Processing All Things Federal Circuit
April 06, 2023 - Last Week in the Federal Circuit

Last Week In The Federal Circuit (March 27 – March 31): Consulting The Federal Circuit On Statutory Interpretation

International Trade Commission

While last week may have been spring break for many of our readers, the Federal Circuit didn’t take the week off. It still issued several interesting decisions, including our case of the week this week—which discusses the relationship between the International Trade Commission and other federal agencies.

Case of the (recent) week: Philip Morris Products S.A. v. ITC, No. 22-1227

Panel: Judges Prost, Reyna, and Stoll, with Judge Stoll writing the opinion

You should read this case if: you have a matter involving the ITC’s duty to consult or the domestic industry requirement

As our readers likely know, Section 337 of the Tariff Act of 1930 authorizes the ITC to investigate allegations that imported goods infringe U.S. patents. In this week’s case, the Federal Circuit reviewed a Section 337 investigation involving patents on electronic cigarettes. The Court addressed a number of questions, including patent infringement and invalidity, but we’ll focus here on two more broadly applicable statutory interpretation issues.

First, by statute, the ITC must “consult with, and seek advice and information from, the Department of Health and Human Services, the Department of Justice, the Federal Trade Commission, and such other departments and agencies as it considers appropriate” during a Section 337 investigation.  19 U.S.C. § 1337(b)(2).

The Federal Circuit held that the ITC met that duty here. When the ITC instituted the investigation, it published a notice in the Federal Register and served the notice on HHS (the parent agency of the FDA). The ITC’s administrative law judge cited multiple FDA documents, including the FDA’s authorization of the importer’s products, in assessing the effect of any remedy on the public interest. And after the administrative law judge’s initial decision, the ITC published an additional notice in the Federal Register that invited interested government agencies to “file written submissions on the issues of remedy, the public interest, and bonding.”

These steps satisfied the ITC’s obligation to “consult with” HHS and the FDA—even though “the FDA chose not to submit any additional information” in response to the ITC’s notices.  As the Federal Circuit put it, the ITC “cannot force the FDA to engage.”

Second, Section 337 complainants must show there is a “domestic industry” in the United States for articles covered by the asserted patents. The Federal Circuit concluded that even products that have not received regulatory authorization can satisfy this domestic-industry requirement. The statute requires only “significant employment of labor or capital” or “substantial investment in [the] exploitation” of the patented articles. 19 U.S.C. § 1337(a)(3). According to the Federal Circuit, “[n]othing in the plain language of the statute requires that the protected articles have regulatory approval.”

Nor did the specific FDA rule governing the complainant’s products here support a different result. That rule required electronic cigarettes to receive premarket authorization, and it retroactively applied to products already on the market. But the rule included grace periods during which the FDA would not take enforcement action against products that had not yet received authorization. And the complainant’s products still fell within such a grace period when it filed the complaint. Thus, the complainant’s products did not even need regulatory approval to remain on the market at the relevant time.


Precedential opinions: 2

Non-precedential opinions: 3

Rule 36: 0

Longest pending case from argument: VirnetX Inc. v. Apple Inc., No. 21-1672 (204 days)

Shortest (non-Rule 36) pending case from argument: Columbia Insurance Company v. Simpson Strong-Tie Company Inc., No. 21-2145 (21 days)