Liquidia Receives Favorable Ruling in Inter Partes Review against United Therapeutics Patent

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[{"type":"text","content":"MORRISVILLE, N.C., July 19, 2022 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Patent Trial and Appeal Board (PTAB) ruled in its favor in the Inter Partes Review (IPR) proceeding against U.S. Patent No. 10,716,793 (‘793 patent) owned by United Therapeutics Corporation (UTC) and listed in the Orange Book for Tyvaso® (treprostinil inhalation solution). In its ruling, the PTAB found that, based on the preponderance of the evidence, all the claims of the ’793 patent have been shown to be unpatentable. Roger Jeffs, Chief Executive Officer of Liquidia said: “We are very pleased with this decision by the PTAB. Today’s decision is another step down the path towards YUTREPIA’s potential final regulatory approval. We will continue to vigorously defend our right to commercialize YUTREPIA as soon as possible and look forward to hearing the final decision from the district court in the Hatch-Waxman litigation.” The PTAB’s decision with respect to the ‘793 patent does not resolve the on-going district court litigation brought by UTC related to YUTREPIA. In June 2020, UTC filed a lawsuit against Liquidia under Hatch-Waxman for infringement of Patents No. 9,604,901 (‘901 patent) and 9,593,066 (‘066 patents). Upon initiation of the lawsuit, the U.S. Food and Drug Administration (FDA) triggered a statutory regulatory stay on the final approval of YUTREPIA until October 27, 2022, or earlier resolution or settlement of the ongoing litigation. UTC later amended the lawsuit to include the ‘793 patent when it was granted in July 2020. In December 2021, UTC agreed to the entry of judgment of Liquidia’s non-infringement of the ’901 patent based on the Court’s construction of certain terms in the patent. Thus, only the ‘066 and ‘793 patents remain at issue in the Hatch-Waxman proceedings in district court. In the event that the Court finds any of the asserted claims of the ‘066 patent or ‘793 patent are valid and infringed, then the Court is expected to issue an order that the effective date of final YUTREPIA approval will not be earlier than the date of expiration of the patent that has been found to be valid and infringed, which would be in the year 2027 in the case of the ‘793 patent and in the year 2028 in the case of the ‘066 patent. Today’s decision by the PTAB would not override an order of the Court in the ...

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