Notice2025-17924
Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Granting Complainant's Motion To Amend the Complaint and Notice of Investigation
Primary source
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Published
September 17, 2025
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. 15) of the presiding Chief administrative law judge ("Chief ALJ") granting Complainant's motion to amend the complaint and notice of investigation.
Full Text
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<title>Federal Register, Volume 90 Issue 178 (Wednesday, September 17, 2025)</title>
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[Federal Register Volume 90, Number 178 (Wednesday, September 17, 2025)]
[Notices]
[Page 44843]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17924]
[[Page 44843]]
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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 Granting Complainant's Motion To
Amend 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. 15) of the presiding Chief
administrative law judge (``Chief ALJ'') granting Complainant's motion
to amend the complaint and notice of investigation.
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#4603020f15750e232a360633352f322568212930"><span class="__cf_email__" data-cfemail="61242528325229040d112114120815024f060e17">[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 U.S. Reissue Patent No.
48,267. Id. at 19532. 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, CA, Ascendis Pharma A/
S of Hellerup, Denmark, and Ascendis Pharma Growth Disorders A/S of
Hellerup, Denmark (collectively ``Ascendis''); and Wacker Biotech GmbH
of Jena, Germany. Id. at 19533. The Office of Unfair Import
Investigations (``OUII'') is participating in the investigation. Id.
On June 20, 2025, the Commission determined not to review Order No.
5, setting a 17-month target date as October 8, 2026, with any final
initial determination to be due no later than June 8, 2026. See Order
No. 5 (May 27, 2025), unreviewed by Comm'n Notice (June 20, 2025).
On June 17, 2025, Complainant filed a motion to amend the complaint
and notice of investigation to add Bachem AG (``Bachem'') as an
additional respondent. Complainant also requested that the Chief ALJ
declassify certain discovery responses. On June 27, 2025, Ascendis
filed a response in opposition to the motion, while OUII filed a
response not opposing the motion. On July 9, Bachem filed a response in
opposition to the motion. On July 14, 2025, Complainant filed a reply
in support of its motion, and OUII filed a reply maintaining its non-
opposition to the motion.
On July 24, 2025, the Chief ALJ issued Order No. 13, granting leave
for Complainant to supplement its motion to amend. On July 30, 2025,
Complainant filed a supplement to its motion to amend, which included a
second proposed amended complaint. On August 1, 2025, OUII filed a
response in support of the motion, while Ascendis and Bachem both filed
responses continuing to oppose the motion.
On August 14, 2025, the Chief ALJ issued the subject ID (Order No.
15), granting Complainant's motion to amend the complaint and notice of
investigation. The subject ID finds that Complainant has demonstrated
good cause for the proposed amendments under Commission Rule 210.14(b),
19 CFR 210.14(b). See ID at 12-15. The Chief ALJ also granted
Complainant's request to declassify certain discovery responses
pursuant to Commission Rule 210.20(a), 19 CFR 210.20(a). See id. at 4-
7. No party filed a petition for review of the subject ID.
The Commission has determined not to review the subject ID. The
complaint and notice of investigation are amended to add Bachem AG of
Bubendorf, Switzerland as a respondent.
The Commission vote for this determination took place on September
12, 2025.
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: September 12, 2025.
Sharon Bellamy,
Supervisory Hearings and Information Officer.
[FR Doc. 2025-17924 Filed 9-16-25; 8:45 am]
BILLING CODE 7020-02-P
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