Colette Downie

Patent Litigation – Life Sciences

• Acted for a multinational pharmaceutical company in Australian patent infringement and revocation proceedings concerning the blockbuster pain treatment, Lyrica®, in the Federal Court and High Court of Australia. These proceedings considered novel questions of patent infringement in the context of an application to list a generic brand on the Pharmaceutical Benefits Scheme.*
• Acted for a biotechnology company in Australian patent opposition proceedings regarding vaccine platform technologies.*
• Acted for a global pharmaceutical company in proceedings before the Federal Court and High Court of Australia, including in relation to Australia's first inquiry into compensation pursuant to an undertaking as to damages following the successful revocation of a pharmaceutical patent.*
• Advised and acted in Australia's first biologic / biosimilar patent dispute in preliminary discovery proceedings concerning a blockbuster biological medicine, Enbrel®, including as part of a coordinated, global litigation strategy.*
• Advised a global biotechnology company in a matter involving a large, complex patent portfolio concerning a monoclonal antibody used in treating inflammatory conditions, formulations and methods of production.*
• Provided pre-litigation and freedom-to-operate advice to numerous multinational generic, biosimilar and innovator companies, and acted in preliminary (interlocutory) injunction, revocation and infringement disputes, concerning patents covering a wide variety of products including allergic rhinitis treatments, anti-viral therapies, a phosphodiesterase-5 inhibitor, therapies targeting immune-mediated / inflammatory conditions, antipsychotics, cholesterol treatments and anti-cancer treatments.*

Patent Litigation – Technology & Consumer Goods

• Acted in patent infringement and revocation proceedings for a global clean energy company and solar cell manufacturer in proceedings before the Federal Court of Australia. This dispute was part of a multijurisdictional dispute involving related actions in the US and Germany.*
• Advised a major Australian retailer and manufacturer on Australian patent infringement issues for various patents concerning FMCGs.*

Life Sciences - Regulatory

• Advised numerous life sciences, medical device and medicinal cannabis companies and medical research institutes on a range of regulatory matters, including the registration of therapeutic goods and medical devices, advertising of products, digital health regulation, interactions with consumers and healthcare professionals, compliance with industry codes, ethics and clinical trial regulations, and interactions with regulators.
• Acted in Federal Court proceedings for a Canadian nutraceuticals client to successfully enforce a foreign arbitral award.*
• Acted for an Australasian pharmaceutical company in the successful defence of Federal Court proceedings concerning claims of misleading and deceptive conduct in relation to advertising an analgesic product.*

Other IP: Trade Marks, Brand Enforcement, Copyright & Food Regulatory

• Acted in numerous trade mark oppositions in the Australian Trade Marks Office, appeals to the Federal Court of Australia, and trade mark infringement and anti-counterfeiting proceedings, including for major Australian financial institutions, multi-national FMCG and luxury goods companies, a global entertainment corporation and automotive companies.*
• Acting in numerous trade mark prosecutions matters, oppositions and appeals, in Australia and New Zealand, in trade mark and brand enforcement matters for a major Australian supplier of building products.
• Acted for a US-headquartered, multinational mass-media and entertainment conglomerate in numerous trade mark opposition proceedings and brand enforcement actions.*
• Acted for an Australian media company in a copyright and licensing dispute in the Federal Court and High Court of Australia.*
• Advised numerous global and Australian clients on trade mark portfolio management, brand enforcement (including in relation to dupes / copy-cat products) and anti-counterfeiting strategies, food regulatory issues (including advertising, labelling, compliance with industry codes, biosecurity and food import regulations, clearance of marketing collateral), and food/medicine/cosmetics regulatory overlap.*

*Denotes experience gained at previous firm