[Federal Register Volume 87, Number 112 (Friday, June 10, 2022)]
[Notices]
[Pages 35570-35572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf). 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