News & Perspectives | Arnold & Porter

Two Weeks After SCOTUS Ruling: Courts Push CBP to Move Forward with IEEPA Tariff Refunds

Mon, 09 Mar 2026 00:00:00 -0500

Two weeks on from the Supreme Court’s decision invalidating President Trump’s tariffs, importers still do not have clarity on how to claim tariff refunds. However, there has been some encouraging movement from the lower courts and potentially from U.S. Customs and Border Protection (CBP).

On Monday, March 2, 2026, the U.S. Court of Appeals for the Federal Circuit in V.O.S. Selections, Inc. v. Trump issued a mandate returning the case to the U.S. Court of International Trade (CIT). The Federal Circuit issued the order over objections from the U.S. Department of Justice (DOJ), which argued that the court should allow 90 days to give the “political branches an opportunity to consider options.” The Federal Circuit’s action allowed the CIT to begin taking steps to implement the decision invalidating the tariffs and to consider the process for providing importers with refunds.

The CIT acted quickly after receiving the mandate from the Federal Circuit, ruling in a related case, Atmus Filtration, Inc. v. United States, that refunds were due to importers and directing CBP to take action.

On March 4, in a somewhat unexpected order issued from the bench during a motion hearing (on a motion that was actually withdrawn prior to the hearing), CIT Senior Judge Richard Eaton found that all importers of record whose entries were subject to the duties invalidated in the Supreme Court’s V.O.S. Selections decision are entitled to the benefit of that decision, and ordered U.S. Customs and Border Protection (CBP) to take immediate action. The CIT order required that:

All unliquidated entries entered subject to IEEPA duties invalidated by the Supreme Court decision must be liquidated without regard to those duties; and
Any liquidated entries for which liquidation is not yet final must be reliquidated without IEEPA duties

In response to the CIT’s Order, the DOJ made an immediate oral motion to suspend the Order and to allow time for the government to appeal. Judge Eaton immediately denied the motion. Instead of appealing, however, on March 6 the U.S. government filed a declaration from a CBP official that provided some details on how the agency might issue tariff refunds. The CBP declaration notes the “unprecedented volume of refunds” and explains that CBP’s existing procedures and technology are not well-suited to the refund task.

Following a closed-door status conference on Friday, March 6, Judge Eaton issued orders suspending his March 4 order requiring CBP to begin paying refunds immediately. In addition, Judge Eaton issued an order requiring CBP to provide a status update on their refund process efforts by Thursday, March 12.

CBP’s declaration does not specifically commit to providing refunds, and we note that the U.S. government may still decide to challenge the CIT’s order directing refunds. However, CBP’s declaration in response to the refund order provides some indication of how the agency plans to proceed with refunds. The declaration states, “CBP is confident that it can develop and implement new ACE functionality that will streamline and consolidate refunds and interest payments on an importer basis, rather than issuing 53,173,939 separate entry-specific refunds with multiple payments going to the same importer.” The declaration notes that CBP anticipates a process that will require importers to file declarations listing their duties paid, which would be verified by CBP, followed by Treasury issuing refunds electronically. The CBP filing is limited to the potential procedures the government could use to process refunds, and does not indicate the government’s position on a range of issues, including whether it believes that importers would be required to file their own court cases challenging the tariffs in order to be eligible for refunds, or how the government might approach liquidated entries (though the declaration suggests the refund procedures could apply at liquidation or as part of a reliquidation process).

Arnold & Porter’s trade and tariff refund team continues to monitor developments and can advise clients on the necessary steps to protect their refund rights while these proceedings are pending.

For related Arnold & Porter updates on tariff refunds, see:

*Sally Alghazali contributed to this Advisory. Ms. Alghazali is admitted only in Minnesota; practicing law in Washington, DC during the pendency of her application for admission to Washington, DC Bar and under the supervision of lawyers of the firm who are members in good standing of the State Bar.

Questions About the SCOTUS Tariff Decision?

The Supreme Court’s ruling on tariff authority marks a pivotal shift in trade policy. As potential refund pathways develop for tariffs already paid, our International Trade team is actively tracking changes and advising clients on potential next steps. Contact us to explore strategies tailored to your business.

© Arnold & Porter Kaye Scholer LLP 2026 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

Ambassador Barbara Leaf Appears on Bloomberg TV and TRT World Now to Discuss Developments in Middle East Conflict

Fri, 06 Mar 2026 00:00:00 -0600

Arnold & Porter Senior International Policy Advisor and former U.S. Ambassador Barbara Leaf appeared on Bloomberg TV and TRT World Now this week to discuss the latest developments in the U.S.-Israeli-led conflict involving Iran and its broader regional implications.

The Next Wave of Tariff Litigation: Consumer Class Actions

Fri, 06 Mar 2026 00:00:00 -0600

Following the United States Supreme Court’s decision invalidating tariffs imposed under the International Emergency Economic Powers Act (IEEPA), the class action plaintiff’s bar has begun filing class actions targeting businesses they claim passed tariff-related costs on to consumers.

