Dr Michael Hopkins

Sussex researcher Michael Hopkins has contributed to a report that highlights the growing conflict between the health service and private enterprise over genetic discoveries. 

Dr Hopkins, who is a Senior Lecturer in SPRU - Science and Technology Policy Research at the University is an expert on the uses of gene patents, where genetic techniques and DNA sequences are licensed as the property of biotech firms and others looking to profit from their research in the fast-growing field of diagnostic genetics. 

The patenting of DNA is increasingly affecting areas of medicine other than clinical genetics, where it was first controversial, and now is prominent in areas such as cancer diagnosis and treatment and in infectious diseases. 

Since the early 1980s the patent offices in the United States, Europe and Japan have granted thousands of patents with claims to sequences of human DNA, raising concerns about whether genetic discoveries should be subject to patenting and whether it is ethical to patent the blueprint for human life. This proliferation has been fuelled further by universities seeking patents to protect new genetic discoveries. 

In 2010 Dr Hopkins took part in a seminar arranged by the Human Genetics Commission, looking at the impact of DNA patents on the development of new diagnostic tests and at policy changes that could help develop fair and equitable frameworks for intellectual property rights in this area. 

Dr Hopkins says: "The trend to patent biological molecules like DNA is reshaping business models in the diagnostics industry. This has important implications for hospital labs who until now have been largely free to conduct tests for patients as they wish, but they are going to face more competition and possibly patent infringement suits in the future." 

The seminar revealed a profound tension between the industry's desire to exploit the financial value of biomarker patents  (a biomarker being a substance that is used to identify a particular biological state) and the routine infringement of such IP in NHS laboratories. 

The resulting report, just published, suggests that while some hospital staff feel that there is little justification for patent rights on genetic tests, and that the proliferation of such patents could stifle innovation in this area, patents that lead to the monopolisation of genetic techniques can have an important role to play in some forms of innovation, such as cancer screening tests, because they encourage private investment. 

The report went on to recommend that: 

• UK research funders and councils review their patents guidelines in response to the reported growth in patenting by academic researchers;
• the Department of Health monitor patenting developments and encourage cooperation between the public and private sectors that make use of DNA sequencing and genetic testing techniques;
• the NHS appoints a senior manager to preside over genetic IP issues;
• more research is commissioned to assess the impact of genetic patenting.