As a result of the Court’s decision, United Therapeutics believes that it is entitled to an order instructing the U.S. Food and Drug Administration (FDA) to withdraw approval of Liquidia’s new drug application (NDA) for Yutrepia as required by 35 U.S.C. § 271(e)(4)(A). If such an order is granted, it may result in Yutrepia being removed from the U.S. market until such time as FDA can approve labeling omitting the PH-ILD indication. United Therapeutics also intends to seek monetary damages for past infringement, which could include a royalty on past sales of Yutrepia. The Court set a deadline of one week for the parties to submit "an agreed upon form of final judgment" including any such order. If the parties cannot agree on the scope of the final judgment, the Court will need to rule on the issue.
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