Certain Liquid Transfer Devices With an Integral Vial Adapter; Notice of a Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions on Issues Under Review and on Remedy, the Public Interest, and Bonding, 45012-45015 [2024-11183]
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
than the close of business on June 6,
2024. 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
(March 19, 2020). Submissions should
refer to the investigation number (Inv.
No. 337–TA–1355) 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, (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. Any non-party
wishing to submit comments containing
confidential information must serve
those comments on the parties to the
investigation pursuant to the applicable
Administrative Protective Order. A
redacted non-confidential version of the
document must also be filed with the
Commission and served on any parties
to the investigation within two business
days of 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 May 16,
2024.
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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: May 16, 2024.
Lisa Barton,
Secretary to the Commission.
of at the scheduled meeting, may be
carried over to the agenda of the
following meeting.
By order of the Commission.
Issued: May 20, 2024.
Sharon Bellamy,
Supervisory Hearings and Information
Officer.
[FR Doc. 2024–11366 Filed 5–20–24; 4:15 pm]
BILLING CODE 7020–02–P
INTERNATIONAL TRADE
COMMISSION
[Investigation No. 337–TA–1362]
Certain Liquid Transfer Devices With
an Integral Vial Adapter; Notice of a
Commission Determination To Review
in Part a Final Initial Determination
Finding a Violation of Section 337;
Request for Written Submissions on
Issues Under Review and on Remedy,
the Public Interest, and Bonding
[FR Doc. 2024–11186 Filed 5–21–24; 8:45 am]
U.S. International Trade
Commission.
ACTION: Notice.
BILLING CODE 7020–02–P
SUMMARY:
AGENCY:
INTERNATIONAL TRADE
COMMISSION
[USITC SE–24–022]
Sunshine Act Meetings
United
States International Trade Commission.
TIME AND DATE: May 31, 2024 at 11:00
a.m.
PLACE: Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 701–
TA–720 and 731–TA–1688
(Preliminary)(Ceramic Tile from
India). The Commission currently is
scheduled to complete and file its
determinations on June 3, 2024; views
of the Commission currently are
scheduled to be completed and filed
on June 10, 2024.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
Sharon Bellamy, Supervisory Hearings
and Information Officer, 202–205–2000.
The Commission is holding the
meeting under the Government in the
Sunshine Act, 5 U.S.C. 552(b). In
accordance with Commission policy,
subject matter listed above, not disposed
AGENCY HOLDING THE MEETING:
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Notice is hereby given that
the U.S. International Trade
Commission (‘‘Commission’’) has
determined to review in part a final
initial determination (‘‘Final ID’’) issued
by the presiding chief administrative
law judge (‘‘CALJ’’) finding a violation
of section 337. The Commission
requests written submissions from the
parties on the issue(s) under review and
submissions from the parties, interested
government agencies, and other
interested persons on the issues of
remedy, the public interest, and
bonding, under the schedule set forth
below.
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
EDIS3Help@usitc.gov. 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,
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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’’),
Dragon Heart Medical Devices Co., Ltd.
(‘‘Dragon Heart Devices’’), Dragon Heart
Medical, Inc. (‘‘Dragon Heart’’), and
Summit International Medical
Technologies, Inc. (‘‘Summit’’). 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 based on
withdrawal of the Complaint. Order No.
9 (Aug. 24, 2023), unreviewed by
Comm’n Notice (Sept. 20, 2023). The
’583 mark was terminated from the
investigation by withdrawal of the
Complaint. Order No. 12 (Sept. 19,
2023), unreviewed by Comm’n Notice
(Oct. 19, 2023). The three asserted
design patents, the D’124 patent, the
D’837 patent, and the D’732 patent,
were also terminated from the
investigation by withdrawal of the
Complaint. Order No. 14 (Oct. 4, 2023),
unreviewed by Comm’n Notice (Nov. 2,
2023). Accordingly, claim 1 of the ’295
patent is the sole remaining claim.
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).
An evidentiary hearing was held on
December 4–5, 2023, and the CALJ
issued the Final ID on March 15, 2024,
finding a violation of section 337 based
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on infringement of claim 1 of the ’295
patent. The Final ID included a
Recommended Determination on
remedy and bonding, recommending the
issuance of a limited exclusion order
and a cease and desist order. See Final
ID at 73–87.
Respondents Summit, Advcare, and
Dragon Heart (collectively,
‘‘Respondents’’) filed a petition for
review of the Final ID on April 6, 2024.
