Form 8-K - Current report
December 20 2023 - 5:00PM
Edgar (US Regulatory)
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2023-12-20
2023-12-20
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15 (d) of
the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
December 20, 2023
United Therapeutics Corporation
(Exact Name of Registrant as Specified in
its Charter)
Delaware |
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000-26301 |
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52-1984749 |
(State or Other |
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(Commission |
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(I.R.S. Employer |
Jurisdiction of |
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File Number) |
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Identification Number) |
Incorporation) |
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|
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1000 Spring Street |
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Silver Spring, MD |
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20910 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s telephone number, including
area code: (301) 608-9292
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant
to Section 12(b) of the Act:
Title of each class |
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Trading symbol(s) |
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Name of each exchange on which
registered |
Common Stock, par value $0.01 per share |
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UTHR |
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Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with
any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On December 20, 2023, the U.S. Court of Appeals for the Federal
Circuit (Federal Circuit) issued a decision regarding United Therapeutics Corporation’s (United Therapeutics or the
Company) U.S. Patent No. 10,716,793 (the ’793 patent). The Federal Circuit affirmed the inter partes review
(IPR) decision from the Patent Trials and Appeals Board that the claims of the ’793 patent should be canceled as invalid.
Liquidia Technologies, Inc. (Liquidia) initiated the IPR.
The '793 patent is listed in the Food and Drug Administration's (FDA)
Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book, for Tyvaso®
(treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder, both of which are marketed by United
Therapeutics.
The Federal Circuit had earlier affirmed a separate decision by the
U.S. District Court for the District of Delaware that Liquidia’s proposed Yutrepia™ product infringes the ’793
patent and that Liquidia had not proved invalidity of the ’793 patent. Thus, Liquidia is currently barred from obtaining final approval
from FDA for launch of its proposed Yutrepia product until expiration of the ’793 patent.
The Federal Circuit’s December 20th decision
would allow Liquidia to launch its proposed Yutrepia product prior to the ’793 patent’s expiration unless the Federal Circuit’s
decision is reversed. United Therapeutics has the right to seek rehearing of this decision by the Federal Circuit and/or seek review of
this decision by the U.S. Supreme Court. The Company is currently evaluating its options.
The claims of the ‘793 patent are not canceled until all appeals
are exhausted.
The FDA tentatively approved Liquidia’s new drug application
(NDA) for Yutrepia to treat pulmonary arterial hypertension (PAH) on November 2021.
In order to launch Yutrepia, (a) the District Court will need
to lift its order barring FDA approval of the NDA, and (b) and FDA would need to grant final approval of the NDA.
Further, in September 2023, Liquidia announced it had amended
its NDA for Yutrepia to include the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and
that the FDA had set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024 to review Liquidia’s
NDA.
In September 2023, United Therapeutics filed a new lawsuit against
Liquidia asserting that Liquidia’s proposed amended NDA infringes the ‘793 patent. In November 2023, United Therapeutics
amended its complaint in this new litigation to add a claim for infringement of a newly-issued patent, U.S. Patent No. 11,826,327.
This new patent expires in January 2042, and covers the use of inhaled treprostinil at specific dosages to improve exercise capacity
in PH-ILD patients.
Forward-looking Statements
Statements included in this Current Report
on Form 8-K 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 the timing and outcome of our litigation
with Liquidia, and the potential launch of Yutrepia and the timing thereof. These forward-looking statements are subject to certain risks
and uncertainties, such as those described in the Company’s periodic and other reports filed with the Securities and Exchange Commission
that could cause actual results to differ materially from anticipated results. Such forward-looking statements are qualified by the cautionary
statements, cautionary language and risk factors set forth in UT’s 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. UT claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking
statements. The Company is providing this information as of December 20, 2023, and assumes no obligation to update or revise the
information contained in this Current Report on Form 8-K whether as a result of new information, future events or any other reason.
TYVASO and TYVASO DPI are registered trademarks of United Therapeutics
Corporation.
YUTREPIA is a trademark of Liquidia Technologies, Inc.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
UNITED THERAPEUTICS CORPORATION |
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Dated: December 20, 2023 |
By: |
/s/ Paul A. Mahon |
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Name: |
Paul A. Mahon |
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Title: |
General Counsel |
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