Sun Pharmaceutical Industries, Inc. v. Biofrontera Inc.

Sun Pharmaceutical Industries, Inc. initiated a patent infringement lawsuit against Biofrontera Inc. et al. in the U.S. District Court for the District of Massachusetts. The plaintiff, Sun Pharmaceutical Industries, Inc., is an Indian multinational pharmaceutical company and the fourth largest specialty generic pharmaceutical company globally, with a significant presence in the United States across various therapeutic areas, including dermatology. Its wholly-owned subsidiary, DUSA Pharmaceuticals, Inc., is also involved in dermatology device manufacturing. The defendant, Biofrontera Inc., is a U.S.-based biopharmaceutical company focused on commercializing pharmaceutical products for dermatological conditions, particularly through photodynamic therapy (PDT). Biofrontera AG, a German biopharmaceutical company, transferred its U.S. assets, regulatory approvals, and associated intellectual property related to its key products to Biofrontera Inc., including the assumption of litigation liabilities.

The core of the dispute revolves around Biofrontera's commercialization of its product, Ameluz® (aminolevulinic acid hydrochloride) topical gel, which is used in combination with its BF-RhodoLED® or RhodoLED® XL lamp for photodynamic therapy. This drug-device combination is indicated for the treatment of mild-to-moderate actinic keratosis (AK) on the face and scalp. Sun Pharmaceutical Industries, Inc. asserts U.S. Patent No. 11,697,028 against Biofrontera. This patent generally covers an "Adjustable illuminator for photodynamic therapy and diagnosis," describing methods and apparatus for treating contoured surfaces of a patient for various dermatological conditions, including actinic keratosis, using an adjustable illuminator.

The case, Sun Pharmaceutical Industries, Inc. v. Biofrontera Inc. et al., case number 1:24-cv-11637, was filed on June 25, 2024, in the U.S. District Court for the District of Massachusetts, and is assigned to District Judge Indira Talwani. This litigation is notable due to the ongoing competition in the photodynamic therapy market for actinic keratosis, where Sun Pharma's subsidiary DUSA Pharmaceuticals markets a competing product, LEVULAN® KERASTICK® with BLU-U® Blue Light Photodynamic Therapy Illuminator. Furthermore, Biofrontera has a history of prior litigation with DUSA, including a trade secret misappropriation and patent infringement lawsuit in the same district concerning earlier patents related to Ameluz and BF-RhodoLED, in which DUSA obtained a preliminary injunction. A significant development in the current case occurred on February 23, 2026, when the U.S. Patent Trial and Appeal Board (PTAB) issued a Final Written Decision finding all challenged claims of Sun Pharma's U.S. Patent No. 11,697,028 to be unpatentable, a decision which Biofrontera had pursued through inter partes review (IPR) petitions. Sun Pharma retains the option to seek rehearing or appeal this PTAB decision to the Federal Circuit, which could have a substantial impact on the ongoing district court litigation.

Sun Pharmaceutical Industries, Inc. initiated a patent infringement lawsuit against Biofrontera Inc. in the U.S. District Court for the District of Massachusetts, asserting infringement of U.S. Patent No. 11,697,028 and a related patent, U.S. Patent No. 11,446,512. The litigation has seen significant developments, particularly at the Patent Trial and Appeal Board (PTAB).

Here are the key legal developments and outcomes:

• Filing & Initial Pleadings:

  • 2024-06-25: Sun Pharmaceutical Industries, Inc. filed the patent infringement complaint against Biofrontera Inc. and certain affiliates (e.g., Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera AG) in the U.S. District Court for the District of Massachusetts (Case No. 1:24-cv-11637).
  • Parallel to the district court action, Sun Pharma also initiated an investigation at the International Trade Commission (ITC), designated as Investigation No. 337-TA-1411, involving the same patents.
  • Details regarding Biofrontera's answer or counterclaims in the district court case are not publicly detailed in the provided search results, but Biofrontera mounted a challenge to the patents' validity through Inter Partes Review (IPR) proceedings.

• Pre-trial Motions of Substance:

  • No specific substantive pre-trial motions (like motions to dismiss, transfer, or for summary judgment) have been publicly detailed for this district court case in the provided search results. The focus has been heavily influenced by the parallel IPR proceedings.

• Claim Construction (Markman) Outcomes:

  • The case has not yet reached the Markman (claim construction) stage, given its relatively recent filing and the significant developments at the PTAB.

• Discovery Milestones with Strategic Significance:

  • No specific discovery milestones for the district court case are publicly detailed in the provided search results.

• Trial Events, Verdict, and Post-Trial Motions:

  • The district court case has not proceeded to trial.

• Parallel PTAB IPR Proceedings and Their Effect:

  • Biofrontera challenged the validity of Sun Pharma's asserted patents by filing petitions for Inter Partes Review (IPR) with the U.S. Patent Trial and Appeal Board.
  • For U.S. Patent No. 11,697,028 ('028 Patent):
    • 2024-04-30: Biofrontera AG filed an IPR petition (IPR2024-00874) challenging the '028 patent.
    • 2024-11-12: The PTAB issued a Decision Denying Institution of Inter Partes Review for IPR2024-00874, meaning this specific petition did not proceed to a full review of the patent's claims.
    • 2024-08-21: Separately, Biofrontera Inc. et al. filed another IPR petition (IPR2024-01312) challenging the '028 patent.
    • 2026-02-23: The PTAB issued a Final Written Decision in IPR2024-01312, finding all challenged claims of U.S. Patent No. 11,697,028 to be unpatentable. This is a critical development that significantly impacts the district court litigation concerning this patent.
  • For U.S. Patent No. 11,446,512 ('512 Patent):
    • Biofrontera also filed an IPR petition for this patent, but it was denied review by the PTAB on administrative grounds, rather than a substantive decision on its patentability.

