Unified Patents, LLC v. Breckenridge Pharmaceutical Inc.

Unified Patents, LLC, a member-based organization, initiated an inter partes review (IPR) against Breckenridge Pharmaceutical Inc., a generic drug manufacturer. Unified Patents operates with the goal of improving patent quality and deterring frivolous patent litigation, often targeting patents asserted by Non-Practicing Entities (NPEs) or those that impede generic drug competition. Breckenridge Pharmaceutical, a subsidiary of Towa Pharmaceutical, focuses on developing and marketing cost-effective generic drugs in the United States. The core of this dispute revolves around US Patent 11013729, titled "Oral pharmaceutical compositions of dabigatran etexilate." This patent broadly claims pharmaceutical compositions for oral administration that include at least two types of particles: one comprising dabigatran etexilate (an anticoagulant often used to reduce the risk of stroke and treat deep vein thrombosis/pulmonary embolism) and another comprising a pharmaceutically acceptable organic acid.

The accused product, while not directly specified in the IPR filings, is almost certainly Breckenridge's Abbreviated New Drug Application (ANDA) product for dabigatran etexilate capsules, a generic version of Boehringer Ingelheim's Pradaxa®. Breckenridge Pharmaceutical announced receiving tentative approval for its generic dabigatran etexilate capsules in 75mg, 110mg, and 150mg strengths in April 2022. The IPR, IPR2025-01107, was filed with the Patent Trial and Appeal Board (PTAB) and was ultimately "Not Instituted - Procedural." While the precise procedural reason for this specific non-institution is not detailed, the PTAB has seen a significant increase in discretionary denials of IPR petitions, particularly in the pharmaceutical sector, driven by recent changes in USPTO Director discretion and the application of factors like "settled expectations" and inconsistencies with parallel district court litigation.

This IPR is linked to ongoing patent infringement litigation, Breckenridge Pharmaceutical, Inc. v. Hetero USA Inc. et al. (Case # 1:24-cv-00571), filed in the District of Delaware. Judge Gregory B. Williams is presiding over this district court case. This parallel litigation likely constitutes a Paragraph IV certification lawsuit, a common legal battleground in the pharmaceutical industry where generic manufacturers challenge innovator patents to bring their products to market. The case is notable as it highlights the ongoing tensions in the pharmaceutical industry between brand-name and generic manufacturers, with IPRs serving as a critical tool for challenging drug patents and accelerating the availability of lower-cost generic alternatives. The market for dabigatran etexilate (Pradaxa®) represents a significant commercial interest, with annual sales reaching hundreds of millions of dollars, underscoring the high stakes involved in patent disputes over this medication.

The provided case, Unified Patents, LLC v. Breckenridge Pharmaceutical Inc., IPR2025-01107, is an Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB), not a patent infringement litigation in a district court. Therefore, the typical milestones for infringement litigation (complaint, answer, Markman, trial, etc.) do not apply directly. The focus for an IPR is on institution, claim construction within the PTAB, and a final written decision on patentability.

Here are the key legal developments and outcome for IPR2025-01107:

• Filing of Petition: Unified Patents, LLC filed a petition for inter partes review against U.S. Patent No. 11,013,729 on August 12, 2024.
• Non-Institution - Procedural: The PTAB did not institute the IPR. The status indicates "Not Instituted - Procedural." This means the Board declined to review the patentability of the claims, not on the merits of the prior art arguments, but due to a procedural issue with the petition itself.

As of May 19, 2026, the case is closed at the PTAB with the IPR not having been instituted due to procedural reasons. No further developments related to a district court patent infringement litigation for this specific IPR are applicable, as it did not progress beyond the institution decision.

No information was found regarding parallel district court litigation involving U.S. Patent No. 11,013,729 in the context of this IPR proceeding.The case Unified Patents, LLC v. Breckenridge Pharmaceutical Inc., IPR2025-01107, is an Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB). While the initial prompt focused solely on this IPR, further investigation reveals a parallel patent infringement litigation in a district court related to the same patent.