OUII also filed a petition for review on
April 6, 2024, and OUII filed a response
to Respondents’ petition on April 15,
2024. Complainants filed responses in
opposition to both petitions on April 15,
2024. Respondents filed a response to
OUII’s petition on April 16, 2024.
Having reviewed the record of the
investigation, including the Final ID,
Order No. 19, and the parties’ petitions
for review and responses thereto, the
Commission has determined to review
the Final ID in part. Specifically, the
Commission has determined to review
the preclusion of Respondents’ and
OUII’s invalidity arguments and
evidence in Order No. 19 (Dec. 1, 2023).
The Commission has also determined to
review the Final ID’s findings with
respect to standing and jurisdiction
(Final ID at 15–17). In addition, the
Commission has determined to correct
an error in the Final ID: On page 13, the
reference to ‘‘one of West’s customers’’
shall be replaced with ‘‘one of Summit’s
customers.’’ The Commission has also
determined to correct a typographical
error in the Markman Order (Order No.
15): On pages 16 and 17, the references
to ‘‘column 4 lines 43 to 45’’ and ‘‘4:43–
45’’ shall be replaced with ‘‘column 4
lines 53 to 55’’ and ‘‘4:53–55.’’ The
Commission has determined not to
review the remaining findings in the
Final ID, including the findings on
claim construction, infringement, and
the technical prong of the domestic
industry requirement.
In connection with its review, the
Commission requests responses to the
following questions. The parties are
requested to brief their positions with
reference to the applicable law and the
existing evidentiary record. In your
responses to the questions below, please
provide citations, if any, to where you
presented these facts and arguments to
the CALJ in connection with
Complainants’ motion in limine no. 2.
1. How and when did Respondents
and OUII disclose their invalidity
contentions? Was this sufficient notice
to Complainants, and how did
Complainants respond to these
disclosures?
2. Please explain whether and to what
extent the substance of Respondents’
and OUII’s written description
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45013
arguments overlap with their claim
construction and non-infringement
arguments? Are the written description
arguments contingent on the claim
construction of ‘‘trifurcated connector
body’’ adopted by the CALJ in Order No.
15 and the Final ID and by the
Commission? Were the full and
complete bases for Respondents’ and
OUII’s alleged written description
defense timely disclosed to
Complainants prior to the close of fact
and expert discovery?
3. Did the parties propound discovery
requests and produce discovery
regarding the alleged lack of written
description under 35 U.S.C. 112? What
discovery was produced by each party?
Did these discovery responses provide
adequate and timely notice of this
affirmative defense?
4. After Mr. Merchant testified that
Summit did not assert any invalidity
defense (Order No. 19 at 4–5), did OUII
question Mr. Merchant regarding any
alleged written description invalidity
defense?
5. How should Respondents’ pro se
status affect the Commission’s
consideration of Respondents’ briefing
and representations as to Respondents’
alleged written description defense?
Please discuss how leniency for pro se
litigants applies specifically to the facts
concerning Respondents’ alleged
written description defense under
Federal Circuit and Supreme Court
precedent. Explain how Courts consider
prejudice and harm to parties when a
pro se litigant fails to provide adequate
and timely notice of an affirmative
defense before the close of discovery.
6. Should OUII be allowed to raise an
invalidity defense that was not pled or
disclosed by Respondents? Under the
CALJ’s Ground Rules and the
Commission’s Rules, when and in what
form was OUII first required to disclose
its contention that the ’295 patent was
invalid based on the affirmative defense
of lack of written description? If the
prehearing brief is the earliest time OUII
is required to make such disclosure,
how should prejudice to Complainants
be considered? Should OUII be required
to respond to any contention
interrogatories, if served upon it by the
private parties?
7. Is there ‘‘good cause’’ to waive the
pleading requirements under
Commission Rule 210.13(b), 19 CFR
210.13(b) (‘‘For good cause, the
presiding administrative law judge may
waive any of the substantive
requirements imposed under this
paragraph or may impose additional
requirements.’’), with respect to
Respondents’ alleged assertion of
invalidity? Did Respondents or OUII in
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their responses to the motion in limine
present an argument that the CALJ
should find good cause to waive the
substantive requirement that the bases
of invalidity defenses must be pled in
the answer to the complaint under Rule
210.13(b)?
