On the Legality of Gene Patents‪.‬

[This article considers the legal and policy deliberations on gene patenting that have occurred since the issue came to the fore in the early 1990s. The analysis is contextualised with brief overviews of the science of genetics and genomics and the law of patents. Legislation, administrative guidelines and case law are analysed, focusing on the jurisdictions of Australia, the US and the UK. This article concludes that, despite ongoing legal and policy developments, clear guidance as to the legality of gene patents remains elusive. It is obviously desirable to have proper and certain gene patenting laws. In time, this is likely to happen. In the interim, it is argued that other mechanisms are also available for dealing with gene patents, negating the desirability of a radical overhaul of gene patenting laws.]/p pre CONTENTS I Introduction II The Historical Context A Primer on Genetics and Genomics B The Rise of the Biotechnology Industry III Characterising Gene Patents IV The Law: What Exactly Can Be Patented? A Patent Law Primer 1 The Invention Requirement 2 Exclusions 3 The Novelty and Inventive Step Requirements 4 The Utility Requirement 5 Patent Scope and Disclosure Requirements B Do Genes Cross the Invention Threshold?