SILVER SPRING, Md. and
RESEARCH TRIANGLE PARK, N.C.,
June 7, 2021 /PRNewswire/ -- United
Therapeutics Corporation (Nasdaq: UTHR) announced today that it is
pursuing additional claims for trade secret misappropriation
against Liquidia Technologies, Inc. (a subsidiary of Liquidia
Corporation, Nasdaq: LQDA) and a former United Therapeutics
employee who later joined Liquidia as an executive. The claims
allege that Liquidia conspired with the former employee to
misappropriate United Therapeutics' trade secrets, including
regulatory submissions and detailed financial forecasts, in the
development of Liquidia's product, LIQ861.
United Therapeutics initially filed a patent infringement
lawsuit in June 2020 in response to a
New Drug Application (NDA) filed by Liquidia with the U.S.
Food and Drug Administration (FDA) requesting approval to
market LIQ861, a dry powder inhalation formulation of treprostinil.
The NDA was filed under the 505(b)(2) regulatory pathway with
United Therapeutics' product, Tyvaso® (treprostinil)
Inhalation Solution, as the reference listed drug. In April 2020, United Therapeutics received a
Paragraph IV notification letter from Liquidia indicating that
Liquidia's NDA contains a certification alleging that LIQ861 will
not infringe any of the patents then listed in the Orange Book for
Tyvaso because those patents are not valid, not enforceable, and/or
will not be infringed by the commercial manufacture, use, or sale
of LIQ861. In response, United Therapeutics sued Liquidia for
infringing two patents, U.S. Patent Nos. 9,604,901 and 9,593,066,
and later added a third patent, U.S. Patent No. 10,716,793, in
the United States District Court
for the District of Delaware.
As a result of United Therapeutics' lawsuit, FDA is precluded
from approving LIQ861 until the expiration of a 30-month stay in
October 2022, or the entry of final
judgment in the litigation, whichever comes first.
During discovery in the patent infringement case, United
Therapeutics uncovered evidence that a former United Therapeutics
employee took United Therapeutics' trade secrets when he left the
company and joined Liquidia to develop LIQ861. The former employee,
who was central to Tyvaso's development, brought to Liquidia
confidential United Therapeutics documents, including confidential
FDA submissions and detailed financial forecasts relating to
Tyvaso. On June 4, 2021, United
Therapeutics filed a motion alleging that Liquidia used these trade
secrets in the development of LIQ861 and seeking permission from
the court to pursue these additional claims based on this
newly-discovered information. United Therapeutics is seeking
monetary damages to compensate it for this misappropriation,
trebled damages, punitive damages, attorneys' fees, and injunctive
relief.
The case is currently scheduled for trial in March 2022.
United Therapeutics: Enabling Inspiration
United
Therapeutics Corporation focuses on the strength of a balanced,
value-creating biotechnology model. We are confident in our future
thanks to our fundamental attributes, namely our obsession with
quality and innovation, the power of our brands, our
entrepreneurial culture, and our bioinformatics leadership. We also
believe that our determination to be responsible citizens – having
a positive impact on patients, the environment, and society – will
sustain our success in the long term.
Through our wholly owned subsidiary, Lung Biotechnology PBC, we
are focused on addressing the acute national shortage of
transplantable lungs and other organs with a variety of
technologies that either delay the need for such organs or expand
the supply. Lung Biotechnology is the first public benefit
corporation subsidiary of a public biotechnology or pharmaceutical
company.
Please visit unither.com to learn more.
Forward-looking Statements
Statements included in this
press release that are not historical in nature are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements include, among others, statements relating to our
litigation plans concerning Liquidia and its product LIQ861, the
impact on that litigation on the potential timing of FDA approval
for LIQ861, our ability to create value and sustain our success in
the long-term, as well as our efforts to develop technologies that
either delay the need for transplantable organs or expand the
supply of transplantable organs. These forward-looking statements
are subject to certain risks and uncertainties, such as those
described in our periodic reports filed with the Securities and
Exchange Commission, that could cause actual results to differ
materially from anticipated results. Consequently, such
forward-looking statements are qualified by the cautionary
statements, cautionary language and risk factors set forth in our
periodic reports and documents filed with the Securities and
Exchange Commission, including our most recent Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on
Form 8-K. We claim the protection of the safe harbor contained in
the Private Securities Litigation Reform Act of 1995 for
forward-looking statements. We are providing this information as of
June 7, 2021, and assume no
obligation to update or revise the information contained in this
press release whether as a result of new information, future events
or any other reason.
TYVASO is a registered trademark of United Therapeutics
Corporation.
For Further Information Contact:
Dewey Steadman at (202) 919-4097
Email: ir@unither.com
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SOURCE United Therapeutics Corporation