[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Notices]
[Pages 45800-45801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16261]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1239]


Certain Gabapentin Immunoassay Kits and Test Strips, Components 
Thereof, and Methods Therefor; Notice of Commission Determination To 
Issue a Limited Exclusion Order Against Defaulting Respondent; 
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 determined to issue a limited exclusion order against 
Kappa City Biotech, SAS of Montlucon, France (``Kappa City''). The 
Commission has also determined to impose a bond equal to one hundred 
(100) percent of the entered value of the infringing products imported 
during the period of Presidential review. The investigation is hereby 
terminated.

FOR FURTHER INFORMATION CONTACT: Lynde Herzbach, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-3228. Copies of non-
confidential documents filed in connection with this investigation may 
be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. General information concerning the Commission may 
also be obtained by accessing its internet server at https://www.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: On January 25, 2021, the Commission 
instituted this investigation under section 337 of the Tariff Act of 
1930, as amended, 19 U.S.C. 1337 (``section 337''), based on a 
complaint filed by ARK Diagnostics, Inc. of Fremont, California 
(``ARK''). See 86 FR 6918-19. The complaint, as supplemented, alleges a 
violation of section 337 based upon the importation into the United 
States, sale for importation, or sale after importation into the United 
States of certain gabapentin immunoassay kits and test strips, 
components thereof, and methods therefor by reason of infringement of 
certain claims of U.S. Patent Nos. 8,828,665 and 10,203,345. Id. The 
complaint further alleges that a domestic industry exists. Id. The 
notice of investigation names fourteen respondents, including Kappa 
City; Healgen Scientific, LLC of Houston, Texas; 12PanelMedical, Inc. 
of Sarasota, Florida; Acro Biotech, Inc. of Rancho Cucamonga, 
California; AlcoPro, Inc. of Knoxville, Tennessee; American Screening, 
LLC of Shreveport, Louisiana; Chemtron Biotech Co., Ltd. of San Diego, 
California; Confirm Biosciences, Inc. of San Diego, California; 
Hangzhou All Test Biotech Co., Ltd. of Hangzhou, China; Mercedes 
Medical, LLC of Lakewood Ranch, Florida; TransMed Co., LLC of 
Alpharetta, Georgia; Transmetron, Inc. of Salt Lake City, Utah; 
Zhejiang Orient Gene Biotech Co., Ltd. of Huzhou, China; and Shanghai 
Chemtron Biotech

[[Page 45801]]