8. Does Commission Rule 210.14(c),
19 CFR 210.14(c) (‘‘When issues not
raised by the pleadings or notice of
investigation, but reasonably within the
scope of the pleadings and notice, are
considered during the taking of
evidence by express or implied consent
of the parties, they shall be treated in all
respects as if they had been raised in the
pleadings and notice. Such amendments
of the pleadings and notice as may be
necessary to make them conform to the
evidence and to raise such issues shall
be allowed at any time, and shall be
effective with respect to all parties who
have expressly or impliedly
consented.’’), apply to the invalidity
contentions asserted by Respondents or
OUII? Is Rule 210.14(c) limited by its
terms to amendment of pleadings to
conform to the evidence admitted at the
hearing by the consent of the parties?
Did Respondents or OUII present an
argument to the CALJ in their responses
to the motion in limine that the
requirements of Rule 210.14(c) were
met?
9. Please discuss any harm or
prejudice to the Complainants from
permitting Respondents and/or OUII to
present evidence at the hearing as to the
affirmative defense of written
description given the facts submitted in
response to questions 1–8 above.
10. Please explain whether and to
what extent the Federal Circuit’s
decision in Lannom Mfg. Co. v. U.S. Int’l
Trade Comm’n, 799 F.2d 1572 (Fed. Cir.
1986) applies to the facts in this
investigation. See Order No. 19 at 6 n.2.
11. If the Commission were to reverse
the grant of Complainants’ motion in
limine no. 2, can the invalidity defense
be decided by the Commission on
review, or should the Commission
remand the investigation to the CALJ for
further proceedings?
12. Based on the present record,
would claim 1 of the ’295 patent be
invalid for lack of written description
pursuant to 35 U.S.C. 112 under the
Commission’s adopted construction for
‘‘trifurcated connector body’’ and
applicable case law?
13. Explain the relevance, if any, of
the circumstances surrounding
Complainants’ voluntary recall of the
Vial2Bag DC product in an assessment
of whether the written description
shows that the inventors were in
possession of an invention covering the
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redesigned Vial2Bag Advanced device
as of the filing date of the ’295 patent.
14. What additional evidence
regarding the written description
defense would the parties have
presented at hearing if Complainants’
motion in limine no. 2 had been denied?
The parties are invited to brief only
the discrete issues requested above and
the issues of remedy, the public interest,
and bonding, as discussed below. The
parties are not to brief other issues on
review, which are adequately presented
in the parties’ existing filings.
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 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 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.
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
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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 issues
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.
In its initial submission,
Complainants are also requested to
identify the remedy sought and
Complainants and OUII are requested to
submit proposed remedial orders for the
Commission’s consideration.
Complainants are further requested to
provide the HTSUS subheadings under
which the accused products are
imported, and to supply the
identification information for all known
importers of the products at issue in this
investigation. The initial written
submissions and proposed remedial
orders must be filed no later than close
of business on May 30, 2024. Reply
submissions must be filed no later than
the close of business on June 10, 2024.
Opening submissions are limited to 80
pages. Reply submissions are limited to
50 pages. 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–1362’’) 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 (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. Any non-party
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wishing to submit comments containing
confidential information must serve
those comments on the parties to the
investigation pursuant to the applicable
Administrative Protective Order. A
redacted non-confidential version of the
document must also be filed
simultaneously with any confidential
filing and must be served in accordance
with Commission Rule 210.4(f)(7)(ii)(A)
(19 CFR 210.4(f)(7)(ii)(A)). 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 May 16,
2024.
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: May 16, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–11183 Filed 5–21–24; 8:45 am]
BILLING CODE 7020–02–P
INTERNATIONAL TRADE
COMMISSION
khammond on DSKJM1Z7X2PROD with NOTICES
[Investigation No. 332–600]
USMCA Automotive Rules of Origin:
Economic Impact and Operation, 2025
Report; Submission of Questionnaire
and Information Collection Plan for
Office of Management and Budget
Review
U.S. International Trade
Commission.
ACTION: Notice of submission of request
for approval of a questionnaire and
information collection to the Office of
Management and Budget.
AGENCY:
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17:06 May 21, 2024
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The information requested by
the questionnaire is for use by the
Commission in connection with
Investigation No. 332–600, USMCA
Automotive Rules of Origin: Economic
Impact and Operation, 2025 Report.
ADDRESSES: All Commission offices are
located in the U.S. International Trade
Commission Building, 500 E Street SW,
Washington, DC. Persons with mobility
impairments who will need special
assistance in gaining access to the
Commission should contact the Office
of the Secretary at 202–205–2000.
