Notice2026-10010
Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Amending the Complaint and Notice of Investigation
Primary source
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Published
May 19, 2026
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission ("Commission") has determined not to review an initial determination ("ID") (Order No. 45) of the presiding Chief administrative law judge ("Chief ALJ") granting complainant's unopposed motion to amend the complaint and notice of investigation to reflect respondent Ascendis Pharma, Inc.'s corporate name change to Ascendis Pharma, LLC.
Full Text
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<title>Federal Register, Volume 91 Issue 96 (Tuesday, May 19, 2026)</title>
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[Federal Register Volume 91, Number 96 (Tuesday, May 19, 2026)]
[Notices]
[Page 29169]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10010]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1447]
Certain Drug Products Containing C-Type Natriuretic Peptide
Variants, and Components Thereof; Notice of a Commission Determination
Not To Review an Initial Determination Amending the Complaint and
Notice of Investigation
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that the U.S. International Trade
Commission (``Commission'') has determined not to review an initial
determination (``ID'') (Order No. 45) of the presiding Chief
administrative law judge (``Chief ALJ'') granting complainant's
unopposed motion to amend the complaint and notice of investigation to
reflect respondent Ascendis Pharma, Inc.'s corporate name change to
Ascendis Pharma, LLC.
FOR FURTHER INFORMATION CONTACT: Jonathan D. Link, Esq., Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 205-3103. Copies of non-
confidential documents filed in connection with this investigation may
be viewed on the Commission's electronic docket (EDIS) at <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#a9ecede0fa9ae1ccc5d9e9dcdac0ddca87cec6df"><span class="__cf_email__" data-cfemail="fcb9b8b5afcfb499908cbc898f95889fd29b938a">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. Hearing-impaired persons are advised that information on
this matter can be obtained by contacting the Commission's TDD terminal
on (202) 205-1810.
SUPPLEMENTARY INFORMATION: The Commission instituted this investigation
on May 8, 2025, based on a complaint filed by BioMarin Pharmaceutical
Inc. of Novato, CA (``Complainant''). 90 FR 19532-33 (May 8, 2025). The
complaint, as supplemented, alleges violations of section 337 of the
Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into
the United States, the sale for importation, or the sale within the
United States after importation of certain drug products containing C-
type natriuretic peptide variants and components thereof by reason of
infringement of claims 15-20, and 31-48 of RE'267 patent. Id. The
complaint further alleges that a domestic industry exists. Id. The
Commission's notice of investigation named as respondents: Ascendis
Pharma, Inc. of Palo Alto, California; Ascendis Pharma A/S of Hellerup,
Denmark; Ascendis Pharma Growth Disorders A/S of Hellerup, Denmark
(collectively ``Ascendis''); and Wacker Biotech GmbH of Jena, Germany.
Id. The Office of Unfair Import Investigations (``OUII'') is
participating in the investigation. Id.
On September 12, 2025, the Commission determined not to review
Order No. 15 granting Complainant's motion to amend the complainant and
notice of investigation to add Bachem Ag as an additional respondent.
See Order No. 15 (Aug. 14, 2025), unreviewed by Comm'n Notice (Sept.
12, 2025), 90 FR 44843 (Sept. 17, 2025).
On March 23, 2026, the Commission determined not to review an
initial determination (Order No. 36) terminating from the investigation
claims 15-22, 31, 33, 35-40, 42, 44, and 45-48 of the RE'267 patent,
with claims 21-22 having been asserted for domestic industry purposes
only. See Order No. 36 (Mar. 3, 2026), unreviewed by Comm'n Notice
(Mar. 23, 2026).
On April 14, 2026, Complainant filed a motion to amend the amended
complaint and notice of investigation to reflect respondent Ascendis
Pharma, Inc.'s corporate name change to Ascendis Pharma, LLC. No
responses to the motion were filed.
On April 27, 2026, the ALJ issued the subject ID (Order No. 45),
granting Complainant's unopposed motion to amend the amended complaint
and notice of investigation. No petitions for review of the ID were
filed.
The Commission has determined not to review the subject ID. The
notice of investigation is amended to reflect respondent Ascendis
Pharma, Inc.'s corporate name change to Ascendis Pharma, LLC.
The Commission vote for this determination took place on May 15,
2026.
The authority for the Commission's determination is contained in
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and
in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR
part 210).
By order of the Commission.
Issued: May 15, 2026.
Sharon Bellamy,
Supervisory Hearings and Information Officer.
[FR Doc. 2026-10010 Filed 5-18-26; 8:45 am]
BILLING CODE 7020-02-P
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