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[Federal Register Volume 90, Number 25 (Friday, February 7, 2025)]
[Notices]
[Pages 9165-9166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02336]

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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1362 (Remand)]

Certain Liquid Transfer Devices With an Integral Vial Adapter; 
Notice of a Commission Determination Finding a Violation of Section 
337; Issuance of a Limited Exclusion Order and a Cease and Desist 
Order; 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 affirm the determination finding a 
violation of section 337 of the Tariff Act of 1930, as amended, in the 
remand initial determination (``Remand ID'') issued by the Chief 
Administrative Law Judge (``CALJ'') and to take no position with 
respect to a portion of the Remand ID. The Commission has also 
determined to issue a limited exclusion order prohibiting further 
importation of infringing products by the three remaining respondents 
and a cease and desist order against one respondent.

FOR FURTHER INFORMATION CONTACT: Edward S. Jou, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-3316. 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 
[email protected]. 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: The Commission instituted this investigation 
on May 11, 2023, based on a complaint, as supplemented, (the 
``Complaint'') filed by West Pharmaceutical Services, Inc. and West 
Pharma. Services IL, Ltd. (collectively, ``West'' or ``Complainants''). 
88 FR 30342 (May 11, 2023). The Complaint alleged violations of section 
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based on the 
importation into the United States, the sale for importation, and the 
sale within the United States after importation of certain liquid 
transfer devices with an integral vial adapter by reason of the 
infringement of claim 1 of U.S. Patent No. 10,688,295 (the `` '295 
patent''); the claim of U.S. Design Patent No. D767,124 (``the D'124 
patent''); the claim of U.S. Design Patent No. D765,837 (``the D'837 
patent''); the claim of U.S. Design Patent No. D630,732 (``the D'732 
patent''); and U.S. Trademark Registration No. 5,810,583 (``the '583 
mark''). Id. at 30342.
    The Commission's notice of investigation named four respondents: 
Advcare Medical, Inc. (``Advcare'') of New Taipei City, Taiwan, Dragon 
Heart Medical Devices Co., Ltd. (``Dragon Heart Devices'') of Kaiping 
City, China, Dragon Heart Medical, Inc. (``Dragon Heart'') of Addison, 
Illinois, and Summit International Medical Technologies, Inc. 
(``Summit'') of Franklin, Massachusetts. Id. The Office of Unfair 
Import Investigations (``OUII'') is also a party to this investigation. 
Id.
    The investigation was terminated as to Dragon Heart Devices by 
withdrawal of the Complaint. Order No. 9 (Aug. 24, 2023), unreviewed by 
Comm'n Notice (Sept. 20, 2023).
    The '583 mark and the three asserted design patents (the D'124 
patent, the D'837 patent, and the D'732 patent) were terminated from 
the investigation by withdrawal of the Complaint. Order No. 12 (Sept. 
19, 2023), unreviewed by Comm'n Notice (Oct. 19, 2023); Order No. 14 
(Oct. 4, 2023), unreviewed by Comm'n Notice (Nov. 2, 2023). 
Accordingly, the '295 patent is the only remaining asserted 
intellectual property in this investigation, and the respondents 
remaining in the investigation are Summit, Advcare, and Dragon Heart 
(collectively, ``Respondents'').
    On October 16, 2023, West filed an unopposed motion for summary 
determination that it satisfied the economic prong of the domestic 
industry requirement, which was granted. Order No. 17 (Nov. 28, 2023), 
unreviewed by Comm'n Notice (Dec. 28, 2023).
    A claim construction hearing was held on October 26, 2023, and the 
CALJ issued a claim construction order on November 13, 2023. Order No. 
15 (Nov. 13, 2023). The parties filed motions in limine, and the CALJ 
precluded certain evidence and arguments in Order No. 19 (Dec. 1, 
2023). In particular, the CALJ granted West's motion in limine no. 2, 
precluding Respondents and OUII from challenging the validity of the 
'295 patent. Id. at 2-6.
    An evidentiary hearing was held on December 4-5, 2023, and the CALJ 
issued a final initial determination (``Final ID'') on March 15, 2024, 
finding a violation of section 337 based on

[[Page 9166]]

infringement of claim 1 of the '295 patent. The Final ID included a 
recommended determination (``RD'') on remedy and bonding that 
recommended issuance of a limited exclusion order directed to the three 
remaining respondents and a cease and desist order directed to Summit. 
See Final ID at 73-87.
    On May 16, 2024, the Commission determined to review the Final ID 
in part. 89 FR 45012-15 (May 22, 2024). The Commission determined not 
to review the Final ID's findings with respect to claim construction, 
infringement, and the technical prong of the domestic industry 
requirement. Id. at 45013. On July 23, 2024, the Commission determined 
to supplement the Final ID and to reverse-in-part Order No. 19 and 
remand the investigation to the CALJ for further proceedings with 
respect to the written description requirement. See Comm'n Notice (July 
23, 2024); Comm'n Op. (July 23, 2024); Remand Order (July 23, 2024).
    On remand, the parties agreed that a live hearing was unnecessary 
and the CALJ set a procedural schedule for the submission of evidence 
and the parties' briefing and extended the target date to February 10, 
2025. Order No. 23 (Aug. 1, 2024), unreviewed by Comm'n Notice (Aug. 
27, 2024). The parties conducted additional expert discovery and the 
CALJ admitted the resulting evidence into the record. Order No. 24 
(Sept. 3, 2024).
    On November 8, 2024, the CALJ issued the Remand ID finding that 
claim 1 of the '295 is not invalid for lack of written description 
under 35 U.S.C. 112. OUII filed a petition for review on November 21, 
2024. Respondents filed a petition for review on November 29, 2024. 
West filed a response to OUII's petition for review on November 29, 
2024. West filed a response to Respondents' petition for review on 
December 6, 2024.
    On December 20, 2024, the Commission determined to review the 
Remand ID in its entirety. On review, the Commission has determined to 
take no position with respect to certain statements in the Remand 
ID.\1\ Specifically, the Commission takes no position on the second 
sentence of the last paragraph on page 5 continuing to page 6 (``The 
Commission concluded that OUII, . . .'') and the subsequent citations 
(``Id. at 18 . . .; see also; . . .; but cf. . . . .''); and the 
Commission takes no position on the second sentence in the first full 
paragraph on page 7 (``Because OUII . . . .''). The Commission has 
determined to affirm the remainder of the Remand ID. Because the 
Commission previously determined not to review the finding on summary 
determination with respect to the economic prong of the domestic 
industry requirement and the findings in the Final ID with respect to 
claim construction, infringement, and the technical prong of the 
domestic industry requirement, the Commission has determined that there 
has been a violation of section 337 with respect to infringement of 
claim 1 of the '295 patent.\2\
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    \1\ Commissioner Schmidtlein stepped down from the Commission on 
January 31, 2025.
    \2\ Commissioner Kearns respectfully dissents from the 
Commission's decision and has filed a separate opinion explaining 
his views.
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    For remedy, the Commission has determined to issue a limited 
exclusion order prohibiting further importation of infringing products 
by the three remaining respondents and a cease and desist order against 
Respondent Summit. The Commission has determined that the public 
interest factors do not counsel against issuing remedial orders. The 
Commission has determined that bond should be set in the amount of zero 
percent (0%) (i.e., no bond).
    The Commission vote for this determination took place on February 
3, 2025.
    This action is taken under the authority of 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: February 3, 2025.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2025-02336 Filed 2-6-25; 8:45 am]
BILLING CODE 7020-02-P
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