FOR FURTHER INFORMATION CONTACT:
Please direct all questions and
comments about this investigation to the
project team via email at
USMCAAutoROO@usitc.gov or via
phone to Aaron Woodward at 202–205–
2663. The Commission is not accepting
paper correspondence for this
investigation.
Comments about the proposal should
be provided to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs,
through the Information Collection
Review Dashboard at https://
www.reginfo.gov. All comments should
be specific, indicating whether any part
of the questionnaire is objectionable,
describing the concern in detail, and
including specific suggested revisions or
language changes. Copies of any
comments should be provided
electronically to the Commission’s
project team via email to
USMCAAutoROO@usitc.gov.
The public record for this
investigation is viewable on the
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov. General
information concerning the Commission
is available on its website (https://
www.usitc.gov). Hearing-impaired
individuals can obtain information on
this matter by contacting the TDD
terminal at 202–205–1810.
SUPPLEMENTARY INFORMATION: The
information requested by the
questionnaire is for use by the
Commission in connection with
Investigation No. 332–600, USMCA
Automotive Rules of Origin: Economic
Impact and Operation, 2025 Report,
instituted under section 202A(g)(2) of
the United States-Mexico-Canada
Agreement Implementation Act (19
U.S.C. 4532(g)(2)) (USMCA
Implementation Act). The USMCA
Implementation Act requires that the
Commission prepare a series of five
biennial reports on the USMCA
automotive rules of origin (ROOs) and
their impact on the U.S. economy and
automotive industry, effect on U.S.
competitiveness, and relevancy in light
SUMMARY:
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45015
of technological changes, and to submit
these reports to the President, the House
Committee on Ways and Means, and the
Senate Committee on Finance. The
Commission delivered the first of the
reports on June 30, 2023, with four more
reports due in 2025, 2027, 2029, and
2031.
This investigation was instituted on
November 15, 2023, and the notice of
investigation was published in the
Federal Register on November 21, 2023
(88 FR 81100). The Commission will
submit the second of its five reports to
the President, the House Committee on
Ways and Means, and the Senate
Committee on Finance by July 1, 2025.
The Commission indicated in its notice
of investigation that it intended to
obtain data and information through a
survey. The survey will assist the
Commission in gathering responses and
data from motor vehicle producers in
the United States to determine the direct
impacts of the ROOs on the
aforementioned factors. Such data are
not publicly available, and without this
information collection, certain aspects
of the Commission’s analysis of the
impact of the ROOs will be less robust
in, or absent from, its report.
The Commission intends to submit
the following draft information
collection plan to the OMB:
(1) Number of forms submitted: 1.
(2) Title of form: The USMCA
Automotive Rules of Origin Motor
Vehicle Producer Questionnaire.
(3) Type of request: New.
(4) Frequency of use: Industry
questionnaire, single data gathering,
scheduled for 2024.
(5) Description of respondents: North
American motor vehicle producers with
U.S. production operations.
(6) Estimated number of questionnaire
requests to be emailed: 30.
(7) Estimated total number of hours to
complete the questionnaire per
respondent: 40 hours.
(8) Information obtained from the
questionnaire that qualifies as
confidential business information will
be so treated by the Commission and not
disclosed in a manner that would reveal
the individual operations of a business.
Information about the investigation
and other supplementary documents
can be accessed on the USITC website
at https://www.usitc.gov/
USMCAAutoROO.
By order of the Commission.
Issued: May 16, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–11184 Filed 5–21–24; 8:45 am]
BILLING CODE 7020–02–P
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]]>Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45012-45015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11183]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1362]
Certain Liquid Transfer Devices With an Integral Vial Adapter;
Notice of a Commission Determination To Review in Part a Final Initial
Determination Finding a Violation of Section 337; Request for Written
Submissions on Issues Under Review and on Remedy, the Public Interest,
and Bonding
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
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SUMMARY: Notice is hereby given that the U.S. International Trade
Commission (``Commission'') has determined to review in part a final
initial determination (``Final ID'') issued by the presiding chief
administrative law judge (``CALJ'') finding a violation of section 337.
The Commission requests written submissions from the parties on the
issue(s) under review and submissions from the parties, interested
government agencies, and other interested persons on the issues of
remedy, the public interest, and bonding, under the schedule set forth
below.
