repealed
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licensing or assignment of IP rights from most of the prohibitions on anti-competitive conduct in the CCA, will be repealed.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
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?
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. ...
The ramifications of a Facebook rant
The Full Court of the Federal Court recently handed down its decisions on an appeal that highlights the dangers of making unsubstantiated social media comments Partner Miriam Stiel and Lawyer Tracy Lu report on a long-running dispute where the court found personal Facebook posts constituted ...
TGA confirms its approach to disclosure of commercially confidential information
The Therapeutic Goods Administration has released the final version of a document outlining its approach to the disclosure of commercially confidential information including information provided by medicine sponsors This follows the release of a draft version in June 2013 and a period of public and ...
Acquiring a business? How to 'transfer' social media accounts
Our IP team frequently assists with the sale or purchase of a business, advising on the scope of relevant IP to be transferred and how to transfer that IP ...
Isolated genetic material confirmed as patentable
In a unanimous decision the Full Federal Court has confirmed that genetic materials in their isolated form remain patentable in Australia The decision related to an appeal from an earlier Federal Court decision in which it was found isolated nucleic acids to be a manner of manufacture as required by ...
The Mark of Milk and Money: a2 vs Lion
The widely reported dispute between The a2 Milk Company and Lion about their milk advertising is proving to be a frothy fight, providing food manufacturers with valuable lessons, even before a judgment has been handed down. ...