Navigating the molecular diagnostic patent landscape

Abstract

Background: The molecular diagnostic patent landscape mostly comprises patents claiming rights over genes and other research tools. Many such patents have been granted and many more await examination. Objective: To explore whether such patents are leading to adverse socio-economic consequences by stifling innovation and access. Method: The article begins with an examination of some key patents in the molecular diagnostic landscape and key aspects of their legality. Evidence of detrimental impact is then examined, using empirical studies conducted by the author in Australia and other researchers in other jurisdictions. Finally, expert opinion is provided on the current impact and future challenges of patenting for the molecular diagnostic industry. Conclusion: While enforcement of relevant patents against public-sector organizations appears to be somewhat less frequently encountered than might be expected, private organizations are likely to be exposed to far more such actions. It is argued that these organizations should consider more cooperative licensing strategies outside the more traditional exclusive-rights model.

Keywords::

• BRCA1
• clearing house
• gene patents
• intron sequence analysis
• molecular diagnostics
• molecular diagnostic industry
• ordre public or morality
• patent pooling