Prototype Enough: Even More Expansion to the ITC Domestic Industry Framework

CAFC, IPR, ITC, Patent

by Dennis Crouch

The Federal Circuit recently affirmed the US International Trade Commission's (ITC) limited exclusion order barring importation of certain Apple Watch models, bringing to a close (at least on this front) one chapter of the sprawling patent war between Masimo and Apple over blood oxygen measurement technology in wearable devices. Apple Inc. v. ITC, No. 24-1285 (Fed. Cir. Mar. 19, 2026).

The Federal Circuit's decision rejected every argument Apple raised on appeal - with the most interesting issues focused on (1) the domestic industry requirement and (2) prosecution laches.

The ITC's Domestic Industry Requirement: Section 337 of the Tariff Act makes it unlawful to import articles that infringe a valid U.S. patent, but the agency can take action only if "an industry in the United States, relating to the articles protected by the patent . . . exists or is in the process of being established." 19 U.S.C. § 1337(a)(2). This domestic industry requirement has two prongs. The "technical prong" asks whether an actual article exists that practices at least one claim of the asserted patent. The "economic prong" asks whether there is significant domestic investment in that article through plant and equipment, labor or capital, or research and development. Both prongs must be satisfied as of the date the complaint is filed. The requirement reflects the reality that the ITC is designed particularly to protect US industry against unfair foreign competition, not to serve as a general patent court.

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No Do-Overs: Federal Circuit Blocks Dismiss-and-Refile Tactic to Restart ITC Stay Deadline

ITC, Patent

by Dennis Crouch

Voluntary dismissal: Under Rule 41(a), a plaintiff can walk away from a lawsuit before the defendant answers or moves for summary judgment, no questions asked, no permission required. The tactic gets used strategically all the time: to avoid an unfavorable ruling, to refile in a better forum, etc. Courts have generally tolerated this practice, recognizing that voluntary dismissals serve important functions in managing litigation. But, there has always been some concern about strategic over-use.  In Ascendis Pharma A/S v. BioMarin Pharmaceutical Inc., No. 26-1026 (Fed. Cir. Mar. 26, 2026), the Federal Circuit drew a line, holding that a party cannot use voluntary dismissal to restart a statutory deadline it already missed. The court affirmed the district court's denial of a mandatory stay under 28 U.S.C. § 1659(a)(2), holding that Ascendis's dismiss-and-refile maneuver could not revive the 30-day window for requesting that the district court halt proceedings pending a parallel ITC investigation.

The case arises from a pharmaceutical patent dispute between two drug manufacturers developing treatments for achondroplasia (ACH), a genetic condition that causes short-limbed dwarfism. BioMarin sells Voxzogo, an FDA-approved ACH treatment covered by U.S. Patent No. RE48,267. Ascendis filed a New Drug Application for its competing product, TransCon CNP, on March 31, 2025. The very next day, BioMarin filed a complaint with the U.S. International Trade Commission alleging that Ascendis's importation of TransCon CNP infringed the '267 patent. Ten days later, on April 11, 2025, Ascendis filed a declaratory judgment action in the Northern District of California seeking a declaration of non-infringement with the argument that its imports were within the 35 U.S.C. § 271(e)(1) safe harbor - i.e., for reasons directly related to obtaining FDA approval.

This setup with parallel ITC and district court proceedings sets up a discussion of the mandatory stay provision of 28 U.S.C. § 1659(a).  That section provides that the district court shall stay proceedings with respect to any claim involving the same issues, at the request of a party that is also a respondent in the ITC proceeding.  But, the stay mandate is only required if requested within 30 days after the district court action is filed.

In our case, Ascendis had waited more than 30 days to request a stay - it then voluntarily dismissed its DJ action without prejudice and immediately refiled a nearly identical complaint the same day for the express purposes of resetting the clock.  Apparently Ascendis realized the DJ action created a problem: once the FDA approved the drug, BioMarin could use the pending district court case as a vehicle to seek a preliminary injunction. A mandatory stay under § 1659 would protect against that occurrence.

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Forthwith, Part II: CIT Orders Refunds for All Importers, Not Just Litigants

CAFC, ITC, Patent

by Dennis Crouch

Two weeks after the Supreme Court declared the IEEPA tariffs illegal, and two days after the Federal Circuit issued its mandates returning the case to the trial court, U.S. Customs and Border Protection was still liquidating import entries with the unlawful duties baked in. No refunds had been issued. White House controlled CBP Automated Commercial Environment system kept churning through previously filed entries as if Learning Resources, Inc. v. Trump, 607 U.S. ___ (2026), had never happened.

In Atmus Filtration, Inc. v. United States (Ct. Int’l Trade Mar. 4, 2026), Judge Richard Eaton issued an order that goes well beyond the individual case before him. Eaton declared that “all importers of record whose entries were subject to IEEPA duties are entitled to the benefit of the Learning Resources decision” and directed CBP to liquidate all unliquidated entries “without regard to the IEEPA duties.” For entries already liquidated but not yet final, CBP must reliquidate on the same terms. The order applies regardless of whether an importer has filed its own complaint. To hold otherwise, Judge Eaton wrote, “would be to thwart the efficient administration of justice and to deny those importers who have filed suit the efficient resolution of their claims, and to deny entirely importers who have not filed suit the benefit of the Learning Resources decision.” The CIT’s Chief Judge has designated Eaton as the sole judge for all IEEPA refund cases, and Eaton has scheduled a closed conference for March 6 at which the government must present a plan for administering refunds without requiring each of the thousands of affected importers to file individual complaints. (more…)

Guest Post: Design Patents at the ITC

Design Patent, ITC, Patent

By Sarah Fackrell, Professor of Law at Chicago-Kent College of Law

In the Matter of Certain Cameras, Camera Systems, and Accessories Used Therewith, No. 337-TA-1400 (ITC 2026).

Last week, the ITC issued a limited exclusion order in a dispute between GoPro, Inc. and Arashi Vision, Inc. (d/b/a Insta360). The order covered “certain cameras and camera systems” which, in the Commission’s view, infringed U.S. Patent No. D789,435.  In reaching this conclusion, the ITC appears to be requiring a much lower standard of visual similarity than the Federal Circuit does.

In deciding that the D’435 patent was infringed, the Commission affirmed—without  further discussion—the finding of infringement in the Initial Determination that was issued by ALJ Doris Johnson Hines on July 10, 2025. In that decision, Judge Hines seems to have been persuaded to not only require a lower overall level of similarity than the Federal Circuit currently requires, but to also effectively ignore several claimed design elements, disregarding them as visually “minor,” “trivial,” or otherwise unimportant.

It is true that there is a longstanding line of Federal Circuit cases saying that “minor differences between a patented design and an accused article’s design cannot, and shall not, prevent a finding of infringement.” See Litton Sys., Inc. v. Whirlpool Corp., 728 F.2d 1423, 1444 (Fed. Cir. 1984). But that doesn’t—and shouldn’t—mean that a judge (or a jury) can completely read claimed visual elements out of a design patent claim. (For more on how I’m using the word “element” here, see Intelligent Design & Egyptian Goddess, 68 Duke L.J. Online 94, 109 (2019)).

For example, consider this image (from GoPro’s expert report) that Judge Hines included in her decision:

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