Document
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
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 C...
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.