Minter Ellison's popular report on the fundamentals of doing business in Australia.
Our pharmaceutical and biosciences team brings together a broad range of legal expertise to deliver comprehensive advice to local and international clients engaged in various aspects of this sector — from early stage medical research to managing participation in the pharmaceutical and medical device industries. Our lawyers advise on intellectual property licensing, protection and disputes, regulation of bioscience research including clinical trial requirements and management of claims arising from adverse outcomes, regulation of pharmaceutical and medical device products including Therapeutic Goods Administration requirements, insurance requirements, compliance with industry standards and issues relating to inclusion on the Pharmaceutical Benefits Scheme and the Prosthesis List. We also advise on commercialisation techniques, venture capital investments, R & D tax concessions, effective tax effective structuring and IPOs. We also have an affinity with and understanding of the science involved – many of our lawyers and consultants are qualified in science-related disciplines such as biochemistry, neuroscience, computing, mathematics, genetics and molecular biology. We have advised on some of the largest, most complex transactions in the pharmaceutical industry and have had extensive involvement in bioscience research projects. Our work has included preparing and negotiating agreements for research collaborations, joint ventures, consultancy agreements, funding agreements, manufacturing and supply agreements, confidentiality agreements and material transfer agreements.
On Tuesday, 29 November 2011, as part of its Mid-Year Economic and Fiscal Outlook 2011-12, the Federal Government announced a package of changes intended to raise A$11.5 billion in new revenue and savings.
The Full Federal Court of Australia recently found that the majority of Wyeth's patent claims covering a method of administering an antidepressant compound were invalid, based on a finding that the patent was not entitled to its earliest priority date. The decision highlights the care required when amending patent claims to ensure they are not broadened to the extent that they cease to be fairly based on the specification and any priority documents.
Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No.3) [2011] FCA 346, the Federal Court found that the secondary patent protecting Sanofi-Aventis' blockbuster leflunomide drug was valid and infringed – a surprising outcome, at least initially, based on the facts of the case.