Complainants Entellus Medical, Inc., Stryker Corporation, and Stryker Sales, LLC accuse Fiagon respondents of importing and selling balloon dilation devices that infringe U.S. Patents 11,083,878, 11,090,472, and 12,274,847. The Office of Unfair Import Investigations is not participating.
What the ALJ found
On June 26, 2026, the ALJ's final initial determination found a violation as to remaining claims 1, 14, 20, 22, and 23 of the '878 patent, claim 1 of the '472 patent, and claims 1 and 11 of the '847 patent. The FID found importation, infringement, no clear-and-convincing invalidity showing, and satisfaction of the domestic-industry technical and economic prongs. The recommended determination favors a limited exclusion order and cease-and-desist orders, with a 61% bond for some accused products during Presidential review.
What the Commission is reviewing
The Commission reviews findings on the importation requirement, induced infringement, written-description invalidity, obviousness, and the economic prong of domestic industry. It asks the parties for briefing on whether imported components assembled in Minnesota with U.S. parts are "articles that infringe," including under the framework discussed in Additional Views in Inv. No. 337-TA-1194, and on post-complaint inducement evidence.
What to watch next
Watch opening remedy, public-interest, and bonding submissions due September 28, 2026, replies due October 5, 2026, and the Commission's determination by the November 13, 2026 target date.