Mateo Aboy (LML Principal Research Associate) has co-authored a featured patent particle in Nature Biotechnology with Jacob Sherkow (Professor of Law at the University of Illinois College of Law).
The US Food and Drug Administration has been criticized for failing to expeditiously approve ground-breaking medical devices. Some commentators have suggested that this has contributed to stagnation in the advancement of the medical device market, and depressed competition among purveyors of new devices. The 21st Century Cures Act of 2016 has been lauded for attempting to tackle these problems by easing several pathways for regulatory allowance, but some of the FDA’s recent guidance may hinder competition by opening the gates to an anticompetitive patent strategy, one whereby marketers of De Novo medical devices can kettle follow-on applicants into patent infringement litigation.
‘The FDA De Novo medical device pathway, patents and anticompetition’ discusses how the interaction between patents and the FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices. The paper is available here.