Second Bite at the Cherry: Adjudicating Redesigns after an ITC Exclusion Order

Recent International Trade Commission (ITC) decisions emphasize the importance of providing concrete evidence of importation when filing a complaint under Section 337 of the U.S. Tariff Act of 1930. In several instances, the ITC has declined to institute an investigation as to certain proposed respondents due to insufficiently supported allegations of importation, underscoring the need for detailed factual and documentary support in every complaint.

Companies that are facing an exclusion order issued by the US International Trade Commission (ITC) should consider their post-investigation options for adjudicating redesigned products to avoid disruption of their importation business.

The fastest approach is to ask US Customs and Border Protection (CBP), through a Part 177 proceeding, to determine that a redesigned product does not infringe the asserted IP rights and should not be subject to the ITC’s exclusion order. Another path is to return to the ITC itself and seek adjudication of the redesigned product in a modification proceeding.

Conversely, the complainant from the original ITC investigation may pursue a subsequent ITC enforcement proceeding to establish that redesigned or additional products are properly covered by the ITC’s exclusion order.

This article explores recent decisions to showcase the mechanisms for adjudicating redesigns and clarifying exclusion orders at the ITC and CBP.

Exclusion orders at the ITC

An ITC exclusion order is a powerful, injunctive-type remedy that directs CBP to exclude articles from importation into the US that have been found by the ITC to infringe US patents or other IP rights.

The ITC issues two types of exclusion orders: limited exclusion orders that are applicable only to infringing articles imported by the respondents named in the original ITC investigation and general exclusion orders, which bar entry of all infringing articles, regardless of the importer (19 U.S.C. § 1337(d)(2)).

Exclusion orders are usually broadly worded to bar entry of any products that infringe the asserted patent claims, often without specifying particular product names or models. It is the responsibility of CBP, in consultation with the parties, to determine which particular products (including redesigned products) should be blocked under the exclusion order.

Specific products that were adjudicated in the ITC investigation may be easy enough for CBP to identify and block, but redesigned products that were not adjudicated may need to be examined by CBP at the behest of the parties, or submitted to the ITC itself for adjudication.

As discussed below, there are multiple post-investigation mechanisms available to resolve any issues regarding redesigned products or otherwise clarify the scope of exclusion orders.

Administrative rulings by CBP

Typically, the fastest way to adjudicate a redesign or clarify the scope of an exclusion order is directly through CBP. CBP issues administrative rulings pursuant to Part 177 of the CBP Regulations regarding whether prospective importations fall within the scope of an exclusion order issued by the ITC (19 C.F.R. § 177).

Any person who, as an importer or exporter of merchandise, or otherwise, has a direct and demonstrable interest in the questions presented may request a ruling. Part 177 ruling requests are usually adjudicated on an inter partes basis, meaning that the complainant from the original ITC investigation is invited to participate.

A named respondent subject to a limited exclusion order from the ITC can utilise Part 177 to expeditiously clear their redesigned product with CBP for importation into the US. Last year, Apple successfully established that its redesigned Apple Watches were not subject to a limited exclusion order from the ITC.

In 2022, the ITC issued a limited exclusion order (LEO) against Apple, excluding Apple Watches with electrocardiogram (ECG) functionality that were found to infringe certain patent claims in Investigation No. 337-TA-1266 (Certain Wearable Electronic Devices with ECG Functionality and Components Thereof, Inv. No. 337-TA-1266, Limited Exclusion Order at 2 [Dec. 22, 2022]).

On January 31, 2024, Apple submitted a letter to CBP requesting an administrative ruling that its redesigned Apple Watches were not subject to the LEO (Customs HQ Ruling No. H338253 [June 20, 2024] at 1, 7, 8, 29).

Both Apple and AliveCor, the complainant from the original investigation, agreed to an inter partes proceeding. Apple produced source code pursuant to a non-disclosure agreement. The parties then submitted opening briefing, oral presentations, and post-presentation submissions to CBP.

On June 20, 2024, CBP issued a ruling that Apple’s redesigned Apple Watches were not subject to the 1266 LEO and could be imported into the US.

Even if a party is not a respondent to the original ITC investigation, its products may be subject to a general exclusion order. In such cases, parties can seek an administrative ruling request from CBP that certain products are not subject to the general exclusion order.

As one example, Hangzhou Golden Sun Autoparts sought a ruling that its pick-up truck folding bed cover was not subject to a general exclusion order issued by the ITC in Investigation No. 337-TA-1353 (Customs HQ Ruling No. H343308 [Apr. 7, 2025] at 1, 4-5).

After CBP initiated an inter partes proceeding, the complainants from the original ITC investigation conceded that the exclusion order did not apply to the products at issue. Because the request was unopposed, CBP permitted importation of the truck bed covers.

Similarly, in 2024, Mountain Voyage sought a ruling that certain money clip and cash strap wallets were not subject to the general exclusion order issued by the ITC in Investigation No. 337-TA-1355 (Customs HQ Ruling No. H340844 [Sept. 27, 2024] at 1-2, 7-9).

