ITC Issues Ban on Infringing Photodynamic Therapy Imports
Published Date: 5/11/2026
Notice
Summary
The U.S. International Trade Commission found that some photodynamic therapy devices and related products imported by certain companies broke patent rules. To fix this, they’re blocking these products from entering the U.S. without permission and ordering the companies to stop selling them. This means affected businesses must act fast or face legal and financial consequences.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Limited Exclusion Order blocking imports
The Commission issued a Limited Exclusion Order (LEO) prohibiting the unlicensed entry into the United States of infringing photodynamic therapy systems, components, and pharmaceutical products that are manufactured by or on behalf of the named respondents or their affiliates. The determination was made by Commission vote on May 6, 2026 and applies to products found to infringe the asserted patents.
Cease-and-desist orders for named respondents
The Commission issued cease-and-desist orders (CDOs) against each named respondent — Biofrontera Inc.; Biofrontera Pharma GmbH; Biofrontera Bioscience GmbH; and Biofrontera AG — requiring them to stop selling the infringing photodynamic therapy systems, components, and related pharmaceutical products. The Commission terminated the investigation after issuing these orders following its May 6, 2026 vote.
Zero percent bond during Presidential review
The Commission set a bond of zero percent (0%) for any importations of the infringing products during the period of Presidential review, under 19 U.S.C. 1337(j). This means importers would not have to post a monetary bond for the covered products during that review period.
Orders suspended for '028 patent pending appeals
The Commission suspended the remedial orders as to U.S. Patent No. 11,697,028 (the '028 patent) in light of a Final Written Decision (FWD) from the Patent Trial and Appeal Board and pending any further action before the Board or potential appeals. The suspension applies while the Board and any appeals remain active.
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