The USPTO’S Increasing Focus on FDA Submissions and the Duty of Disclosure

The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application. The USPTO has recently clarifies that the Duty of Disclosure includes disclosure of statements made to the other governmental agencies (e.g., the FDA) that are inconsistent with disclosures made to the USPTO. Read more