Notice2026-09243
Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination With the Same; Notice of the Commission's Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order and Cease and Desist Orders; Termination of the Investigation
Primary source
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Published
May 11, 2026
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission ("Commission") has found a violation of section 337 in the above-captioned investigation. The Commission has determined to issue a limited exclusion order ("LEO") prohibiting the unlicensed entry of infringing oil vaporizing devices, components thereof, and products containing the same that are manufactured by or on behalf of, or imported by or on behalf of, the respondents and cease and desist orders ("CDOs") against every named respondent. The investigation is terminated.
Full Text
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<title>Federal Register, Volume 91 Issue 90 (Monday, May 11, 2026)</title>
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[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Notices]
[Pages 25595-25596]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09243]
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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
the Commission's Final Determination Finding a Violation of Section
337; Issuance of a Limited Exclusion Order and Cease and Desist Orders;
Termination of the Investigation
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 found a violation of section 337 in the
above-captioned investigation. The Commission has determined to issue a
limited exclusion order (``LEO'') prohibiting the unlicensed entry of
infringing oil vaporizing devices, components thereof, and products
containing the same that are manufactured by or on behalf of, or
imported by or on behalf of, the respondents and cease and desist
orders (``CDOs'') against every named respondent. The investigation is
terminated.
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#e0a5a4a9b3d3a8858c90a09593899483ce878f96"><span class="__cf_email__" data-cfemail="60252429335328050c102015130914034e070f16">[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 (``the '028 patent'')
(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 each of 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.
On January 28, 2026, the Commission determined to review the FID in
part. 91
[[Page 25596]]
FR 4630 (Feb. 2, 2026). Specifically, the Commission determined to
review: (1) the construction of the claim term ``nested hinges'' and
(2) whether the asserted claims of the Asserted Patents are invalid as
obvious. Id. The notice also reiterates that Order No. 23 remains under
review. Id. The Commission did not request briefing on any of the
issues under review. The notice also requested submissions on remedy,
the public interest, and bonding. Id. at 4631.
On February 11, 2026, Complainant and Respondents submitted their
respective initial submissions on remedy, the public interest, and
bonding. On February 18, 2026, Complainant the parties submitted their
respective replies.
On February 24, 2026, Respondents submitted a letter requesting
that the Commission take judicial notice of a final written decision
(``FWD'') issued by the U.S. Patent and Trademark Office Patent Trial
and Appeal Board (``Board'') finding claims 1, 2, 4-6, 16, 17, and 19-
21 of the '028 patent unpatentable as obvious. On March 5, 2026, the
Commission requested additional briefing from the parties on ``whether,
and to what extent, the FWD should impact the Commission's
determination regarding the validity of the asserted claims of both the
'028 patent and the '512 patent.'' Comm. Not. at 3 (Mar. 5, 2026). On
March 12, 2026, the parties submitted their initial responses. On March
19, 2026, the parties submitted their responsive submissions.
Having examined the record in this investigation, including the
FID, the parties' petitions for review and responses thereto, the
parties' submissions regarding the FWD and responses thereto, and the
submissions to the Commission regarding remedy, the public interest,
and bonding, the Commission has determined to find a violation of
section 337 as to both Asserted Patents. As set forth in the
simultaneously-issued Commission opinion, the Commission affirms the
construction of the claim term ``nested hinges'' with modified
reasoning. The Commission also affirms the FID's findings that none of
the asserted claims of the Asserted Patents are invalid as obvious,
with modified and additional reasoning. Finally, the Commission affirms
Order No. 23's finding that Complainant has satisfied the economic
prong of the domestic industry requirement under section 337(a)(3)(B)
with modified reasoning.
The Commission has determined that the appropriate form of relief
is an LEO prohibiting the unlicensed entry of infringing photodynamic
therapy systems, components thereof, and pharmaceutical products used
in combination with the same that are manufactured by or on behalf of
Respondents or any of their affiliated companies, parents,
subsidiaries, or other related business entities, or their successors
or assigns. The Commission has also determined to issue CDOs against
each of Respondents. The Commission has determined to suspend the
orders as to the '028 patent in light of the FWD, pending any further
action before the Board and any potential appeals.
The Commission has further determined that the public interest
factors enumerated in subsections (d)(l) and (f)(1) (19 U.S.C.
1337(d)(l), (f)(1)) do not preclude issuance of the above-referenced
remedial orders. Additionally, the Commission has determined to impose
a bond in the amount of zero percent (0%) of the infringing products
imported during the period of Presidential review (19 U.S.C. 1337(j)).
The investigation is terminated.
The Commission vote for this determination took place on May 6,
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: May 6, 2026.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2026-09243 Filed 5-8-26; 8:45 am]
BILLING CODE 7020-02-P
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