ITC Seeks Comments on Section 337 Complaint on Certain Drug Products
The International Trade Commission seeks comments by April 16 on a Section 337 complaint alleging that imports of drug products containing C-Type natriuretic peptide variants infringe patents held by BioMarin Pharmaceutical Inc., it said in a notice set for April…
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8 publication. According to the complaint, BioMarin is seeking a limited exclusion order and cease and desist orders against Ascendis Pharma and Wacker Biotech to bar from entry "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," that violate the complainant's patents. 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."