`Washington, D.C.
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`In the Matter of
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`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`OF PRODUCING THE SAME
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`Investigation No. 337-TA-1120
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`LIMITED EXCLUSION ORDER
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`The United States International Trade Commission (“Commission”) has determined that
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`there is a violation of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), in
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`the unlawful importation, sale for importation, or sale within the United States after importation
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`by Jennewein Biotechnologie GmbH (“Jennewein” or “Respondent”) of certain 2’-fucosyllactose
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`oligosaccharides that infringe one or more of claims 1-3, 5, 8, 10, 12, 18, and 24-28 (“the
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`Asserted Claims”) of U.S. Patent No. 9,970,018 (“the ’018 patent”).
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`Having reviewed the record of this investigation, including the written submissions of the
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`parties, the Commission has made its determination on the issues of remedy, public interest, and
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`bonding. The Commission has determined that the appropriate form of relief includes a limited
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`exclusion order prohibiting the unlicensed entry into the United States of 2’-fucosyllactose
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`oligosaccharides manufactured abroad by or on behalf of, or imported by or on behalf of, Respondent
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`or any of its affiliated companies, parents, subsidiaries, or other related business entities, or its
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`successors or assigns. The exclusion order does not apply to Respondent’s TTFL12 bacterial
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`strain and 2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
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`determined, do not infringe the Asserted Claims.
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`The Commission has also determined that the public interest factors enumerated in 19
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`U.S.C. § 1337(d) do not preclude the issuance of the limited exclusion order, and that the bond
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`1
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`during the period of Presidential review shall be in the amount of five (5) percent of the entered
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`value of the covered articles.
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`Accordingly, the Commission hereby ORDERS that:
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`1.
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`2’-fucosyllactose oligosaccharides that infringe one or more of the Asserted
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`Claims that are manufactured abroad by or on behalf of, or imported by or on behalf of,
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`Respondent, or its affiliated companies, parents, subsidiaries, or other related business entities, or
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`its successors or assigns (“covered articles”), are excluded from entry for consumption into the
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`United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse
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`for consumption, for the remaining term of the ’018 patent, except under license of the patent
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`owner or as provided by law.
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`2.
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`This Order does not apply to Respondent’s TTFL12 bacterial strain and
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`2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
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`determined, do not infringe the Asserted Claims.
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`3.
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`Notwithstanding paragraph 1 of this Order, covered articles are entitled to entry
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`into the United States for consumption, entry for consumption from a foreign trade zone, or
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`withdrawal from a warehouse for consumption, under bond in the amount of five (5) percent of
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`the entered value of the infringing products pursuant to subsection (j) of section 337 of the Tariff
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`Act of 1930, as amended (19 U.S.C. § 1337(j)), and the Presidential Memorandum for the United
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`States Trade Representative of July 21, 2005, (70 FR 43251), from the day after this Order is
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`received by the United States Trade Representative, and until such time as the United States
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`Trade representative notifies the Commission that this Order is approved or disapproved but, in
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`any event, not later than sixty (60) days after the date of receipt of this Order. All entries of
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`2
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`covered articles made pursuant to this paragraph are to be reported to U.S. Customs and Border
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`Protection (“CBP”), in advance of the date of the entry, pursuant to procedures CBP establishes.
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`4.
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`At the discretion of CBP and pursuant to the procedures it establishes, persons
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`seeking to import 2’-fucosyllactose oligosaccharides, that are potentially subject to this Order may
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`be required to certify that they are familiar with the terms of this Order, that they have made
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`appropriate inquiry, and thereupon state that, to the best of their knowledge and belief, the
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`products being imported are not excluded from entry under paragraph 1 of this Order. At its
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`discretion, CBP may require persons who have provided the certification described in this
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`paragraph to furnish such records or analyses as are necessary to substantiate this certification.
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`5.
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`In accordance with 19 U.S.C. § 1337(l), the provisions of this Order shall not
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`apply to 2’-fucosyllactose oligosaccharides that are imported by or for the use of the United
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`States, or imported for and to be used for, the United States with the authorization or consent of
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`the Government.
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`6.
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`The Commission may modify this Order in accordance with the procedures
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`described in Rule 210.76 of the Commission’s Rules of Practice and Procedure (19 C.F.R.
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`§ 210.76).
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`7.
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`The Secretary shall serve copies of this Order upon each party of record in this
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`Investigation and upon CBP.
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`8.
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`Notice of this Order shall be published in the Federal Register.
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`3
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`By order of the Commission.
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`Issued: May 19, 2020
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`Lisa R. Barton
`Secretary to the Commission
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`4
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`
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`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`PUBLIC CERTIFICATE OF SERVICE
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`I, Lisa R. Barton, hereby certify that the attached ORDER, COMMISION has been
`served via EDIS upon the Commission Investigative Attorney, Lisa Murray, Esq., and the
`following parties as indicated, on May 19, 2020.
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`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
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`On Behalf of Complainant Glycosyn LLC:
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`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Boston, MA 02111
`Email: MCNewman@mintz.com
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
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`On Behalf of Respondent Jennewein Biotechnologie GmbH:
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`Gary M. Hnath
`MAYER BROWN LLP
`1999 K Street, NW
`Washington, DC 20006
`Email: ghnath@mayerbrown.com
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability to Download
`
`