ITC Section 337 investigations

Section 337 of the Tariff Act of 1930 prohibits the importation of articles that infringe a valid United States patent, where a domestic industry exists or is in the process of being established. Investigations are conducted by the U.S. International Trade Commission on a fast schedule — typically sixteen to eighteen months from institution to final determination — and result in in rem exclusion orders that bar infringing imports at the border.

The rule

Section 337 makes unlawful the importation, sale for importation, or sale within the United States after importation of articles that infringe a valid and enforceable United States patent. To prevail, the complainant must prove four things: (1) importation; (2) infringement of an asserted patent claim; (3) validity and enforceability of the asserted patent; and (4) the existence of a domestic industry relating to articles protected by the patent. The first three issues track the merits of patent infringement; the fourth — the domestic industry requirement — is unique to Section 337.

Section 337 remedies are in rem. Rather than a money judgment against the named respondents, the Commission issues an exclusion order directing U.S. Customs and Border Protection to bar entry of infringing articles, and where appropriate a cease-and-desist order against named respondents preventing sale, distribution, or use of accused articles already in the United States. There are no damages.

Governing statute

The principal statutory text is 19 U.S.C. § 1337. The Commission's procedural rules appear at 19 C.F.R. Part 210. Federal Circuit review of Commission final determinations is governed by 28 U.S.C. § 1295(a)(6) and the Administrative Procedure Act, 5 U.S.C. § 706. Substantive patent law applies as it does in district court — Section 337(a)(1)(B) incorporates the standards for infringement and validity under Title 35.

Key statutory provisions:

• § 1337(a)(1)(B) — unlawful importation of articles that infringe a valid United States patent.
• § 1337(a)(2) and (3) — domestic industry requirement, defined by economic activities in the United States with respect to articles protected by the patent.
• § 1337(b)(1) — Commission shall conclude investigations "at the earliest practicable time."
• § 1337(d) — exclusion orders (limited and general).
• § 1337(f) — cease-and-desist orders.
• § 1337(j) — Presidential review and disapproval on policy grounds.

The framework: complaint to remedy

Pre-filing investigation

A complainant must conduct a thorough pre-filing investigation. The complaint must allege facts establishing each statutory element with substantial particularity, and the Commission's Office of Unfair Import Investigations vets every complaint before institution.

Filing the complaint

The complaint identifies the patents asserted, the proposed respondents, the accused articles, and the basis for the domestic industry showing. It must include claim charts demonstrating that one or more domestic industry products practice the asserted claims (the "technical prong") and economic data showing investment in the domestic industry (the "economic prong").

Institution

The Commission decides whether to institute the investigation typically within thirty days. Institution publishes a Notice of Investigation in the Federal Register and assigns the case to one of the Commission's administrative law judges (ALJs).

Procedural schedule

The ALJ issues a procedural schedule shortly after institution. A typical schedule includes:

• Discovery (interrogatories, document requests, depositions) on a compressed timeline. Discovery limits are larger than in district court — often thirty depositions per side and unlimited interrogatories — and discovery responses are typically due in ten days.
• A claim construction or "Markman" process, often handled at or near the start of the merits hearing.
• An evidentiary hearing before the ALJ, typically eight to twelve months after institution and lasting one to three weeks.
• Post-hearing briefing.
• An Initial Determination by the ALJ.

Initial Determination and Commission review

The ALJ's Initial Determination is referred to the Commission. Any party may petition for review. The Commission may adopt, modify, or reverse the Initial Determination, in whole or in part. The Commission issues a Final Determination, including the appropriate remedy, within roughly four months of the Initial Determination.

Domestic industry — the technical and economic prongs

The complainant must prove a domestic industry by satisfying both:

• Technical prong. One or more articles protected by the patent must be made, used, or sold in the United States. The complainant must chart the asserted claims against a domestic-industry product. InterDigital Communications, LLC v. ITC, 707 F.3d 1295 (Fed. Cir. 2013).
• Economic prong. Section 337(a)(3)(A)–(C) provides three pathways: significant investment in plant and equipment, significant employment of labor or capital, or substantial investment in exploitation of the patent (including engineering, research and development, or licensing). The investments must relate to the protected articles and must be domestic.

