U.S. Patent Trial and Trademark Appeal Board Decides to Institute Inter Partes Review of United Therapeutics’ Tyvaso® Patent
August 12 2021 - 8:00AM
Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S.
Patent Trial and Appeal Board (PTAB) has instituted inter partes
review (IPR) 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).
In deciding to institute the IPR with respect to the ‘793
patent, the PTAB stated that Liquidia had demonstrated a reasonable
likelihood of prevailing in its assertion that all of the claims of
the ‘793 patent are unpatentable as obvious over the combination of
certain prior art cited by Liquidia in its petition to the
PTAB.
“The PTAB’s decision to institute an IPR against the ‘793 patent
is another important step forward for Liquidia’s ongoing effort to
bring LIQ861, a convenient and well tolerated inhaled dry powder
formulation of treprostinil, to the PAH community. With a decision
in the IPR for U.S. Patent No. 9,604,901 expected in October and
our continued efforts in the ongoing litigation against United
Therapeutics, we remain confident that the patents asserted against
us will be found invalid and not infringed by Liquidia,” stated
Damian deGoa, Chief Executive Officer at Liquidia.
In June 2020, UTC filed a lawsuit against Liquidia under the
Hatch-Waxman Act, based on the LIQ861 New Drug Application (NDA),
for infringement of Tyvaso patents that triggered a 30-month stay
on an FDA regulatory approval. The 30-month stay expires on the
earlier of October 24, 2022 or resolution of the litigation,
whichever occurs first.
In July 2020, UTC filed an amended complaint asserting
infringement of the ‘793 patent. Although UTC’s amended complaint
brought the ‘793 patent into the pending lawsuit, the statutory
30-month stay on regulatory approval is not associated with the
allegations of infringement of the ‘793 patent and should have no
effect on the FDA’s review of the LIQ861 NDA.
On June 2, 2021, the FDA accepted for review the NDA
resubmission for LIQ861 (treprostinil) inhalation powder and set a
PDUFA goal date of November 7, 2021. The NDA has been submitted
under the 505(b)(2) regulatory pathway and Tyvaso®, a nebulized
treprostinil solution, is the Reference Listed Drug for the LIQ861
NDA.
About LIQ861LIQ861 is an investigational
inhaled dry powder formulation of treprostinil designed using
Liquidia’s PRINT® technology with the goal of enhancing deep-lung
delivery using a convenient, palm-sized dry powder inhaler for the
treatment of pulmonary arterial hypertension (PAH). PRINT®
technology enables the development of drug particles that are
precise and uniform in size, shape and composition, and that are
engineered for optimal deposition in the lung following oral
inhalation. Liquidia believes LIQ861 can overcome the limitations
of current inhaled therapies and has the potential to maximize the
therapeutic benefits of treprostinil in treating PAH by safely
delivering higher doses into the lungs. Liquidia has completed an
open-label, multi-center phase 3 clinical study of LIQ861 in
patients diagnosed with PAH known as INSPIRE, or Investigation of
the Safety and Pharmacology of Dry Powder Inhalation of
Treprostinil.
About Liquidia CorporationLiquidia
Corporation is a biopharmaceutical company focused on the
development and commercialization of products in pulmonary
hypertension and other applications of its PRINT® Technology. The
company operates through its two wholly owned subsidiaries,
Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia
Technologies is developing LIQ861, an inhaled dry powder
formulation of treprostinil for the treatment of pulmonary arterial
hypertension (PAH). Liquidia PAH provides the commercialization for
rare disease pharmaceutical products, such as generic Treprostinil
Injection. For more information, please visit www.liquidia.com.
Contact InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
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