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, 56982-56983 [2022-20042]
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Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
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
International Trade
Commission.
ACTION: Notice.
AGENCY:
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 plantderived 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
EDIS3Help@usitc.gov. General
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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16:43 Sep 15, 2022
Jkt 256001
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
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Sfmt 4703
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
E:\FR\FM\16SEN1.SGM
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Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
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 plantderived 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 abovereferenced 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).
VerDate Sep<11>2014
16:43 Sep 15, 2022
Jkt 256001
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
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation and Liability
Act
On September 13, 2022, the
Department of Justice lodged a proposed
Consent Decree with the District Court
of the Southern District of New York in
a lawsuit entitled United States v.
American Iron & Metal Co., et al., Civil
Action No. 22–7800.
In this action the United States seeks,
as provided under the Comprehensive
Environmental Response, Compensation
and Liability Act, recovery of response
costs from four parties regarding the
Port Refinery Superfund Site (‘‘Site’’) in
the Village of Rye Brook, New York. The
proposed Consent Decree resolves the
United States’ claims and requires
American Iron & Metal Co., Inc., Culp
Industries, Inc., Paramount Global, and
Public Service Company of New
Hampshire, to pay, in aggregate,
$437,255, in reimbursement of the
United States’ past response costs
regarding the Site.
The publication of this notice opens
the public comment on the proposed
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. American Iron & Metal
Co., et al., Civil Action No. 22–7800, D.J.
Ref. 90–11–3–1142/8. All comments
must be submitted no later than 30 days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
Department website: https://
www.usdoj.gov/enrd/Consent_
Decrees.html. We will provide a paper
copy of the Consent Decree upon
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56983
written request and payment of
reproduction costs. Please email your
request and payment to: Consent Decree
Library, U.S. DOJ—ENRD, P.O. Box
7611, Washington, DC 20044–7611.
Please enclose a check or money order
for $5.50 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Henry S. Friedman,
Assistant Chief, Environmental Enforcement
Section, Environment and Natural Resources
Division.
[FR Doc. 2022–20071 Filed 9–15–22; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF LABOR
Office of the Secretary
All Items Consumer Price Index for All
Urban Consumers; United States City
Average
Pursuant to section 33105(c) of Title
49, United States Code, and the
delegation of the Secretary of
Transportation’s responsibilities under
that Act to the Administrator of the
Federal Highway Administration (49
CFR, section 1.95 (a)), the Secretary of
Labor has certified to the Administrator
and published this notice in the Federal
Register that the United States City
Average All Items Consumer Price Index
for All Urban Consumers (1967=100)
increased 160.9 percent from its 1984
annual average of 311.1 to its 2021
annual average of 811.705.
Signed at Washington, DC.
Martin J. Walsh,
Secretary of Labor.
[FR Doc. 2022–20077 Filed 9–15–22; 8:45 am]
BILLING CODE 4510–24–P
DEPARTMENT OF LABOR
Office of the Secretary
All Items Consumer Price Index for All
Urban Consumers; United States City
Average
Pursuant to section 112 of the 1976
amendments to the Federal Election
Campaign Act, 52 U.S.C. 30116(c), the
Secretary of Labor has certified to the
Chairman of the Federal Election
Commission and publishes this notice
in the Federal Register that the United
States City Average All Items Consumer
Price Index for All Urban Consumers
(CPI–U) (1967=100) increased 449.6
percent from its 1974 annual average of
147.7 to its 2021 annual average of
811.705 and that it increased 53.0
percent from its 2001 annual average of
E:\FR\FM\16SEN1.SGM
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]]>Agencies
[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]
[[Page 56982]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 56983]]
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
