Untitled case

This patent infringement lawsuit, captioned Breckenridge Pharmaceutical, Inc. v. Hetero USA Inc. et al, Case No. 1:24-cv-00571-GBW, was filed on May 10, 2024, in the United States District Court for the District of Delaware and is presided over by Judge Gregory B. Williams. The plaintiff, Breckenridge Pharmaceutical, Inc., is an operating pharmaceutical company. The defendants, Hetero USA, Inc., Hetero Labs Limited Unit-III, Hetero Labs Limited, and Camber Pharmaceuticals, Inc., are also operating companies, likely generic drug manufacturers, who are accused of infringing U.S. Patent No. 11,013,729.

The asserted patent, U.S. Patent No. 11,013,729, covers "Oral pharmaceutical compositions of dabigatran etexilate." This patent describes specific formulations of dabigatran etexilate, an anticoagulant used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and to prevent venous thromboembolic events following surgeries like hip or knee replacement. The patented composition features a mixture of at least two distinct types of particles: one containing the active pharmaceutical ingredient (dabigatran etexilate) and another comprising at least one pharmaceutically acceptable organic acid, designed to address the drug's acid-sensitive nature and improve bioavailability. The accused products are likely generic versions of dabigatran etexilate, indicating a Hatch-Waxman Act dispute.

The District of Delaware is a prominent venue for patent litigation, particularly for pharmaceutical cases, due to its experienced judiciary, predictable docket management, and a well-developed body of patent-specific precedent. This case is notable as it involves competition in the pharmaceutical market for a critical anticoagulant medication, typical of disputes between innovator and generic drug companies. Further, U.S. Patent No. 11,013,729 has been challenged in a parallel inter partes review (IPR) proceeding, IPR2025-01107, initiated by MSN Pharmaceuticals, Inc. and MSN Laboratories Private Limited, though it was not procedurally instituted. A significant procedural step in the district court case, a claim construction (Markman) hearing, was held on May 15, 2025, with a Memorandum Opinion on claim construction issued on June 26, 2025.

Key Legal Developments and Outcome for Breckenridge Pharmaceutical, Inc. v. Hetero USA Inc. et al (D. Del. Case No. 1:24-cv-00571)

This patent infringement litigation concerns U.S. Patent No. 11,013,729, which pertains to oral pharmaceutical compositions of dabigatran etexilate. The case is currently active in the District of Delaware with a trial scheduled for late 2026.

Chronological Developments:

• 2024-05-10: Complaint Filed. Breckenridge Pharmaceutical, Inc. filed a patent infringement lawsuit against Hetero USA Inc. and other defendants in the District of Delaware. The case was assigned civil action number 1:24-cv-00571. Breckenridge Pharmaceutical Inc. is identified as the current assignee of the patent in suit, US11013729B2.

• 2024-11-06: Proposed Scheduling Order. A document (Document 31) was filed, which outlines a proposed schedule for the case. This document indicates that the court anticipates issuing its claim construction (Markman) order within sixty days of a specified approval. It also references a parallel Inter Partes Review (IPR) proceeding, "MSN v. Breckenridge, IPR2025-01107," related to the asserted patent.

• 2025-04-01: Discovery Discussions. A court document (Document 70) further discusses aspects of discovery in the case.

• Parallel PTAB IPR Proceeding: An Inter Partes Review (IPR) petition, IPR2025-01107, was filed against U.S. Patent No. 11,013,729. The petitioner is "Unified Patents PTAB Data." The status of this IPR is "Not Instituted - Procedural," meaning the Patent Trial and Appeal Board (PTAB) decided not to institute a review of the patent's claims. This IPR was filed after the district court litigation commenced. The district court has acknowledged this IPR in its scheduling discussions.

Current Posture:

The litigation is ongoing. The District of Delaware has scheduled a Final Pretrial Conference for 2026-09-24, and a Jury Trial is set to commence on 2026-10-13. As of the current date, there has been no reported Markman ruling, trial, verdict, settlement, or final judgment. The case continues through its scheduled pre-trial phases, including discovery and anticipated claim construction. The non-institution of the parallel IPR means that the validity challenge at the PTAB is not proceeding, leaving the district court as the primary forum for resolving the patent dispute.

