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[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Page 92976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27568]

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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 
Commission Determination Not To Review an Initial Determination 
Granting in Part Complainant's Motion To Amend the Complaint and Notice 
of 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 has determined not to review an initial determination 
(``ID'') (Order No. 8) of the presiding administrative law judge 
(``ALJ'') issued in the above-captioned investigation, granting in part 
complainant's motion to amend the complaint and notice of investigation 
(``NOI'') to add infringement allegations as to claims 17 and 18 of 
U.S. Patent No. 11,446,512 (``the '512 patent'').

FOR FURTHER INFORMATION CONTACT: Richard P. Hadorn, Esq., Office of the 
General Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 205-3179. 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, telephone (202) 205-1810.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on August 1, 2024, based on a complaint filed by Sun Pharmaceutical 
Industries, Inc. (``Sun Pharma'') 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 '512 patent and U.S. Patent No. 
11,697,028 (``the '028 patent''). 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, ``Biofrontera''). Id. The Office of Unfair Import 
Investigations is not a party to this investigation. Id.
    On October 7, 2024, Sun Pharma filed a motion to amend the 
complaint and NOI to add infringement allegations as to claims 9, 11, 
17, and 18 of the '512 patent and claims 10 and 12 of the '028 patent. 
On October 17, 2024, Biofrontera filed a response opposing-in-part the 
motion. Specifically, Biofrontera did not oppose the motion with 
respect to adding infringement allegations as to claims 17 and 18 of 
the '512 patent, but opposed the remainder of the motion.
    On October 22, 2024, the ALJ issued the subject ID granting the 
motion in part. The ID finds that, in accordance with Commission Rule 
210.14(b) (19 CFR 210.14(b)), good cause exists for amending the 
complaint and NOI to add infringement allegations as to claims 17 and 
18 of the '512 patent, noting that ``Biofrontera agrees that Sun 
Pharma's allegations with respect to these claims are based on 
information obtained through discovery.'' ID at 3. The ALJ, however, 
found that Sun Pharma has not shown the requisite good cause to amend 
the complaint and NOI to add infringement allegations as to claims 9 
and 11 of the '512 patent and claims 10 and 12 of the '028 patent 
because ``Sun Pharma failed to demonstrate why it was unable to bring 
the allegations [of those claims] in the complaint.'' Id. at 3-5. No 
petitions for review of the subject ID were filed.
    The Commission has determined not to review the subject ID. The 
complaint and NOI are amended to add infringement allegations as to 
claims 17 and 18 of the '512 patent.
    The Commission vote for this determination took place on November 
20, 2024.
    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: November 20, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024-27568 Filed 11-22-24; 8:45 am]
BILLING CODE 7020-02-P
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