Notice2022-12500
Certain Plant-Derived Recombinant Human Serum Albumins (“rHSA”) and Products Containing Same Notice of Commission Determination To Review the Final Initial Determination in Its Entirety; Schedule for Filing Written Submissions
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 10, 2022
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission has determined to review the final initial determination ("final ID") issued by the presiding administrative law judge ("ALJ") on April 7, 2022, in its entirety. The Commission requests briefing from the parties on certain issues under review, as indicated in this notice. The Commission also requests briefing from the parties, interested government agencies, and interested persons on the issues of remedy, the public interest, and bonding.
Full Text
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<title>Federal Register, Volume 87 Issue 112 (Friday, June 10, 2022)</title>
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[Federal Register Volume 87, Number 112 (Friday, June 10, 2022)]
[Notices]
[Pages 35570-35572]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12500]
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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 Commission Determination To
Review the Final Initial Determination in Its Entirety; Schedule for
Filing Written Submissions
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 review the final initial determination
(``final ID'') issued by the presiding administrative law judge
(``ALJ'') on April 7, 2022, in its entirety. The Commission requests
briefing from the parties on certain issues under review, as indicated
in this notice. The Commission also requests briefing from the parties,
interested government agencies, and interested persons on the issues of
remedy, the public interest, and bonding.
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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#7732333e24443f121b073702041e031459101801"><span class="__cf_email__" data-cfemail="7f3a3b362c4c371a130f3f0a0c160b1c51181009">[email protected]</span></a>. General information concerning the Commission may
also be obtained by accessing its internet server at <a href="https://www.usitc.gov">https://www.usitc.gov</a>. 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 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 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: Wuhan Healthgen Biotechnology Corp. of Wuhan, China
(``Healthgen''); ScienCell Research Laboratories, Inc. of Carlsbad,
California (``ScienCell''); Aspira Scientific, Inc. of Milpitas,
California (``Aspira''); and eEnzyme LLC of Gaithersburg, Maryland
(``eEnzyme'') (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 by Healthgen and the Defaulting Respondents as to infringement of
the '951 patent and found the requirements of section 337(g)(1) met as
to 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 100% bond 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).
[[Page 35571]]
Having examined the record in this investigation, including the
final ID, the petition for review, and the responses thereto, the
Commission has determined to review the final ID in its entirety.
The parties are requested to brief their positions with reference
to the applicable law and the evidentiary record regarding the
questions provided below:
(1) Given the construction of aggregated albumin (``non-monomeric
albumin (e.g., albumin dimers)''), what distinguishes ``non-monomeric
albumin'' from ``monomeric albumin''? How can this distinction be
determined from testing data, such as by electrophoresis or
chromatographic testing data?
(2) Given the construction of aggregated albumin (``non-monomeric
albumin (e.g., albumin dimers)''), the applicable burdens of proof, and
any other relevant considerations, which of the following should be
considered within the scope of ``aggregated albumin'':
(a) fragments of native mammalian albumin;
(b) the combination of (i) one or more recombinant albumins (i.e.,
albumins heterologous or foreign to the transgenic plant producing it)
which has the amino acid sequence of a native mammalian albumin or
which is a variant, derivative, or fusion protein, and (ii) one or more
fragments of native mammalian albumin;
(c) the combination of two or more fragments of native mammalian
albumin;
(d) any substance identified via electrophoresis or chromatographic
techniques with a molecular weight greater than the molecular weight
corresponding to the ``main band'' that is not a discrete, integer
multiple of the molecular weight corresponding to that ``main band;''
(e) non-covalently linked aggregated albumin; and
(f) ``low molecular weight impurities,'' such as those included in
the May 2021 reducing SDS-PAGE test results from SGS Life Science
Services (JX-0129.0006-7).
(3) Given the '951 patent specification's identification of
``aggregates at around 250 KDa'' (see col. 72, ll. 51-54), explain:
(a) whether the molecular weight(s) of those ``aggregates at around
250 KDa'' are or are not discrete, integer multiple(s) of the molecular
weight(s) of the main band(s) (see Figs. 9A and/or 9B); and
(b) whether the answer to subpart (a) above affects the result of
any responses to (2)(a)-(f)?
(4) Does the parties' agreement that dimers are the simplest form
of an aggregated albumin preclude any of the species in (2)(a)-(f) from
contributing towards ``aggregated albumin''?
(5) Does the resolution of whether any of (2)(a)-(f) are within the
scope of ``aggregated albumin'' (or what constitutes ``non-monomeric
albumin'') require further claim construction, or are these
determinations purely factual? If further claim construction is
required, should the Commission remand the investigation to the ALJ?
(6) If species identified in (2)(d) that are detected via an
electrophoresis or chromatographic technique are within the scope
``aggregated albumin,'' could an assay that does not use molecular
weight markers or standards be able to determine whether or not a
sample has ``less than 2% aggregated albumin''?
(7) How can the Commission determine whether species detected via
an electrophoresis, chromatographic, or other technique retain the
biological or therapeutically beneficial activity of native mammalian
albumin? If the Commission is unable to determine whether such a
species retains that activity, how should that inability factor into
determining whether a product satisfies the ``less than 2% aggregated
albumin'' claim limitation, considering, for example, the burdens of
proof?
(8) In instances where species detected in electrophoresis or
chromatographic techniques are determined not to be within the scope of
``aggregated albumin,'' how is the percentage of ``aggregated albumin''
calculated? Is the percentage of ``aggregated albumin'' calculated by
dividing the sum total of ``band volume'' (or equivalent) of species
within the scope of aggregated albumin by the sum total of the band
volume of both ``aggregated'' and non-``aggregated'' albumin?
