USITC Institutes Section 337 Investigation of Certain Drug Products Containing C-type Natriuretic Peptide Variants, and Components Thereof

May 2, 2025
News Release 25-054
Inv. No(s). 337-TA-1447
Contact: Claire Huber, 202-205-1819

The U.S. International Trade Commission (Commission or USITC) voted to institute an investigation of certain drug products containing C-type natriuretic peptide variants, and components thereof. The products at issue in the investigation are described in the Commission’s notice of investigation.

The investigation is based on a complaint filed by behalf BioMarin Pharmaceutical Inc. of Palo Alto, Calif., as amended, on April 2, 2025. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain drug products containing C-type natriuretic peptide variants, and components thereof that infringe the patent asserted by the complainant. The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the USITC issue a limited exclusion order and cease and desist orders. 

The USITC has identified the following respondents in this investigation:

• Ascendis Pharma, Inc., of Palo Alto, Calif.
• Ascendis Pharma A/S of Hellerup, Denmark
• Ascendis Pharma Growth Disorders A/S of Hellerup, Denmark
• Wacker Biotech GmbH of Jena, Germany

By instituting this investigation (337-TA-1447), the USITC has not yet made any decision on the merits of the case. The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing. The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission. 

The USITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation. USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.