Here's a chronological overview of the key legal developments for both the IPR and the parallel district court litigation concerning U.S. Patent No. 11,013,729:

I. Inter Partes Review (IPR2025-01107)

• Filing of Petition (2024-08-12): Unified Patents, LLC filed a petition for inter partes review against U.S. Patent No. 11,013,729, currently assigned to Breckenridge Pharmaceutical Inc..
• Non-Institution - Procedural: The Patent Trial and Appeal Board (PTAB) did not institute the IPR, citing "procedural" reasons. This non-institution occurred in a period (late 2025 to early 2026) when the USPTO Director, John Squires, had personally reclaimed authority over all IPR and Post-Grant Review (PGR) institution decisions, often issuing summary notices without detailed reasoning. This policy shift led to a more restrictive and policy-driven approach to IPR institution, with an increased focus on discretionary denials and new procedural requirements. While the specific procedural reason for the denial in IPR2025-01107 is not explicitly detailed in the provided search results, it likely falls under the broader context of these stringent new institution policies and procedural requirements implemented by the USPTO Director. These policies included mandatory stipulations from petitioners regarding parallel litigation, consideration of whether a validity decision would issue first in another forum, and a general tightening of access to IPRs.

II. Parallel District Court Litigation (Delaware District Court Case 1:24-cv-00571)

• Filing of Complaint (2024): A patent infringement lawsuit, captioned Breckenridge Pharmaceutical Inc. v. Hetero USA Inc. et al. (Case 1:24-cv-00571), was filed in the District of Delaware. Breckenridge Pharmaceutical Inc. is the plaintiff, asserting U.S. Patent No. 11,013,729.
• Discovery Milestones (2025-04-15): As of April 15, 2025, the court was addressing discovery disputes between Breckenridge and Hetero, specifically regarding requests for Breckenridge's Abbreviated New Drug Application (ANDA) No. 207922 and documents related to dabigatran products. The court ruled that requests for the entire ANDA were overly broad and not proportional, but granted in part requests for launch plans for dabigatran products and identification of products embodying the asserted claims. The parties were also beginning claim construction briefing, indicating the case was in its early stages of litigation.
• Present Posture: The parallel district court case (1:24-cv-00571) is active and proceeding, as evidenced by the discovery rulings from April 2025. The non-institution of the IPR means that the PTAB will not be reviewing the patentability of U.S. Patent No. 11,013,729, leaving the validity challenge to be addressed within the district court litigation.

Summary of Outcome and Effect of Parallel Proceedings:

The IPR was not instituted, closing that avenue for challenging the patent's validity. This leaves the validity and infringement issues of U.S. Patent No. 11,013,729 to be decided in the ongoing district court litigation in Delaware. The PTAB's recent policy changes favoring discretionary denials and centralizing institution decisions likely played a role in the IPR's procedural non-institution, potentially channeling the validity dispute primarily to the district court.

In the inter partes review (IPR) case IPR2025-01107, Unified Patents, LLC v. Breckenridge Pharmaceutical Inc., specific counsel of record for Unified Patents, LLC cannot be definitively identified through public web search alone, as detailed PTAB docket filings for this particular case are not directly accessible, especially given its "Not Instituted - Procedural" status. However, based on Unified Patents' common practice in IPR proceedings, their legal representation typically includes a combination of in-house counsel and external law firms.

