Prototype Enough: Even More Expansion to the ITC Domestic Industry Framework

by Dennis Crouch

The Federal Circuit recently affirmed the US International Trade Commission's (ITC) limited exclusion order barring importation of certain Apple Watch models, bringing to a close (at least on this front) one chapter of the sprawling patent war between Masimo and Apple over blood oxygen measurement technology in wearable devices. Apple Inc. v. ITC, No. 24-1285 (Fed. Cir. Mar. 19, 2026).

The Federal Circuit's decision rejected every argument Apple raised on appeal - with the most interesting issues focused on (1) the domestic industry requirement and (2) prosecution laches.

The ITC's Domestic Industry Requirement: Section 337 of the Tariff Act makes it unlawful to import articles that infringe a valid U.S. patent, but the agency can take action only if "an industry in the United States, relating to the articles protected by the patent . . . exists or is in the process of being established." 19 U.S.C. § 1337(a)(2). This domestic industry requirement has two prongs. The "technical prong" asks whether an actual article exists that practices at least one claim of the asserted patent. The "economic prong" asks whether there is significant domestic investment in that article through plant and equipment, labor or capital, or research and development. Both prongs must be satisfied as of the date the complaint is filed. The requirement reflects the reality that the ITC is designed particularly to protect US industry against unfair foreign competition, not to serve as a general patent court.

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