What can trigger the stay?
For an ANDA, 21 U.S.C. 355(j)(5)(B)(iii) addresses an infringement action filed within 45 days after receipt of Paragraph IV notice. The provision applies to qualifying patent information submitted before the relevant ANDA submission. When its conditions are met, the general 30-month period runs from receipt of the notice, not from the complaint's filing date.
Can approval occur on a different date?
Yes. The statute provides for specified court decisions and orders, and permits adjustment where a party failed reasonably to cooperate in expediting the action. Other approval requirements and exclusivities also require separate analysis. Calculate the relevant notice, patent-submission, application, and court-event dates instead of treating 30 months as an unconditional launch date.
What should the legal teams coordinate?
Keep FDA counsel and patent counsel working from the same notice and application records. Section 271(e)(2) supplies the patent-infringement framework for specified drug applications; section 355 supplies the approval-timing rules. Winning a timing argument and winning the patent merits are different tasks.