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,
[[Page 45013]]
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''), Dragon Heart Medical Devices Co.,
Ltd. (``Dragon Heart Devices''), Dragon Heart Medical, Inc. (``Dragon
Heart''), and Summit International Medical Technologies, Inc.
(``Summit''). 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 based
on withdrawal of the Complaint. Order No. 9 (Aug. 24, 2023), unreviewed
by Comm'n Notice (Sept. 20, 2023). The '583 mark was terminated from
the investigation by withdrawal of the Complaint. Order No. 12 (Sept.
19, 2023), unreviewed by Comm'n Notice (Oct. 19, 2023). The three
asserted design patents, the D'124 patent, the D'837 patent, and the
D'732 patent, were also terminated from the investigation by withdrawal
of the Complaint. Order No. 14 (Oct. 4, 2023), unreviewed by Comm'n
Notice (Nov. 2, 2023). Accordingly, claim 1 of the '295 patent is the
sole remaining claim.
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).
An evidentiary hearing was held on December 4-5, 2023, and the CALJ
issued the Final ID on March 15, 2024, finding a violation of section
337 based on infringement of claim 1 of the '295 patent. The Final ID
included a Recommended Determination on remedy and bonding,
recommending the issuance of a limited exclusion order and a cease and
desist order. See Final ID at 73-87.
Respondents Summit, Advcare, and Dragon Heart (collectively,
``Respondents'') filed a petition for review of the Final ID on April
6, 2024. OUII also filed a petition for review on April 6, 2024, and
OUII filed a response to Respondents' petition on April 15, 2024.
Complainants filed responses in opposition to both petitions on April
15, 2024. Respondents filed a response to OUII's petition on April 16,
2024.
Having reviewed the record of the investigation, including the
Final ID, Order No. 19, and the parties' petitions for review and
responses thereto, the Commission has determined to review the Final ID
in part. Specifically, the Commission has determined to review the
preclusion of Respondents' and OUII's invalidity arguments and evidence
in Order No. 19 (Dec. 1, 2023). The Commission has also determined to
review the Final ID's findings with respect to standing and
jurisdiction (Final ID at 15-17). In addition, the Commission has
determined to correct an error in the Final ID: On page 13, the
reference to ``one of West's customers'' shall be replaced with ``one
of Summit's customers.'' The Commission has also determined to correct
a typographical error in the Markman Order (Order No. 15): On pages 16
and 17, the references to ``column 4 lines 43 to 45'' and ``4:43-45''
shall be replaced with ``column 4 lines 53 to 55'' and ``4:53-55.'' The
Commission has determined not to review the remaining findings in the
Final ID, including the findings on claim construction, infringement,
and the technical prong of the domestic industry requirement.
In connection with its review, the Commission requests responses to
the following questions. The parties are requested to brief their
positions with reference to the applicable law and the existing
evidentiary record. In your responses to the questions below, please
provide citations, if any, to where you presented these facts and
arguments to the CALJ in connection with Complainants' motion in limine
no. 2.
1. How and when did Respondents and OUII disclose their invalidity
contentions? Was this sufficient notice to Complainants, and how did
Complainants respond to these disclosures?
2. Please explain whether and to what extent the substance of
Respondents' and OUII's written description arguments overlap with
their claim construction and non-infringement arguments? Are the
written description arguments contingent on the claim construction of
``trifurcated connector body'' adopted by the CALJ in Order No. 15 and
the Final ID and by the Commission? Were the full and complete bases
for Respondents' and OUII's alleged written description defense timely
disclosed to Complainants prior to the close of fact and expert
discovery?
3. Did the parties propound discovery requests and produce
discovery regarding the alleged lack of written description under 35
U.S.C. 112? What discovery was produced by each party? Did these
discovery responses provide adequate and timely notice of this
affirmative defense?
4. After Mr. Merchant testified that Summit did not assert any
invalidity defense (Order No. 19 at 4-5), did OUII question Mr.
Merchant regarding any alleged written description invalidity defense?
5. How should Respondents' pro se status affect the Commission's
consideration of Respondents' briefing and representations as to
Respondents' alleged written description defense? Please discuss how
leniency for pro se litigants applies specifically to the facts
concerning Respondents' alleged written description defense under
Federal Circuit and Supreme Court precedent. Explain how Courts
consider prejudice and harm to parties when a pro se litigant fails to
provide adequate and timely notice of an affirmative defense before the
close of discovery.
