[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Notices]
[Pages 19532-19533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07994]
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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 Institution of Investigation
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that a complaint was filed with the
U.S. International Trade Commission on April 2, 2025, under section 337
of the Tariff Act of 1930, as amended, on behalf of BioMarin
Pharmaceutical Inc. of Novato, California. The complaint alleges
violations of section 337 based upon the importation into the United
States, the sale for importation, and the sale within the United States
after importation of certain drug products containing C-type
natriuretic peptide variants and components thereof by reason of the
infringement of certain claims of U.S. Reissue Patent No. RE48,267 (the
``RE'267 patent''). The complaint further alleges that an industry in
the United States exists as required by the applicable Federal Statute.
The complainant requests that the Commission institute an investigation
and, after the investigation, issue a limited exclusion order and cease
and desist orders.
ADDRESSES: The complaint, except for any confidential information
contained therein, may be viewed on the Commission's electronic docket
(EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email
[email protected]. Hearing impaired individuals are advised that
information on this matter can be obtained by contacting the
Commission's TDD terminal on (202) 205-1810. Persons with mobility
impairments who will need special assistance in gaining access to the
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be
obtained by accessing its internet server at https://www.usitc.gov.
FOR FURTHER INFORMATION CONTACT: Pathenia Proctor, The Office of Unfair
Import Investigations, U.S. International Trade Commission, telephone
(202) 205-2560.
SUPPLEMENTARY INFORMATION:
Authority: The authority for institution of this investigation is
contained in section 337 of the Tariff Act of 1930, as amended, 19
U.S.C. 1337, and in section 210.10 of the Commission's Rules of
Practice and Procedure, 19 CFR 210.10 (2025).
Scope of Investigation: Having considered the complaint, the U.S.
International Trade Commission, on May 2, 2025, ordered that--
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of
1930, as amended, an investigation be instituted to determine whether
there is a violation of subsection (a)(1)(B) of section 337 in the
importation into the United States, the sale for importation, or the
sale within the United States after importation of certain products
identified in paragraph (2) by reason of infringement of one or more of
claims 15-20 and 31-48 of the RE'267 patent, and whether an industry in
the United States exists as required by subsection (a)(2) of section
337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of
Practice and Procedure, 19 CFR 210.10(b)(1), the plain language
description of the accused products or category of accused products,
which defines the scope of the investigation, is ``a prodrug of CNP,
including the drug substance, the linker of the drug substance, and
other components, such as the synthetic polymeric group, and vials,
prefilled syringes, autoinjectors, or other presentations of TransCon
CNP containing the same, for the treatment of achondroplasia'';
(3) Pursuant to Commission Rule 210.50(b)(l), 19 CFR 210.50(b)(1),
the presiding administrative law judge shall take evidence or other
information and hear arguments from the parties or other interested
persons with respect to the public interest in this investigation, as
appropriate, and provide the Commission with findings of fact and a
recommended determination on this issue, which shall be limited to the
statutory public interest factors set forth in 19 U.S.C. l337(d)(l),
(f)(1), (g)(1);
(4) For the purpose of the investigation so instituted, the
following are hereby named as parties upon which this notice of
investigation shall be served:
(a) The complainant is:
BioMarin Pharmaceutical Inc., 105 Digital Drive, Novato, CA 94949
(b) The respondents are the following entities alleged to be in
violation of
[[Page 19533]]
section 337, and are the parties upon which the complaint is to be
served:
Ascendis Pharma, Inc., 1000 Page Mill Road, Palo Alto, CA 94304
Ascendis Pharma A/S, Tuborg Boulevard 12, 2900 Hellerup, Denmark
Ascendis Pharma Growth Disorders A/S, Tuborg Boulevard 12, 2900
Hellerup, Denmark
Wacker Biotech GmbH, Hans-Kn[ouml]ll-Stra[szlig]e 3, 07745, Jena,
Germany
(c) The Office of Unfair Import Investigations, U.S. International
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(5) For the investigation so instituted, the Chief Administrative
Law Judge, U.S. International Trade Commission, shall designate the
presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be
submitted by the named respondents in accordance with section 210.13 of
the Commission's Rules of Practice and Procedure, 19 CFR 210.13.
Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be
considered by the Commission if received not later than 20 days after
the date of service by the Commission of the complaint and the notice
of investigation. Extensions of time for submitting responses to the
complaint and the notice of investigation will not be granted unless
good cause therefor is shown.
Failure of a respondent to file a timely response to each
allegation in the complaint and in this notice may be deemed to
constitute a waiver of the right to appear and contest the allegations
of the complaint and this notice, and to authorize the administrative
law judge and the Commission, without further notice to the respondent,
to find the facts to be as alleged in the complaint and this notice and
to enter an initial determination and a final determination containing
such findings, and may result in the issuance of an exclusion order or
a cease and desist order or both directed against the respondent.
By order of the Commission.
Issued: May 2, 2025.
Susan Orndoff,
Supervisory Attorney.
[FR Doc. 2025-07994 Filed 5-7-25; 8:45 am]
BILLING CODE 7020-02-P