Office of the Secretary
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`June 2, 2020
`
`Michael C. Newman, Esq.
`Mintz Levin Cohn Ferris Glovsky and Popeo, PC
`1 Financial Center
`
`Boston, MA 02111
`
`Re:
`
`Exclusion Order in Certain Human Milk Oligosaccharides and Methods of Producing the Same,
`Inv. No. 337-TA-1120
`
`Dear Mr. Newman:
`
`On May 19, 2020, the Commission, having found a violation of Section 337 of the Tariff Act of
`1930, as amended, 19 U.S.C. 1337, in the above-referenced investigation, issued a limited exclusion order.
`The exclusion order directs U.S. Customs and Border Protection to exclude certain human milk
`
`oligosaccharides and methods of producing the same from entry into the United States while U.S. Patent
`No. 9,970,018 remains in force. A copy of the order is attached to this letter.
`
`Should the Complainant, Glycosyn LLC, have questions about the administration of this order, it
`may contact the Intellectual Property Rights Branch of U.S. Customs and Border Protection at (202) 325-
`0020. Although Customs will be administering the exclusion order, you may also contact Megan
`Valentine, the Commission’s Assistant General Counsel for Section 337 investigations, at (202) 708-2301,
`if you have questions pertaining to the exclusion order.
`
`Since FY 2000, the Commission has conducted four surveys of exclusion order holders to help
`assess the effectiveness of such orders, and the Commission anticipates conducting another such survey in
`the future. To facilitate fiJture communications with Complainant about the anticipated survey, the
`Commission requests that Complainant identify a person at Glycosyn LLC with knowledge of the order
`who may be contacted in the future regarding the survey.
`It would be particularly helpful if Complainant
`would provide an email address, along with a name and mailing address, for this contact. The requested
`contact information may be emailed to secretary@usitc.gov or provided by mail to the undersigned.
`
`Sincerely,
`
`Lisa R. Barton
`
`Secretary to the Commission
`
`Enclosure
`
`
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, DC 20436
`
`June 2, 2020
`
`Michael C. Newman, Esq.
`Mintz Levin Cohn Ferris Glovsky and Popeo, PC
`1 Financial Center
`
`Boston, MA 02111
`
`Re:
`
`Exclusion Order in Certain Human Milk Oligosaccharides and Methods of Producing the Same,
`Inv. No. 337-TA-1120
`
`Dear Mr. Newman:
`
`On May 19, 2020, the Commission, having found a violation of Section 337 of the Tariff Act of
`1930, as amended, 19 U.S.C. 1337, in the above-referenced investigation, issued a limited exclusion order.
`The exclusion order directs U.S. Customs and Border Protection to exclude certain human milk
`
`oligosaccharides and methods of producing the same from entry into the United States while U.S. Patent
`No. 9,970,018 remains in force. A copy of the order is attached to this letter.
`
`Should the Complainant, Glycosyn LLC, have questions about the administration of this order, it
`may contact the Intellectual Property Rights Branch of U.S. Customs and Border Protection at (202) 325-
`0020. Although Customs will be administering the exclusion order, you may also contact Megan
`Valentine, the Commission’s Assistant General Counsel for Section 337 investigations, at (202) 708-2301,
`if you have questions pertaining to the exclusion order.
`
`Since FY 2000, the Commission has conducted four surveys of exclusion order holders to help
`assess the effectiveness of such orders, and the Commission anticipates conducting another such survey in
`the future. To facilitate fiJture communications with Complainant about the anticipated survey, the
`Commission requests that Complainant identify a person at Glycosyn LLC with knowledge of the order
`who may be contacted in the future regarding the survey.
`It would be particularly helpful if Complainant
`would provide an email address, along with a name and mailing address, for this contact. The requested
`contact information may be emailed to secretary@usitc.gov or provided by mail to the undersigned.
`
`Sincerely,
`
`Lisa R. Barton
`
`Secretary to the Commission
`
`Enclosure
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS
`
`OF PRODUCING THE SAME
`
`
`
`Investigation No. 337-TA-1120
`
`LIMITED EXCLUSION ORDER
`
`The United States International Trade Commission (“Commission”) has determined that
`
`there is a Violation of Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), in
`
`the unlawful importation, sale for importation, or sale within the United States after importation
`
`by Jennewein Biotechnologie GmbH (“Jennewein” or “Respondent”) of certain 2’-fi.1cosyllactose
`
`oligosaccharides that infringe one or more of claims 1-3, 5, 8, 10, 12, 18, and 24-28 (“the
`
`Asserted Claims”) of US. Patent No. 9,970,018 (“the ’018 patent”).
