Yutrepia® (treprostinil inhalation powder)
Case Name: Liquidia Techs., Inc. v. FDA, No. 24-2428 (TJK), 2025 WL 637413 (D.D.C. May 2, 2025) (Kelly, J.)
Drug Product and Patent(s)-in-Suit: Yutrepia® (treprostinil inhalation powder)
Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted summary judgment in favor of Defendants. UTC’s cross-claims—challenging FDA’s decision to allow Liquidia to amend Yutrepia’s NDA to add a new indication—remained pending.
Originally, the Yutrepia NDA sought approval only for the treatment of pulmonary arterial hypertension (“PAH”). In conjunction with the filing of its NDA, Liquidia submitted Paragraph IV certifications, and UTC filed suit. In the initial patent litigation, Liquidia prevailed; it did not infringe any valid UTC patent. While that patent litigation was pending, Liquidia submitted an amendment to its tentatively approved NDA, seeking to add a new indication: treatment of pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). The amendment included additional Paragraph IV certifications, including two for patents UTC had added to the Orange Book between the filing of Yutrepia’s initial NDA and the amendment.
Despite this second suit, in September 2023, the “FDA accepted for review Liquidia’s amendment to add the new PH-ILD indication to Liquidia’s Original 505(b)(2) NDA. FDA decided, though, that it could not immediately approve the NDA because it was blocked by a temporary period of exclusivity held by UTC. The court dismissed UTC’s cross claims.
Why Liquidia Prevailed: The court found that UTC lacked standing and that its claims were not ripe because it had no statutory right to a 30-month stay. Specifically, the court explained that § 355(c)(3)(C), by its own terms, is discretionary, stating that if the NDA holder timely files suit, FDA “may” make its approval of an otherwise acceptable NDA “effective upon the expiration of the thirty-month period beginning on the date of the receipt.” Section 355(c)(3)(C) contains nothing to suggest that Congress intended to vest patent holders with a statutory right to a 30-month stay. In sum, the statute did not state that any patent holder has a “right” to such a stay.
The court next explained that even assuming UTC had a statutory right to a 30-month stay, the FDA did not cause any deprivation of that right. In particular, the court explained that it was entirely speculative whether, if the FDA rejected Liquidia’s amendment, Liquidia would have decided to file a new, standalone NDA. Finally, the court explained that UTC had not plausibly alleged that the court could redress its loss of the 30-month stay.
The court also explained that UTC lacked standing based on alleged future economic harm. The “competitor standing” doctrine was not available to UTC because it was rooted in an attenuated chain of events leading from the challenged agency action to possible future competition and harm. FDA’s decision to permit Liquidia to amend Yutrepia’s NDA moved Liquidia one step closer to competing with, and therefore economically injuring UTC,” but the amendment was only a “first step in the direction of future competition.” UTC made no allegation other than saying that the “FDA may approve Liquidia’s NDA for both the PAH and PH-ILD indications at some later date.
The court found that UTC’s claims were not ripe. FDA’s decision to accept Liquidia’s amendment was merely a decision to process that aspect of the NDA and consider Yutrepia for treatment of PH-ILD. Though tentative approval makes it “more likely that the FDA will eventually grant final approval, the agency's tentative approval caused UTC no hardship that was fit for review.
[View source.]
