Liquidia Receives Favorable Ruling in Inter Partes Review against United Therapeutics Patent
October 08 2021 - 5:23PM
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.
9,604,901 (‘901 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 seven of the nine claims were
unpatentable. Only the narrower dependent claims 6 and 7 remain,
both of which require actual storage at ambient temperature of
treprostinil sodium. The PTAB’s decision primarily relates to the
issue of patentability based on a review of prior art. This
decision does not preclude the invalidation of the remaining claims
on other grounds as part of the ongoing Hatch Waxman litigation,
nor does it mean that Liquidia infringes either of the surviving
claims.
Damian deGoa, President and Chief Executive Officer of Liquidia
said: “We are very pleased with this decision by the PTAB. This is
a clear win in our on-going patent dispute with United
Therapeutics, and we remain confident that we will ultimately
prevail on all patent claims they have asserted against us. We will
continue to vigorously defend our right to commercialize LIQ861 as
soon as possible.”
The PTAB’s decision with respect to the ‘901 patent does not
resolve the on-going litigation brought by UTC related to LIQ861.
In June 2020, UTC filed a lawsuit against Liquidia under the
Hatch-Waxman Act for infringement of three Tyvaso® patents,
including the ‘901 patent, referenced in the 505(b)(2) regulatory
filing for the LIQ861 New Drug Application (NDA). The lawsuit
triggered a 30-month stay on an FDA regulatory approval of LIQ861,
which expires on the earlier of October 24, 2022, or resolution of
the litigation.
Tyvaso® is a registered trademark of United Therapeutics.
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.
Cautionary Statements Regarding Forward-Looking
StatementsThis 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 our response to the Complete Response Letter
received in November 2020, the potential for eventual FDA approval
of the NDA for LIQ861, the timeline or outcome related to our
patent litigation pending in the U.S. District Court for the
District of Delaware or our inter partes review with the PTAB, the
issuance of patents by the USPTO and our ability to execute on our
strategic or financial initiatives, involve significant risks and
uncertainties and actual results could differ materially from those
expressed or implied herein. The favorable decision of the PTAB in
the IPR for the ’901 patent is not determinative of the outcome of
any appeal of that decision, any IPRs that have been instituted by
the PTAB with respect to any other patents of UTC or the
Hatch-Waxman litigation between Liquidia and UTC. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “would,” and similar expressions are intended
to identify forward-looking statements. We have based these
forward-looking statements largely on our current expectations and
projections about future events and financial trends that we
believe may affect our financial condition, results of operations,
business strategy, short-term and long-term business operations and
objectives and financial needs. These forward-looking statements
are subject to a number of risks discussed in our filings with the
SEC, including the impact of the coronavirus (COVID-19) outbreak on
our Company and our financial condition and results of operations,
as well as a number of uncertainties and assumptions. Moreover, we
operate in a very competitive and rapidly changing environment and
our industry has inherent risks. New risks emerge from time to
time. It is not possible for our management to predict all risks,
nor can we assess the impact of all factors on our business or the
extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any
forward-looking statements we may make. In light of these risks,
uncertainties and assumptions, the future events discussed in this
press release may not occur and actual results could differ
materially and adversely from those anticipated or implied in the
forward-looking statements. Nothing in this press release should be
regarded as a representation by any person that these goals will be
achieved, and we undertake no duty to update our goals or to update
or alter any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
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