Certain Gabapentin Immunoassay Kits and Test Strips, Components Thereof, and Methods Therefor; Commission Determination Not To Review an Initial Determination Granting Complainant's Motion for Leave To Amend the Complaint and Notice of Investigation

AGENCY:

U.S. International Trade Commission.

ACTION:

Notice.

SUMMARY:

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 8) of the presiding administrative law judge (“ALJ”) granting the complainant's motion for leave to amend the complaint and notice of investigation.

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 EDIS3Help@usitc.gov. 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 (“Complainant”). 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 12PanelMedical, Inc. of Sarasota, Florida (“12PanelMedical”) and AlcoPro, Inc. of Knoxville, Tennessee (“AlcoPro”). See id.

On February 19, 2021, Complainant filed a motion seeking leave to file a Second Amended Complaint and to amend the notice of investigation to name current respondent 12PanelMedical's affiliates: 12Panel Now, Inc. and Hospital Connect, Inc., both of Boynton Beach, Florida. Complainant's motion also seeks to update the address information for respondents 12PanelMedical and AlcoPro. No responses to the motion were filed.

On March 9, 2021, the ALJ issued the subject ID (Order No. 8) granting Complainant's motion for leave to amend the complaint and notice of investigation to add the two 12PanelMedical affiliates and update the address information for 12PanelMedical and AlcoPro. Order No. 8 (March 9, 2021). Specifically, the ID finds that amending the Complaint and Notice of Investigation to add the 12PanelMedical affiliates will aid in the development of the Investigation and is necessary to avoid prejudicing the public interest and rights of the parties to the Investigation. The subject ID finds that Complainant's motion is supported by good cause pursuant to Commission Rule 210.14(b) (19 CFR 210.14(b)) and that there is no prejudice to any party if the motion is granted. No party petitioned for review of the subject ID.

The Commission has determined not to review the subject ID. 12Panel Now, Inc. and Hospital Connect, Inc. are named respondents in this investigation and the address information for respondents 12PanelMedical and AlcoPro has been updated.

The Commission vote for this determination took place on March 24, 2021.

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 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).