Biofrontera Pharma GMBH et al. v. Sun Pharmaceutical Industries Inc.

The case Biofrontera Pharma GMBH et al. v. Sun Pharmaceutical Industries Inc. (IPR2024-01312) is an Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. This IPR was initiated by Biofrontera Pharma GMBH, Biofrontera Inc., Biofrontera Bioscience GMBH, and Biofrontera AG (collectively, "Biofrontera") to challenge the validity of U.S. Patent No. 11,697,028, owned by Sun Pharmaceutical Industries Inc. ("Sun Pharma").

Biofrontera is a biopharmaceutical company specializing in the development and commercialization of dermatological drugs, with its lead product being Ameluz®, a topical prescription drug used in photodynamic therapy (PDT) for certain skin cancers and precancerous lesions, in combination with its RhodoLED® lamp series. Sun Pharmaceutical Industries Inc. is a global pharmaceutical company headquartered in India, known for manufacturing, developing, and marketing a wide range of branded and generic pharmaceutical products across various therapeutic areas, including dermatology.

The patent at issue, U.S. Patent No. 11,697,028, titled "Adjustable illuminator for photodynamic therapy and diagnosis," covers technology related to light-delivery systems used in photodynamic therapy. While IPRs do not involve an "accused product" in the same way as traditional infringement litigation, the validity challenge was a direct response to patent infringement proceedings initiated by Sun Pharma against Biofrontera in June 2024. Sun Pharma had alleged that Biofrontera infringed the '028 patent and a related patent, U.S. Patent No. 11,446,512, in the U.S. District Court for the District of Massachusetts (case 1:2024cv11637) and the International Trade Commission (ITC Inv. No. 337-TA-1411).

The procedural posture of this case is an IPR before the PTAB, which concluded with a Final Written Decision on February 23, 2026. In this decision, the PTAB ruled in favor of Biofrontera, finding all challenged claims of Sun Pharma's U.S. Patent No. 11,697,028 to be unpatentable. This venue, the PTAB, is critical for challenging patent validity based on prior art, and a successful IPR can significantly impact ongoing or potential patent infringement litigation. The case is notable because the PTAB's decision to invalidate Sun Pharma's patent claims directly undermines Sun Pharma's earlier infringement allegations against Biofrontera in district court and the ITC, where Sun Pharma had already secured a "Violation Found" judgment on the merits at the ITC concerning both the '028 and '512 patents. This outcome represents a significant victory for Biofrontera, potentially clearing the way for its Ameluz® product in the market by removing a key patent asserted against it. Sun Pharma retains the right to request a review of the PTAB's decision or appeal it to the United States Court of Appeals for the Federal Circuit.

Key Legal Developments and Outcome for Biofrontera Pharma GMBH et al. v. Sun Pharmaceutical Industries Inc.

This case involves parallel proceedings in the U.S. District Court, the U.S. International Trade Commission (ITC), and the Patent Trial and Appeal Board (PTAB) concerning U.S. Patent No. 11,697,028 (the "’028 Patent") and U.S. Patent No. 11,446,512 (the "’512 Patent").

Chronological Developments:

• 2024-06-25 – District Court Complaint Filed: Sun Pharmaceutical Industries, Inc. ("Sun Pharma") initiated a patent infringement lawsuit against Biofrontera Pharma GMBH, Biofrontera Inc., Biofrontera Bioscience GMBH, and Biofrontera AG (collectively "Biofrontera") in the U.S. District Court for the District of Massachusetts, Case No. 1:24-cv-11637. The complaint alleged infringement of U.S. Patent Nos. 11,697,028 and 11,446,512.

• 2024-06-26 – ITC Investigation Initiated: Sun Pharma also filed a Section 337 complaint with the U.S. International Trade Commission (ITC), leading to Investigation No. 337-TA-1411, which asserted infringement of the '028 and '512 patents against Biofrontera. The ITC formally instituted the investigation on August 1, 2024.

• 2024-08-21 – IPR Petition Filed: In response to Sun Pharma's infringement allegations, Biofrontera filed an Inter Partes Review (IPR) petition, IPR2024-01312, with the Patent Trial and Appeal Board (PTAB), challenging the validity of U.S. Patent No. 11,697,028.