(9) How should the Commission address the situation where the
accused products or domestic industry products are found to satisfy the
``less than 2% aggregated albumin'' claim limitation under one testing
methodology, but not under another?
(10) Assuming the reducing agents used in reducing SDS-PAGE convert
aggregated albumin into ``monomeric albumin,'' does the evidence show
the extent that reducing agents do so? Please specify whether the
evidence of conversion, if any, depends on the form of the product (for
example, lyophilized/freeze dried powder versus liquid products).
(11) If Optibumin is found to be the only asserted product to
satisfy the technical prong of the domestic industry requirement for
the '951 patent and the scope of the products that can be considered in
the economic prong analysis include only Optibumin, discuss whether
(and why or why not) Complainant Ventria's investments and expenditures
in the alleged domestic industry are significant and/or substantial
within the meaning of 19 U.S.C. 1337(a)(3)(A), (B), and/or (C) with
citations to record evidence.
In connection with the final disposition of this investigation, the
statute authorizes issuance of, inter alia, (1) an exclusion order that
could result in the exclusion of the subject articles from entry into
the United States, and/or (2) cease and desist orders that could result
in the respondents being required to cease and desist from engaging in
unfair acts in the importation and sale of such articles. Accordingly,
the Commission is interested in receiving written submissions that
address the form of remedy, if any, that should be ordered. If a party
seeks exclusion of an article from entry into the United States for
purposes other than entry for consumption, the party should so indicate
and provide information establishing that activities involving other
types of entry either are adversely affecting it or are likely to do
so. For background, see Certain Devices for Connecting Computers via
Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op.
at 7-10 (Dec. 1994).
The statute requires the Commission to consider the effects of that
remedy upon the public interest. The public interest factors the
Commission will consider include the effect that an exclusion order
and/or cease and desist orders would have on: (1) the public health and
welfare, (2) competitive conditions in the U.S. economy, (3) U.S.
production of articles that are like or directly competitive with those
that are subject to investigation, and (4) U.S. consumers. The
Commission is therefore interested in receiving written submissions
that address the aforementioned public interest factors in the context
of this investigation.
Please address the following questions relevant to the public
interest considerations in this investigation, including evidence in
support:
(1) Please identify Healthgen's customers of the accused products
and state the uses for which these customers are using its products.
Are Ventria's products substitutes for these products and uses?
(2) Is there any vaccine or therapeutics research currently using
Healthgen's accused products? If so, please describe.
[[Page 35572]]
(3) For any current uses of the accused products, can Ventria's
products be used as substitutes?
(4) Can Ventria adequately supply U.S. demand for rHSA products?
(5) Are there uses for which a pHSA product cannot substitute for a
plant-based rHSA product? To what extent should pHSA products be
considered when examining the question of available substitutes for the
accused products?
If the Commission orders some form of remedy, the U.S. Trade
Representative, as delegated by the President, has 60 days to approve,
disapprove, or take no action on the Commission's determination. See
Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005).
During this period, the subject articles would be entitled to enter the
United States under bond, in an amount determined by the Commission and
prescribed by the Secretary of the Treasury. The Commission is
therefore interested in receiving submissions concerning the amount of
the bond that should be imposed if a remedy is ordered.
Written Submissions: The parties to the investigation are requested
to file written submissions on the questions identified in this notice.
Parties to the investigation, interested government agencies, and any
other interested parties are encouraged to file written submissions on
the issues of remedy, the public interest, and bonding. Such initial
written submissions should include views on the RD that issued on April
7, 2022.
Initial written submissions, limited to 80 pages, must be filed no
later than the close of business on June 20, 2022. Complainants are
requested to identify the form of the remedy sought and to submit
proposed remedial orders for the Commission's consideration.
Complainants are also requested to state the HTSUS subheadings under
which the accused articles are imported, and to supply identification
information for all known importers of the accused products. Reply
submissions, limited to 50 pages, must be filed no later than the close
of business on June 27, 2022. No further submissions on these issues
will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document
electronically on or before the deadlines stated above. The
Commission's paper filing requirements in 19 CFR 210.4(f) are currently
waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the
investigation number (``Inv. No. 337-TA-1238'') in a prominent place on
the cover page and/or the first page. (See Handbook for Electronic
Filing Procedures, <a href="https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf">https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf</a>). Persons with questions regarding
filing should contact the Secretary at (202) 205-2000.
Any person desiring to submit a document to the Commission in
confidence must request confidential treatment by marking each document
with a header indicating that the document contains confidential
information. This marking will be deemed to satisfy the request
procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b)
& 210.5(e)(2)). Documents for which confidential treatment by the
Commission is properly sought will be treated accordingly. A redacted
non-confidential version of the document must also be filed
simultaneously with any confidential filing. All information, including
confidential business information and documents for which confidential
treatment is properly sought, submitted to the Commission for purposes
of this investigation may be disclosed to and used: (i) by the
Commission, its employees and Offices, and contract personnel (a) for
developing or maintaining the records of this or a related proceeding,
or (b) in internal investigations, audits, reviews, and evaluations
relating to the programs, personnel, and operations of the Commission
including under 5 U.S.C. Appendix 3; or (ii) by U.S. government
employees and contract personnel, solely for cybersecurity purposes.
All contract personnel will sign appropriate nondisclosure agreements.
All nonconfidential written submissions will be available for public
inspection on EDIS.
The Commission vote for this determination took place on June 6,
2022.
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).
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: June 6, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022-12500 Filed 6-9-22; 8:45 am]
BILLING CODE 7020-02-P
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