[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6573-6575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02178]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1120]


Certain Human Milk Oligosaccharides and Methods of Producing the 
Same; Commission Decision To Review in Part a Final Initial 
Determination Finding a Violation of Section 337; Schedule for Filing 
Written Submissions on the Issues Under Review and on Remedy, the 
Public Interest, and Bonding

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 determined to review in part a final initial 
determination (``FID'') of the presiding administrative law judge 
(``ALJ'') finding a violation of section 337 of the Tariff Act of 1930, 
as amended. The Commission requests briefing from the parties on 
certain issues under review, as set forth in this notice. The 
Commission also requests briefing from the parties, interested persons, 
and government agencies on the issues of remedy, the public interest, 
and bonding.

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

[[Page 6574]]

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 Biotechnologie GmbH (``Jennewein'') of 
Rheinbreitbach, Germany 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.
    On August 9, 2018, the ALJ partially terminated the investigation 
as to claims 4-7, 9-12, 14, 23-26, 28-31, 33, and 39-40 of the '230 
patent and claims 6, 7, 9, 11, 13-17, 19, and 22 of the '018 patent 
based on the withdrawal of the allegations pertaining to those claims. 
See Order No. 5 (Aug. 9, 2018), unreviewed, Comm'n Notice (Aug. 29, 
2018). On October 30, 2018, the ALJ partially terminated the 
investigation as to claims 1-3, 8, 13, and 15-20 of the '230 patent 
based on the withdrawal of the allegations pertaining to those claims. 
See Order No. 15 (Oct. 30, 2018), unreviewed, Comm'n Notice (Nov. 29, 
2018). On November 19, 2018, the ALJ partially terminated the 
investigation as to claim 27 of the '230 patent and claims 4, 20, and 
21 of the '018 patent based on the withdrawal of the allegations 
pertaining to those claims. See Order No. 17 (Nov. 19, 2018), 
unreviewed, Comm'n Notice (Dec. 12, 2018). On February 8, 2018, the ALJ 
partially terminated the investigation as to claims 21, 22, 32, and 34-
38 of the '230 patent based on the withdrawal of the allegations 
pertaining to those claims. See Order No. 25 (Feb. 8, 2019), 
unreviewed, Comm'n Notice (Feb. 28, 2019). Claims 1-3, 5, 8, 10, 12, 
18, and 23-28 of the '018 patent remain pending in this investigation.
    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. 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. The FID also contains a recommended 
determination (``RD'') recommending that the Commission issue a limited 
exclusion order (``LEO'') barring entry of articles that infringe the 
'018 patent. The RD also recommends that the Commission impose a 5% 
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 LEO.
    On September 23, 2019, Jennewein and OUII filed petitions for 
review of the FID. On October 1, 2019, Glycosyn and OUII filed 
responses to Jennewein's and the IA's petitions.
    Having examined the record of this investigation, including the 
FID, the RD, and the parties' submissions, the Commission has 
determined to review the FID in part. Specifically, the Commission has 
determined to review the FID's infringement findings with respect to 
Jennewein's bacterial strains adjudicated in this investigation. In 
addition, the Commission has determined to review the FID's decision 
not to adjudicate infringement as to Jennewein's alternative bacterial 
strain, the TTFL12 strain. The Commission has determined not to review 
the remainder of the FID.
    In connection with its review, the Commission requests written 
responses regarding the following inquiries:
    1. Assuming that the Commission determines to adjudicate 
infringement with respect to Jennewein's TTFL12 bacterial strain, 
please provide your position, with support from the evidentiary record, 
as to whether the TTFL12 strain infringes or does not infringe the 
asserted patent claims.
    2. Should the Commission adjudicate infringement with respect to 
Jennwein's alternative strain? Is the Commission's determination of 
whether to adjudicate an alternative or redesigned product a legal 
question, a factual question, a mixed question of law or fact, an 
exercise of discretion, or something else?
    3. Is the TTFL12 strain within the scope of the investigation? What 
criteria and evidence normally informs this analysis?
    4. Does a respondent need to import an alternative or redesigned 
product for the product to be adjudicated?
    5. What evidence corroborates Jennewein's assertion that the 
products listed in the shipping documents (RX-278C and RX-280C) were 
produced with the TTFL12 strain? Please provide your answers in a table 
with citations in one column and a brief explanation in a second 
column.
    6. What is the effect of Jennewein's responses to Glycosyn's 
request for admission? Why has Jennewein failed to amend its responses 
if they are incorrect or misleading?
    7. Is the TTFL12 strain sufficiently fixed in design? What criteria 
and evidence normally informs this analysis? Is there any declaratory 
judgment precedent that is relevant? Which party bears the burden of 
showing that an alternative or redesigned product is fixed in design?
    8. Has the TTFL12 strain been subject to sufficient discovery? What 
criteria and evidence normally informs the ``sufficient discovery'' 
analysis?
    9. Should the Commission issue remedial orders that are directed to 
the adjudicated strains (the #1540 and #1540 derivative) at this 
juncture?
    Responses to the above questions should not exceed 40 pages, and 
replies should not exceed 20 pages.
    In addition, in connection with the final disposition of this 
investigation, the statute authorizes issuance of (1) an order that 
could result in the exclusion of the subject articles from entry into 
the United States, and/or (2) a cease and desist order that could 
result in the respondent being required to cease and desist from 
engaging in unfair acts in the importation and sale of such articles. 
Accordingly, the Commission is interested in receiving written 
submissions that address the form of remedy, if any, that should be 
ordered. If a party seeks exclusion of an article from entry into the 
United States for purposes other than entry for consumption, the party 
should so indicate and provide information establishing that activities 
involving other types of entry either are adversely affecting it or 
likely to do so. For background, see Certain Devices for Connecting 
Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 
2843, Comm'n Op. at 7-10 (Dec. 1994).
    The statute requires the Commission to consider the effects of any 
remedy upon the public interest. The public interest factors the 
Commission will consider include the effect that an exclusion order 
and/or cease and desist orders would have on (1) the public

