ITC bans photodynamic-therapy device imports over patent violation
The U.S. International Trade Commission has issued a limited exclusion order (LEO) barring unlicensed imports of infringing photodynamic therapy systems, their components, and related pharmaceutical products. The final determination, published 11 May 2026, finds a violation of Section 337 (unfair competition via patent infringement) and imposes cease-and-desist orders on all named respondents. The investigation is now closed.
Photo: Cnordic Nordic / PexelsSection 337 Patent Infringement Finding Triggers Import Ban
On 11 May 2026, the U.S. International Trade Commission announced a final determination of patent infringement in its investigation of photodynamic therapy systems and associated products. As stated in the Federal Register notice, "the Commission has determined to issue a limited exclusion order ('LEO') prohibiting the unlicensed entry of infringing oil vaporizing devices, components thereof, and products containing the same that are manufactured by or on behalf of, or imported by or on behalf of, the respondents."
Who Is Affected
The LEO targets all named respondents—any party manufacturing, importing, or selling the infringing photodynamic therapy systems and components without a license from the patent holder. The order covers:
- Oil vaporizing devices (the core infringing product)
- Components of those devices
- Pharmaceutical products used in combination with the devices
All three categories face import prohibition into the United States.
Enforcement Mechanism
The Commission has paired the LEO with cease-and-desist orders (CDOs) against every named respondent, creating a two-pronged enforcement strategy:
- Limited Exclusion Order: Blocks infringing goods at the U.S. border
- Cease-and-Desist Orders: Prevents respondents from further manufacturing, importing, selling, or offering for sale the infringing products within the United States
These orders remain in effect unless modified or terminated by subsequent Commission action or presidential review.
Investigation Termination
With this final determination, the investigation is terminated. No further discovery, hearings, or appeals are pending before the Commission on the merits of the infringement claim, though respondents may seek presidential review of the LEO under 19 U.S.C. § 1337(j).
What this means for shippers
If your freight or e-commerce shipments include photodynamic therapy systems, oil vaporizing devices, components, or pharmaceutical products intended for use with such systems, verify immediately that they are not manufactured by or imported on behalf of any named respondent. Unlicensed goods will face seizure at U.S. ports of entry. Update your supplier due diligence and product sourcing to ensure compliance. Consult the full ITC determination and respondent list to confirm your supply chain is clear; failure to do so risks shipment detention and forfeiture. Check the /hs-codes/search tool to confirm proper classification and identify any duty or licensing implications for compliant imports.
