IP Hot Topic: Federal Circuit Affirms Small U.S. Investments Can Satisfy Domestic Industry Requirement

A domestic industry may never be too small so long as the commercial product is 100% American-made according to the latest Federal Circuit opinion.

In Wuhan Healthgen Biotech v. ITC, the Federal Circuit affirmed the Commission’s conclusion that a patentee satisfied the economic prong of the domestic industry requirement by showing that 100% of the manufacturing occurred in the United States even though the actual investments were small.

The respondent argued that the patentee’s investments in a recombinant albumin cell culture media were too small to be significant or substantial under § 337(a)(3). It further argued that the patentee’s domestic industry product’s low revenue further undermined the conclusion that the patentee satisfied the domestic industry requirement. The Court rejected these arguments and concluded that the substantial evidence supported the Commission’s findings. The Court explained that small market segments can still be significant and substantial enough to satisfy the domestic industry requirement. “[A] finding of domestic industry cannot hinge on a threshold dollar value or require a rigid formula; rather, the analysis requires a holistic review of all relevant considerations that is very context dependent.” Wuhan Healthgen Biotech v. ITC, Case No. 23-1389, slip op. at 7 (Fed. Cir. Feb. 7, 2025). The Court concluded that although the dollar amount of the patentee’s investments were small, all of the investments were domestic, all market activities occurred within the United States, and a high investment-to-revenue ratio indicated this is a valuable market. Therefore, the Court found that there was substantial evidence for the Commission’s finding that the domestic industry requirement was satisfied.

This holding underscores that even lower dollar investments in domestic industry can be sufficient to establish domestic industry particularly if all of the domestic industry product is manufactured in the United States. It also confirms that the ITC is a forum open to domestic industries of any size.