💊ITC Investigation on Drug Products and Patent Violations
Certain Drug Products Containing C-Type Natriuretic Peptide Variants and Components Thereof; Notice of Institution of Investigation
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.
Agencies
- International Trade Commission
Business Impact
$$$ - High
The regulatory text details a significant investigation into alleged patent infringements related to drug products, which may affect businesses involved in the importation, sale, or manufacturing of these products. The potential for exclusion orders and cease and desist orders indicates high stakes for involved parties.