[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

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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