Capital Snapshot: A Monthly Overview of the Issues, Events, and Timelines Driving Federal Policy Decisions

Fri, 06 Mar 2026 00:00:00 -0600

Our Legislative & Public Policy team is pleased to provide the March 2026 edition of Capital Snapshot, which includes a monthly summary of the issues, events, and timelines driving federal policy and political decisions.

Deborah Curtis Talks With Global Investigations Review on BIS Semiconductor Enforcement

Thu, 05 Mar 2026 00:00:00 -0600

Deborah Curtis, Co-Chair of Arnold & Porter’s White Collar Defense & Investigations practice, was recently quoted in the Global Investigations Review article, “Applied Materials settlement a ‘warning shot’ for US exporters.”

Law360 Features Arnold & Porter’s State AG Task Force

Thu, 05 Mar 2026 00:00:00 -0600

Arnold & Porter’s dedicated State Attorneys General Investigations & Litigation Task Force was featured in a recent Law360 article, “Arnold & Porter Forms Team To Tackle Scrutiny By State AGs,” which included an interview with Commercial Litigation partner Benjamin Mizer and White Collar Defense & Investigations partner Meredith Osborn.

China Anti-Corruption: 2025 Year in Review

Thu, 05 Mar 2026 00:00:00 -0600

Anti-corruption remained a key area of focus for Chinese regulators in 2025. This Advisory summarizes key legislative developments and major enforcement trends from the past year.

FDA Issues Draft Guidance Clarifying Three-Year New Clinical Investigation Exclusivity

Thu, 05 Mar 2026 00:00:00 -0600

The U.S. Food and Drug Administration (FDA) just issued a much-anticipated guidance on New Clinical Investigation exclusivity (also known as three-year exclusivity) for new drug applications (NDAs) and NDA supplements.[[N:FDA Guidance for Industry, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers (March 2026), New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.]] FDA’s draft guidance is organized in a question-and-answer format that covers the statutory and regulatory eligibility criteria and provides recommendations on requests for exclusivity.

For years, FDA’s approach to three-year exclusivity demanded an understanding of policy and precedent scattered across regulatory preambles, select exclusivity determinations released under Freedom of Information Act requests, and published court opinions. This draft guidance offers a consolidated articulation of FDA’s current three-year exclusivity policy and interpretive framework.

Below, we provide a brief summary of FDA’s standard for eligibility for three-year exclusivity and a discussion of several key examples.

Three-Year Exclusivity Framework

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations establish the criteria for qualifying for three-year exclusivity.[[N:The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments) established the exclusivity framework in the FD&C Act. Congress’s intent behind the law, more generally, was balancing innovation with making lower cost generic drugs available.]] An NDA or a supplemental NDA may qualify for exclusivity if it –

Contains a previously-approved active moiety[[N:For a single-entity NDA, the active moiety must have been previously approved in another 505(b) application; for a fixed-combination drug product, each of the active moieties must have been previously approved in another 505(b) application. ]] and
Contains reports of new clinical investigations that are –
- not bioavailability studies
- essential to the approval of the application (or supplement) and
- conducted or sponsored by the applicant[[N:See sections 505(c)(3)(E)(iii) and (iv), and 505(j)(5)(F)(iii) and (iv) of the FD&C Act; 21 CFR 314.108.]]

As suggested above, both NDAs and supplemental NDAs are eligible for exclusivity. In the case of NDA supplements (typically efficacy supplements), three-year exclusivity attaches to the changes approved in the supplement that were supported by the new clinical investigation(s) essential to the supplement's approval and conducted or sponsored by the applicant submitting the supplement. In this case, exclusivity does not cover the previously approved conditions of approval for the NDA being supplemented

FDA considers eligibility requests on an application-by-application basis. Applicants who believe their drug product is eligible for exclusivity must submit to FDA, per 21 CFR 314.50(j), the following information, prior to approval:

A statement that the applicant is claiming exclusivity
A reference to the appropriate paragraph under § 314.108 that supports its claim
Information to show that the NDA contains “new clinical investigations” (other than bioavailability studies) that are “essential to approval of the NDA or supplement” and “were conducted or sponsored by the applicant”

The Appendix section of the guidance provides representative language that may aid in preparing an exclusivity request.

Mechanistically, the draft guidance lays out a process that leans heavily on FDA’s Office of Generic Drug Policy. Specifically, the draft guidance explains that the process for making three-year exclusivity determinations involves coordination between several offices in the Center for Drug Evaluation and Research (CDER) within FDA, namely, the Office of New Drugs (OND) and the Office of Generic Drugs (OGD). The applicable review division in OND provides OGD with the exclusivity summary to aid OGD’s eligibility determination. As needed, the Office of Generic Drug Policy may consult with CDER’s Exclusivity Board for advice regarding a pending exclusivity matter. After OGD Policy determines that a product is eligible for three-year exclusivity, the relevant information is reflected in an update to the Orange Book. FDA updates exclusivity-related information in the Orange Book approximately every 2 weeks.

