Patent 11084865

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

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PTAB activity (1)

AIA trial proceedings — IPR, PGR, CBM — filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced directly from the PTAB Trial API.

  • IPR2025-01268IPRfiled Jul 14, 2025vs. Fresenius Kabi SwissBioSim GmbH et al.Discretionary Denial

Cached for 24 hours. Status strings are sourced verbatim from the PTAB API; the colored badge is our heuristic classification.

Cases on file (8)

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Specific litigation cases in our database that name US patent 11084865. The free-form analysis below may also discuss cases beyond this list.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

The search results provide substantial details for the litigation involving US Patent 11084865, particularly highlighting the extensive Biologics Price Competition and Innovation Act (BPCIA) litigation related to Regeneron's Eylea® and its biosimilar versions.

Here is a summary of the known litigation involving US Patent 11084865:

Plaintiff: Regeneron Pharmaceuticals, Inc. (common plaintiff across all identified cases related to the '865 patent).

1. Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al.

  • Jurisdiction: U.S. District Court for the Northern District of West Virginia, and subsequently appealed to the U.S. Court of Appeals for the Federal Circuit.
  • Case Number:
    • District Court: 1:22-cv-00061 (N.D.W. Va.)
    • MDL: 1:24-md-03103 (N.D.W. Va.)
    • CAFC Appeals: 24-1965, 24-1966, 24-2002, 24-2009, 24-2019, 24-2058, 24-2082, 24-2083, 24-2147, 24-2156, 24-2351 (various appeals involving Mylan and other defendants, all related to the '865 patent)
  • Filing Date: August 2022 (District Court case against Mylan)
  • Outcome/Current Status: In the district court, Regeneron secured a victory, with the court finding that Mylan infringed certain claims of the '865 patent and had not shown those claims to be invalid. Mylan appealed this judgment. On April 15, 2025, Biocon (associated with Mylan for biosimilar Yesafili™) announced a settlement agreement with Regeneron, leading to the dismissal of CAFC Appeal No. 24-2002 and District Court Case No. 1:22-cv-00061, allowing commercialization of Yesafili™ in the second half of 2026. CAFC Appeals 24-1965, 24-1966, 24-2082, 24-2083 were decided on January 29, 2025, affirming preliminary injunctions against Samsung Bioepis and Formycon, which were linked to the Mylan case. CAFC Appeal 24-2351 was dismissed on March 14, 2025.

2. Regeneron Pharmaceuticals, Inc. v. Samsung Bioepis Co., Ltd.

  • Jurisdiction: U.S. District Court for the Northern District of West Virginia, and U.S. Court of Appeals for the Federal Circuit. Also PTAB.
  • Case Number:
    • District Court: 1:23-cv-00094 (N.D.W. Va.), 1:23-cv-00106 (N.D.W. Va.)
    • MDL: 1:24-md-03103 (N.D.W. Va.)
    • CAFC Appeal: 24-1965, 24-1966, 24-2082, 24-2083 (related to preliminary injunctions)
    • PTAB IPR: IPR2025-00176
  • Filing Date: Late 2023 (District Court), November 20, 2024 (IPR2025-00176)
  • Outcome/Current Status: The district court granted a preliminary injunction against Samsung Bioepis on June 14, 2024, finding Regeneron likely to succeed on infringement and validity. The Federal Circuit affirmed this preliminary injunction on January 29, 2025. For IPR2025-00176, the PTAB denied institution on discretionary grounds.

3. Regeneron Pharmaceuticals, Inc. v. Formycon AG

  • Jurisdiction: U.S. District Court for the Northern District of West Virginia, and U.S. Court of Appeals for the Federal Circuit. Also PTAB.
  • Case Number:
    • District Court: 1:23-cv-00097 (N.D.W. Va.)
    • MDL: 1:24-md-03103 (N.D.W. Va.)
    • CAFC Appeal: 24-2009 (related to preliminary injunction)
    • PTAB IPR: IPR2025-00233
  • Filing Date: Late 2023 (District Court), December 2, 2024 (IPR2025-00233)
  • Outcome/Current Status: The district court granted a preliminary injunction against Formycon on June 21, 2024. The Federal Circuit affirmed this preliminary injunction on January 29, 2025. For IPR2025-00233, the PTAB denied institution on discretionary grounds.

4. Regeneron Pharmaceuticals, Inc. v. Celltrion, Inc.

  • Jurisdiction: U.S. District Court for the Northern District of West Virginia, and U.S. Court of Appeals for the Federal Circuit. Also PTAB.
  • Case Number:
    • District Court: 1:23-cv-00089 (N.D.W. Va.), 1:24-cv-00053 (N.D.W. Va.)
    • MDL: 1:24-md-03103 (N.D.W. Va.)
    • CAFC Appeal: 24-2058, 24-2147
    • PTAB IPR: IPR2025-00456
  • Filing Date: Late 2023 (District Court), January 15, 2025 (IPR2025-00456)
  • Outcome/Current Status: The district court granted a preliminary injunction against Celltrion in June-July 2024. The Federal Circuit affirmed this preliminary injunction on March 5, 2025. For IPR2025-00456, the PTAB denied institution on discretionary grounds.

