01—Abstract
Summary
Summary of the 8-K filed February 27, 2024. Cited figures are marked; the original filing is the authoritative source.
On February 26, 2024, United Therapeutics Corporation filed a motion in the U.S. District Court for the District of Delaware seeking a preliminary injunction in its patent litigation with Liquidia Technologies, Inc. The Company alleges that Liquidia's product for pulmonary hypertension associated with interstitial lung disease (PH-ILD) infringes its U.S. Patent No. 11,826,327 (the '327 patent), which expires in 2042.
The Company asked the court to enjoin Liquidia from marketing its product for PH-ILD until the infringement claims are adjudicated. Liquidia's investigational product is currently tentatively approved by the FDA for pulmonary arterial hypertension (PAH) but not PH-ILD. Separately, the Company has sued the FDA in the U.S. District Court for the District of Columbia over the agency's review of Liquidia's amendment to its pending new drug application (NDA) seeking a PH-ILD indication.
The Company argues that FDA rules require a new indication to be pursued in a new NDA, and it believes that if Liquidia must file a new NDA, the Company would be entitled to a 30-month stay of any PH-ILD approval based on the '327 patent litigation. The filing states that if either a preliminary injunction or a 30-month stay is granted, Liquidia's product would be precluded from marketing for PH-ILD while the patent litigation proceeds.
The filing notes that Liquidia's NDA relies on clinical data underlying the Company's Tyvaso (treprostinil) Inhalation Solution, which is FDA-approved for both PAH and PH-ILD, with the PH-ILD indication added to the nebulized Tyvaso label in 2021. Further litigation details are referenced in Note 14 to the Company's Annual Report on Form 10-K filed on February 21, 2024.
02—Key points
Key Highlights
- February 26, 2024: Company filed a motion for a preliminary injunction in the U.S. District Court for the District of Delaware against Liquidia Technologies.
- The Company alleges Liquidia's PH-ILD product infringes U.S. Patent No. 11,826,327, which expires in 2042 and covers inhaled treprostinil for improving exercise capacity in PH-ILD patients.
- Liquidia's product is tentatively approved by the FDA for PAH only, not PH-ILD.
- A separate suit against the FDA in the U.S. District Court for the District of Columbia challenges Liquidia's amendment to its pending NDA as an improper route to a PH-ILD indication.
- The Company believes a new NDA would entitle it to a 30-month stay of any PH-ILD approval for Liquidia's product.
- Tyvaso (treprostinil) Inhalation Solution is FDA-approved for both PAH and PH-ILD, and Liquidia's NDA relies on the clinical data underlying it.
- Litigation details are referenced in Note 14 of the Company's Form 10-K filed February 21, 2024.
03—Questions
Frequently Asked Questions
What is the core dispute between United Therapeutics and Liquidia?
Liquidia is seeking FDA approval for an inhaled treprostinil product for PH-ILD, in addition to its tentatively approved PAH indication. The Company alleges that this PH-ILD product infringes its '327 patent and is challenging the FDA's handling of Liquidia's application.
What relief is the Company seeking in the Delaware court?
The Company asked the U.S. District Court for the District of Delaware to enjoin Liquidia from marketing its product for PH-ILD until the court adjudicates the infringement claims.
Why does the Company argue Liquidia should file a new NDA?
The Company's suit against the FDA alleges that FDA rules, precedents, and procedures require a new indication to be pursued in a new NDA rather than as an amendment to a pending NDA. The Company believes a new NDA would entitle it to a 30-month stay of any PH-ILD approval.
What would the outcome mean for Liquidia's PH-ILD ambitions?
The filing states that if either a preliminary injunction or a 30-month stay is granted, Liquidia's product would be precluded from being marketed for PH-ILD while the underlying '327 patent litigation proceeds.
How does this relate to the Company's existing Tyvaso products?
Liquidia's NDA relies on the clinical data underlying the Company's Tyvaso (treprostinil) Inhalation Solution, which is FDA-approved for PAH and PH-ILD. The PH-ILD indication was added to the nebulized Tyvaso label in 2021, following a pivotal trial.
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