90 FR 88 pgs. 19532-19533 - Certain Drug Products Containing C-Type Natriuretic Peptide Variants and Components Thereof; Notice of Institution of Investigation
Type: NOTICEVolume: 90Number: 88Pages: 19532 - 19533
Pages: 19532, 19533Docket number: [Investigation No. 337-TA-1447]
FR document: [FR Doc. 2025-07994 Filed 5-7-25; 8:45 am]
Agency: International Trade Commission
Official PDF Version: PDF Version
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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.
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 EDIS3Help@usitc.gov. 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
[top] (b) The respondents are the following entities alleged to be in violation of
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-Knöll-Straße 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