[Federal Register Volume 85, Number 10 (Wednesday, January 15, 2020)]
[Notices]
[Pages 2439-2440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00509]


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 INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1189]


Certain Dissolving Microneedle Patches for Cosmetic and 
Pharmaceutical Use; 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 November 21, 2019, under section 
337 of the Tariff Act of 1930, as amended, on behalf of TheraJect, Inc. 
of Fremont, California. Supplements were filed on November 27 and 
December 2, 2019. A first amended complaint was filed on December 10, 
2019, and a second amended complaint was filed on December 19, 2019. 
The second amended complaint 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 
dissolving microneedle patches for cosmetic and pharmaceutical use by 
reason of infringement of certain claims of U.S. Patent No. 6,945,952 
(``the '952 patent''). The second amended complaint further alleges 
that an industry in the United States is in the process of being 
established as required by the applicable Federal Statute.
    The second amended complaint requests that the Commission institute 
an investigation and, after the investigation, issue a limited 
exclusion order and a cease and desist order. Addresses: The second 
amended complaint, except for any confidential information contained 
therein, is available for inspection during official business hours 
(8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW, Room 112, Washington, 
DC 20436, telephone (202) 205-2000. 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 by accessing its internet server at https://www.usitc.gov. The 
public record for this investigation may be viewed on the Commission's 
electronic docket (EDIS) at https://edis.usitc.gov.

FOR FURTHER INFORMATION CONTACT: Pathenia M. Proctor, The Office of 
Unfair Import Investigations, U.S. International Trade Commission, 
telephone (202) 205-2560.

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 (2019).
    Scope of Investigation: Having considered the second amended 
complaint, the U.S. International Trade Commission, on January 9, 2020, 
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 1-13 of the '952 patent; and whether an industry in the United 
States is in the process of being established 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 ``dissolving 
microneedle patch[es]'';
    (3) Pursuant to section 210.10(b)(3) of the Commission's Rules of 
Practice and Procedure, 19 CFR 210.10(b)(3), the presiding 
Administrative Law Judge shall hold an early evidentiary hearing, find 
facts, and issue an early decision, within 100 days of institution 
except for good cause shown, as to whether the complainant has 
satisfied the economic prong of the domestic industry requirement. 
Notwithstanding any Commission Rules to the contrary, which are hereby 
waived, any such decision should be issued in the form of an initial 
determination (ID) under Commission Rule 210.42(a)(3), 19 CFR 
210.42(a)(3). The ID will become the Commission's final determination 
30 days after the date of service of the ID unless the Commission 
determines to review the ID. Any such review will be conducted in 
accordance with Commission Rules 210.43, 210.44, and 210.45, 19 CFR 
210.43, 210.44, and 210.45. The issuance of an early ID finding that 
the complainant does not satisfy the economic prong of the domestic 
industry requirement shall stay the investigation unless the Commission 
orders otherwise; any other decision shall not stay the investigation 
or delay the issuance of a final ID covering the other issues of the 
investigation;
    (4) 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: TheraJect, Inc., 39270 Paseo Padre #112, 
Fremont, CA 94538.
    (b) The respondent is the following entity alleged to be in 
violation of section 337, and is the party upon which the second 
amended complaint is to be served: Raphas Co., Ltd, (07793) 62, 
Magokjingang 8-ro-1-gil, Gangseo-gu, Seoul, Republic of Korea.
    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
    (5) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    Responses to the second amended complaint and the notice of 
investigation must be submitted by the named respondent 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), 
such responses will be considered by the Commission if received not 
later than 20 days after the date of service by the Commission of the

[[Page 2440]]

second amended complaint and the notice of investigation. Extensions of 
time for submitting responses to the second amended 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 second amended complaint and in this notice may be 
deemed to constitute a waiver of the right to appear and contest the 
allegations of the second amended 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 second amended 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 10, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020-00509 Filed 1-14-20; 8:45 am]
BILLING CODE 7020-02-P