6. Should OUII be allowed to raise an invalidity defense that was
not pled or disclosed by Respondents? Under the CALJ's Ground Rules and
the Commission's Rules, when and in what form was OUII first required
to disclose its contention that the '295 patent was invalid based on
the affirmative defense of lack of written description? If the
prehearing brief is the earliest time OUII is required to make such
disclosure, how should prejudice to Complainants be considered? Should
OUII be required to respond to any contention interrogatories, if
served upon it by the private parties?
7. Is there ``good cause'' to waive the pleading requirements under
Commission Rule 210.13(b), 19 CFR 210.13(b) (``For good cause, the
presiding administrative law judge may waive any of the substantive
requirements imposed under this paragraph or may impose additional
requirements.''), with respect to Respondents' alleged assertion of
invalidity? Did Respondents or OUII in
[[Page 45014]]
their responses to the motion in limine present an argument that the
CALJ should find good cause to waive the substantive requirement that
the bases of invalidity defenses must be pled in the answer to the
complaint under Rule 210.13(b)?
8. Does Commission Rule 210.14(c), 19 CFR 210.14(c) (``When issues
not raised by the pleadings or notice of investigation, but reasonably
within the scope of the pleadings and notice, are considered during the
taking of evidence by express or implied consent of the parties, they
shall be treated in all respects as if they had been raised in the
pleadings and notice. Such amendments of the pleadings and notice as
may be necessary to make them conform to the evidence and to raise such
issues shall be allowed at any time, and shall be effective with
respect to all parties who have expressly or impliedly consented.''),
apply to the invalidity contentions asserted by Respondents or OUII? Is
Rule 210.14(c) limited by its terms to amendment of pleadings to
conform to the evidence admitted at the hearing by the consent of the
parties? Did Respondents or OUII present an argument to the CALJ in
their responses to the motion in limine that the requirements of Rule
210.14(c) were met?
9. Please discuss any harm or prejudice to the Complainants from
permitting Respondents and/or OUII to present evidence at the hearing
as to the affirmative defense of written description given the facts
submitted in response to questions 1-8 above.
10. Please explain whether and to what extent the Federal Circuit's
decision in Lannom Mfg. Co. v. U.S. Int'l Trade Comm'n, 799 F.2d 1572
(Fed. Cir. 1986) applies to the facts in this investigation. See Order
No. 19 at 6 n.2.
11. If the Commission were to reverse the grant of Complainants'
motion in limine no. 2, can the invalidity defense be decided by the
Commission on review, or should the Commission remand the investigation
to the CALJ for further proceedings?
12. Based on the present record, would claim 1 of the '295 patent
be invalid for lack of written description pursuant to 35 U.S.C. 112
under the Commission's adopted construction for ``trifurcated connector
body'' and applicable case law?
13. Explain the relevance, if any, of the circumstances surrounding
Complainants' voluntary recall of the Vial2Bag DC product in an
assessment of whether the written description shows that the inventors
were in possession of an invention covering the redesigned Vial2Bag
Advanced device as of the filing date of the '295 patent.
14. What additional evidence regarding the written description
defense would the parties have presented at hearing if Complainants'
motion in limine no. 2 had been denied?
The parties are invited to brief only the discrete issues requested
above and the issues of remedy, the public interest, and bonding, as
discussed below. The parties are not to brief other issues on review,
which are adequately presented in the parties' existing filings.
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 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
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.
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 issues 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.
In its initial submission, Complainants are also requested to
identify the remedy sought and Complainants and OUII are requested to
submit proposed remedial orders for the Commission's consideration.
Complainants are further requested to provide the HTSUS subheadings
under which the accused products are imported, and to supply the
identification information for all known importers of the products at
issue in this investigation. The initial written submissions and
proposed remedial orders must be filed no later than close of business
on May 30, 2024. Reply submissions must be filed no later than the
close of business on June 10, 2024. Opening submissions are limited to
80 pages. Reply submissions are limited to 50 pages. 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-1362'') 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 (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. Any non-
party
[[Page 45015]]
wishing to submit comments containing confidential information must
serve those comments on the parties to the investigation pursuant to
the applicable Administrative Protective Order. A redacted non-
confidential version of the document must also be filed simultaneously
with any confidential filing and must be served in accordance with
Commission Rule 210.4(f)(7)(ii)(A) (19 CFR 210.4(f)(7)(ii)(A)). 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 May 16,
2024.
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: May 16, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024-11183 Filed 5-21-24; 8:45 am]
BILLING CODE 7020-02-P