Co., Ltd. of Shanghai, China (``Shanghai Chemtron''). See id. The 
complaint and notice of investigation were later amended to add two 
respondents, 12Panel Now, Inc. and Hospital Connect, Inc., both of 
Boynton Beach, Florida. Order No. 8 (March 9, 2021), unreviewed by 86 
FR 16640-41 (March 30, 2021).
    The Commission previously terminated six respondents based on 
consent orders. Order Nos. 11 and 12 (Mar. 31, 2021), unreviewed by 
Comm'n Notice (Apr. 15, 2021) (TransMed Co., LLC, 12PanelMedical, Inc., 
12Panel Now, Inc., and Hospital Connect, Inc.); Order No. 14 (April 9, 
2021), unreviewed by Comm'n Notice (Apr. 22, 2021) (Mercedes Medical, 
LLC); Order No. 15 (April 12, 2021), unreviewed by Comm'n Notice (May 
12, 2021) (Transmetron Inc.). The Commission also previously terminated 
four respondents based on settlement agreements. Order No. 13 (Apr. 5, 
2021), unreviewed by Comm'n Notice (Apr. 19, 2021) (Confirm 
Biosciences, Inc.); Order No. 17 (May 5, 2021), unreviewed by Comm'n 
Notice (May 18, 2021) (AlcoPro, Inc.); Order No. 18 (May 20, 2021), 
unreviewed by Comm'n Notice (June 21, 2021) (American Screening, LLC); 
Order No. 29 (Jan. 31, 2022), unreviewed by 87 FR 11096-98 (Feb. 28, 
2022) (Shanghai Chemtron). The Commission also terminated five 
respondents based on partial withdrawal of the complaint. Order No. 20 
(June 4, 2021), unreviewed by Comm'n Notice (June 28, 2021) (Chemtron 
Biotech, Inc.); Order No. 21 (June 14, 2021), unreviewed by Comm'n 
Notice (July 1, 2021) (Hangzhou AllTest Biotech Co., Ltd.; Acro 
Biotech, Inc.; Zhejiang Orient Gene Biotech Co, Ltd.; Healgen 
Scientific, LLC).
    On May 18, 2021, the Commission determined not to review an initial 
determination (Order No. 16) finding Kappa City in default. Order No. 
16 (Apr. 30, 2021), unreviewed by Comm'n Notice (May 18, 2021).
    On December 7, 2021, ARK filed a declaration seeking immediate 
entry of a limited exclusion order and cease and desist order against 
Kappa City.
    On February 22, 2022, the Commission determined not to review an 
initial determination granting a motion to terminate Shanghai Chemtron 
based on settlement. See Order No. 29 (Jan. 31, 2022), unreviewed by 87 
FR 11096-98 (Feb. 28, 2022). The Commission concurrently determined 
that ARK's declaration was moot given the termination of the final 
remaining non-defaulting respondent in this investigation. 87 FR at 
11097. The Commission also requested briefing on the issues of remedy, 
bonding, and the public interest. Id.
    On March 8, 2022, ARK filed the sole response to the Commission's 
request for briefing. No replies or other submissions were received.
    Upon review of the record, including ARK's submission, and in the 
absence of any response from Kappa City or from other interested 
persons or government agencies, the Commission has determined to issue 
a limited exclusion order against Kappa City pursuant to section 
337(g)(1). The Commission has determined not to issue a cease and 
desist order against Kappa City, which is a foreign respondent. See, 
e.g., In the Matter of Certain Powered Cover Plates, Inv. No. 337-TA-
1124, Comm'n Op. at 24-28 (July 10, 2020); Certain Earpiece Devices and 
Components Thereof, Inv. No. 337-TA-1121, Comm'n Op. at 42-44 (Nov. 9, 
2019); Certain Electric Skin Care Devices, Brushes and Chargers 
Therefore, and Kits Containing the Same, Inv. No. 337-TA-959, Comm'n 
Op. at 28-33 (Feb. 13, 2017). The Commission has determined that the 
public interest factors do not preclude issuance of the remedial order. 
The Commission has further determined to set a bond in the amount of 
one hundred (100) percent of the entered value of the covered products 
imported during the period of Presidential review (19 U.S.C. 1337(j)). 
The Commission's order was delivered to the President and the United 
States Trade Representative on the day of its issuance. The 
investigation is hereby terminated.
    Commissioners Schmidtlein and Karpel would issue both a limited 
exclusion order and a cease and desist order against Kappa City 
pursuant to section 337(g)(1) because all requirements of this 
provision are met. 19 U.S.C. 1337(g)(1)(A)-(E). Specifically, Kappa 
City was named in the complaint and was served the complaint and notice 
of investigation. See Order No. 16 (Apr. 30, 2021), unreviewed by 
Comm'n Notice (May 18, 2021). Kappa City failed to show good cause why 
it should not be held in default for failing to respond to the 
complaint and notice of investigation. See id. These findings satisfy 
subsections 337(g)(1)(A)-(D). ARK requested a limited exclusion order 
and a cease and desist order against Kappa City satisfying subsection 
337(g)(1)(E). Given that subsections 337(g)(1)(A)-(E) are satisfied, 
the statute directs the Commission to issue the requested limited 
exclusion order and cease and desist order, subject to consideration of 
the public interest. Commissioners Schmidtlein and Karpel find that 
issuance of the requested relief would not adversely impact the public 
interest factors.
    While temporary remote operating procedures are in place in 
response to COVID-19, the Office of the Secretary is not able to serve 
parties that have not retained counsel or otherwise provided a point of 
contact for electronic service. Accordingly, pursuant to Commission 
Rules 201.16(a) and 210.7(a)(1) (19 CFR 201.16(a), 210.7(a)(1)), the 
Commission orders that the complainant complete service for any party/
parties without a method of electronic service noted on the attached 
Certificate of Service and shall file proof of service on the 
Electronic Document Information System (EDIS).
    The Commission vote for this determination took place on July 25, 
2022.
    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: July 25, 2022.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2022-16261 Filed 7-28-22; 8:45 am]
BILLING CODE 7020-02-P