Protecting yourself from your assertions: navigating multiple regulatory schemes and disclosure.
This article discusses the conflicting requirements of and assertions made to the Food and DrugAdministration 510(k) approval process and the United States Patent and Trademark Office patent application process for a medical device. Generally, in a 510(k) submission, a company asserts that its device is a substantial equivalent of a predicate device. Conversely, in a patent application, a company asserts that its device is new and nonobvious over all prior art devices. This article explores the risks that arise for a company, whether as a patent holder or an accused patent infringer, because of assertions made as part of a 510(k) submission. The authors look at the possibility of using a 510(k) submission against a company to invalidate that company's patent, then examine the possibility of using a company's 510(k) submission to show infringement of another company's patent. They discuss how regulatory and patent counsel can work together to navigate both regulatory schemes to minimize associated risks-requiring credible arguments of substantial equivalence simultaneous with arguments of novelty and nonobviousness.
Mills
Alicia Griffin
AG
Dorsey & Whitney's Technology and Patent Groups, USA. mills.alicia@dorsey.com
D'Emanuele
Ross
R
D017277:Drug Approval; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration