Simone Mitchell
Partner, Sydney
An expert in intellectual property, I advise a broad range of companies on intellectual property (including patents, copyright, trademarks, designs and plant breeder's rights). I have been practising in area of intellectual property litigation for over 18 years and have a particular focus on pharmaceutical and biopharmaceutical patent litigation. I also advise on regulatory issues pertaining to therapeutic goods, cosmetics, chemicals and foods.

I have significant experience representing clients in intellectual property disputes, including appeals before the Australian Patent Office. I have acted for companies representing diverse industries, including pharmaceutical, biopharmaceutical, medical device, gene technology, consumer goods, telecommunications, mining and construction, in some of Australia's leading and most complex intellectual property disputes. I have specific expertise in acting in multinational patent disputes and advising on successful implementation strategies.

I assist clients comply with Australia's complex regulatory framework for therapeutic goods, including advising on issues relating to research and development, clinical trials, GMP, pricing and reimbursement, marketing approvals, compliance with industry codes, recalls and advertising complaints and disputes with regulators.

I also advise clients on the commercialisation, licensing, management and protection of their intellectual property.

In addition to my legal qualifications, I also have a degree in veterinary sciences and am a registered veterinary surgeon.

Career highlights

  • I acted for Helsinn Healthcare SA and Mundipharma Australia Pty Limited in Federal Court proceedings relating to a formulation patent for the anti-emetic pharmaceutical, ALOXI. The litigation was conducted in the context of multi-jurisdictional patent litigation occurring across the United States, Mexico, Korea and Vietnam. In addition to the Federal Court proceedings, I assisted in opposition proceedings before the Australian Patents Office in respect of the same patent.
  • I successfully acted for Branhaven LLC in an appeal from a decision of the Australian Patent Office. The patent application in issue claimed the provision of means to determine the genetic potential of bovines for an range of economically important traits. It was the first Federal Court decision to consider the patentability of methods that use genetic information.
  • I regularly advise clients on the enforcement of their patent portfolios in Australia as well as defending clients who have been subject of enforcement actions. I provide clients with freedom to operate advices, in particular in the pharmaceutical and biopharmaceutical sector. I have advised on a broad range of patents including those claiming products, pharmaceutical compounds, formulations, purity, methods of treatment, dosing regimens and business methods. Clients include Celltrion, Boral, Parnell Technologies, Sun Pharmaceuticals, Travel Caddy and Australian Wool Innovation.
  • I act in copyright disputes and have experiences enforcing and defending copyright relating to logos, photographs, fabric designs, building plans, floor layouts and databases. I acted in the first Federal Court proceeding to consider whether copyright can be assigned by email pursuant to the Electronic Transactions Act.
  • I have acted in a number of trade mark, misleading and deceptive conduct and passing off cases, including for Solahart Industries and Newell Rubbermaid.
  • I acted for a top five innovator biopharmaceutical company, successfully challenging a recommendation by PBAC to list a new drug on the PBS on the basis that it was interchangeable on an individual basis and was non-inferior to other therapeutically related drugs, thus avoiding a statutory price reduction.
  • I have also acted for numerous life sciences companies in connection with promotional campaigns and, in particular defending clients against complaints relating to their promotional campaigns, prosecuting complaints and acting in proceedings commenced in the Federal Court of Australian involving claims of misleading and deceptive conduct relating to promotional material.

Awards & recognition

  • Recognised in Chambers Asia Pacific, Life Sciences, Band 3, 2019.
  • Listed as a leading lawyer for Life Sciences – Australia in Expert Guides, 2018
  • Listed as a Notable Practitioner in Chambers & Partners (Life Sciences: Asia Pacific), 2016, 2015 and 2014.
  • Features in Managing Intellectual Property's IP Stars Handbook for Patent Litigation, 2015.
  • Co-author of the Australian chapter of the Practical Law Company's Multi- Jurisdictional Guide: Life Sciences (2012- 2016) as well as Marketing and Distribution of Drugs (2015).

Visit our Intellect blog home to sign up to our newsletter.