The U.S. Patent Trial and Appeal Board issued a Final Written Decision on February 23, 2026 that found all challenged claims of Sun Pharmaceutical Industries’ U.S. Patent No. 11,697,028 unpatentable. The Board’s decision was publicly announced on February 26, 2026 and applies directly to Biofrontera Inc., which had been facing potential infringement litigation over the patent’s claims.
The ruling eliminates a major legal risk for Biofrontera, freeing the company to concentrate on research and development of its photodynamic therapy (PDT) portfolio, particularly the Ameluz® product and its associated RhodoLED lamp series. By removing the threat of costly infringement litigation, the decision strengthens Biofrontera’s intellectual‑property position and supports a clearer path for commercialization and future product expansion.
While the decision removes liability for Patent No. 11,697,028, Sun Pharmaceutical retains the right to request a 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. Additionally, the Board’s ruling does not affect Biofrontera’s petition concerning Sun Pharma’s related U.S. Patent No. 11,446,512, which was denied review on administrative grounds. Consequently, some legal uncertainty remains in the broader dispute.
"Biofrontera is pleased with the Board's Final Written Decision. We remain focused on clinical research and development in the PDT space to better serve clinicians and improve their patients' lives," said Hermann Luebbert, CEO and Chairman of Biofrontera.
The lawsuit that led to this PTAB proceeding was initiated by Sun Pharmaceutical in June 2024, marking the latest chapter in a series of legal confrontations between the two companies over patent rights in the PDT field.
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