United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation
24 Julho 2023 - 12:45PM
Business Wire
United Therapeutics Corporation (Nasdaq: UTHR), a public
benefit corporation, announced today that the United States Court
of Appeals for the Federal Circuit affirmed the district court
decision in the patent litigation United Therapeutics brought
against Liquidia Technologies, Inc. The Federal Circuit affirmed
that Liquidia’s proposed Yutrepia™ product infringes a United
Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793
patent). As a result, the U.S. Food and Drug Administration
(FDA) cannot grant Liquidia final approval for its Yutrepia
product until expiration of the ’793 patent, May 14, 2027, except
in certain circumstances discussed below.
The Federal Circuit affirmed the district court’s decision that
Liquidia would induce infringement of various claims of the ’793
patent by marketing Yutrepia and that Liquidia failed to prove any
claim of that patent invalid. The ‘793 patent relates to a method
of administering treprostinil via inhalation.
The Federal Circuit also affirmed the district court’s decision
that certain claims of another United Therapeutics patent, U.S.
Patent No. 9,593,066 (the ’066 patent), are either invalid
or not infringed by Liquidia. The ’066 patent relates to a method
of making treprostinil, the active pharmaceutical ingredient in
both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI®
(treprostinil) Inhalation Powder.
“Today’s decision vindicates our position, as confirmed earlier
by the district court, that Yutrepia is an infringing product. We
will continue to vigorously defend our intellectual property,” said
Shaun Snader, Vice President and Associate General Counsel – IP and
Litigation at United Therapeutics.
Both parties have the opportunity to request rehearing by the
Federal Circuit with respect to the adverse portions of the Federal
Circuit’s affirmance.
Last year, the Patent Trial and Appeal Board (PTAB) of
the U.S. Patent and Trademark Office issued a final written
decision in an inter partes review (IPR) of the ’793 patent
initiated by Liquidia finding all claims of the patent to be
unpatentable. United Therapeutics appealed that decision to the
Federal Circuit, and that appeal is pending. United Therapeutics
expects that the PTAB decision will not affect the district court’s
order barring FDA from granting final approval for Yutrepia unless
all claims Liquidia was found to infringe are found invalid
following exhaustion of all appeals.
United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use
our enthusiasm, creativity, and persistence to innovate for the
unmet medical needs of our patients and to benefit our other
stakeholders. We are bold and unconventional. We have fun, we do
good. We are the first publicly-traded biotech or pharmaceutical
company to take the form of a public benefit corporation
(PBC). Our public benefit purpose is to provide a brighter
future for patients through (a) the development of novel
pharmaceutical therapies; and (b) technologies that expand the
availability of transplantable organs.
You can learn more about what it means to be a PBC here:
unither.com/PBC.
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
regarding ongoing patent litigation with Liquidia, the potential
timing of FDA approval for Yutrepia, and our goals of innovating
for the unmet medical needs of our patients and to benefit our
other stakeholders and furthering our public benefit purpose of
developing novel pharmaceutical therapies and technologies that
expand the availability 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 July 24, 2023, 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 and TYVASO DPI are registered trademarks of United
Therapeutics Corporation and/or its subsidiaries.
YUTREPIA is a trademark of Liquidia Corporation.
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version on businesswire.com: https://www.businesswire.com/news/home/20230724981807/en/
Dewey Steadman (202) 919-4097 ir@unither.com
United Therapeutics (NASDAQ:UTHR)
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