[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56982-56983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20042]



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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1238]


Certain Plant-Derived Recombinant Human Serum Albumins (``rHSA'') 
and Products Containing Same; Notice of the Commission's Final 
Determination Finding a Violation of Section 337; Issuance of a Limited 
Exclusion Order and Cease and Desist Orders; Termination of the 
Investigation

AGENCY: International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has found a violation of section 337 in the above-captioned 
investigation. The Commission has determined to issue: (1) a limited 
exclusion order (``LEO'') prohibiting the unlicensed entry of 
infringing plant-derived recombinant human serum albumins (``rHSA'') 
and products containing the same covered by certain claims of U.S. 
Patent No. 10,618,951 that are manufactured by or on behalf of, or 
imported by or on behalf of, respondents Wuhan Healthgen Biotechnology 
Corp. (``Healthgen''); ScienCell Research Laboratories, Inc. 
(``ScienCell''); Aspira Scientific, Inc. (``Aspira''); and eEnzyme LLC 
(``eEnzyme'') or any of their affiliated companies, parents, 
subsidiaries, or other related business entities, or their successors 
or assigns; and the entry of plant-derived rHSAs and products 
containing the same that include a false designation of origin that are 
manufactured by or on behalf of, or imported by or on behalf of, 
ScienCell, Aspira, or eEnzyme or any of their affiliated companies, 
parents, subsidiaries, agents, or other related business entities, or 
their successors or assigns; and (2) cease and desist orders (``CDOs'') 
directed against ScienCell, Aspira, and eEnzyme, and any of their 
affiliated companies, parents, subsidiaries, or other related business 
entities, or their successors or assigns. This investigation is 
terminated.

FOR FURTHER INFORMATION CONTACT: Ronald A. Traud, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-3427. 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 January 25, 2021, based on a complaint filed on behalf of Ventria 
Bioscience Inc. (``Ventria'') of Junction City, Kansas. 86 FR 6916 
(Jan. 25, 2021). The complaint, as supplemented, alleged violations of 
section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, 
based upon the importation into the United States, the sale for 
importation, and the sale within the United States after importation of 
certain plant-derived rHSA and products containing the same by reason 
of infringement of certain claims of U.S. Patent Nos. 10,618,951 (``the 
'951 patent'') and 8,609,416 (``the '416 patent''). Id. The complaint 
also alleged violations of section 337 based on the importation into 
the United States, or in the sale of, certain plant-derived rHSA and 
products containing the same by reason of false designation of origin, 
the threat or effect of which is to destroy or substantially injure an 
industry in the United States. Id. The notice of investigation named 
four respondents: Healthgen of Wuhan, China; ScienCell of Carlsbad, 
California; Aspira of Milpitas, California; and eEnzyme of 
Gaithersburg, Maryland (collectively, the ``Respondents''). Id. at 
6917. The Office of Unfair Import Investigations (``OUII'') was also 
named as a party in this investigation. Id.
    Of the four Respondents named in the notice of investigation, only 
Healthgen participated in the investigation. ScienCell, Aspira, and 
eEnzyme were found in default. See Order No. 13 (July 28, 2021), 
unreviewed by Comm'n Notice (Aug. 18, 2021). ScienCell, Aspira, and 
eEnzyme are collectively referred to herein as the ``Defaulting 
Respondents.''
    Prior to the issuance of the final ID, the investigation terminated 
as to all asserted claims of the '416 patent, claims 2 and 3 of the 
'951 patent, and the false designation of origin claims against 
Healthgen. See Order No. 12 (July 16, 2021), unreviewed by Comm'n 
Notice (Aug. 10, 2021); Order No. 29 (Nov. 3, 2021), unreviewed by 
Comm'n Notice (Nov. 29, 2021). The false designation of origin claims 
against the Defaulting Respondents were not terminated. See Order No. 
12 at 1. Accordingly, at the time the final ID issued, only claims 1 
and 11-13 of the '951 patent remained pending against Healthgen, and 
only claims 1 and 11-13 of the '951 patent and the false designation of 
origin (or Lanham Act) claims remained pending against the Defaulting 
Respondents.
    On April 7, 2022, the ALJ issued the final ID, which found that 
Respondents violated section 337. The ALJ found a violation of section 
337 under section 337(a)(1)(B) by Healthgen as to infringement of the 
'951 patent and found the requirements of section 337(g)(1) met as to 
infringement of the '951 patent and the Lanham Act claim with respect 
to the Defaulting Respondents.
    The final ID included the ALJ's recommendation on remedy, the 
public interest, and bonding (the ``RD''). The RD recommended that, if 
the Commission finds a violation of section 337, the Commission should 
issue a limited exclusion order against Healthgen and the Defaulting 
Respondents, cease and desist orders against the Defaulting 
Respondents, and impose a bond of one hundred percent (100%) of entered 
value during the period of Presidential review.
    On April 19, 2022, Healthgen filed a petition for review of the 
final ID. On April 22, 2022, OUII filed a response to Healthgen's 
petition, and on April 27, 2022, Ventria filed a response to 
Healthgen's petition. On May 9, 2022, Ventria and Healthgen filed their 
public interest comments pursuant to Commission Rule 210.50(a)(4) (19 
CFR 210.50(a)(4)). The Commission also received several submissions 
from third parties in response to the Commission's Federal Register 
notice seeking comment on the public interest. 87 FR 21923-24 (Apr. 13, 
2022).
    On June 6, 2022, after considering the petition and responses 
thereto, the Commission determined to review the final ID in its 
entirety. 87 FR 35570-72 (June 10, 2022). The Commission requested 
briefing on the issues under review and on remedy, the public interest, 
and bonding. Id.
    On review, and as explained in the simultaneously-issued Commission 
opinion, the Commission has determined that there has been a violation 
of section 337 with respect to the Asserted Patent by respondent Wuhan 
Healthgen Biotechnology Corp. (``Healthgen'') and that the requirements 
of section 337(g)(1) are met as to the defaulting respondents based on 
a violation of section 337 alleged in the complaint with respect to 
both the Asserted Patent claims and the Lanham Act claim. As to 
Ventria's allegations of a section 337 violation based on

