Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could also violate 19 U.S.C. § 1337, and thus may be stopped at the U.S. border by U.S. Customs and Border Protection based on an exclusion order issued by the U.S. International Trade Commission.

False advertising claims in the life sciences sector frequently involve false or misleading statements about a product’s composition, its efficacy for treating a disease, its regulatory approval status, and similarities and differences with respect to a competing product. Section 337 authorizes the ITC to investigate unlawful and unfair trade with respect to imported drugs, dietary supplements and medical devices that may also be regulated by a government agency, such as the U.S. Food and Drug Administration. A narrow exception to the ITC’s broad jurisdiction was recently articulated by the U.S. Court of Appeals for the Federal Circuit in Amarin Pharma Inc. v. ITC.

Amarin, the manufacturer of Vascepa (an FDA-approved drug) filed a complaint in the ITC alleging violations of the Lanham Act. In the complaint, Amarin alleged that the labeling of imported Omega-3 products as “dietary supplements” constituted false advertising because the products are alleged to be unapproved “new drugs,” not “dietary supplements,” according to the Federal Food, Drug and Cosmetic Act.[1] Amarin requested that the ITC institute an investigation and issue an exclusion order to stop the importation of the allegedly unapproved new drugs.

Soon after the complaint was filed, the ITC received comments from the FDA requesting that the commission decline to initiate an investigation in this instance because initiating an investigation would require the commission to decide “open questions of law and policy on which the FDA had not reached final conclusions.” Agreeing with the FDA’s recommendation, the ITC concluded that Amarin’s Lanham Act claims are precluded by the FDCA and declined to institute an investigation. Amarin appealed the ITC’s decision to the Federal Circuit. Amarin argued that Section 337, which states “the following are unlawful, and when found by the Commission to exist shall be dealt with,” required institution of an investigation. The Federal Circuit did not agree and affirmed the ITC’s decision to not institute an investigation.

However, the Federal Circuit’s ruling in Amarin is narrow and does not prevent the ITC from instituting investigations based on Lanham Act claims involving FDA regulations. Rather, the Amarin opinion narrowly addressed situations where the regulatory agency has not decided the law or policy governing the dispute.[2] In contrast, when the alleged unfair act does not require the ITC to determine an open question of agency law or policy, the ITC does not shy away from instituting an investigation, even when regulatory issues and agency regulations, including FDA regulations, are implicated.[3]

The Amarin decision may affect other Lanham Act disputes but will likely not impact trade dress claims because they generally do not implicate regulatory law and policy. Pharmaceutical companies that use color and/or shape as a trade dress to brand its products, such as, e.g., Pfizer Inc.’s Viagra (the little blue pill), AstraZeneca PLC’s Nexium (the purple pill), and GlaxoSmithKline PLC’s Requip (pentagon shaped pill) should consider the ITC to stop infringing products at the U.S. border. The ITC has investigated many trade dress infringement claims.[4]

The Federal Circuit also recently addressed the ITC’s trade dress jurisprudence, by fine-tuning the secondary-meaning test.[5] The Federal Circuit enumerated a new set of factors ((1) association with a particular source by the purchaser, (2) length, degree, and exclusivity of use, (3) amount and manner of advertising, (4) amount of sales and number of customers, (5) intentional copying, and (6) unsolicited media coverage of the product embodying the trade dress) to be considered when analyzing whether a trade dress has acquired secondary meaning.

After modifying the ITC’s secondary meaning test, the Federal Circuit remanded back to the ITC. Now on remand in Certain Footwear Products, the ITC is implementing the Federal Circuit’s new factors. That case is scheduled to conclude in early January 2020. Pharmaceutical companies should monitor the developments of that case.

The ITC is ideal for pharmaceutical and life sciences companies to enforce their rights under the Lanham Act. Established and trusted brands can block importation of competitors’ copycat products, and the importer competitors’ false or misleading claims about its products may be enjoined.[6]

Further, if the source of unlawful products changes, is unknown, and/or is difficult to serve, the ITC’s general exclusion order may be the only adequate remedy available. No other forum provides this advantage. Moreover, the ITC’s experienced judges, unique international in rem jurisdiction, fast time to a decision on the merits, and powerful injunctive remedy are extra advantages. The ITC may be the right prescription to stop unlawful products at the U.S. border.

[1] Certain Synthetically Produced, Predominately EPA Omega-3 Products, Inv. No. 337-TA-3137.

[2] Amarin Pharma Inc. v. Int’l Trade Comm’n, 2018-114, 2019 WL 1925649 (Fed. Cir. May 1, 2019), at *7 (“We note that this limited holding is consistent with the Commission’s arguments in its briefing, which indicated that Amarin’s claims are precluded at least until the FDA has provided guidance as to whether the products at issue are dietary supplements.”)

[3] See, e.g., Certain Periodontal Lasers, 337-TA-1070 (Sept. 11. 2017) (investigation instituted against products alleged to not be FDA cleared but advertised as “equivalent” to Complainant’s FDA-cleared product); Certain Potassium Chloride Powder Products, Inv. No. 337-TA-1013 (June 27, 2016) (investigation instituted against certain Potassium Chloride for Oral Solution, alleged to falsely claim FDA approval); Certain Cigarettes & Packaging Thereof, Inv. No. 337-TA-424 (instituted investigation into false claims implicating the Federal Trade Commission’s Federal Cigarette Labeling and Advertising Act of 1964); Certain Nut Jewelry & Parts Thereof Initial Determination, Inv. No. 337-TA-229 (July 30, 1986) (instituted investigation into alleged violation of Federal Trade Commission regulation).

[4] See, e.g., Certain Food Waste Disposers and Components and Packaging Thereof, Inv. No. 337-TA-838; Certain Footwear Products, Inv. No. 337-TA-936; Certain Hand Dryers and Housing for Hand Dryers, Inv. No. 337-TA-1015; Certain Motorized Vehicles and Components Thereof, Inv. No. 337-TA-1132; Certain Pocket Lighters, Inv. No. 337-TA-1142.

[5] Converse, Inc. v. ITC, 909 F.3d 1110 (Fed. Cir. 2018).

[6] See, e.g., Certain Periodontal Lasers, 337-TA-1070; Certain Potassium Chloride Powder Products, Inv. No. 337-TA-1013.