The FDA De Novo medical device pathway, patents and anticompetition.

Abstract

The Food and Drug Administration (“FDA”) has long been criticized—perhaps, unfairly—for failing to expeditiously approve groundbreaking medical devices. In the views of some, thishas contributed to stagnation in the advancement of the medical device market and depressed competition among purveyors of new devices. The 21st Century Cures Act has been lauded for attempting to tackle these problems by easing several pathways for regulatory allowance. But some of the Agency’s recent guidances in the area may hinder competition by opening the gates to an anticompetitive patent strategy, one where marketers of “De Novo” medical devices— medical devices given their own “device type” category—can kettle follow-on applicants into patent infringement litigation. Knowing this, marketers of medical devices may avoid the 21st Century Cures Act’s expansion of the 510(k) pathway for “De Novo” device types, defeating one of the principal purposes of the Act.