Life sciences

The pharmaceutical, biotech and medical devices sectors are facing a period rich with opportunity. However, in order to capitalise on that opportunity, businesses are confronted by a rapidly changing regulatory landscape, ongoing pricing and reimbursement pressures, the difficulty of generating growth in mature, competitive markets, and disruption from new market entrants.

We are helping the life sciences industry address those challenges to deliver innovative and accessible healthcare solutions to the market – both in Australia, and globally.

Our multi-disciplinary team includes registered patent attorneys and lawyers qualified in scientific disciplines including biochemistry, neuroscience, computing, mathematics, genetics and molecular biology. As a result, we approach litigation and commercial matters alike with a deep understanding of the technology and science involved, and we offer comprehensive services across every stage of the life sciences lifecycle.

Research and development
Commercialisation
Regulatory compliance and disputes
Sales and marketing
Patent protection and litigation

Research and development

Innovations in the development of drugs, vaccines, diagnostics and medical devices, along with cutting-edge research in genetic engineering, synthetic biology, genomics and proteomics, have resulted in significant advances in the diagnosis, prevention and treatment of diseases.

However, researchers and organisations face a number of obstacles when conducting life sciences R&D, including the increasingly competitive fight for funding, intensified regulatory scrutiny, rising costs of doing business, the need to navigate intellectual property risk and technological change, and the inherent uncertainty of research success.

Our team can unpack the complexity of the R&D process. We have expertise in government and other funding arrangements, research and collaborative research arrangements, R&D tax concessions and other tax structuring, the establishment of specialist research centres, development of specialist research centres and laboratories, intellectual property protection and enforcement, regulation of R&D activities (including clinical trial requirements and management of claims arising from adverse outcomes), and pre-commercialisation due diligences and audits.

Commercialisation

We work with Boards, executives, funders and investors to determine optimal business models for commercialising new products. We have particular expertise in early stage venture capital, ongoing fund raising, debt and hybrid capital markets transactions, and market exits by way of trade sale, IPO or joint venture. We are also experienced in market assessments and market entry strategies, development of strategic plans, licensing and partnering strategies, identifying counterparties for local international markets, mergers and acquisition activity, corporate governance and restructuring.

Regulatory compliance and disputes

Life sciences companies operate within a strict, but rapidly changing, legal and regulatory framework. We provide regulatory advice and solutions across the life sciences life cycle including:

Advising on Australia's Therapeutic Goods Act 1989 (Cth) and associated regulatory framework for medicines, medical devices and complementary medicines, including the listing of goods on the Australian Register of Therapeutic Goods (ARTG) and obtaining conformity assessment certification.
Advising on foreign regulatory approval processes including International Coalition of Medicines Regulatory Authorities (ICMRA), US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Defending alleged breaches of the Australian regulatory framework, including challenging administrative decisions in the Administrative Appeals Tribunal and Federal Court.
Liaising with the Department of Health and preparing submissions to the Pharmaceutical Benefits Advisory Committee to obtain approval for listing of drugs on the PBS.
Assisting clients to navigate product recall procedures and defend product liability claims.

Sales and marketing

We work with marketing and management teams in the life sciences sector on brand selection, trade mark registration and promotion / advertising strategies. We are experienced in conducting cutting edge trade mark litigation, and can advise on risks regarding misleading and deceptive conduct and product performance claims.

Advertising therapeutic goods is also highly regulated, and we assist clients to navigate the Australian co-regulatory scheme, including compliance with the Therapeutic Goods Advertising Code, and making or defending complaints through the TGA's Complaints Resolution Panel.

Patent protection and litigation

High stakes patent litigation is commonplace in the life sciences sector. We have acted on many of the most complex pharmaceutical patent disputes, including cases that have been appealed to the High Court, and disputes that involve biological products and the entry of biosimilars onto the market.

With a fully integrated patent practice, our team implements patent registration strategies with a view to anticipating issues that could arise in a litigation or commercial context, and in light of a deep understanding of multi-jurisdictional issues.

We are also experienced in addressing the overlap between patent litigation and the patent certification requirements of the Therapeutic Goods Act. In addition, our patent strategies include considering the timing of PBS applications in the context of interlocutory injunction applications, and the impact of PBS price mechanisms on damages calculations.

Experience

Mylan Health - pharmaceutical patent litigation regarding the diabetes drug fenofibrate

Bristol-Myers Squibb - biologic patent litigation relating to PD-1 antibodies

Watson Pharma, Ascent Pharma and Actavis Australia - pharmaceutical patent litigation regarding block-buster cholesterol drug rosuvastatin, including successfully defending a High Court appeal

Hospira / Pfizer - defending a novel merits review challenge to the regulatory requirements for a biosimilar product

CSIRO - wide range of patent, IP commercialisation ventures and life sciences disputes

Mayne Pharma Group Limited - $888million equity raising

Antisense Ltd - worldwide acromegaly drug licence and equity placement with Strongbridge Pharma

Hexima Ltd - $10million equity deal

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Fibrotech -sale to global specialty biopharmaceutical company Shire plc
Spinifex - sale to Novartis which involved an initial upfront consideration payment of US$200 million plus significant milestone payments and royalties.
Medical Research Commercialisation Fund - a joint venture collaboration between superannuation funds, 35 major research institutes and State governments, on the establishment and formation of the fund as well as governance advice
Numerous life sciences initial public offerings, ASX listings and secondary capital raisings including Acrux Limited and Mesoblast Limited.
The University of Melbourne in relation to the establishment of various centres including the Bio21 Molecular Science and Biotechnology Institute, and Bionic Vision Australia.