The Federal Circuit confirmed in Lelo, Inc. v. ITC, 786 F.3d 879 (Fed. Cir. 2015), that the economic prong requires quantitative analysis. Conclusory expenditures will not suffice.

Importation

The complainant must show importation, sale for importation, or sale within the United States after importation. Even one importation can satisfy the requirement. Suprema, Inc. v. ITC, 796 F.3d 1338 (Fed. Cir. 2015) (en banc), held that Section 337 reaches induced infringement even where the direct infringement occurs after importation.

Remedies

The Commission may issue:

• Limited Exclusion Order (LEO). Bars entry of infringing articles imported by the named respondents.
• General Exclusion Order (GEO). Bars entry of infringing articles regardless of source. Available only where the complainant shows a widespread pattern of unauthorized use and difficulty identifying sources, or business conditions that allow respondents to circumvent an LEO. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340 (Fed. Cir. 2008).
• Cease-and-Desist Order (CDO). Directs named respondents to stop selling, marketing, or distributing accused articles already imported. Civil penalties for violations may reach the greater of $100,000 per day or twice the value of the goods involved.
• Bond during Presidential review. The Commission sets a bond that allows continued importation during the sixty-day Presidential review period.

Public interest

Before issuing an exclusion order, the Commission must consider the public interest factors enumerated in § 1337(d)(1): public health and welfare, competitive conditions in the United States economy, production of like or directly competitive articles in the United States, and U.S. consumers. The Commission has refused to issue exclusion orders on public-interest grounds rarely but with growing frequency in cases involving healthcare and standard-essential technology.

Presidential review

The President (in practice, the U.S. Trade Representative under delegated authority) has sixty days from issuance to disapprove a Commission remedy on policy grounds. If not disapproved, the order takes effect. Presidential disapprovals are rare — the most prominent was the 2013 disapproval of an exclusion order against certain Apple products on competition policy grounds.

Burden, timing, and key deadlines

The complainant bears the burden of proving each statutory element by a preponderance of the evidence. Respondents must prove invalidity by clear and convincing evidence, as in district court.

Section 337 is the fastest patent forum in the United States. The standard schedule:

• Day 0: Complaint filed.
• ~Day 30: Institution.
• ~Day 60: ALJ issues procedural schedule.
• Months 4–10: Discovery, depositions, claim construction.
• Months 8–12: Evidentiary hearing.
• Month 13–14: Initial Determination.
• Month 16–18: Final Determination by the Commission.
• +60 days: Presidential review concludes.

An appeal to the Federal Circuit follows. See Federal Circuit appeals.

Interaction with related procedural mechanisms

Parallel district court litigation

Complainants often file parallel district court patent suits seeking damages, since the ITC offers no monetary relief. A respondent in an ITC investigation may invoke 28 U.S.C. § 1659 to stay the parallel district court action until the Commission's determination becomes final, including any appeal.

Inter partes review

Respondents frequently file IPR petitions against asserted patents. The ITC does not stay an investigation pending IPR. Where the PTAB issues a final written decision invalidating claims before the Commission acts, the Commission has historically reconsidered its own determination.

Section 337 estoppel

Federal Circuit precedent has rejected the argument that ITC findings have full preclusive effect in district court. Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558 (Fed. Cir. 1996); Tessera, Inc. v. ITC, 646 F.3d 1357 (Fed. Cir. 2011). Commission patent rulings are not res judicata in district court but may be considered persuasive.

Settlement and consent orders

Investigations may resolve by settlement agreement, consent order, or both. Consent orders carry the same enforceability as exclusion orders and may impose civil penalties for breach.

Modification and rescission

Once an exclusion order issues, parties may seek modification or rescission under 19 C.F.R. § 210.76 — for example, where claims are later invalidated or where the complainant's domestic industry has ceased.

Practical notes

Domestic industry is the case

Many investigations turn on the economic prong. Counsel should build the domestic industry record from the outset — engineering investments, jobs, U.S. R&D — and tie those investments specifically to the articles asserted to practice the patent.

Plan for compressed discovery

Ten-day discovery responses, monthly depositions, and rolling document productions create unrelenting pressure. Investigation teams must scale to meet the pace; coordination with district court and IPR teams must be tight.