The complainant from the original investigation, The Ridge Wallet, did not argue that the articles at issue infringed—it argued that Mountain Voyage did not sufficiently describe its labelling practices in the ruling request. Because Ridge conceded non-infringement, CBP issued a ruling that the articles could be imported subject to appropriate certification procedures by Mountain Voyage.

Part 177 rulings are not limited to the prospective importers—the complainant from the original ITC investigation may also request a Part 177 ruling. Complainants can use Part 177 rulings to: 1) address the enforcement of exclusion orders against respondents attempting to import products not specifically adjudicated in the original investigation; or 2) to clarify the scope of the exclusion order.

Part 177 rulings can be particularly useful for patent holders to prevent the importation of new, infringing products or to help clarify orders that may confuse customs agents.

While CBP rulings are useful for their speed, practitioners should be aware that CBP rulings can be overridden at the ITC through modification or enforcement proceedings.

Modification proceedings

ITC modification proceedings can be useful for importers seeking to adjudicate a redesigned product or for complainants seeking to override a CBP ruling.

A party seeking a ruling on a redesigned product can ask the ITC to initiate a modification proceeding to adjudicate whether a redesigned product should be subject to a previously issued exclusion order. The ITC is permitted to modify previously issued exclusion orders in response to changed conditions of fact or law (19 C.F.R. § 210.76).

If the ITC determines that the redesigned product does not infringe, the exclusion orders can be modified to carve out those products.

This is a useful mechanism for importers who were unable to adjudicate their redesigned product during the original ITC investigation. Modification proceedings are slower than CBP rulings but provide more certainty for the importer because they are binding on CBP (while CBP rulings are not binding on the ITC).

Conversely, a complainant from the original investigation can use modification proceedings in an attempt to overturn an adverse CBP ruling. For example, after Hitachi Koki USA successfully petitioned CBP for a ruling request allowing importation of its redesigned nail guns, see Customs HQ Ruling No. H305358 (June 30, 2020), the original complainant Kyocera Senco Brands took the fight to the ITC.

Kyocera argued that the release of Koki’s redesign and the adverse CBP ruling constituted a changed condition of fact allowing the ITC to institute a modification proceeding (Certain Gas Spring Nailer Products and Components Thereof, Investigation No. 337-TA-1082, Petition for Modification Proceeding at 5 [August 17, 2020]; Gas Spring Nailer Products, Institution of Modification Proceeding [September 16, 2020]).

However, the ITC ultimately agreed with Koki and CBP, entering an order that Koki’s redesigned nail guns are not subject to the LEO (Gas Spring Nailer Products, Comm’n Order [August 4, 2021]).

Enforcement proceedings

Enforcement proceedings provide another mechanism for complainants to override an adverse ruling from CBP or clarify which products fall within the scope of an exclusion order.

Complainants DISH DBS, DISH Technologies, and Sling TV (collectively, DISH) utilised an enforcement proceeding to challenge an adverse CBP ruling in ITC Investigation No. 337-TA-1265.

CBP entered a ruling that ICON Health & Fitness, FreeMotion Fitness, and NordicTrack (collectively, iFIT) could import certain fitness devices with streaming capabilities because they were not subject to DISH’s limited exclusion order (Customs HQ Ruling No. H330951 [June 30, 2023]).

DISH took the issue to the ITC, arguing, inter alia, that the redesigned devices allowed by CBP violated the original LEO and cease-and-desist orders, and that the original LEO should be modified to prevent importation of the redesigned devices (Certain Fitness Devices, Streaming Components Thereof, and Systems Containing Same, Investigation No. 337-TA-1265, Enforcement Complaint at 3-4, 21-24, 32 [September 11, 2023]).

The ITC instituted an enforcement proceeding to determine if iFit violated those orders (Fitness Devices, Comm’n Order [October 11, 2023]).

Although the investigation was ultimately settled, (Fitness Devices, Initial Determination Terminating the Enforcement Proceeding Based on a Settlement Agreement [March 19, 2024]), its institution demonstrates that a complainant may use an enforcement proceeding to attempt to override an adverse CBP ruling.

Understanding options for adjudicating redesigns and clarifying exclusion orders

It is important for parties impacted by exclusion orders to know the paths they can take to clarify those orders or seek rulings on redesigns.

The fastest path to resolving the scope of an exclusion order is to request a Part 177 ruling from CBP, but such rulings apply only to CBP and can be overridden by the ITC. For a more secure ruling, importers can take their redesigns directly to the ITC by petitioning for a modification of the original exclusion order.

On the flip side, complainants at the ITC should be prepared to interact with CBP and initiate subsequent proceedings as needed to protect the full scope of the exclusion order.

Complainants should communicate with CBP when an exclusion order issues to provide guidance regarding the coverage of the order, and should be prepared to participate in inter partes Part 177 proceedings initiated by the importers.

Complainants should also stand prepared to initiate modification or enforcement proceedings at the ITC to override any adverse CBP rulings or clarify the scope of the exclusion order.