Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


U.S. International Trade Commission.




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.


The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at For help accessing EDIS, please email 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 Start Printed Page 6919by accessing its internet server at

Start Further Info


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

End Further Info End Preamble Start Supplemental 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.

Start Signature

By order of the Commission.

Issued: January 19, 2021.

William Bishop,

Supervisory Hearings and Information Officer.

End Signature End Supplemental Information

[FR Doc. 2021-01548 Filed 1-22-21; 8:45 am]