The plaintiff in Breckenridge Pharmaceutical, Inc. v. Hetero USA Inc. et al (1:24-cv-00571) is Breckenridge Pharmaceutical, Inc.. Counsel of record representing Breckenridge Pharmaceutical, Inc. in this patent infringement case include:

• Kelly E. Farnan

  • Role: Local Counsel
  • Firm: Richards, Layton & Finger, P.A.
  • Office Location: Wilmington, Delaware
  • Note: Kelly Farnan is a director at Richards, Layton & Finger, P.A., focusing on corporate and commercial litigation in the Delaware Court of Chancery, the Delaware Supreme Court, and the U.S. District Court for the District of Delaware. She has significant experience in complex business and intellectual property disputes.

• Sara M. Metzler

  • Role: Local Counsel
  • Firm: Richards, Layton & Finger, P.A.
  • Office Location: Wilmington, Delaware
  • Note: Sara Metzler is an associate at Richards, Layton & Finger, P.A., with experience in intellectual property litigation, particularly in the District of Delaware.

• Christopher J. Sorenson

  • Role: Lead Counsel
  • Firm: Merchant & Gould P.C.
  • Office Location: Minneapolis, Minnesota
  • Note: Christopher Sorenson is a partner at Merchant & Gould P.C., specializing in patent litigation, particularly in the pharmaceutical and biotechnology industries. He has a history of representing Breckenridge Pharmaceutical in patent disputes, including a 2018 Federal Circuit case. Merchant & Gould P.C. has a long-standing practice serving the generic pharmaceutical industry and deep experience as lead counsel in Hatch-Waxman Act litigation and in federal district courts.

Here is the counsel of record representing the defendant(s) in Breckenridge Pharmaceutical, Inc. v. Hetero USA Inc. et al, Case No. 1:24-cv-00571, in the Delaware District Court:

The defendants, Hetero USA Inc., Hetero Labs Limited Unit-III, Hetero Labs Limited, and Camber Pharmaceuticals, Inc., are represented by a team of lead counsel and will also have local Delaware counsel.

Lead Counsel (Pro Hac Vice):

• Alexander Alfano
  • Role: Lead Counsel (admitted pro hac vice)
  • Firm: (Firm information not explicitly available in provided search results for this case. Further research needed.)
  • Note: (Specific patent litigation experience not explicitly available in provided search results for this case. Further research needed.)
• Christopher Coleman
  • Role: Lead Counsel (admitted pro hac vice)
  • Firm: (Firm information not explicitly available in provided search results for this case. Further research needed.)
  • Note: (Specific patent litigation experience not explicitly available in provided search results for this case. Further research needed.)
• Ryan N. Kaiser
  • Role: Lead Counsel (admitted pro hac vice)
  • Firm: (Firm information not explicitly available in provided search results for this case. Further research needed.)
  • Note: (Specific patent litigation experience not explicitly available in provided search results for this case. Further research needed.)
• Adam C. LaRock
  • Role: Lead Counsel (admitted pro hac vice)
  • Firm: (Firm information not explicitly available in provided search results for this case. Further research needed.)
  • Note: (Specific patent litigation experience not explicitly available in provided search results for this case. Further research needed.)
• Dennies Varughese
  • Role: Lead Counsel (admitted pro hac vice)
  • Firm: (Firm information not explicitly available in provided search results for this case. Further research needed.)
  • Note: (Specific patent litigation experience not explicitly available in provided search results for this case. Further research needed.)

Local Counsel:

The specific names of the local Delaware counsel for the defendants were not explicitly identified in the provided search results, though the docket indicates that "Delaware counsel shall be the registered users of CM/ECF and shall be required to file all papers" per Local Rule 83.5(d). In District of Delaware patent cases, firms like Morris, Nichols, Arsht & Tunnell LLP and Potter Anderson & Corroon LLP are frequently engaged as local counsel due to their extensive experience in intellectual property litigation within the district. Without direct docket access showing their appearance for the defendants in this specific case, the exact local counsel cannot be confirmed at this time.