OCTOBER 2021CIOAPPLICATIONS.COM8dvances in molecular testing are making patent protection and monitoring ever more difficult. Jürgen Schneider says its time for the sector to reach for new tools.A quiet revolution in identifying diseases is making IP management in molecular diagnostics increasingly difficult ­ and, ironically,threatens to undermine our ambition to makereliable testing for human ailments easily accessible to all mankind. The COVID-19 pandemic has made polymerase chain reaction (PCR) a household term as a gold-standard test for the SARS-CoV-2 virus. But for about a dozen years,so-called syndromic PCR-testing has been on the march. Instead of testing for one pathogen at a time, syndromic testing looks for 50, 100 or even 250 pathogens in parallel in a sample to more quickly and surely identify the viral, bacterial or fungal causes of patients' symptoms (or what doctors call "syndromes").Molecular testing is a young industry and patent protection abounds. When a so-called syndromic panel is ready for launch, IP expertshave to secure patents for its innovations and assess the company's freedom to make and market the new product without infringing on other companies' IP rights. Freedom to operate (FTO) analyses for single-pathogen kits forcean IP expert to wade through hundreds or thousands of patents approved and pending, and cost between $5,000 and $20,000. Multiplying that effort for50 to250 pathogens means FTO analyses for panels already cost up to $800,000, with the price tag rising rapidly. The problem for molecular-diagnostics companies is that FTO expenditures are rising towards levels that could threaten their products' commercial viability(and the profits to fund the development of the next innovation). And there is no way obvious was to escape a tyranny of numbers. Syndromic-testing panels covering new or more pathogens are likely to hit the market, while the number of patents to check against rises inexorably. From 2010 to 2019, the number ofallpatents in force worldwide jumped from less than 9 million to 15.2 million and patent applications from less than two million to 3.2 million every year. Complicating this situation is the fact that patents at the molecular level are different from those on big, robust engineering products like car engines. Living materials made from DNA or RNA change continually ­ there were no SARS-CoV2 pathogens and no mutations two years ago. That means the products that interact with them AJÜRGEN SCHNEIDER, VICE PRESIDENT, HEAD OF GLOBAL IP & LICENSING, QIAGENIn My ViewRNA, DNA AND THE RISING COST OF IP MANAGEMENT
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