Areas of Clarification

The draft guidance addresses several foundational interpretive issues, the basic mechanisms of requesting and obtaining exclusivity, and key interpretive criteria and policy. For example, FDA delves further into the meaning of regulatory terms such as “bioavailability study”, “clinical investigation,” “new clinical investigation,” and “essential to approval”. FDA also explains what type of information the Agency expects to see in an exclusivity request, for example, to support that a clinical investigation is “new” or “conducted or sponsored” by the applicant.

Other discussions focus on threshold eligibility issues. For instance, the guidance clarifies that studies that only administer a placebo to subjects are not typically considered to meet the definition of a clinical investigation for purposes of the exclusivity regulations and would not qualify the product for three-year exclusivity. The guidance also clarifies that the drug used in the clinical investigation need not be the same as that approved for the application to qualify for exclusivity, provided that the relevant statutory and regulatory exclusivity requirements are met.[[N:See 21 CFR 314.108 and 21 U.S.C. 355(c)(3)(E)(iii), (iv).]] For example, a clinical investigation that “used a similar or earlier version of the drug product in development, which contains the same active moiety or combination of active moieties as the version of the drug in the approved application,” could be eligible.

FDA also sheds light on more niche topics that have evolved in drug development since the framework was established in the 1980s and 1990s. For example, the response to QB.8 explains that when a study involves multiple cohorts or treatment arms (at least one of which was previously relied upon to approve an application), another cohort or treatment arm may still qualify as a new clinical investigation under certain circumstances. This determination will be made on a case-by-case basis through application of a multifactorial approach to determine whether a cohort or treatment arm constitutes a distinct new clinical investigation. FDA will consider in its analysis whether there is an acceptable scientific or medical reason for the separate cohort or treatment arm; whether the separate cohort or treatment arm evaluates different patient populations and/or different drug products; and whether the separate cohort or treatment arm was prespecified in the protocol. Such a policy is intended to “encourage efficiencies” in clinical trial design and to incentivize sponsors to submit results from distinct cohorts or treatment arms as soon as they are available, thereby enabling new information to be included in drug labeling more quickly.

* * *

FDA’s draft guidance provides long-awaited clarity to an area of regulatory practice that has historically required navigating multiple resources. This guidance consolidates FDA’s policy and practice into a single document with extensive footnote references that provide the underpinnings for the Agency’s positions. Comments on this guidance are due on May 4, 2026.

For background on another key exclusivity pathway – five-year new chemical entity exclusivity – FDA’s previous guidance on New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (Oct. 2014) remains a useful resource.[[N:FDA Guidance for Industry, New Chemical Entity Exclusivity Determinations for Certain Fixed Combination Drug Products Guidance for Industry (October 2014). ]] The authors are longstanding followers of exclusivity issues and are pleased to discuss any questions that may arise.

The Future of Banking — An In-Person Financial Services Summit

Wed, 04 Mar 2026 00:00:00 -0600

We are pleased to invite you to The Future of Banking: Transactions, Regulation, and Political Insight, an in-person Financial Services Summit hosted by Arnold & Porter.

Inside EPA Quotes Jonathan Martel on DOJ’s Clean Air Act Anti-Tampering Enforcement Shift

Wed, 04 Mar 2026 00:00:00 -0600

Jonathan Martel, Co-Chair of Arnold & Porter’s Environmental practice group and a former attorney at the U.S. Environmental Protection Agency’s (EPA) Office of General Counsel, was quoted in the Inside EPA article, “DOJ Inconsistently Enforcing Vehicle Tampering Policy, Defendants Charge,” which examined questions surrounding the U.S. Department of Justice’s (DOJ) recent announcement that it would no longer pursue criminal charges under Clean Air Act (CAA) anti-tampering provisions.

Bloomberg TV Interviews Claire Reade on Supreme Court’s Recent Tariffs Ruling

Wed, 04 Mar 2026 00:00:00 -0600

Arnold & Porter senior counsel Claire Reade, former Assistant U.S. Trade Representative for China Affairs, appeared on Bloomberg TV to discuss the U.S. Supreme Court’s recent ruling on the International Emergency Economic Powers Act (IEEPA) and its implications for tariffs imposed by the Trump Administration.

What You Need To Know About the SEC’s Enforcement Manual Update

Wed, 04 Mar 2026 00:00:00 -0600

On February 24, 2026, the U.S. Securities and Exchange Commission’s (SEC or Commission) Division of Enforcement (Division or Enforcement) announced updates to its Enforcement Manual (Manual), last revised in 2017.

China Life Sciences: 2025 Year in Review

Wed, 04 Mar 2026 00:00:00 -0600

2025 was a year of notable developments for China’s life sciences industry, marked by significant revisions to major legislation and regulations. Heightened regulatory scrutiny across all sectors — from anti-corruption to medical insurance fraud — led to intensified enforcement action at all levels, accompanied by the introduction of new enforcement priorities and adoption of novel regulatory approaches.

New Date: Arnold & Porter’s 2026 Life Sciences Future Forum