U.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma's Patent 11,697,028 To Be Unpatentable
MWN-AI** Summary
Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on photodynamic therapy (PDT), announced a significant legal victory on February 23, 2026, when the U.S. Patent Trial and Appeal Board (PTAB) declared all challenged claims of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028 unpatentable. This decision comes amid ongoing litigation initiated by Sun Pharma in June 2024, where they accused Biofrontera and its affiliates of infringing on the '028 Patent and an associated patent, U.S. Patent No. 11,446,512.
In response to these claims, Biofrontera sought to challenge the validity via Inter Partes Review petitions to the Board. The PTAB's unanimous finding aligns with Biofrontera's position and marks a pivotal moment in the ongoing dispute. Following this decision, Sun Pharma retains the option to appeal the ruling to the U.S. Court of Appeals for the Federal Circuit. It is also noteworthy that the decision does not impact the status of the '512 Patent; the Patent Office previously declined to review that petition on administrative grounds.
Hermann Luebbert, CEO and Chairman of Biofrontera, expressed satisfaction with the ruling, underscoring the company’s commitment to advancing clinical research and development in the PDT field. Biofrontera specializes in treatments for dermatological conditions, specifically targeting pre-cancerous skin lesions with its product Ameluz®, designed to work alongside the RhodoLED® lamp system.
As Biofrontera continues to enhance its portfolio and clinical capabilities, it acknowledges that various risks exist in the pharmaceutical sector, including uncertainties tied to litigation outcomes and clinical trial results. The company's strategic focus remains on delivering innovative solutions to dermatological challenges and fulfilling unmet patient needs.
MWN-AI** Analysis
The recent U.S. Patent Trial and Appeal Board's (PTAB) decision to invalidate all challenged claims of Sun Pharma's U.S. Patent No. 11,697,028 is a significant development for Biofrontera Inc. (Nasdaq: BFRI) and its market positioning. This ruling could enhance Biofrontera's competitive landscape in the photodynamic therapy (PDT) space, especially for its flagship product, Ameluz®, used to treat dermatological conditions, including actinic keratosis and potentially non-melanoma skin cancers.
From an investment perspective, this decision may serve as a catalyst for Biofrontera's stock, given the removal of potential litigation threats associated with the '028 Patent. Historically, patent litigation can drain resources and create uncertainty for companies, especially in the volatile biotech sector. With this legal hurdle cleared, Biofrontera can redirect its focus towards clinical research and expanding indications for Ameluz®. Investors should watch for any forthcoming announcements regarding new clinical trials or product expansions, which could drive significant revenue growth.
However, it is essential to remain cautious. The unresolved patent dispute over Sun Pharma's U.S. Patent No. 11,446,512 could still pose risks, even if the '028 Patent is no longer a concern. Furthermore, the company faces intrinsic and extrinsic risks typical in the biopharmaceutical sector, such as the uncertainties of clinical trial outcomes and regulatory approvals.
Overall, while the recent ruling positively impacts Biofrontera's short-term prospects, investors should consider the broader patent landscape and clinical trial developments. As always, maintaining a diversified portfolio remains prudent, given the inherent volatility and risks associated with biotech investments. Investors are advised to stay tuned for further updates from Biofrontera to better gauge the long-term viability of their investment in the wake of these developments.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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**
How does the Board's Final Written Decision regarding the unpatentability of Sun Pharma's ‘028 Patent impact the future commercialization efforts of Biofrontera Inc. Warrants BFRIW?
In light of the ongoing litigation, what strategies does Biofrontera Inc. Warrants BFRIW have to mitigate potential risks associated with the appeal process regarding the ‘0Patent?
Can Biofrontera Inc. Warrants BFRIW provide insights into how the outcome of the patent challenges may affect its R&D investments in the PDT market?
With the decision on the ‘028 Patent being favorable, how does Biofrontera Inc. Warrants BFRIW plan to capitalize on this milestone in terms of market expansion or product development?
**MWN-AI FAQ is based on asking OpenAI questions about Biofrontera Inc. (NASDAQ: BFRI).
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