“Duty of Disclosure Considerations for Medical Device Patent Applicants with Parallel FDA Submissions”
November 12, 2025In an article published by Med Device Online, Marshall Gerstein Partner Meggan Duffy and former Summer Associate Ria Patel analyze the “complex dance” that medical device innovators often encounter when simultaneously submitting information to the Food and Drug Administration (FDA) while filing patent applications.
“While these processes serve different purposes, they are intertwined in ways that can significantly impact an invention’s patentability and enforceability,” the authors write. “Understanding the subtle but crucial overlaps between FDA disclosures and patent law is important for anyone seeking to innovate responsibly and protect their intellectual property.”
Meggan and Ria cover the duty of disclosure required of patent applicants, and how that process intersects with FDA approvals.
“For medical device companies, the guidelines highlight a critical consideration: statements and data shared during FDA proceedings, such as a 510(k) premarket notification, may contain material information relevant to patentability,” Meggan and Ria write.
Read their guidance to medical device companies in Med Device Online here.