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FDA guidance: notify agency within 14 days of patent-infringement suits filed within Section IV window
Summary
Strandberg said applicants must notify FDA within 14 days when a patent-infringement action is filed within 45 days of receipt of Paragraph IV notice; notifications should include the court case number and patent numbers, and applicants should not supply placeholder or "dummy" case numbers.
Heather Strandberg told attendees that when patent-infringement litigation is filed within 45 days of the brand owner's receipt of a Paragraph IV notice, the ANDA applicant must notify FDA within 14 days and provide identifying details such as the court case number and the patents at issue. "Applicants must notify FDA within 14 days of the filing of any legal action that is filed within 45 days of receipt of notice of P4 certification," she said.
She recommended submitting a complete copy of the original civil complaint with the civil action number to meet requirements and cautioned against using dummy case numbers. Strandberg also explained that if no legal action has been filed after the 45-day window, applicants should submit an amendment notifying FDA after the 45 days have passed, and that applicants must also notify FDA within 14 days of final court orders or judgments.