`
`Having reviewed the record of this investigation, including the written submissions of the
`
`parties, the Commission has made its determination on the issues of remedy, public interest, and
`
`bonding. The Commission has determined that the appropriate form of relief includes a limited
`
`exclusion order prohibiting the unlicensed entry into the United States of 2’-fucosyllactose
`
`oligosaccharides manufactured abroad by or on behalf of, or imported by or on behalf of, Respondent
`
`or any of its affiliated companies, parents, subsidiaries, or other related business entities, or its
`
`successors or assigns. The exclusion order does not apply to Respondent’s TTFL12 bacterial
`
`strain and 2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
`
`determined, do not infringe the Asserted Claims.
`
`The Commission has also determined that the public interest factors enumerated in 19
`
`U.S.C. § 1337(d) do not preclude the issuance of the limited exclusion order, and that the bond
`
`
`
`during the period of Presidential review shall be in the amount of five (5) percent of the entered
`
`value of the covered articles.
`
`Accordingly, the Commission hereby ORDERS that:
`
`1.
`
`2’-fucosyllactose oligosaccharides that infringe one or more of the Asserted
`
`Claims that are manufactured abroad by or on behalf of, or imported by or on behalf of,
`
`Respondent, or its affiliated companies, parents, subsidiaries, or other related business entities, or
`
`its successors or assigns (“covered articles”), are excluded from entry for consumption into the
`
`United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse
`
`for consumption, for the remaining term of the ’018 patent, except under license of the patent
`
`owner or as provided by law.
`
`2.
`
`This Order does not apply to Respondent’s TTFL12 bacterial strain and
`
`2’-fucosyllactose oligosaccharides produced by that strain, which, as the Commission
`
`determined, do not infringe the Asserted Claims.
`
`3.
`
`Notwithstanding paragraph 1 of this Order, covered articles are entitled to entry
`
`into the United States for consumption, entry for consumption from a foreign trade zone, or
`
`withdrawal from a warehouse for consumption, under bond in the amount of five (5) percent of
`
`the entered value of the infringing products pursuant to subsection (1) of section 337 of the Tariff
`
`Act of 1930, as amended (19 U.S.C. § 13370)), and the Presidential Memorandum for the United
`
`States Trade Representative of July 21, 2005, (70 FR 43251), from the day after this Order is
`
`received by the United States Trade Representative, and until such time as the United States
`
`Trade representative notifies the Commission that this Order is approved or disapproved but, in
`
`any event, not later than sixty (60) days after the date of receipt of this Order. All entries of
`
`
`
`covered articles made pursuant to this paragraph are to be reported to US. Customs and Border
`
`Protection (“CBP”), in advance of the date of the entry, pursuant to procedures CBP establishes.
`
`4.
`
`At the discretion of CBP and pursuant to the procedures it establishes, persons
`
`seeking to import 2’-fucosy11actose oligosaccharides, that are potentially subject to this Order may
`
`be required to certify that they are familiar with the terms of this Order, that they have made
`
`appropriate inquiry, and thereupon state that, to the best of their knowledge and belief, the
`
`products being imported are not excluded from entry under paragraph 1 of this Order. At its
`
`discretion, CBP may require persons who have provided the certification described in this
`
`paragraph to furnish such records or analyses as are necessary to substantiate this certification.
`
`5.
`
`In accordance with 19 U.S.C. § 1337(1), the provisions of this Order shall not
`
`apply to 2’-fucosyllactose oligosaccharides that are imported by or for the use of the United
`
`States, or imported for and to be used for, the United States with the authorization or consent of
`
`the Government.
`
`6.
`
`The Commission may modify this Order in accordance with the procedures
`
`described in Rule 210.76 of the Commission’s Rules of Practice and Procedure (19 C.F.R.
`
`§ 210.76).
`
`7.
`
`The Secretary shall serve copies of this Order upon each party of record in this
`
`Investigation and upon CBP.
`
`8.
`
`Notice of this Order shall be published in the Federal Register.
`
`
`
`By order of the Commission.
`
`Issued: May 19, 2020
`
`fiflfi
`
`Lisa R. Barton
`
`Secretary to the Commission
`
`
`
`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`
`Inv. No. 337-TA-1120
`
`METHODS OF PRODUCING THE SAME
`
`PUBLIC CERTIFICATE OF SERVICE
`
`1, 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.
`
`Lisa R. Barton, Secretary
`US. International Trade Commission
`
`500 E Street, SW, Room 112
`Washington, DC 20436
`
`On Behalf of Complainant Glycosyn LLC:
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY AND POPEO, PC
`1 Financial Center
`Erfdfir'lMB/glqgihiain@mintz com
`
`'
`
`'
`
`On Behalf of Resyondent Jennewein Biotechnologie GmbH:
`
`Gary M. Hnath
`MAYER BROWN LLP
`1999 K Street, NW
`Washington, DC 20006
`Email: ghnath@mayerbrown.com
`
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