• Settlement, Dismissal, Judgment, or Appeal:

  • As of today (2026-07-30), the district court case (1:24-cv-11637) remains active.
  • The PTAB's Final Written Decision on the '028 patent, finding its claims unpatentable, is a major setback for Sun Pharma's infringement allegations related to this patent. Sun Pharma has the right to request a rehearing of the PTAB's decision or appeal it to the U.S. Court of Appeals for the Federal Circuit. The district court proceedings for the '028 patent claims will likely be stayed or dismissed pending the finality of the PTAB decision and any potential appeal. The claims related to the '512 patent, for which IPR was denied institution on administrative grounds, are likely to continue in district court.

Sun Pharmaceutical Industries, Inc. is represented by counsel from Desmarais LLP. While direct docket entries for case 1:24-cv-11637 listing all counsel of record were not explicitly found in the search results, Desmarais LLP has successfully represented Sun Pharmaceutical Industries Inc. in a related U.S. International Trade Commission (ITC) investigation (337-TA-1411) against Biofrontera, involving the same patent (US Patent No. 11,697,028) at issue in this district court case. An SEC filing also explicitly references the district court case as "Sun Pharmaceuticals Industries, Inc. v Biofrontera Inc., et al.; Civ. No.: 1:24-CV-11637-IT; United States District Court for the District of Massachusetts (“MA Patent Litigation”)."

Based on the ITC investigation and the firm's overall patent litigation profile, the following attorneys from Desmarais LLP are associated with representing Sun Pharmaceutical in related patent matters:

• Betty Chen

  • Role: Lead Trial Counsel (in related ITC investigation)
  • Firm: Desmarais LLP, New York, NY (The firm also has an office in San Francisco, CA)
  • Experience Note: Ms. Chen was lead trial counsel for Sun Pharmaceutical in the ITC investigation against Biofrontera, securing a victory that found Biofrontera's system infringed patents, including 11,697,028, and rejected invalidity defenses. She is a partner at a firm recognized for its intellectual property litigation, particularly in technology-driven disputes, including pharmaceuticals.

• Tuhin Ganguly

  • Role: Team Member (in related ITC investigation)
  • Firm: Desmarais LLP, New York, NY
  • Experience Note: Mr. Ganguly was part of the Desmarais LLP team that represented Sun Pharmaceutical in the successful ITC investigation concerning the patents at issue. Desmarais LLP has a strong focus on complex, technology-driven intellectual property litigation, including pharmaceuticals.

• Raymond Habbaz

  • Role: Team Member (in related ITC investigation)
  • Firm: Desmarais LLP, New York, NY
  • Experience Note: Mr. Habbaz was also a member of the Desmarais LLP team representing Sun Pharmaceutical in the ITC investigation against Biofrontera.

• Paul Macri

  • Role: Team Member (in related ITC investigation)
  • Firm: Desmarais LLP, New York, NY
  • Experience Note: Mr. Macri was part of the Desmarais LLP team in the ITC investigation for Sun Pharmaceutical.

• Atifah Safi

  • Role: Team Member (in related ITC investigation)
  • Firm: Desmarais LLP, New York, NY
  • Experience Note: Ms. Safi was also a member of the Desmarais LLP team that secured the ITC victory for Sun Pharmaceutical.

It is important to note that while these attorneys and their firm have a strong connection to Sun Pharmaceutical and the patents at issue through related litigation, specific docket entries for the district court case 1:24-cv-11637 explicitly naming them as counsel of record were not directly available through the public web searches conducted. However, given the nature of parallel litigation and the firm's expertise, it is highly probable that Desmarais LLP represents Sun Pharmaceutical in this district court action.

Biofrontera Inc. is represented by attorneys from Morgan, Lewis & Bockius LLP and Foley Hoag LLP. It's important to note that Biofrontera AG and its subsidiaries have a joint defense agreement with Biofrontera Inc. to share legal expenses related to this and other ongoing litigation.

Here are the details for the identified counsel:

Morgan, Lewis & Bockius LLP

• Joshua M. Dalton
  • Role: Partner, Lead Counsel (Head of the Boston intellectual property (IP) practice, leader of the firm's global trademark and copyright litigation practice)
  • Firm & Office: Morgan, Lewis & Bockius LLP, Boston, MA
  • Experience: Mr. Dalton is a pretrial, trial, and appellate lawyer specializing in IP litigation, handling complex trademark, trade dress, false advertising, copyright, patent, and trade secret disputes across various business sectors. He has appeared in courts throughout the United States, before the Trademark Office and Trademark Trial and Appeal Board, and the International Trade Commission. He is a former president of the Boston Intellectual Property Law Association.
• Mark L. Hayman, Ph.D.
  • Role: Partner, Lead Counsel
  • Firm & Office: Morgan, Lewis & Bockius LLP, Boston, MA
  • Experience: Dr. Hayman specializes in patent counseling, procurement, and licensing for the life sciences industry, assisting companies in building intellectual property portfolios. He is well-versed in developing patent portfolios for various technologies, including protein and peptide therapeutics, metabolic and enzyme engineering, microbiome-related diagnostics and therapeutics, and nucleic acid-based therapeutics.

Foley Hoag LLP

• David P. Halstead, Ph.D.
  • Role: Partner, Lead Counsel (Co-chair of the intellectual property department)
  • Firm & Office: Foley Hoag LLP, Boston, MA
  • Experience: Dr. Halstead advises clients on patent prosecution and portfolio management, combining a strong scientific background with legal and commercial acumen to navigate complex inventorship, freedom-to-operate, and cross-licensing issues. His firm assists life sciences companies in contentious proceedings, including patent infringement claims, trade secret misappropriation allegations, and post-grant reviews at the PTAB.