USITC Rescinds Limited Exclusion Order on Human Milk Oligosaccharides
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The U.S. International Trade Commission (USITC) has ended a limited exclusion order that barred some human milk oligosaccharides (HMOs) from entering the United States. The decision follows a settlement between the parties involved.
The case began on June 21, 2018, when Glycosyn LLC of Waltham, Massachusetts, filed a complaint. Glycosyn said that certain imports from Jennewein Biotechnologie GmbH (now Chr. Hansen HMO GmbH) infringed on their patents. These patents, U.S. Patent Nos. 9,453,230 and 9,970,018, deal with HMOs and how to make them.
The USITC investigated the case and issued a limited exclusion order on May 19, 2020. This order stopped the unlicensed import of some HMOs made with bacterial strains found to infringe Glycosyn’s patent. The order stopped Jennewein Biotechnologie GmbH from importing these HMOs into the U.S. The Federal Circuit Court affirmed this decision in September 2021.
On June 6, 2025, Glycosyn filed a petition to rescind, or reverse, the order. They explained that they had reached a settlement with Jennewein Biotechnologie GmbH. The petition was unopposed; no responses were filed against it.
The USITC found that the reasons for the limited exclusion order no longer exist now that Glycosyn and Jennewein have settled. The Commission decided to start a rescission proceeding and then rescinded the order. This action was taken under section 337(k) of the Tariff Act of 1930 and Commission Rule 210.76(a).
The action terminates the rescission proceeding and officially lifts the ban. The Commission notified the Secretary of the Treasury about its decision on July 7, 2025.
The legal authority for these decisions comes from section 337 of the Tariff Act of 1930, as amended, and from Part 210 of the USITC’s Rules of Practice and Procedure. The vote for the decision took place on July 7, 2025.
For more information, documents related to this investigation can be found through the USITC’s electronic docket. General details about the Commission are online at www.usitc.gov.
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