• 2024-08-23 – District Court Proceedings Stayed: The District Court for the District of Massachusetts granted Biofrontera's unopposed motion to stay the infringement litigation (1:24-cv-11637) pending the resolution of the ITC Investigation No. 337-TA-1411.

• 2024-11-20 – ITC Complaint Amended (in part): In the ITC investigation, Sun Pharma's motion to amend its complaint to add infringement allegations for additional claims of both patents was granted in part. The Administrative Law Judge (ALJ) allowed the addition of claims 17 and 18 of the '512 patent but denied the inclusion of other claims for the '512 and '028 patents due to lack of good cause for the delay.

• 2025-02-24 – IPR Instituted: The PTAB issued a decision to institute IPR2024-01312, commencing review of the patentability of the challenged claims of U.S. Patent No. 11,697,028.

• 2026-02-23 – IPR Final Written Decision: The PTAB issued its Final Written Decision in IPR2024-01312, finding all challenged claims of U.S. Patent No. 11,697,028 to be unpatentable. Sun Pharma retains the right to appeal this decision to the U.S. Court of Appeals for the Federal Circuit.

• 2026-05-06 – ITC Final Determination: The ITC Investigation No. 337-TA-1411 concluded with a final determination finding a violation by Biofrontera. The ITC entered a judgment on the merits in favor of Sun Pharma, finding that Biofrontera's RhodoLED XL system infringed certain asserted claims of both U.S. Patent Nos. 11,446,512 and 11,697,028. The ITC also rejected Biofrontera's invalidity defenses and issued limited exclusion orders and cease-and-desist orders preventing the importation and sale of infringing products.

Outcome and Present Posture:

• PTAB (IPR2024-01312): The PTAB found all challenged claims of the '028 patent unpatentable in its Final Written Decision on February 23, 2026. This is a significant victory for Biofrontera concerning this patent. Sun Pharma has the option to appeal this decision to the Federal Circuit.

• ITC (337-TA-1411): The ITC issued a final determination on May 6, 2026, concluding that Biofrontera violated Section 337 by infringing both the '028 and '512 patents. This resulted in exclusion and cease-and-desist orders against Biofrontera. This ITC finding of validity and infringement for the '028 patent stands in direct contrast to the PTAB's unpatentability decision for the same patent. The ITC decision itself can be appealed to the Federal Circuit.

• District Court (1:24-cv-11637): The district court litigation remains stayed pending the resolution of the ITC investigation. With the ITC's final determination now issued, the stay is expected to be lifted. The conflicting outcomes regarding the '028 patent from the PTAB (unpatentable) and the ITC (valid and infringed) will be a critical factor in the resumption of the district court case. While PTAB decisions can influence district courts, they do not automatically bind them due to differing standards of proof (preponderance of the evidence at PTAB vs. clear and convincing evidence at district court for invalidity). The parties will likely file status reports with the district court, and further motions regarding the impact of both the PTAB and ITC decisions on the district court proceedings are anticipated.

The following counsel from McGuireWoods LLP represented the plaintiff(s), Biofrontera Pharma GMBH et al., in the related Inter Partes Review (IPR2024-00874) concerning the same patent, U.S. Patent No. 11,697,028. Given McGuireWoods' long-standing relationship as Biofrontera's U.S. counsel for various litigation matters, it is highly probable they also represented the plaintiffs in IPR2024-01312.

• George B. Davis

  • Role: Counsel
  • Firm: McGuireWoods LLP, Richmond, Virginia
  • Experience Note: George B. Davis focuses on intellectual property litigation, specifically patent and trade secrets. He possesses nearly a decade of experience in patent law, including litigation and prosecution, and has handled numerous disputes in federal district courts, post-grant proceedings at the USPTO (including oral arguments in IPRs), and appeals to the Federal Circuit. He has experience in technical areas such as medical devices.

• Tyler T. VanHoutan

  • Role: Partner, Managing Partner of the Houston office
  • Firm: McGuireWoods LLP, Houston, Texas
  • Experience Note: Tyler T. VanHoutan provides strategic counsel in all aspects of intellectual property law, with a strong emphasis on patent litigation and Patent Trial and Appeal Board (PTAB) disputes. With nearly twenty-five years of experience, he has represented clients in diverse industries, including pharmaceuticals and medical devices, and has extensive experience in federal court and International Trade Commission (ITC) investigations. He is recognized for his deep trial experience and strategic approach to PTAB proceedings.

