Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination With the Same; Notice of a Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions on Remedy, the Public Interest, and Bonding
Published Date: 2/2/2026
Notice
Summary
The U.S. International Trade Commission is rechecking part of a decision that found some photodynamic therapy products broke patent rules. This affects companies making or selling these products in the U.S., including Sun Pharmaceutical and others. The Commission is asking for ideas on how to fix the problem, protect the public, and handle money issues, with deadlines coming soon.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
Possible U.S. Import Exclusion
The Commission may order an exclusion that could block the subject photodynamic therapy systems, components, and related pharmaceutical products from entry into the United States. The Final Initial Determination (issued September 30, 2025) found a violation of section 337, and the Commission is considering remedy options in its review (Commission vote occurred January 28, 2026).
Cease-and-Desist Orders Could Stop Sales
The Commission may issue cease and desist orders requiring the named respondents to stop importing and selling the accused photodynamic therapy products in the United States. The ALJ's recommended determination included cease and desist orders as a remedy if the Commission finds a violation of section 337.
Bonding During 60‑Day Presidential Review
If the Commission orders a remedy, the U.S. Trade Representative (delegated 60 days) may review it; during that 60‑day Presidential review period subject articles may enter under bond as determined by the Commission and prescribed by the Secretary of the Treasury. The ALJ recommended a bond of zero percent for any importations during Presidential review, and the Commission is requesting submissions on the appropriate bond amount.
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