An ITC Section 337 exclusion order could soon affect Nanomics protein research systems, kits, software, and laboratory supplies entering the United States. With Nanomics in default, importers, research organizations, distributors, and customs brokers should prepare for the remedy decision and possible entry restrictions.
What the Nanomics Default Means for Investigation 337-TA-1508
The Case Has Advanced to the Remedy Phase
The U.S. International Trade Commission instituted Investigation 337-TA-1508 on July 2, 2026. The case concerns certain systems, devices, software, compositions, chemicals, and laboratory supplies used for studying proteins. Seer, Inc. and The Brigham and Women's Hospital allege infringement of five U.S. patents covering protein research technology, including nanoparticle-based protein enrichment applications.
Nanomics Biotechnology Co., Ltd., the sole respondent, filed a notice of intent to default on September 14, 2026. The company cited the cost and burden of continuing to participate, while expressly declining to concede infringement or patent validity. An administrative law judge found Nanomics in default on September 16, and the Commission voted on October 13 not to review that determination. No petitions for review had been filed.
A default is procedurally significant, but it is not itself an exclusion order. The Commission must still determine the appropriate remedy, evaluate the public interest, and establish any bond applicable during the Presidential review period. The potential remedies include an exclusion order directed at covered imports and cease and desist orders affecting certain domestic commercial activities.
Key Dates for Interested Parties
Initial written submissions addressing remedy, public interest, and bonding are due by close of business on October 30, 2026. Reply submissions are due by close of business on November 6, 2026. Party submissions are generally limited to 15 pages initially and 10 pages for replies. Third-party and government agency submissions are generally limited to 10 pages.
Importers, laboratories, distributors, and other affected organizations should not treat these deadlines as routine litigation milestones. They provide a limited opportunity to explain how a proposed remedy could affect research operations, product availability, competition, public health, or U.S. consumers.
How a Potential Exclusion Order Could Affect Imports
Product Scope Matters More Than Product Labels Alone
An ITC exclusion order is enforced at the border by U.S. Customs and Border Protection. If an order issues, CBP may deny entry to products that fall within its legal and technical scope. The practical analysis typically depends on the language of the remedial order, the identity of the manufacturer or supplier, the imported product's technical characteristics, and the underlying patent claims.
The accused products include protein research systems, workstations, kits, consumables, reagents, software, chemicals, and related laboratory supplies. Commercial descriptions or broad tariff classifications may not provide enough information to determine whether a particular shipment is covered. Two products classified under the same Harmonized Tariff Schedule of the United States subheading can receive different treatment if only one falls within the order's scope.
For that reason, importers should not rely solely on HTSUS classification when evaluating Section 337 exposure. Product model numbers, manufacturer identities, technical specifications, component lists, intended uses, and supporting documentation may all become relevant during entry review.
Limited Exclusion and Cease and Desist Remedies
Because Nanomics is the named respondent, a remedy could target articles manufactured by or on behalf of Nanomics. The final language will determine whether the restriction reaches specific products, downstream articles, affiliated entities, or imports conducted through third parties.
A cease and desist order operates differently from an exclusion order. It can restrict certain domestic activities involving covered inventory already present in the United States, such as sale, marketing, distribution, or transfer. This distinction matters for U.S. distributors and laboratories holding Nanomics products when the Commission issues its final determination.
Customs brokers should also distinguish a Section 337 restriction from sanctions or denied-party screening. Nanomics' default does not automatically make the company a prohibited party. The central compliance question is whether the merchandise is covered by a final remedial order and therefore admissible under the order's terms.
Compliance Steps for Importers and Customs Brokers
Map the Supply Chain Before a Remedy Issues
Importers should identify whether their purchasing channels include Nanomics products, components, kits, workstations, reagents, or supplies. This review should extend beyond direct purchases from Nanomics. Distributors, resellers, contract research organizations, and affiliated suppliers may introduce products into the supply chain without making the original manufacturer obvious on a purchase order.
A practical product review should capture the manufacturer, exporter, seller, model number, catalog number, country of origin, HTSUS classification, technical description, end use, and expected entry date. Importers should also preserve specification sheets, invoices, purchase contracts, and correspondence identifying the product's source.
Brokers generally should obtain clear written instructions from the importer when merchandise may be affected by a Section 337 order. Brokers are not expected to decide patent infringement independently, but they should avoid filing entries based on incomplete product descriptions or unsupported assumptions about admissibility.
Prepare for Entry Under Bond
If the Commission issues a remedial order, the decision generally enters a 60-day Presidential review period administered through the U.S. Trade Representative. Covered articles may be permitted to enter during that period under a bond established by the Commission. Entry under bond is not equivalent to unconditional release. It creates financial and operational exposure if the remedy remains effective after review.
