Liquidia Corp 8-K, filed Dec 1, 2023
Liquidia Corp (LQDA)
About this 8-K
Liquidia Corp filed this 8-K on December 1, 2023, reporting on events of November 30, 2023.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
As previously disclosed on the Current Report on Form 8-K filed by Liquidia Corporation, a Delaware corporation (the “Company”) on June 29, 2023, United Therapeutics Corporation (“United Therapeutics”) received a notice of allowance with respect to its patent application number 17/233,061, the claims of which generally cover the treatment of patients having pulmonary hypertension associated with interstitial lung disease (“PH-ILD”) through the inhaled administration of treprostinil. On November 28, 2023, a new patent, U.S. Patent No. 11,826,327 (the “’327 Patent”) was issued from that patent application.
As previously disclosed on the Current Report on Form 8-K filed by the Company on September 6, 2023, United Therapeutics filed a patent infringement action in the United States District Court for the District of Delaware (the “District Court”) under the Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”) alleging the infringement of U.S. Patent No. 10,716,793 (the “’793 Patent”) in response to the Company’s amendment to add the PH-ILD indication to the label for the tentatively approved New Drug Application for YUTREPIA (treprostinil) inhalation powder.
On November 30, 2023, United Therapeutics filed an amended complaint in the District Court adding allegations that the Company infringes the ’327 Patent as a result of its amendment to add the PH-ILD indication to the label for YUTREPIA.
Because neither the ’793 Patent nor the ’327 Patent was issued prior to the filing of the original NDA for YUTREPIA, we believe United Therapeutics is not entitled to a statutory 30-month stay with respect to either of these patents. The Company intends to vigorously defend itself against these allegations, so that patients suffering from pulmonary arterial hypertension (“PAH”) and PH-ILD can have the potential to access the Company’s products.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Exhibit | |
| 104 | Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| December 1, 2023 | Liquidia Corporation | |
| By: | /s/ Michael Kaseta | |
| Name: Michael Kaseta | ||
| Title: Chief Financial Officer | ||