U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma’s Patent 11,697,028 To Be Unpatentable
Rhea-AI Summary
Biofrontera (Nasdaq: BFRI) announced the U.S. Patent Trial and Appeal Board issued a Final Written Decision on Feb 23, 2026 finding all challenged claims of Sun Pharma’s U.S. Patent No. 11,697,028 unpatentable. Biofrontera had filed Inter Partes Review petitions after Sun Pharma sued for alleged infringement in June 2024.
The decision does not affect Biofrontera’s separate petition on the ’512 patent, which the Patent Office denied review for administrative reasons. Sun Pharma may seek rehearing or appeal to the Federal Circuit.
Positive
- PTAB decision found all challenged ’028 claims unpatentable
- Legal risk reduced from the ’028 patent for Biofrontera
Negative
- Sun Pharma retains right to seek rehearing or appeal
- Company’s petition on the ’512 patent denied review administratively
News Market Reaction – BFRIW
On the day this news was published, BFRIW gained 35.53%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
WOBURN, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- 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.
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 Biofrontera (BFRI) announce about the PTAB decision on Feb 23, 2026?
How does the PTAB decision affect Biofrontera’s litigation with Sun Pharma (BFRI)?
Can Sun Pharma challenge the PTAB Final Written Decision affecting the ’028 patent versus BFRI?
What is the status of Biofrontera’s petition on Sun Pharma’s ’512 patent (BFRI)?
Does the PTAB decision immediately end Sun Pharma’s infringement claims against Biofrontera (BFRI)?
