Notice2024-11183
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
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Published
May 22, 2024
Issuing agencies
International Trade Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 100 (Wednesday, May 22, 2024)</title>
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[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45012-45015]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#fabfbeb3a9c9b29f968aba8f89938e99d49d958c"><span class="__cf_email__" data-cfemail="0a4f4e435939426f667a4a7f79637e69246d657c">[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 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, <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 (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
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