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 – BFRI

+1.23%

1 alert

+1.23% News Effect

On the day this news was published, BFRI gained 1.23%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Final Written Decision date: February 23, 2026 Sun patent number: U.S. Patent No. 11,697,028 Related patent number: U.S. Patent No. 11,446,512 +1 more

4 metrics

Final Written Decision date February 23, 2026 Date PTAB found all challenged claims of ’028 patent unpatentable

Sun patent number U.S. Patent No. 11,697,028 Patent whose challenged claims were found unpatentable by PTAB

Related patent number U.S. Patent No. 11,446,512 Separate Sun Pharma patent; Biofrontera petition denied review on administrative grounds

Litigation start June 2024 Month Sun Pharma initiated infringement proceedings against Biofrontera

Market Reality Check

Price: $0.9116 Vol: Volume 241,571 vs 20-day ...

low vol

$0.9116 Last Close

Volume Volume 241,571 vs 20-day average 891,680 (relative volume 0.27x) indicates subdued trading interest. low

Technical Price $0.9155 is trading above the 200-day MA at $0.85, reinforcing a modestly improving trend into this legal update.

Peers on Argus

BFRI is up 7.76% while momentum-screened peers are mixed: SBFM up 4.27% and YCBD...

1 Up 1 Down

BFRI is up 7.76% while momentum-screened peers are mixed: SBFM up 4.27% and YCBD down 4.07%. With peers moving in opposite directions and no same-day peer news, the move appears stock-specific rather than sector-driven.

Historical Context

5 past events · Latest: Feb 17 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 17	Clinical PK milestone	Positive	+6.6%	Phase 1 PK study database lock for Ameluz supporting planned sNDA in Q3 2026.
Feb 11	sNDA accepted	Positive	-1.3%	FDA acceptance of sNDA for Ameluz PDT in superficial basal cell carcinoma.
Feb 09	Phase 3 success	Positive	-1.3%	Positive Phase 3 AK results with Ameluz PDT meeting primary endpoint.
Jan 13	Record revenues	Positive	+0.9%	Preliminary Q4 2025 record revenue and double‑digit full‑year growth guidance.
Jan 08	Data locks	Positive	+3.1%	Database locks for Phase 3 AK and Phase 2 acne studies enabling topline readouts.

Pattern Detected

Recent news shows 3 aligned and 2 divergent price reactions to generally positive catalysts, indicating inconsistent follow-through on good news.

Recent Company History

Over the past few months, Biofrontera reported multiple clinical milestones for Ameluz®, including positive Phase 3 AK data (Feb 9, 2026) and database locks for key studies (Jan 5, 2026), alongside FDA acceptance of a supplemental NDA for sBCC with a PDUFA date of September 28, 2026. The company also disclosed record preliminary Q4 2025 revenue between $17.0M and $17.5M and full-year 2025 revenue of $41.5M–$42.0M. Today’s patent decision complements this clinical and commercial progress by easing competitive IP pressure.

Market Pulse Summary

This announcement highlights a favorable U.S. Patent Trial and Appeal Board decision finding all cha...

Analysis

This announcement highlights a favorable U.S. Patent Trial and Appeal Board decision finding all challenged claims of Sun Pharma’s ’028 patent unpatentable, potentially easing legal pressure on Biofrontera. It complements recent milestones, including positive Phase 3 Ameluz® data and record preliminary Q4 2025 revenues between $17.0M and $17.5M. Investors should also weigh prior disclosures on liquidity constraints and Nasdaq minimum bid‑price compliance, monitoring future clinical, regulatory, and capital-structure updates for a fuller risk picture.

Key Terms

photodynamic therapy, pdt, patent trial and appeal board, inter partes review

4 terms

photodynamic therapy medical

"a biopharmaceutical company specializing in the commercialization and development of photodynamic therapy"

Photodynamic therapy is a medical treatment that uses a special light-sensitive substance and a specific type of light to target and destroy abnormal or diseased cells, often in cancer treatment. It is important to investors because advances in this technology can lead to new, minimally invasive treatment options, potentially expanding healthcare markets and driving growth for biotech companies involved in developing such therapies.

pdt medical

"development of photodynamic therapy (“PDT”), today announced that on February 23, 2026"

PDT stands for “pattern day trader,” a regulatory designation applied to brokerage accounts that make frequent same-day buy-and-sell trades within a short period. It matters because once an account is labeled, the broker requires a minimum equity balance and imposes limits on how often the account can trade, which is like needing a higher license to drive faster — it changes how easily and quickly an investor can execute active trading strategies.

patent trial and appeal board regulatory

"the U.S. Patent Trial and Appeal Board (the “Board”) issued a Final Written Decision"

The Patent Trial and Appeal Board is an administrative body that reviews and decides challenges to the validity of issued patents and hears appeals of patent office decisions. For investors, its rulings can make or break a company’s exclusive rights to a product or technology—similar to a referee overturning a game-winning call—affecting future revenue, legal costs, and the value of related securities.

inter partes review regulatory

"by filing petitions for Inter Partes Review with the Board."

An inter partes review is a formal proceeding at the U.S. Patent Office where a third party asks a panel to re-examine and possibly cancel all or part of an issued patent based on earlier public information. Investors care because the outcome can remove or uphold a company’s exclusive rights, directly affecting product exclusivity, potential revenue, legal exposure and the valuation of businesses that rely on that patent—like asking a neutral referee to re-check a key call in a game.

AI-generated analysis. Not financial advice.

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.

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 Biofrontera (BFRI) announce about the PTAB decision on Feb 23, 2026?

The PTAB issued a Final Written Decision finding all challenged claims of the ’028 patent unpatentable. According to the company, Biofrontera’s Inter Partes Review petitions prevailed on every challenged claim.

How does the PTAB decision affect Biofrontera’s litigation with Sun Pharma (BFRI)?

The PTAB ruling removes asserted patent strength tied to the ’028 patent, easing infringement pressure. According to the company, this supports Biofrontera’s defense while Sun Pharma may still appeal.

Can Sun Pharma challenge the PTAB Final Written Decision affecting the ’028 patent versus BFRI?

Yes. Sun Pharma may request rehearing from the Board or appeal to the Federal Circuit. According to the company, those are the remaining procedural options.

What is the status of Biofrontera’s petition on Sun Pharma’s ’512 patent (BFRI)?

The petition relating to the ’512 patent was denied review for administrative reasons, not on substance. According to the company, that petition’s substantive validity challenge remains unresolved by the PTAB.

Does the PTAB decision immediately end Sun Pharma’s infringement claims against Biofrontera (BFRI)?

No. The PTAB decision resolves patentability for the ’028 claims but does not automatically dismiss district court or ITC claims. According to the company, Sun Pharma retains appellate and procedural options.