The legacy of Myriad for gene-based diagnostics: a new policy and regulatory option

• Published in: Journal of intellectual property law & practice 2009-04, Vol.4 (4), p.267-277
• Main Author: Odell-West, Amanda
• Format: Article
• Language: English
• ISSN: 1747-1532; 1747-1540
• DOI: 10.1093/jiplp/jpp005

Legal context The international controversy concerning the scope and management of patents over gene-based diagnostics and their effects on public health, medical discretion, and research reached a crescendo in 2005 following a highly publicized, successful legal challenge at the European Patent Office against Myriad Genetics, concerning their patents to the BRCA1 gene. Since then, the Department of Health has shown little continuing concern to anticipate a similar situation which could compromise domestic healthcare provision and/or gene-testing services. Key points A patent granted over a gene-based diagnostic test can be managed according to the patentee's commercial policy, regardless of any conflict with the public health interest. Neither compulsory licensing nor crown use provisions within patent law could necessarily be relied upon to resolve matters in situations where conflict with the public health interest arises. Empirical evidence conducted is presented demonstrating concerns about the effects of patents on gene-based diagnostic tests, adding to those of other key stake-holders. Practical significance Two key proposals are put forward; first, a new policy to confine the scope of patents on gene-based diagnostics to their defined purpose or use and secondly, a regulatory scheme for genetic diagnostic tests based on the NHS Pharmaceutical Price Regulation Scheme (PPRS) for drugs.