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
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Abstract
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.
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<title>Federal Register, Volume 87 Issue 145 (Friday, July 29, 2022)</title>
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[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Notices]
[Pages 45800-45801]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#2461606d77176c4148546451574d50470a434b52"><span class="__cf_email__" data-cfemail="5712131e04641f323b271722243e233479303821">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. 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
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