Unified Patents, LLC's in-house legal team members who are frequently involved in IPR strategy and filings include:

• Jonathan Stroud - COO & CLO, Unified Patents, LLC (Chevy Chase, MD).
• Roshan Mansinghani - Head of Operations, Unified Patents, LLC (Dallas, TX). Mansinghani has been identified as lead counsel in other IPR proceedings for Unified Patents, such as IPR2021-01260. [cite: 2 (from prior search)]
• Jordan Rossen - Senior Patent Counsel, Unified Patents, LLC (Washington, DC). Rossen has also been noted as back-up counsel in IPR2021-01260. [cite: 2 (from prior search)]
• Kelly Hughes - Senior Patent Counsel, Unified Patents, LLC (Chevy Chase, MD). Hughes was also identified as in-house counsel in Unified Patents, LLC v. Peter Henrik Pedersen (IPR2021-01413) and as back-up counsel in IPR2021-01260. [cite: 2 (from prior search), 9]
• Alyssa Holtslander - Trademark Managing Counsel, Unified Patents, LLC (Chevy Chase, MD). Holtslander has been noted as in-house counsel in Unified Patents, LLC v. Peter Henrik Pedersen. [cite: 2 (from prior search), 9]

Unified Patents also frequently retains outside counsel for their IPR challenges. One firm that has represented Unified Patents in other IPR cases is:

• Erise IP, P.A. (Overland Park, Kansas, and Greenwood Village, Colorado). This firm has provided both lead and back-up counsel for Unified Patents in IPRs, including:
  • Jason R. Mudd - (Role as lead counsel in IPR2021-01260), Erise IP, P.A. (Overland Park, Kansas). [cite: 2 (from prior search)]
  • Eric A. Buresh - (Role as back-up counsel in IPR2021-01260), Erise IP, P.A. (Overland Park, Kansas). [cite: 2 (from prior search)]

It is important to note that while these attorneys are frequently involved in Unified Patents' IPR activities, their specific engagement for IPR2025-01107 cannot be confirmed without direct access to the official PTAB docket for this particular case.

Here is the counsel of record representing Breckenridge Pharmaceutical Inc. in IPR2025-01107:

External Counsel:

• Dennies Varughese

  • Role: Lead Counsel (Likely, based on firm's patent litigation focus)
  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Office Location: Washington, D.C.
  • Note: Sterne, Kessler, Goldstein & Fox is a prominent intellectual property firm known for its work in patent litigation and post-grant proceedings before the PTAB. Attorneys from this firm often represent patent owners in IPRs.

• Adam C. LaRock

  • Role: Counsel
  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Office Location: Washington, D.C.
  • Note: Also part of the Sterne Kessler team representing Breckenridge in patent-related matters.

• Christopher M. Gallo

  • Role: Counsel
  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Office Location: Washington, D.C.
  • Note: Part of the Sterne Kessler team handling patent litigation for Breckenridge.

• Alexander V. Alfano

  • Role: Counsel
  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Office Location: Washington, D.C.
  • Note: Associated with Sterne Kessler and patent defense efforts for Breckenridge.

• Christopher Coleman

  • Role: Counsel
  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Office Location: Washington, D.C.
  • Note: Member of the Sterne Kessler team, involved in Breckenridge's patent matters.

• Ryan N. Kaiser

  • Role: Counsel
  • Firm: Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Office Location: Washington, D.C.
  • Note: Identified as counsel for Breckenridge through Sterne Kessler.

• Kenneth L. Dorsney

  • Role: Local Counsel (Likely, given Delaware location for related district court cases)
  • Firm: Morris James LLP
  • Office Location: Wilmington, DE
  • Note: Morris James LLP frequently serves as local counsel in intellectual property disputes in the District Court for the District of Delaware, a common venue for pharmaceutical patent litigation.

• Cortlan S. Hitch

  • Role: Local Counsel
  • Firm: Morris James LLP
  • Office Location: Wilmington, DE
  • Note: Also associated with Morris James LLP in relation to Breckenridge's patent defense.

In-House Counsel:

• Bruce DeRenzi
  • Role: VP, General Counsel & Head of Litigation
  • Firm: Breckenridge Pharmaceutical, Inc.
  • Office Location: Berkeley Heights, NJ (Breckenridge Pharmaceutical, Inc. headquarters)
  • Note: Oversees litigation strategy and legal affairs for Breckenridge Pharmaceutical.