Importers considering bonded entry should evaluate the bond amount, shipment value, inventory urgency, customer commitments, and risk that the merchandise may ultimately be excluded. Brokers should confirm that entry documentation accurately identifies the merchandise and follows applicable CBP instructions.
Separate Section 337 Issues From Duty Drawback
Section 337 exclusion orders determine whether covered goods may enter the United States. Duty drawback addresses the potential refund of duties, taxes, and fees after qualifying import and export or destruction activity. The Nanomics proceeding does not change drawback rules.
Goods refused entry generally do not create the same drawback posture as merchandise lawfully entered and later exported or destroyed. Products admitted under bond during Presidential review may also require fact-specific analysis. Importers should keep admissibility, bond liability, duty payment, and drawback eligibility as separate compliance workstreams.
- On October 15, 2026, the ITC published notice (91 FR 65596) that it will not review the ALJ's September 16 initial determination finding sole respondent Nanomics Biotechnology Co., Ltd. (Hangzhou, China) in default in Investigation 337-TA-1508 after Nanomics filed a September 14 notice of intent to default citing cost and burden (without conceding infringement or validity). The Commission now seeks written submissions on remedy, public interest, and bonding, with initials due October 30, 2026, and replies November 6, 2026.
- The investigation, instituted July 2, 2026, involves alleged infringement of five Seer/Brigham and Women's Hospital patents covering nanoparticle protein enrichment technology used in proteomics systems, devices, software, kits, and supplies (accused products include Nanomics Proteonano kits and workstations). Complainants originally sought a limited exclusion order and cease-and-desist order.
- A parallel U.S. district court patent case (N.D. Ill.) filed May 12, 2026, remains stayed pending the ITC outcome. An October 8, 2026, Bloomberg Law article highlighted the Seer-BWH partnership in this litigation and noted Nanomics' September default, with an ITC decision expected by year-end.
- Chinese trade remedy sites reported the Commission's action on October 13-14, 2026, as a partial final determination finding Nanomics in default and recommending a general exclusion order plus cease-and-desist order, with public comments due October 30. No significant practitioner discussions on X were identified in the past 30 days.
Frequently Asked Questions
Is Nanomics Already Subject to an Exclusion Order?
Not solely because of the default determination. Nanomics is in default in Investigation 337-TA-1508, but the Commission must still decide whether to issue an exclusion order, a cease and desist order, or another appropriate remedy. Importers should monitor the case closely while continuing to comply with any existing CBP requirements.
What Products Could Be Affected?
Potentially affected merchandise includes certain systems, devices, software, kits, chemicals, compositions, and laboratory supplies used to study proteins. The investigation involves Nanomics protein research products, including Proteonano kits and workstations. The final remedial language, rather than a general product category or HTSUS heading, will control the legal scope.
What Public Interest Factors Will the ITC Consider?
The Commission generally considers public health and welfare, competitive conditions in the U.S. economy, U.S. production of like or directly competitive articles, and the interests of U.S. consumers. Research laboratories, healthcare-related organizations, distributors, and other affected entities may address issues such as product availability, switching costs, research continuity, alternative suppliers, and potential disruptions.
What Information Must Complainants Provide During the Remedy Phase?
The complainants have been asked to identify the remedy sought, relevant patent expiration dates, HTSUS subheadings associated with the accused products, and all known importers. The complainants and the Office of Unfair Import Investigations are also expected to provide proposed remedial orders. These submissions help define the potential scope and administration of any final remedy.
Can Covered Products Enter During Presidential Review?
If a remedy issues, covered products may generally enter under bond during the 60-day Presidential review period, subject to the Commission's order and CBP procedures. Importers should not assume that normal entry procedures remain sufficient. The bond requirement, product scope, documentation, and consequences of an upheld order should be evaluated before shipment.
Does the Case Affect Duty Drawback Claims?
The proceeding does not directly alter duty drawback eligibility or filing requirements. Section 337 governs import admissibility, while drawback generally concerns refunds associated with qualifying imported merchandise that is later exported or destroyed. Companies should maintain separate records and legal analyses for exclusion order compliance, bonded entry, and drawback claims.
How Stable Software Can Help
Keep Drawback Operations Separate and Controlled
The Nanomics case illustrates why customs brokers need to separate border admissibility questions from post-entry refund programs. An exclusion order may determine whether merchandise can enter, while duty drawback remains a distinct process governed by the underlying import, export, destruction, and recordkeeping facts.
Stable Software offers DrawbackAI, flat-license duty drawback software that U.S. customs brokers can white-label for importer clients and use to file under their own filer codes. Stable Software charges a flat software license and never takes a percentage of the refund. Brokerage firms assessing how to support importer clients can learn more about Stable Software's approach for customs brokers.
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