Life sciences

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.

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.

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:

 

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.

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.