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infringement of the '951 patent, Ventria has shown such a violation 
only as to the clinical grade products. (Commissioner Stayin does not 
join the Commission's determination as to medium grade products and 
would find a violation as to all accused products.)
    The Commission has determined that the appropriate form of relief 
is a limited exclusion order prohibiting (1) the unlicensed entry of 
infringing plant-derived recombinant human serum albumins (``rHSA'') 
and products containing the same manufactured by or on behalf of, or 
imported by or on behalf of, Healthgen or the Defaulting Respondents or 
any of their affiliated companies, parents, subsidiaries, agents, or 
other related business entities, or their successors or assigns; and 
(2) the entry of plant-derived recombinant human serum albumins 
(``rHSA'') and products containing same that fail to accurately 
designate the country of origin, and which are manufactured abroad by 
or on behalf of, or imported by or on behalf of, the Defaulting 
Respondents or any of their affiliated companies, parents, 
subsidiaries, agents, or other related business entities, or their 
successors or assigns. The Commission has determined to issue cease and 
desist orders against respondents ScienCell, Aspira, and eEnzyme.
    The Commission has further determined that the public interest 
factors enumerated in subsections (d)(l) and (g)(1) (19 U.S.C. 
1337(d)(l), (g)(1)) do not preclude issuance of the above-referenced 
remedial orders. Additionally, the Commission has determined to impose 
a bond of one hundred percent (100%) of the entered value of the 
covered products during the period of Presidential review (19 U.S.C. 
1337(j)).
    The investigation is hereby terminated in its entirety.
    The Commission vote for this determination took place on September 
12, 2022.
    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(s) 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).

    By order of the Commission.

    Issued: September 12, 2022.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2022-20042 Filed 9-15-22; 8:45 am]
BILLING CODE 7020-02-P