Notice2026-18101
Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination With the Same; Notice of the Commission's Determination To Lift the Partial Suspension of Enforcement of the Remedial Orders as to U.S. Patent No. 11,697,028
Primary source
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Published
September 4, 2026
Issuing agencies
International Trade Commission
Abstract
Notice is hereby given that the U.S. International Trade Commission ("Commission") has determined to grant a request submitted by Sun Pharmaceutical Industries, Inc. ("Complainant") of Princeton, New Jersey to lift the partial suspension of enforcement of the limited exclusion order ("LEO") and cease and desist orders ("CDOs") as to U.S. Patent No. 11,697,028 ("the '028 patent").
Full Text
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<title>Federal Register, Volume 91 Issue 171 (Friday, September 4, 2026)</title>
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[Federal Register Volume 91, Number 171 (Friday, September 4, 2026)]
[Notices]
[Pages 56900-56901]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18101]
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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 Determination To Lift the Partial Suspension of
Enforcement of the Remedial Orders as to U.S. Patent No. 11,697,028
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 grant a request submitted
by Sun Pharmaceutical Industries, Inc. (``Complainant'') of Princeton,
New Jersey to lift the partial suspension of enforcement of the limited
exclusion order (``LEO'') and cease and desist orders (``CDOs'') as to
U.S. Patent No. 11,697,028 (``the '028 patent'').
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#afeaebe6fc9ce7cac3dfefdadcc6dbcc81c8c0d9"><span class="__cf_email__" data-cfemail="e0a5a4a9b3d3a8858c90a09593899483ce878f96">[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 Complainant. 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 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 Respondents as
respondents. Id. The Office of Unfair Import Investigations was not a
party to this investigation. Id.
On September 30, 2026, the presiding administrative law judge
issued a final initial determination (``FID'') finding a violation of
section 337 with respect to each of the asserted claims. As relevant to
the subject request, the FID finds that the asserted claims of the '028
patent are not invalid as obvious.
On January 28, 2026, the Commission determined to review the FID in
part. 91 FR 4630 (Feb. 2, 2026). As relevant to the current request,
the Commission determined to review the FID's finding that the asserted
claims of the '028 patent are not invalid as obvious.
On February 23, 2026, the Patent Trial and Appeal Board issued a
final written decision (``FWD'') finding all asserted claims of the
'028 patent invalid as obvious.
On May 6, 2026, the Commission issued a final determination finding
a violation of section 337 by Respondents with respect to all remaining
asserted claims. 91 FR 25595-96 (May 11, 2026). As relevant to the
subject request, the Commission affirmed the FID's finding that the
asserted claims of the '028 patent are not invalid as obvious and found
a violation of section 337 as to the '028 patent and the '512 patent.
Id. at 25596. The Commission determined to issue an LEO and CDOs as to
each of Respondents and also set a bond in the amount of zero percent
during the period of Presidential review. Id. However, the Commission
suspended enforcement of the remedial orders in part upon issuance as
to the '028 patent, in light of the FWD. Id.
On July 29, 2026, the Director of the United States Patent and
Trademark Office issued an order vacating the FWD in its entirety. See
Biofrontera Inc. et al. v. Sun Pharm. Indus. Inc., IPR2024-01312, Paper
No. 58 (Order) (July 29, 2026).
On July 31, 2026, Complainant submitted a letter requesting that
the
[[Page 56901]]
Commission take judicial notice of the order vacating the FWD and lift
the suspension of enforcement of the remedial orders as to the '028
patent.
The Commission, having reviewed the record in this investigation,
including Complainant's letter and the Director's order vacating the
FWD, has determined to lift the suspension of enforcement of the
remedial orders as to the '028 patent.
The Commission vote for this determination took place on September
1, 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: September 1, 2026.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2026-18101 Filed 9-3-26; 8:45 am]
BILLING CODE 7020-02-P
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