Opportunity
Federal Register #337-TA-1411
ITC Exclusion Order for Infringing Photodynamic Therapy Systems and Related Products
Buyer
International Trade Commission
Posted
May 11, 2026
Identifier
337-TA-1411
This notice details the U.S. International Trade Commission's (ITC) final determination in Investigation No. 337-TA-1411 regarding photodynamic therapy systems and related pharmaceutical products: - Government Buyer - U.S. International Trade Commission (ITC), Office of the General Counsel - OEMs and Vendors Involved - Sun Pharmaceutical Industries, Inc. (patent holder) - Biofrontera Inc. (Woburn, MA) - Biofrontera Pharma GmbH, Biofrontera Bioscience GmbH, Biofrontera AG (Leverkusen, Germany) - Products/Services Involved - Photodynamic therapy systems, their components, and pharmaceutical products used in combination with these systems - No specific part numbers or quantities listed - Unique or Notable Requirements - The ITC found infringement of U.S. Patent Nos. 11,446,512 and 11,697,028 held by Sun Pharmaceutical Industries, Inc. - Issuance of a limited exclusion order prohibiting unlicensed importation of infringing products - Cease and desist orders against Biofrontera entities - No procurement or purchase is being solicited; this is a regulatory enforcement action - Locations - ITC Headquarters, 500 E Street SW, Washington, DC 20436 - Biofrontera Inc. (Woburn, MA) - Biofrontera affiliates (Leverkusen, Germany) - Additional Context - The Commission also declined to review antidumping and countervailing duty orders on coated paper imports from Indonesia; no new procurement or review was initiated for these products.
Description
The U.S. International Trade Commission has found a violation of section 337 in an investigation concerning certain photodynamic therapy systems, components thereof, and pharmaceutical products used in combination with the same. The Commission issued a limited exclusion order prohibiting the unlicensed entry of infringing products manufactured or imported by the respondents. Cease and desist orders were also issued against all named respondents. The investigation has been terminated following these determinations.