Prepare the importation evidence early

Even one accused unit imported into the United States can satisfy importation. Early third-party purchases or test buys often supply the cleanest proof.

Address the public interest in the complaint

Public-interest considerations now appear in nearly every investigation. Complainants should affirmatively address the four factors. Respondents should marshal evidence on supply, alternatives, and impact on consumers — particularly in healthcare, network infrastructure, and standard-essential technology cases.

Negotiate bond carefully

The bond imposed during Presidential review can be set at zero, at a percentage of value, or at the difference between price-comparable products. The bond decision is often the last contested issue and has substantial financial consequences during the sixty-day review window.

Consider FRAND defenses

Where the asserted patents are subject to a fair, reasonable, and non-discriminatory (FRAND) commitment, respondents should plead and develop public-interest arguments early. Ericsson, Inc. v. D-Link Systems, Inc., 773 F.3d 1201 (Fed. Cir. 2014), supplies relevant FRAND framework.

Pressure points

Domestic industry by licensing alone

Whether substantial investment in licensing under § 1337(a)(3)(C) — without manufacturing — qualifies for domestic industry remains tightly contested, especially where the complainant is a non-practicing entity. InterDigital and Microsoft Corp. v. ITC, 731 F.3d 1354 (Fed. Cir. 2013), set guideposts but the line continues to move.

Components and downstream products

Whether a downstream product containing an accused component can be excluded under an LEO has produced extensive litigation, particularly after Kyocera. Modern practice frequently relies on cease-and-desist orders against downstream sales as a complement to LEOs against components.

Public interest scrutiny

Public-interest analysis has expanded markedly in the last decade, especially in cases involving medical devices, network infrastructure, and FRAND-encumbered patents. Whether the Commission should adopt a more searching, structured public-interest framework is an open policy question.

NPE access to the ITC

Whether non-practicing entities should have access to the in rem remedy under § 337 remains contested in policy debates and occasional bills. The current statute permits NPE access through the substantial investment in licensing pathway.

FRAND, SEPs, and exclusion

Whether the ITC should grant an exclusion order on a standard-essential patent subject to a FRAND commitment is a recurring controversy that has produced presidential disapproval, agency policy statements, and continuing litigation.

See also

• Patent venueThe contrast between district court venue and ITC's national jurisdiction.
• Patent discoveryDiscovery in district court is far less compressed than at the ITC.
• Markman hearingsClaim construction at the ITC follows the same Phillips framework but on a faster schedule.
• Standing in patent casesITC complainants must show domestic industry rather than § 281 standing.
• Federal Circuit appealsAppeals from final ITC determinations under 28 U.S.C. § 1295(a)(6).
• Permanent injunctionseBay does not apply at the ITC; exclusion orders are quasi-mandatory on a finding of violation.
• Literal infringementThe substantive infringement standard applied at the ITC.
• Indirect infringementSuprema confirmed ITC reach over induced infringement.
• AnticipationSection 102 invalidity is litigated as in district court.
• ObviousnessSection 103 invalidity at the ITC.
• Inter partes reviewParallel PTAB proceedings often run alongside ITC investigations.
• Federal CircuitThe court that reviews ITC final determinations.

Authorities

Statutes and rules

• 19 U.S.C. § 1337 (Section 337 of the Tariff Act of 1930)
• 19 C.F.R. Part 210 (Commission rules of practice)
• 28 U.S.C. § 1295(a)(6) (Federal Circuit review)
• 28 U.S.C. § 1659 (stay of district court actions)
• 5 U.S.C. § 706 (administrative procedure)

Cases

• Suprema, Inc. v. ITC, 796 F.3d 1338 (Fed. Cir. 2015) (en banc)
• InterDigital Communications, LLC v. ITC, 707 F.3d 1295 (Fed. Cir. 2013)
• Kyocera Wireless Corp. v. ITC, 545 F.3d 1340 (Fed. Cir. 2008)
• Lelo, Inc. v. ITC, 786 F.3d 879 (Fed. Cir. 2015)
• Microsoft Corp. v. ITC, 731 F.3d 1354 (Fed. Cir. 2013)
• Tessera, Inc. v. ITC, 646 F.3d 1357 (Fed. Cir. 2011)
• Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558 (Fed. Cir. 1996)

Last reviewed: 2026