Counsel of record representing Sun Pharmaceutical Industries Inc. (defendant/patent owner) in IPR2024-01312 are provided by Desmarais LLP. Given the common patent (11,697,028) and parties across related litigation and IPRs, the following attorneys from Desmarais LLP are identified as representing Sun Pharmaceutical:

• Betty Chen

  • Role: Partner, likely lead counsel. She was lead trial counsel for Sun Pharmaceutical in a related ITC investigation (337-TA-1411) involving the same patent.
  • Firm & Office Location: Desmarais LLP, San Francisco, CA
  • Experience: Ms. Chen has two decades of experience successfully representing technology companies in over 150 high-stakes patent, Hatch-Waxman, trade secret, and antitrust cases, with approximately 20 trials in federal district courts, state courts, and the International Trade Commission. Her practice focuses on strategic patent prosecution and portfolio management, particularly in the pharmaceutical and medical device sectors.

• Yung-Hoon (Sam) Ha, Ph.D.

  • Role: Partner. Listed as an attorney for Sun Pharmaceutical in a related IPR (IPR2024-00874) concerning patent 11,697,028.
  • Firm & Office Location: Desmarais LLP, New York, NY
  • Experience: Dr. Ha has significant experience in all aspects of patent litigation, with a particular focus on pre-trial phases and Inter Partes Review (IPR) proceedings. He has a deep technical background and has achieved successful outcomes in IPRs, including invalidating numerous claims before the PTAB.

• Gabrielle E. (Gaby) Higgins

  • Role: Partner. Listed as an attorney for Sun Pharmaceutical in a related IPR (IPR2024-00874) concerning patent 11,697,028.
  • Firm & Office Location: Desmarais LLP, San Francisco, CA
  • Experience: Ms. Higgins is an accomplished district court trial lawyer and a prolific PTAB practitioner, having served as counsel of record in over 130 IPR proceedings. With more than 30 years of patent litigation experience, she represents clients in a wide array of technologies, including medical devices and pharmaceuticals.

• Tuhin Ganguly

  • Role: Partner. He was a member of the Desmarais team representing Sun Pharmaceutical in the related ITC investigation (337-TA-1411) involving patent 11,697,028.
  • Firm & Office Location: Desmarais LLP, Washington, D.C.
  • Experience: Mr. Ganguly is a trial lawyer specializing in Section 337 patent litigation before the U.S. International Trade Commission (ITC), with experience in over 20 ITC investigations covering diverse technologies, including medical devices. He also handles district court patent litigation and is registered to practice before the USPTO.

• Raymond N. Habbaz

  • Role: Associate. He was a member of the Desmarais team representing Sun Pharmaceutical in the related ITC investigation (337-TA-1411) involving patent 11,697,028.
  • Firm & Office Location: Desmarais LLP, New York, NY
  • Experience: Mr. Habbaz focuses on intellectual property and technology-related litigation, including patent litigation, appellate litigation, and Patent Trial and Appeal Board proceedings, with experience in matters involving medical devices, diagnostics, and consumer electronics.

• Paul Macri

  • Role: Associate. He was a member of the Desmarais team representing Sun Pharmaceutical in the related ITC investigation (337-TA-1411) involving patent 11,697,028.
  • Firm & Office Location: Desmarais LLP, New York, NY
  • Experience: Mr. Macri's practice includes intellectual property and technology-related litigation, particularly before the Patent Trial and Appeal Board. He has experience in pharmaceutical, biopharmaceutical, and medical device cases, including Hatch-Waxman and BPCIA litigation matters.

• Atifah Safi

  • Role: Associate. She was a member of the Desmarais team representing Sun Pharmaceutical in the related ITC investigation (337-TA-1411) involving patent 11,697,028.
  • Firm & Office Location: Desmarais LLP, Washington, D.C.
  • Experience: Ms. Safi's practice centers on patent infringement litigation across various patented technologies and intellectual property matters before U.S. Federal Courts and the International Trade Commission. She also represents pharmaceutical companies in ANDA litigation.