Shaping law and practice that drives fast paced innovation in biotechnology

The biotechnology industry in Australia is experiencing rapid growth and change as participants continue to develop new technologies and adapt business models to an evolving regulatory and competitive environment.

With continued developments in genomic and proteomic medicine, gene editing and engineering, biologics and biopharmaceuticals as well as in AI, big data and analytics, our team are helping clients with leading commercial and regulatory advice across the full range of issues they face.

We assist clients to take advantage of M&A opportunities in an active market.

Our advice includes:

  • 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 litigation 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.

Our experience in biotechnology

  • Avexa: advising the Australian based biotechnology and research development company in its merger with Progen Pharmaceuticals, subsequently creating one of the largest biopharmaceutical companies in Australia.
  • Queensland Biocapital Fund: advising on various acquisitions, investment management and divestures.
  • Telesso Technologies: advising the Australian-based biotechnology company on its acquisition of UATC business from Uniquest and investment in Telesso.
  • Biota: advising Biota on its US$231 million contract with the United States’ Office of Biomedical Advanced Research and Development Authority (“BARDA”) for the development of an anti-viral drug.
  • CSIRO: advising on a range of regulatory and commercial dealings, including in relation to the regulatory and contracting architecture for the BioFoundry robotic synthetic construction facility.
  • The University of Queensland: advising on commercial agreements in relation to the development of a novel coronavirus vaccine and in relation to risk, liability and regulatory issues in relation to development of vaccines.
  • Arcus Biosciences: advising on clinical trial regulation in Australia.
  • Samsung Bioepis: advising in relation to the Australian aspects of a multi-jurisdictional series of patent disputes concerning patents for formulations for an antirheumatic drug.
  • Sandoz: defending an action brought by Roche against Sandoz relating to patents for leading haematology drug, rituximab – this was the first case in Australia relating to the launch of a biosimilar.
Our Expertise in Healthcare & Pharmaceuticals
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Latest Thinking

Insight

Not just hot air: civil penalties for unlawful advertising of therapeutic products

In late October 2023, the Federal Court of Australia awarded civil penalties against both Vapor Kings Pty Ltd and its sole director for unlawfully advertising nicotine vaping products (NVPs) — known as “vapes” — in breach of the Commonwealth Therapeutic Goods Act 1989 (the TG Act).

22 November 2023

Insight

The Therapeutic Goods Administration’s new compliance and enforcement priorities

At the start of each financial year, the Therapeutic Goods Administration (TGA) publishes its compliance and enforcement priorities for the next 12 months and the TGAs recent publication indicates what the TGA will be focusing on in FY2023-2024.

02 August 2023

Insight

Proposed redesign of Australia’s designs law

IP Australia is proposing to extend the Australian design rights system to protect virtual designs such as iPhone’s swipe-to-unlock design, in-game fashion items in Fortnite, or avatars created for virtual reality experiences.

27 July 2023

Latest News

NEWS

KWM assists Queensland Museum with NASA exhibition landing

King & Wood Mallesons (KWM) has advised Queensland Museum to ensure the successful arrival of its latest and largest ever exhibition, NASA – A Human Adventure.

10 May 2019

NEWS

KWM zips up Australia’s largest fintech debt market deal

King & Wood Mallesons (KWM) advised ASX listed fintech company, zipMoney Limited on a $260 million facility led by National Australia Bank (NAB) - representing the largest debt market deal to date in the Australian fintech sector.

01 June 2017

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