Molecular Diagnostics | Intellectual Property
RNA, DNA and the rising cost of IP management
September 6, 2021
Advances in molecular testing are making patent protection and monitoring ever more difficult. Jürgen Schneider, Vice President, Head of Global IP & Licensing, QIAGEN, says its time for the sector to reach for new tools.
Freedom to operate (FTO) analyses for single-pathogen kits force an IP expert to wade through hundreds or thousands of patents approved and pending. Multiplying that effort for 50 to 250 pathogens means FTO analyses for panels already cost up to $800,000.
The problem for molecular-diagnostics companies is that FTO expenditures are rising towards levels that could threaten their products’ commercial viability. And there is no obvious way to escape a tyranny of numbers.
The IP sector is lucky that the US limits the problem by banning patents on natural genetic material […] The EU, for its part, differentiates between essential and non-essential features and so also narrows the scope for court action […] But neither approach is a durable answer.