Notice2026-01954
Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination With the Same; Notice of a Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions on Remedy, the Public Interest, and Bonding
Primary source
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Published
February 2, 2026
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 ("FID") of the presiding administrative law judge ("ALJ"), finding a violation of section 337 of the Tariff Act of 1930, as amended. The Commission requests written 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 91 Issue 21 (Monday, February 2, 2026)</title>
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[Federal Register Volume 91, Number 21 (Monday, February 2, 2026)]
[Notices]
[Pages 4630-4631]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01954]
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INTERNATIONAL TRADE COMMISSION
[Investigation No. 337-TA-1411]
Certain Photodynamic Therapy Systems, Components Thereof, and
Pharmaceutical Products Used in Combination With the Same; Notice of a
Commission Determination To Review in Part a Final Initial
Determination Finding a Violation of Section 337; Request for Written
Submissions 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 (``FID'') of the presiding administrative law
judge (``ALJ''), finding a violation of section 337 of the Tariff Act
of 1930, as amended. The Commission requests written 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: B. Rashmi Borah, Esq., Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW,
Washington, DC 20436, telephone (202) 205-2518. 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#aaefeee3f999e2cfc6daeadfd9c3dec984cdc5dc"><span class="__cf_email__" data-cfemail="2f6a6b667c1c674a435f6f5a5c465b4c01484059">[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 August 1, 2024, based on a complaint filed by Sun Pharmaceutical
Industries, Inc. (``Complainant'') of Princeton, New Jersey. 89 FR
62790 (Aug. 1, 2024). The complaint, as supplemented, alleges
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 photodynamic therapy systems, components
thereof, and pharmaceutical products used in combination with the same
by reason of infringement of certain claims of the U.S. Patent Nos.
11,446,512 (``the '512 patent'') and 11,697,028 (collectively, ``the
Asserted Patents''). Id. The complaint further alleges that a domestic
industry exists or is in the process of being established. Id. The
notice of investigation names four respondents: (1) Biofrontera Inc. of
Woburn, Massachusetts; (2) Biofrontera Pharma GmbH of Leverkusen,
Germany; (3) Biofrontera Bioscience GmbH of Leverkusen, Germany; and
(4) Biofrontera AG of Leverkusen, Germany (collectively,
``Respondents''). Id. The Office of Unfair Import Investigations is not
a party to this investigation. Id.
On November 20, 2024, the Commission amended the complaint and
notice of investigation to add infringement allegations as to claims 17
and 18 of the '512 patent. Order No. 8 (Oct. 22, 2024), unreviewed by
Comm'n Notice (Nov. 20, 2024).
On June 25, 2025, the ALJ issued Order No. 23 granting, pursuant to
Commission Rule 210.18 (19 CFR 210.18), Complainant's motion for
summary determination that it has satisfied the economic prong of the
domestic industry requirement.
On July 25, 2025, the Commission determined to review Order No. 23.
Comm'n Notice at 2 (July 25, 2025).
On September 30, 2025, the ALJ issued the FID, finding a violation
of section 337. The FID finds that: (1) claims 1, 3, 5, 8, 17-18, and
20 of the '512 patent and claims 1, 2, 4, 16, 17, and 19-21 of the '028
patent, are directly infringed; (2) claims 8, 17, and 18 of the '512
patent are indirectly infringed via inducement; (3) none of the claims
asserted for infringement and/or domestic industry are invalid under 35
U.S.C. 103 and/or 112, ] 1; and (4) Complainant has satisfied the
technical prong of the domestic industry requirement for both Asserted
Patents by practicing claims 1, 2, 4, 5, 8, 19, and 20 of the '512
patent and claims 1, 3, 4, 5, 7, 9, 16-18, and 21 of the '028 patent.
The FID also includes the ALJ's recommended determination (``RD'') on
remedy, the public interest, and bonding, should the Commission find a
violation of section 337. Specifically, the RD recommends entry of a
limited exclusion order against Respondents' infringing products, entry
of a cease and desist orders against Respondents, and a bond of zero
percent for any importations of infringing products during the period
of Presidential review.
On November 17, 2025, Complainant filed a petition for review
seeking review of the following findings: (1) that the preamble of each
asserted claim is limiting and (2) the RD's recommendation to set a
bond of zero percent for any importations of infringing products during
the period of Presidential review. On the same day, Respondents filed a
petition for review seeking review of the following findings: (1) that
the claim terms ``nested hinges'' and ``higher intensity proximate''
are not indefinite; (2) that the asserted claims are not invalid under
35 U.S.C. 103 for obviousness, or under Sec. 112 ] 1 for lack of
written description; (3) that certain claims are either directly or
indirectly infringed; and (4) that certain declarations from inter
partes review proceedings are admissible. On November 24, 2025,
Complainant and Respondents filed their respective petition responses.
Having reviewed the record of the investigation, including the FID,
and the parties' submissions, the Commission has determined to review
the FID in part. Specifically, the Commission has determined to review:
(1) the construction of the claim term ``nested hinges'' and (2)
whether the asserted claims of the Asserted Patents are invalid under
35 U.S.C. 103 for obviousness. The Commission has determined not to
review the remainder of the FID. Order No. 23 remains under Commission
review. Comm'n Notice at 2 (July 25, 2025). The Commission will
consider the reviewed issues identified above as well as any issues
concerning Order No. 23 and the RD in connection with the final
disposition of this Investigation.
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
[[Page 4631]]
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. Such
submissions should address the recommended determination by the ALJ on
remedy and bonding.
In its initial submission, Complainant is also requested to
identify the remedy sought and Complainant is requested to submit
proposed remedial orders for the Commission's consideration.
Complainant is further requested to state the dates that the Asserted
Patents expire, 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. All initial written submissions, from the parties and/or
third parties/interested government agencies, and proposed remedial
orders from the parties must be filed no later than close of business
on February 11, 2026. All reply submissions must be filed no later than
the close of business on February 18, 2026. Opening submissions from
the parties are limited to 25 pages. Reply submissions from the parties
are limited to 15 pages. All submission from third parties and/or
interested government agencies are limited to 10 pages. No further
submissions on any of 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 pursuant to 19
CFR 210.4(f). Submissions should refer to the investigation number
(Inv. No. 337-TA-1411) 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 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 January
28, 2026.
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).
By order of the Commission.
Issued: January 28, 2026.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2026-01954 Filed 1-30-26; 8:45 am]
BILLING CODE 7020-02-P
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