UNITED STATES INTERNATIONAL TRADE COMMISSION
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`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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`NOTICE OF COMMISSION FINAL DETERMINATION FINDING
`A VIOLATION OF SECTION 337; ISSUANCE OF A LIMITED EXCLUSION
`ORDER; TERMINATION OF THE INVESTIGATION
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` U.S. International Trade Commission.
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`Notice.
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`AGENCY:
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`ACTION:
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`SUMMARY: Notice is hereby given that the U.S. International Trade Commission has found a
`violation of section 337 of the Tariff Act of 1930 (“section 337”), as amended, in this
`investigation. The Commission has issued a limited exclusion order (“LEO”) prohibiting the
`importation by respondent Jennewein Biotechnologie GmbH (“Jennewein”) of Rheinbreitbach,
`Germany of certain human milk oligosaccharides that infringe complainant’s asserted claims.
`The investigation is terminated.
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`FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General
`Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436,
`telephone (202) 708-4716. Copies of non-confidential documents filed in connection with this
`investigation are or will be available for inspection during official business hours (8:45 a.m. to
`5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street
`SW., Washington, D.C. 20436, telephone (202) 205-2000. General information concerning the
`Commission may also be obtained by accessing its Internet server at https://www.usitc.gov. The
`public record for this investigation may be viewed on the Commission’s electronic docket
`(EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this
`matter can be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
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`SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on June
`21, 2018, based on a complaint, as amended and supplemented, filed on behalf of Glycosyn LLC
`of Waltham, Massachusetts (“Glycosyn”). See 83 Fed. Reg. 28865 (June 21, 2018). The
`complaint, as amended and supplemented, alleges violations of section 337 of the Tariff Act of
`1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United
`States, the sale for importation, and the sale within the United States after importation of certain
`human milk oligosaccharides by reason of infringement of claims 1-40 of U.S. Patent No.
`9,453,230 (“the ’230 patent”) and claims 1-28 of U.S. Patent No. 9,970,018 (“the ’018 patent”).
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`See id. The notice of investigation named Jennewein as a respondent in this investigation. See
`id. The Office of Unfair Import Investigations (“OUII”) is also named as a party to the
`investigation. See id.
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`The ALJ conducted an evidentiary hearing on May 14-17, 2019, and on September 9,
`2019, issued the FID finding a violation of section 337 based on the infringement of claims 1-3,
`5, 8, 10, 12, 18, and 24-28 of the ’018 patent (hereinafter, the “Asserted Claims”). In addition,
`the FID finds that the Asserted Claims are neither invalid under 35 U.S.C. §§ 103 and 112, nor
`unenforceable for inequitable conduct. Furthermore, the FID finds that the domestic industry
`requirement is satisfied. All asserted claims in the ’230 patent were withdrawn during the
`investigation. The FID also contains a recommended determination (“RD”) recommending that
`the Commission issue an LEO barring entry of articles that infringe the ’018 patent. The RD
`also recommends that the Commission impose a 5 percent bond during the period of Presidential
`review. Furthermore, as directed by the Commission, the RD provides findings with respect to
`the public interest and recommends that the Commission determine that the public interest
`factors do not preclude entry of the proposed LEO. Glycosyn does not seek and the RD does not
`recommend issuance of a cease and desist order.
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`On October 9 and 10, 2019, respectively, Glycosyn and Jennewein filed statements on the
`public interest pursuant to Commission Rule 210.50. On October 23, 2019, non-party DuPont
`Nutrition & Health filed a public interest submission pursuant to the Commission’s notice
`requesting public interest comments. See 84 Fed. Reg. 49335 (Sept. 19, 2019).
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`On January 30, 2020, the Commission issued a notice determining to review the FID in
`part. See 85 Fed. Reg. 6573 (Feb. 5, 2020). The Commission’s notice requested written
`submissions in response to certain questions relating to issues under review and on issues of
`remedy, the public interest, and bonding. On February 18, 2020, the parties, including OUII,
`filed written submissions in response to the notice, and on February 25, 2020, the parties filed
`responses to each other’s submissions. On February 18, 2020, non-party Abbott Laboratories
`filed a written submission concerning the public interest.
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`Having examined the record of this investigation, including the FID, the RD, and the
`parties’ and non-parties’ submissions, the Commission has determined to affirm with
`modification the FID’s determination of a violation of section 337 with respect to claims 1-3, 5,
`8, 10, 12, 18, and 24-28 of the ’018 patent. Specifically, as explained in the Commission
`Opinion filed concurrently herewith, the Commission has determined to affirm with modification
`the FID’s findings with respect to infringement by the accused Jennewein bacterial strains and to
`reverse the FID’s decision not to adjudicate infringement with respect to Jennewein’s TTFL12
`bacterial strain. As to the TTFL12 strain, the Commission has determined that it does not
`infringe the Asserted Claims. All findings in the FID that are not inconsistent with the
`Commission’s determination are affirmed.
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`The Commission has determined that the appropriate remedy is an LEO against
`Jennewein’s infringing products. The Commission has also determined that the public interest
`factors enumerated in subsection 337(d)(1) (19 U.S.C. 1337(d)(1)) do not preclude the issuance
`of the LEO. The Commission has further determined to set a bond during the period of
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`Presidential review at five (5) percent of the entered value of Jennewein’s infringing products
`(19 U.S.C. 1337(j)).
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`The Commission’s order and opinion were delivered to the President and to the United
`States Trade Representative on the day of their issuance.
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`The Commission’s vote for these determinations took place on May 19, 2020.
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`The authority for the Commission’s determination is contained in section 337 of the
`Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of
`Practice and Procedure (19 CFR part 210).
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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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`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
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`PUBLIC CERTIFICATE OF SERVICE
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`I, Lisa R. Barton, hereby certify that the attached NOTICE 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
`
`