[Federal Register Volume 86, Number 14 (Monday, January 25, 2021)]
[Notices]
[Pages 6918-6919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01548]


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INTERNATIONAL TRADE COMMISSION

[Inv. No. 337-TA-1239]


Certain Gabapentin Immunoassay Kits and Test Strips, Components 
Thereof, and Methods Therefor; Institution of Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on December 2, 2020, under section 
337 of the Tariff Act of 1930, as amended, on behalf of ARK 
Diagnostics, Inc. of Fremont, California. A supplement to the complaint 
was filed on December 2, 2020 and an amended complaint was filed on 
December 23, 2020. The complaint, as amended, alleges violations of 
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 gabapentin immunoassay kits and test strips, 
components thereof, and methods therefor by reason of infringement of 
certain claims of U.S. Patent No. 8,828,665 (``the '665 patent'') and 
U.S. Patent No. 10,203,345 (``the '345 patent''). The complaint further 
alleges that an industry in the United States exists as required by the 
applicable Federal Statute. The complainant requests that the 
Commission institute an investigation and, after the investigation, 
issue a limited exclusion order and cease and desist orders.

ADDRESSES: The complaint, except for any confidential information 
contained therein, may be viewed on the Commission's electronic docket 
(EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email 
[email protected]. Hearing impaired individuals are advised that 
information on this matter can be obtained by contacting the 
Commission's TDD terminal on (202) 205-1810. Persons with mobility 
impairments who will need special assistance in gaining access to the 
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be 
obtained

[[Page 6919]]

by accessing its internet server at https://www.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Katherine Hiner, Office of Docket 
Services, U.S. International Trade Commission, telephone (202) 205-
1802.

SUPPLEMENTARY INFORMATION: 
    Authority: The authority for institution of this investigation is 
contained in section 337 of the Tariff Act of 1930, as amended, 19 
U.S.C. 1337, and in section 210.10 of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10 (2020).
    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on January 19, 2021, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as amended, an investigation be instituted to determine whether 
there is a violation of subsection (a)(1)(B) of section 337 in the 
importation into the United States, the sale for importation, or the 
sale within the United States after importation of certain products 
identified in paragraph (2) by reason of infringement of one or more of 
claims 1-3, 6, 7, 9, 14, 17, 18, 20, and 21 of the '665 patent; and 
claims 1, 2, 7, 8, 11, 12, 19, 20, 26, and 27 of the '345 patent; and 
whether an industry in the United States exists as required by 
subsection (a)(2) of section 337;
    (2) Pursuant to section 210.10(b)(1) of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10(b)(1), the plain language 
description of the accused products or category of accused products, 
which defines the scope of the investigation, is ``gabapentin 
immunoassays kits, gabapentin-specific test strips, multi-drug test 
kits and strips that test for gabapentin among other drugs, and 
components of such kits and test strips'';
    (3) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainant is:

ARK Diagnostics, Inc., 48089 Fremont Boulevard, Fremont, CA 94538.
    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the complaint 
is to be served:

Hangzhou AllTest Biotech Co., Ltd., No. 550, Yinhai Street, Hangzhou 
Economy and Technology Development Area, Hangzhou, China 210018.
Shanghai Chemtron Biotech Co., Ltd., No. 518, Qingdai Rd., 
International Medical Park, Pudong 201318, Shanghai, China.
Chemtron Biotech Co., Ltd., 9425 Brown Deer Road, Suite B, San Diego, 
CA 92121.
Zhejiang Orient Gene Biotech Co., Ltd., #3787 East Yangguang Ave., Dipu 
St., Anji 313300, Huzhou, Zhejiang, China.
Healgen Scientific, LLC, 3818 Fuqua Street, Houston, TX 77047.
Kappa City Biotech, SAS, 32 Rue Danton, 03100 Montlucon, France.
12PanelMedical, Inc., 846 Wee Burn Street, Apt. E306, Sarasota, FL 
34243.
Acro Biotech, Inc., 9500 7th Street, Unit M, Rancho Cucamonga, CA 
91730.
AlcoPro, Inc., 2547 Sutherland Ave., Knoxville, TN 37919.
American Screening, LLC, 9742 St. Vincent Ave., Ste. 100, Shreveport, 
LA 71106.
Confirm Biosciences, Inc., 10123 Carroll Canyon Road, San Diego, CA 
92131.
Mercedes Medical, LLC, 12210 Rangeland Parkway, Lakewood Ranch, FL 
34211.
TransMed Co., LLC, 1887 McFarland Parkway, Alpharetta, GA 30005.
Transmetron, Inc., 1476 S Major Street (50 East), Salt Lake City, UT 
84115.

    (4) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    The Office of Unfair Import Investigations will not participate as 
a party in this investigation.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondents in accordance with section 210.13 of 
the Commission's Rules of Practice and Procedure, 19 CFR 210.13. 
Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 
(March 19, 2020), such responses will be considered by the Commission 
if received not later than 20 days after the date of service by the 
complainant of the complaint and the notice of investigation. 
Extensions of time for submitting responses to the complaint and the 
notice of investigation will not be granted unless good cause therefor 
is shown.
    Failure of a respondent to file a timely response to each 
allegation in the complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the respondent, 
to find the facts to be as alleged in the complaint and this notice and 
to enter an initial determination and a final determination containing 
such findings, and may result in the issuance of an exclusion order or 
a cease and desist order or both directed against the respondent.

    By order of the Commission.

    Issued: January 19, 2021.
William Bishop,
Supervisory Hearings and Information Officer.
[FR Doc. 2021-01548 Filed 1-22-21; 8:45 am]
BILLING CODE 7020-02-P