[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Page 31549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11176]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1120]


Certain Human Milk Oligosaccharides and Methods of Producing the 
Same; Notice of Commission Final Determination Finding a Violation of 
Section 337; Issuance of a Limited Exclusion Order; Termination of the 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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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.

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, DC 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.

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 FR 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''). 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.
    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.
    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 FR 49335 (Sept. 19, 2019).
    On January 30, 2020, the Commission issued a notice determining to 
review the FID in part. See 85 FR 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.
    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.
    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 Presidential review at five (5) percent of the entered value 
of Jennewein's infringing products (19 U.S.C. 1337(j)).
    The Commission's order and opinion were delivered to the President 
and to the United States Trade Representative on the day of their 
issuance.
    The Commission's vote for these determinations took place on May 
19, 2020.
    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).

    By order of the Commission.

    Issued: May 19, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-11176 Filed 5-22-20; 8:45 am]
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