LQDA - Liquidia Corporation Files Response to United Therapeutics Lawsuit and Files Counterclaims | Benzinga
- Seeks dismissal of all claims related to ‘793 patent based on prior findings of invalidity which have been affirmed by the Federal Circuit
- Requests declaration that ‘327 patent is not infringed, is invalid and is unenforceable
- Files counterclaims asserting United Therapeutics failed to properly disclose prior art references and additional material information in its prosecution of the ‘327 patent that would have rendered the claims unpatentable
MORRISVILLE, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ:LQDA) (Liquidia or the Company) announced today it filed its answer, affirmative defenses and a partial motion to dismiss in response to the amended patent infringement complaint filed by United Therapeutics Corporation (UTHR) on November 30, 2023, under the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act) in the U.S. District Court for the District of Delaware (District Court) that alleges the infringement of U.S. Patent No. 10,716,793 (the ‘793 patent) and U.S. Patent No. 11,826,327 (the ‘327 patent) in association with Liquidia's New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder. Simultaneously, Liquidia filed counterclaims against UTHR seeking a declaration that all asserted claims of the ‘327 patent are not infringed, are invalid and are unenforceable. Furthermore, the counterclaims summarize certain publications, references and information that UTHR failed to submit to the United States Patent and Trademark Office (USPTO) during the prosecution of the ‘327 patent.
Dr. Roger Jeffs, Chief Executive Officer, said: "United Therapeutics seeks to interfere with our launch of YUTREPIA in PH-ILD by relitigating the same ‘793 patent that was previously found to be invalid and asserting a new patent that was procured without submitting highly material prior art references and important additional information to the USPTO. We will continue to aggressively defend ourselves and the ability of patients suffering from PAH and PH-ILD to have a choice of products to treat their rare and deadly disease."
As previously disclosed, the asserted ‘793 patent was previously held to be invalid in a prior proceeding before the Patent Trial and Appeal Board (PTAB). On December 20, 2023, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) affirmed the PTAB's finding that the ‘793 patent is invalid. Liquidia has therefore filed a partial motion to dismiss requesting that all claims related to the ‘793 patent be dismissed based on collateral estoppel.
With regard to the ‘327 patent, the counterclaims request declarations from the District Court that the patent is not infringed, is invalid and is unenforceable. Specifically, the counterclaims allege that UTHR failed to disclose to the USPTO the following prior art references, among others:
| (i) |
| a 2016 publication that UTHR helped support entitled "Safety and Tolerability of High-dose Inhaled Treprostinil in Pulmonary Hypertension" authored by Parikh et al. and published in the Journal of Cardiovascular Pharmacology, Volume 67, No. 4, pp. 322-325, which discloses methods improving exercise capacity in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) by administering a dose of at least 15 micrograms of the inhalation formulation of treprostinil in a single event with each breath containing at least 6 micrograms and a demonstrated improvement in the 6 minute walk test and other efficacy measures; |
| (ii) |
| UTHR's arguments and expert testimony that the ‘793 patent, ... |