I regularly assist clients in navigating the regulatory landscape for medicines and medical devices, including advising on, and acting in, disputes regarding PBS reimbursement and compliance with the Therapeutic Goods Act 1989 (Cth).

As a litigator, I have acted on many major IP disputes in the Federal Court and High Court, including some of the country’s biggest pharmaceutical patent cases, and ground-breaking copyright and trade mark matters.

Another key focus of my practice is IT disputes, reflecting the passion I have for technology and innovation. The majority of those disputes end up being resolved in mediation.

Career highlights

• Successfully acted for Hospira / Pfizer in Australia's first litigated regulatory dispute regarding biosimilars, which was litigated in the Administrative Appeals Tribunal.
• Advised a number of pharmaceutical, biotech and medical devices clients on regulatory issues and disputes.
• Worked on interlocutory injunction applications and substantive patent infringement and invalidity litigation, including the Actavis Group’s successful application to have AstraZeneca’s patents for blockbuster cholesterol drug rosuvastatin (Crestor) declared invalid (and successful defence of AstraZeneca's infringement allegations), which was ultimately decided by the High Court.
• Acted in a number of trade mark, misleading and deceptive conduct, and passing off cases, including successfully defending Sweet Rewards against trade mark infringement claims pursued by Mars Australia in the Federal Court (an on appeal to the Full Court).
• Advised on more than 20 IT contract disputes arising from technology outsourcing, systems implementations and software licensing, acting for both customers and suppliers.
• Acted for copyright owners, and alleged infringers, on copyright disputes regarding source code, songs, photographs, building plans, databases, training materials, computer programs, video clips of sporting highlights, and technical documents submitted to regulatory authorities.
• Advised on breach of confidence disputes arising from ex-employees working for competitors, or companies misusing information obtained in the course of exploring potential commercial collaborations.

Education
LLB, BEcon (University of Tasmania)

• Federal Court decides scope of Crown copyright laws
  

  First judicial interpretation of section 183(1) of the Copyright Act clarifies the scope of the exception to copyright infringement.

• PBS damages claim lands in the High Court
  

  The High Court this week hears the Commonwealth's claim for PBS compensation in its patent injunction damages case against Sanofi.

• MinterEllison achieves landmark victory for Alphapharm in high stakes win
  

  Federal Court refuses to grant Sanofi interlocutory injunction to stop launch of insulin glargine injector pen.

• "Catch up" price reductions for PBS-listed medicines are coming – what should you be thinking about?
  

  Sponsors who anticipate that their PBS-listed medicines may be included in the indicative list of "catch up" price reductions on 1 July 2022 should start considering now whether to ask the Minister to intervene in any proposed reduction.

• MinterEllison successfully acts for Hytera in one of Australia's biggest ever patent cases
  

  In a pivotal dispute regarding digital mobile radios, the Federal Court of Australia has found in favour of Hytera Communications with respect to two of three patents that Motorola Solutions sought to enforce in a case that has been running since 2017. Hytera is a ing global provider of digital mobile radios.

   

• New regulations for e-prescribing and their impact on patent litigation in Australia
  We provide an update on changes to electronic prescribing of medicines in Australia, and how this might impact on patent disputes.
• High Court considers distinctiveness of foreign words
  
• Managing possible medicine shortages in Australia during COVID-19
  

  The COVID-19 pandemic has given rise to concerns about shortages of essential medicines which are manufactured in, or require ingredients supplied by, countries affected by business closures and other operational delays.

• Fast drugs: accelerating the regulatory approval pathway for COVID-19
  

  As the COVID-19 crisis continues to take hold globally, attention is increasingly turning to the tireless work being done by medical researchers to address the effects of the pandemic. What are the options for fast-tracking regulatory approval for vaccines, diagnostic tests and treatments for COVID-19 and when are we likely to see results?

• Rapid Antigen testing
  

  Rapid Antigen Tests are now being used as part of Australia's response to COVID-19. We explore how they are being used during their pilot phase.

• Still no all-Encompass-ing test for patentability of computer-implemented inventions
  

  The Full Federal Court's latest judgment regarding the patentability of computer-implemented inventions in Australia.

• Commonwealth fails in $325 million compensation claim after generic medicine kept off market
  In the first judgment of its kind, Justice Nicholas has ruled that Sanofi is not liable to compensate the Commonwealth of Australia for $325 million in Pharmaceutical Benefits Scheme (PBS) reimbursement payments, where Sanofi enforced its patent to restrain the launch of Apotex's generic clopidogrel product, and Sanofi's patent was later found invalid: Commonwealth v Sanofi (No 5) [2020] FCA 543.
• Astrazeneca's Rosuvastatin (Crestor) patents remain invalid - the outcome of the Full Bench Federal Court appeal
  
• Are you ready for the new Therapeutic Goods Advertising Code?
  

  On 1 January 2022, the new Therapeutic Goods Advertising Code 2021 (Cth) (Code) came into effect. The Code, sets out the requirements for the promotion of therapeutic goods (such as medicines and medical devices) in Australia with a view to ensuring that such advertising, promotes the quality use of products, is socially responsible and does not mis or deceive consumers.

• Federal Government introduces legislation for Patent Box tax scheme
  

  The much anticipated 'patent box' tax scheme, first proposed in last year's Federal Budget, has taken a further step towards implementation, with the Government introducing draft legislation into Parliament on 10 February 2022.

   

• A 'patent box' for Australia – what does it mean and how will it work?
  

  The 'patent box' tax incentive, proposed in the Federal Government's budget on Tuesday, has been heralded as a major boost for Australian medical and biotech manufacturing. But what does it mean and how will it work? We provide a brief overview of the government's proposal, and discuss some key aspects that will need to be considered as the scheme is developed.

• High Court confirms proper approach to assessing inventive step
  

  The High Court in Australia last week handed down its decision in the patent dispute regarding blockbuster cholesterol drug rosuvastatin (sold by AstraZeneca as Crestor).

• COVID-19 and recent developments in the health regulatory space
  

  The outbreak of the COVID-19 pandemic has led to a dramatic increase in the promotion and sale of various products which may be used to combat the virus. By stepping up to manufacture, advertise and supply products such as hand sanitiser and disinfectants, companies are also stepping into the regulatory framework for therapeutic goods. 

• CAR-T cell therapy's unique legal considerations | A new era for pharmaceuticals
  

  What do you need to know about CAR-T cell therapy? We explore the CAR-T patent landscape, deep dive into specific infringement and litigation strategy and consider patent validity issues likely to arise for CAR-T patents in Australia.

• The 'wicked' question of trade mark ownership – the devil is in the detail
  

  The Federal Court's decision in PDP v Grasshopper reinforces the importance of ensuring that the trade mark applicant is the owner of the trade mark at the time of applying for registration.

   

• 2020-21 Therapeutic Goods Advertising Compliance Report | actions and priorities
  

  The report outlines the therapeutic goods advertising breaches, penalties issued and other enforcement actions the TGA took in 2020-21. Promotion of COVID-19 products were a key priority and will continue to be in 2022.

• IP Australia Fee Review 2024: Upcoming changes
  

  From October 1, IP Australia will introduce fee increases and change when excess claim fees are payable for patent applications.

• ToolGen loses appeal in first Australian CRISPR patent judgment
  

  The Federal Court has delivered a landmark judgment, applying the "same invention" principle from the UK and Europe to assess the priority date of ToolGen's patent application.