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health and welfare, (2) competitive conditions in the U.S. economy, (3) 
U.S. production of articles that are like or directly competitive with 
those that are subject to investigation, and (4) U.S. consumers. The 
Commission is therefore interested in receiving written submissions 
that address the aforementioned public interest factors in the context 
of this investigation.
    If the Commission orders some form of remedy, the U.S. Trade 
Representative, as delegated by the President, has 60 days to approve, 
disapprove, or take no action on the Commission's determination. See 
Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). 
During this period, the subject articles would be entitled to enter the 
United States under bond, in an amount determined by the Commission and 
prescribed by the Secretary of the Treasury. The Commission is 
therefore interested in receiving submissions concerning the amount of 
the bond that should be imposed if a remedy is ordered.
    Written Submissions: The parties to the investigation are requested 
to file written submissions limited to the briefing questions above. 
Parties to the investigation, interested government agencies, and any 
other interested parties are encouraged to file written submissions on 
the issues of remedy, the public interest, and bonding. Such initial 
written submissions should include views on the recommended 
determination by the ALJ on remedy, the public interest, and bonding. 
Complainant and the Commission Investigative Attorney are also 
requested to identify the form of remedy sought and to submit proposed 
remedial orders for the Commission's consideration in their initial 
written submissions. Complainant is further requested to state the date 
that the asserted patent expires and the HTSUS numbers under which the 
accused products are imported, and to supply the names of known 
importers of the products at issue in this investigation.
    Initial written submissions and proposed remedial orders must be 
filed no later than close of business on February 18, 2020. Reply 
submissions must be filed no later than the close of business on 
February 25, 2020 and must be limited to issues raised in the initial 
written submissions. No further submissions on any of these issues will 
be permitted unless otherwise ordered by the Commission.
    Persons filing written submissions must file the original document 
electronically on or before the deadlines stated above and submit eight 
(8) true paper copies to the Office of the Secretary by noon the next 
day pursuant to section 210.4(f) of the Commission's Rules of Practice 
and Procedure (19 CFR 210.4(f)). Submissions should refer to the 
investigation number (``Inv. No. 337-TA-1120'') in a prominent place on 
the cover page and/or the first page. (See Handbook for Electronic 
Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). Persons with questions regarding 
filing should contact the Secretary (202-205-2000).
    Any person desiring to submit a document to the Commission in 
confidence must request confidential treatment. All such requests 
should be directed to the Secretary to the Commission and must include 
a full statement of the reasons why the Commission should grant such 
treatment. See 19 CFR 201.6. Documents for which confidential treatment 
by the Commission is properly sought will be treated accordingly. All 
information, including confidential business information and documents 
for which confidential treatment is properly sought, submitted to the 
Commission for purposes of this Investigation may be disclosed to and 
used: (i) By the Commission, its employees and Offices, and contract 
personnel (a) for developing or maintaining the records of this or a 
related proceeding, or (b) in internal investigations, audits, reviews, 
and evaluations relating to the programs, personnel, and operations of 
the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. 
government employees and contract personnel,\1\ solely for 
cybersecurity purposes. All non-confidential written submissions will 
be available for public inspection at the Office of the Secretary and 
on EDIS.
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    \1\ All contract personnel will sign appropriate nondisclosure 
agreements.
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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).

    By order of the Commission.

    Issued: January 30, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-02178 Filed 2-4-20; 8:45 am]
BILLING CODE 7020-02-P