ITC Begins Section 337 Investigation on Certain Drug Products
The International Trade Commission is beginning a Section 337 investigation on drug products containing C-Type natriuretic peptide variants (ITC Inv. No. 337-TA-1447) after receiving allegations filed by BioMarin Pharmaceutical that Ascendis Pharma and Wacker Biotech are importing products that infringe its patents, the agency said in a notice to be published May 8.
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In a complaint filed in April (see 2504070037), the complainant said the respondents are importing products that infringe the patent on “drug products containing a c-type natriuretic peptide variant, and components of the drug product; specifically, 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.” The complainant said that the drugs "have not been approved by the U.S. Food and Drug Administration for any indication, but are expected to be used for therapeutic purposes, such as treating achondroplasia in children." The ITC will consider a limited exclusion order and cease and desist orders against the respondents.