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United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation SILVER SPRING, Md. and

Key Takeaway: United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 24, 2023 -- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals

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United Therapeutics Wins Appeal in
Dry Powder Inhaler Patent Litigation
SILVER SPRING, Md. and RESEARCH TRIANGLE
PARK, N.C., July 24, 2023 -- 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
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
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
For Further Information Contact:
Dewey Steadman at (202) 919-4097
Last updated: Jul 24, 2023