Biofrontera (NASDAQ: BFRI) wins PTAB decision on Sun Pharma patent claims
Rhea-AI Filing Summary
Biofrontera Inc. reports a significant development in its patent dispute with Sun Pharmaceutical Industries. On February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun’s U.S. Patent No. 11,697,028 unpatentable.
Sun may still request rehearing, seek review by the Director of the U.S. Patent and Trademark Office, or appeal to the U.S. Court of Appeals for the Federal Circuit, so the outcome is not yet final. The company notes that the impact of this decision on ongoing proceedings in the U.S. District Court for the District of Massachusetts and the International Trade Commission cannot be determined at this time.
Positive
- None.
Negative
- None.
Insights
Patent board backs Biofrontera on key Sun patent, but appeals remain.
The U.S. Patent Trial and Appeal Board issued a Final Written Decision on
Sun retains several options: it can seek rehearing, petition the USPTO Director for review, or appeal to the Federal Circuit. The company states that the impact of this decision on the Massachusetts federal case and ITC matter is not determinable from today’s information, underscoring continued legal uncertainty.
The other asserted patent, U.S. Patent No. 11,446,512, is unaffected because the related petition was denied review on administrative grounds rather than on the merits. Future court and agency decisions will shape how this PTAB ruling influences Biofrontera’s PDT-focused dermatology business.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code:
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (the “Exchange Act”) (§240.12b-2 of this chapter).
Emerging
growth company
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01 Other Events
As previously disclosed in reports filed by Biofrontera Inc. (the “Company”) with the Securities and Exchange Commission, in June 2024, Sun Pharmaceutical Industries, Inc. (“Sun”) instituted proceedings against the Company and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of two patents held by Sun (the “Sun Patents”). In connection with these proceedings, the Company challenged the validity of the Sun Patents by filing separate petitions for review at the U.S. Patent Trial and Appeal Board (the “Board”) for each of the Sun Patents.
On February 23, 2026, the Board issued a Final Written Decision (the “Decision”) finding all challenged claims of Sun’s U.S. Patent No. 11,697,028 unpatentable. Sun has the right to request a rehearing of the Decision, to petition the Director of the U.S. Patent and Trademark Office for review of the Decision, and to appeal the Decision to the United States Court of Appeals for the Federal Circuit. The Decision does not affect the petition filed by the Company relating to the other Sun Patent, which was denied review by the Board.
The impact of the Decision on the proceedings pending in the U.S. District Court for the District of Massachusetts and the International Trade Commission is not determinable at this time. For additional information regarding the proceedings, reference is made to Note 18 to the Condensed Consolidated Financial Statements included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025.
The Company issued a press release regarding the foregoing matters on February 26, 2026. The full text of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The information contained in Item 8.01 of this Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
| 99.1 | Press Release dated February 26, 2026 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
February 26, 2026 (Date) |
Biofrontera Inc. (Registrant) |
/s/ E. Fred Leffler III | |
| E. Fred Leffler III | |
| Chief Financial Officer |
Exhibit 99.1
U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma’s Patent 11,697,028 To Be Unpatentable
WOBURN, Mass., February 26, 2026 — Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization and development of photodynamic therapy (“PDT”), today announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board (the “Board”) issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries, Inc.’s U.S. Patent No. 11,697,028 (the “’028 Patent”) to be unpatentable.
As previously disclosed in Biofrontera’s filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of the ‘028 Patent and a related patent, U.S. Patent No. 11,446,512 (the “’512 Patent”). In response to these proceedings, Biofrontera challenged the validity of Sun Pharma’s asserted claims by filing petitions for Inter Partes Review with the Board. The Board has now agreed with Biofrontera on all challenged claims of the ‘028 Patent.
Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit. The decision does not affect the petition filed by the Company relating to the ‘512 patent, which was denied review by the Patent Office on administrative, rather than substantive, grounds.
“Biofrontera is pleased with the Board’s Final Written Decision.,” commented Hermann Luebbert, CEO and Chairman of Biofrontera . “We remain focused on clinical research and development in the PDT space to better serve clinicians and improve their patients’ lives.”
About Biofrontera Inc.
Biofrontera is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers1. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.
1. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera’s commercial opportunities and the commercial success of its products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the conduct and outcomes involved in commercial litigation; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED® and/or RhodoLED® XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
Investor Relations
Ben Shamsian
646-829-9701
shamsian@lythampartners.com
FAQ
What did the U.S. Patent Trial and Appeal Board decide regarding Biofrontera (BFRI) and Sun Pharma?
How does the PTAB decision affect Biofrontera’s ongoing litigation with Sun Pharma?
Can Sun Pharma appeal the Patent Trial and Appeal Board ruling mentioned by Biofrontera (BFRI)?
Does the PTAB decision involve Sun Pharma’s other patent asserted against Biofrontera (BFRI)?
What products and therapeutic area does Biofrontera Inc. (BFRI) focus on?
Where can investors find more details on Biofrontera’s (BFRI) litigation with Sun Pharma?
Filing Exhibits & Attachments
6 documents