Biotech & Health
As governments and private corporations increasingly recognise the benefits of investing in this dynamic and fast growing industry, specialist legal services have become far more important to organisations at all stages of their development.
How we can help
Whether your organisation is a start-up company, an established research and development institution, a university, a co-operative research centre or a multinational pharmaceutical company, Allens is able to offer a specialist, fully integrated range of services.
Our biotech and healthcare team brings together lawyers and patent attorneys who have the experience, expertise and professional networks to assist in every aspect of your organisation's operation – from funding start ups to commercialising innovations in biomedical research to stock exchange listing and beyond.
Allens is one of very few law firms in Australia which offers a one-stop-shop of legal, intellectual property and corporate advisory services to the biotech and healthcare industry. This streamlined service not only brings together the very best of people in the one firm; it also saves time and money.
Experience you can count on
Our team is comprised of a highly skilled range of lawyers, patent attorneys and corporate advisers, many of whom also hold qualifications in the health sciences, engineering and computer programming. For instance, our scientific qualifications include disciplines such as microbiology, pharmacy, genetics and chemistry. This gives our practice a powerful combination of technical, commercial and legal know-how.
Our expertise in biotechnology builds upon decades of partnerships with some of Australia's major players in the health sector. We have extensive experience in establishing and structuring health practices and facilities, infrastructure projects, taxation, insurance, litigation as well as dealing with health technology issues.
We also have extensive experience in advising on the patentability of biomedical research and other inventions as well as on the many issues that concern the development of a biotechnology enterprise - the management, protection and commercialisation of intellectual property assets; technology licensing; commercialisation strategies; collaborative research and clinical trial agreements; corporate governance; capital raising; company floats; mergers; acquisitions and joint ventures.
We have also dealt extensively with:
- legislation, rules and codes of practise which affect the pharmaceutical and biotechnology industries and the drug approval process;
- regulatory matters including, PBS pricing and dealing with therapeutic goods regulation, ASX and ASIC compliance;
- clinical trial studies including ethical and consent issues, ICH guidelines and arrangements with investigators and IECs;
- establishment of manufacturing operations; and
- labelling, packaging and advertising.
Optimising opportunities
Whether we're working with a spin off company, an international venture capital fund wishing to invest in a brilliant idea or a health infrastructure provider, we are focused on achieving optimal commercial outcomes.
We are also focused on understanding your business and your commercial objectives. We deliver innovative and cutting edge solutions.
Experience
Commercialisation
Act for biotechnology companies, research organisations, academic institutions and cooperative research centres; advise on biotechnology commercialisation, including technology licensing, research and development agreements, commercialisation strategies and business planning.
Infrastructure
Work on complex hospital developments in both the private and public sector, including in relation to project finance, capital works and information technology infrastructure.
Intellectual property creation, management and protection
Help our clients identify, capture, protect, manage, and defend intellectual property assets, including invention appraisal, patent drafting and prosecution worldwide, intellectual property portfolio management, and design and trade mark protection. We deal extensively with inventions in relation to immunology, microbiology, molecular biology, genetics, proteomics, chemistry, pharmaceuticals, diagnostics and treatment of diseases, and medical devices.
Litigation and disputes
Extensive experience in wide-ranging patent litigation. For example, we ran the first successful Australian opposition to a pharmaceutical patent term extension; we act for clients in drug-related patent oppositions; we advise on patent litigation involving orders for preliminary discovery to ascertain whether patent infringement is an issue; and manage major pharmaceutical patent infringement and patent revocation disputes in the Federal Court.
Product liability
Our product liability team handles a wide variety of disputes in relation to pharmaceuticals and medical devices. We have expertise in establishing and implementing global defence strategies and dealing with multi-jurisdictional, multi-claimant matters (including class actions). We also effectively manage the product and company reputational issues that often arise.
Marketing and advertising
Help with the marketing, sales and advertising of pharmaceutical products and services, including therapeutic goods regulations, trade practices, advertising compliance and labelling and packaging issues.
Corporate transactions
We provide IP advice on corporate transactions, including on mergers and acquisitions, capital raising and corporate structures. We advised the Macquarie Bank-led consortium on the IP issues associated with its US$1.7 billion purchase of the global explosives business, Dyno Nobel, and Pfizer Inc on the Australian IP issues associated with the global sale of its consumer healthcare division to Johnson & Johnson.
Regulatory
Deal extensively with the legislation, rules and codes of practice that affect the pharmaceutical and biotechnology industries, including in relation to the drug approval process, ASX and ASIC compliance, clinical trial studies and the establishment of manufacturing operations.
Risk management
Offer time-critical advice and practical solutions for risk management. We help implement effective risk-management policies and conduct audits, covering issues such as recall policies, quality assurance systems, product information and packaging, regulatory interface, crisis management, document management policies and risk-transfer mechanisms.