MORRISVILLE, N.C., Oct. 27, 2022 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) introduced in the present day that on October 26, 2022, the Precedential Opinion Panel (POP) of the United States Patent and Trademark Office (USPTO) denied a request by United Therapeutics (UTC) to assessment the choice by the Patent Trial and Appeals Board (PTAB), which present in July 2022 by inter partes assessment (IPR) that each one claims in U.S. Patent No. 10,716,793 (‘793 Patent) are unpatentable over certain prior art cited by Liquidia.
The PTAB’s choice, which invalidated the ‘793 patent claims, was based on three specific pieces of prior art, one patent and two publications. The prior art status of the previously issued patent is not at issue. To establish the prior art status of the two publications, Liquidia presented evidence in the IPR that: (1) the publications were presented at major medical conferences, (2) the publications were publicly accessible at public libraries, and (3) the publications were referenced in other articles in large medical journals, which served as research aids. Any one of these three grounds, alone, could establish that the publications constitute prior art. Based on these arguments presented in the IPR, the PTAB determined that the publications did constitute prior art for purposes of the ‘793 Patent.
In UTC’s August request for a rehearing of the PTAB’s choice, and later request for POP assessment, UTC took problem with solely the third of the three grounds supporting the 2 publications’ standing as prior artwork. In issuing its rejection of the POP request, the POP famous that the PTAB is finest suited to make the suitable factual findings on the prior artwork standing of the references as a result of the file had been totally developed on these points through the ‘793 IPR process. The PTAB has been directed to clarify the grounds upon which it based its finding that the publications constitute prior art. The PTAB’s assessment of UTC’s rehearing request stays ongoing.
Roger Jeffs, Chief Executive Officer of Liquidia, said: “Yesterday’s decision clears the way for the PTAB to make a final decision with respect to UTC’s rehearing request. We believe that the requested clarification of the PTAB’s original decision will help to make the PTAB’s decision even stronger. We remain confident that the rehearing request will be denied and that the PTAB’s favorable decision will be affirmed on appeal, thereby unlocking the path to potential approval of YUTREPIA by mid-2024, if not earlier.”
About YUTREPIA™ (treprostinil) inhalation powder
YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered by a confirmed, handy, palm-sized gadget. On November 5, 2021, the FDA issued a tentative approval for YUTREPIA, which is indicated for the remedy of pulmonary arterial hypertension (PAH) to enhance train potential in grownup sufferers with New York Heart Association (NYHA) Functional Class II-III signs. YUTREPIA was designed utilizing Liquidia’s PRINT® expertise, which allows the event of drug particles which might be exact and uniform in measurement, form, and composition, and which might be engineered for optimum deposition within the lung following oral inhalation. Liquidia has accomplished INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center section 3 medical research of YUTREPIA in sufferers recognized with PAH who’re naïve to inhaled treprostinil or who’re transitioning from Tyvaso® (nebulized treprostinil). YUTREPIA was beforehand known as LIQ861 in investigational research.
Tyvaso® is a registered trademark of United Therapeutics Corporation.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical firm targeted on the event and commercialization of merchandise in pulmonary hypertension and different functions of its PRINT® Technology. The firm operates by its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia Technologies has developed YUTREPIA™ (treprostinil) inhalation powder for the remedy of pulmonary arterial hypertension (PAH). Liquidia PAH supplies the commercialization for pharmaceutical merchandise to deal with pulmonary illness, resembling generic Treprostinil Injection. For extra data, please go to www.liquidia.com.
Cautionary Statements Regarding Forward-Looking Statements
This press launch could embody forward-looking statements throughout the that means of the Private Securities Litigation Reform Act of 1995. All statements contained on this press launch apart from statements of historic info, together with statements relating to our future outcomes of operations and monetary place, our strategic and monetary initiatives, our business technique and plans and our aims for future operations, are forward-looking statements. Such forward-looking statements, together with statements relating to medical trials, medical research and different medical work (together with the funding therefor, anticipated affected person enrollment, security knowledge, research knowledge, trial outcomes, timing or related prices), regulatory functions and associated submission contents and timelines, together with the potential for remaining FDA approval of the NDA for YUTREPIA, the timeline or consequence associated to appeals or rehearing requests arising from our patent litigation within the U.S. District Court for the District of Delaware or inter partes assessment proceedings performed on the PTAB, the issuance of patents by the USPTO and our potential to execute on our strategic or monetary initiatives, contain vital dangers and uncertainties and precise outcomes may differ materially from these expressed or implied herein. The favorable selections of the PTAB within the IPRs for the ’793 and ‘901 patents and of the Court within the Hatch-Waxman litigation aren’t determinative of the result of any attraction of these selections. The phrases “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and comparable expressions are supposed to establish forward-looking statements. We have primarily based these forward-looking statements largely on our present expectations and projections about future occasions and monetary developments that we consider could have an effect on our monetary situation, outcomes of operations, business technique, short-term and long-term business operations and aims and monetary wants. These forward-looking statements are topic to plenty of dangers mentioned in our filings with the SEC, together with the affect of the coronavirus (COVID-19) outbreak on our Company and our monetary situation and outcomes of operations, in addition to plenty of uncertainties and assumptions. Moreover, we function in a really aggressive and quickly altering surroundings and our business has inherent dangers. New dangers emerge sometimes. It isn’t attainable for our administration to foretell all dangers, nor can we assess the affect of all components on our business or the extent to which any issue, or mixture of things, could trigger precise outcomes to vary materially from these contained in any forward-looking statements we could make. In mild of those dangers, uncertainties and assumptions, the longer term occasions mentioned on this press launch could not happen and precise outcomes may differ materially and adversely from these anticipated or implied within the forward-looking statements. Nothing on this press launch needs to be considered a illustration by any person who these objectives shall be achieved, and we undertake no obligation to replace our objectives or to replace or alter any forward-looking statements, whether or not because of new data, future occasions or in any other case.
Contact Information
Media & Investors:
Jason Adair
Senior Vice President, Corporate Development and Strategy
919.328.4400
[email protected]
