The freedom to tinker: patent law and experimental use

Abstract

This article considers the origins and the development of the defence of experimental use in patent law – the ‘freedom to tinker’. It explores the impact of such an exemption upon a number of important industries – such as agriculture, biotechnology and pharmaceutical drugs. This article takes a comparative approach in its analysis of patent law and experimental use. It highlights the competing norms, and lack of harmonisation between a number of jurisdictions, including the United States, the European Union and Australia. Section 2 provides a critique of the development of the common law defence of experimental use in the US. It considers a series of precedents – including Roche Products, Inc. v Bolar Pharmaceuticals, Madey v Duke University, Integra Lifesciences I Ltd v Merck KgaA, and Applera v MJ Research. Section 3 explores the operation of patent law and experimental use in Euro-pean jurisdictions. It looks at a number of significant precedents in the UK, the Netherlands, France, Italy and Germany. Section 4 considers the policy debate in a number of forums over the defence of experimental use in Australia. It examines the controversy over Genetic Technologies Limited asking research organisations to obtain a licence in respect of its patents associated with non-coding DNA and genomic mapping. It also considers the inquiries of the Australian Law Reform Commission and the Advisory Council on Intellectual Property, as well as the impact of the TRIPS Agreement and the Australia – US Free Trade Agreement. The conclusion contends that there is a need for a broad-based defence of experimental use for all the member states of the Organisation for Economic Cooperation and Development.

• agricultural chemicals
• biotechnology
• clinical testing
• experimental use
• patent law
• pharmaceutical drugs
• research exemption