Notice2024-27568
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 25, 2024
Issuing agencies
International Trade Commission
Abstract
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").
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 227 (Monday, November 25, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Page 92976]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27568]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://edis.usitc.gov">https://edis.usitc.gov</a>. For help accessing EDIS, please email
<a href="/cdn-cgi/l/email-protection#793c3d302a4a311c1509390c0a100d1a571e160f"><span class="__cf_email__" data-cfemail="0540414c56364d6069754570766c71662b626a73">[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, 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 25, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.