Full Press Release Details
United States Supreme Court Declines to
Review Rulings that Invalidate United Therapeutics' Patent
MORRISVILLE, N.C., October 7, 2024 - Liquidia
Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases, today
announced that the United States Supreme Court has rejected United Therapeutics' (UTHR) petition for a writ of certiorari, which
requested permission to appeal prior decisions which found that all claims of U.S. Patent No. 10,716,793 ( 793
Patent) are unpatentable due to prior art. As a result, the decision by the Patent Trial and Appeal Board (PTAB) in July 2022, which
was affirmed by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in December 2023, is now final and
not subject to further appeal.
Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said:
"We are pleased that the Supreme Court has denied the petition by United Therapeutics and affirmed previous rulings that every claim
of the 793 patent is invalid. We are grateful that this specific chapter has come to a close and that the 793 patent will
now be forever unenforceable. We will continue to fight for the earliest possible launch of YUTREPIA so that patients and physicians have
access to the unique benefits that YUTREPIA can provide."
On August 16, 2024, the U.S. Food and Drug Administration (FDA)
granted tentative approval of YUTREPIA (treprostinil) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and
pulmonary hypertension associated with interstitial lung disease (PH-ILD). In doing so, FDA confirmed that the amendment to add PH-ILD
to the YUTREPIA New Drug Application (NDA) was proper and that application otherwise meets the requirements for approval under the Federal
Food, Drug, and Cosmetic Act. Final approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity
for Tyvaso DPI on May 23, 2025.
There are no patents that are preventing final FDA approval of YUTREPIA.
None of the valid claims of the three patents asserted by UTHR in original Hatch-Waxman litigation have been found to be infringed. All
of the decisions are final and not subject to further appeal. Additionally, the U.S. District Court of the District of Delaware denied
UTHR's request for a preliminary injunction with respect to a fourth patent, U.S. Patent No. 11,826,327 ( 327 Patent),
in a separate patent lawsuit filed by UTHR in September 2023. A trial in the 327 Patent lawsuit is scheduled for June 2025.
About YUTREPIA (treprostinil) Inhalation
YUTREPIA is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device.
YUTREPIA was designed using Liquidia's PRINT technology, which enables the development of drug particles that
are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. Liquidia has
completed INSPIRE, or Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center
phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who are na ve to inhaled treprostinil or who are transitioning
from Tyvaso (nebulized treprostinil). YUTREPIA is currently being studied in the ASCENT trial, an Open-Label Prospective
Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension, with the objective
of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA was previously referred to as LIQ861
in investigational studies.
About Liquidia Corporation
Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company's
current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary
PRINT Technology. PRINT enabled the creation of Liquidia's lead candidate, YUTREPIA (treprostinil)
inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation
of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the
treatment of PAH. To learn more about Liquidia, please visit https://www.liquidia.com.
a registered trademark of United Therapeutics Corporation
Cautionary Statements Regarding Forward-Looking
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release other than statements of historical facts, including statements regarding our future results
of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for
future operations, are forward-looking statements. Such forward-looking statements,
including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated
patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related submission
contents and timelines, including the potential for final FDA approval of the NDA for YUTREPIA, the timeline or outcome of our lawsuit
against the FDA or the cross-claims that United Therapeutics has brought in that lawsuit, the timeline or outcome related to patent litigation
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