Shaping law and practice that drives fast paced innovation in healthcare
The pharmaceutical sector plays a critical role in advancing health, wellbeing and prosperity. The industry also continues to embrace digital innovation and utilise AI, big data and analytics to develop novel therapies and services that address rising instances of chronic disease whilst also improving processes, driving cost efficiencies and striving to improve patient outcomes.
King & Wood Mallesons is a top tier advisor to clients across all stages of the product life cycle – from the laboratory to supply chain and to the consumer. Clients rely on KWM for critical commercial and regulatory guidance.
KWM has a unique offering that incorporates the following market leading services:
- Regulatory know-how and commercial advice: KWM advises many new and established players on Australian regulation and legal and commercial aspects of research and development, clinical trials, and related services and supply agreements.
- Unrivalled patent litigation expertise: KWM boasts exceptional patent litigation expertise.
- A market-leading transactional record: KWM is the leading M&A firm in the Australian market and across the majority of Private Equity deals involving healthcare assets in Australia.
We also advise pharmaceutical companies on all areas of their business including:
- Patent, patent term extension and other intellectual property litigation
- Regulatory law
- Competition and anti-trust issues
- Licensing, commercialisation and supply arrangements
- Commercial dispute resolution (including product liability, competition and regulatory litigation)
- Marketing and advertising issues
- Brand clearance, protection, exploitation and enforcement
- Corporate advice (including fund formation, capital raising, corporate structures, joint ventures, tax, mergers and acquisitions, takeovers and de-mergers)
- Finance, advising both lenders and borrowers.
Work highlights
- Teva: acting on a wide range of commercial and regulatory matters relating to all aspects of Teva’s business in Australia including pharmaceutical distribution arrangements, import controls, advertising and marketing compliance issues, patent disputes and licensing, and competition regulatory issues.
- Aspen Pharma Pty Ltd: advising in relation to research and development and commercialisation arrangements in relation to the development of new formulations. Seeking a review of a decision of the Minister for Health in relation to a decision of the Therapeutic Goods Administration concerning delisting listed pharmaceutical products for treating pain.
- The University of Sydney: advising on all aspects of intellectual property and in developing precedent documents for use by in a range of patent licenses and commercialisation and research agreements, also developing additional precedent documents relating to clinical trials. Also advising on major Federal Court litigation involving mfVEP technology (with uses in glaucoma, MS, optic neuritis detection), including copyright infringement, trade secrets and breaches of patent licence allegations.
- Alphapharm: advising on their material patent litigation and associated TGA regulatory matters, raising a number of significant issues in relation to the validity of claims covering methods of use of existing drugs.
- Sigma and Mylan: acting against Pfizer/Wyeth for compensation arising from a wrongly granted preliminary injunction.
- Mundipharma: advising on the acquisition of a pharmaceutical company with a significant product portfolio, including in relation to IP and regulatory issues. Also advising on enforcement action by the Therapeutic Goods Administration in relation to promotion of therapeutic goods to health care practitioners.
- Consumer Healthcare Products Australia: advising on changes to the regulatory regime in relation to advertising therapeutic goods to consumers.