5. Regeneron Pharmaceuticals, Inc. v. Amgen Inc.

  • Jurisdiction: U.S. District Court for the Central District of California (transferred to N.D.W. Va.), and U.S. Court of Appeals for the Federal Circuit.
  • Case Number:
    • District Court: 2:24-cv-00264 (C.D. Cal.) (transferred to N.D.W. Va., C.A. 1:24-cv-00039)
    • MDL: 1:24-md-03103 (N.D.W. Va.)
    • CAFC Appeal: 24-2351
  • Filing Date: January 10, 2024 (District Court)
  • Outcome/Current Status: The district court denied Regeneron's motion for a preliminary injunction against Amgen because it found Regeneron unlikely to succeed on infringement, due to Amgen's biosimilar design-around related to the buffer component. The Federal Circuit upheld this denial of a preliminary injunction on March 14, 2025. Amgen launched its biosimilar, Pavblu™, at-risk in October 2024.

6. Regeneron Pharmaceuticals, Inc. v. Sandoz Inc.

  • Jurisdiction: U.S. District Court for the Northern District of West Virginia.
  • Case Number: 1:24-cv-00085 (N.D.W. Va.)
    • MDL: 1:24-md-03103 (N.D.W. Va.)
  • Filing Date: Not explicitly found in search results, but referenced alongside other 2024 cases.
  • Outcome/Current Status: Ongoing. Sandoz's biosimilar Enzeevu™ was approved in August 2024.

7. Fresenius Kabi SwissBioSim GmbH v. Regeneron Pharmaceuticals, Inc.

  • Jurisdiction: PTAB
  • Case Number: IPR2025-01268
  • Filing Date: Not explicitly stated, but the "Effective date" is July 14, 2025. (Unified Patents lists filing date 2024-11-20 in other context, but the Google patent entry gives an effective date of July 14, 2025, for the opponent names)
  • Outcome/Current Status: Not Instituted - Procedural. The petition relies on different prior art than other IPRs.

8. PTAB Cases with "Not Instituted - Procedural" Status (Details not fully identified in search results beyond the PTAB status)

  • Jurisdiction: PTAB
  • Case Number:
    • IPR2025-00176 (Samsung Bioepis) - Covered under Samsung Bioepis above.
    • IPR2025-00233 (Formycon AG) - Covered under Formycon AG above.
    • IPR2025-00456 (Celltrion, Inc.) - Covered under Celltrion, Inc. above.

9. Court of Appeals for the Federal Circuit Cases (Specific details for these individual entries are generally covered by the consolidated appeals mentioned above involving Regeneron vs. Mylan, Samsung Bioepis, Formycon, Amgen, and Celltrion, which often involve multiple appeals under one decision or related issues.)

  • Jurisdiction: Court of Appeals for the Federal Circuit
  • Case Numbers:
    • 24-1402, 24-1405: Dismissed for lack of jurisdiction on April 12, 2024.
    • 24-1965, 24-1966, 24-2002, 24-2009, 24-2019, 24-2082, 24-2083, 24-2147, 24-2156, 24-2351: These are Federal Circuit appeals primarily involving Regeneron against various biosimilar manufacturers (Mylan, Samsung Bioepis, Formycon, Celltrion, Amgen) concerning preliminary injunctions and district court judgments regarding the '865 patent. Their outcomes are integrated into the specific defendant entries above.

10. New Jersey District Court Case:

  • Jurisdiction: New Jersey District Court
  • Case Number: 3:24-cv-08760
  • Filing Date: Not explicitly found in search results.
  • Outcome/Current Status: Status unknown from current search results, but context indicates likely BPCIA litigation against another biosimilar applicant.

Summary of Litigation involving US Patent 11084865:

US Patent 11084865, owned by Regeneron Pharmaceuticals, Inc., is extensively involved in BPCIA (Biologics Price Competition and Innovation Act) litigation concerning biosimilar versions of Regeneron's Eylea® (aflibercept). The majority of these cases are in the U.S. District Court for the Northern District of West Virginia, often consolidated under MDL 1:24-md-03103, with numerous appeals to the U.S. Court of Appeals for the Federal Circuit and challenges at the PTAB.

The patent is directed to ophthalmic formulations of aflibercept suitable for intravitreal administration, claiming specific stability and formulation requirements.

Known Litigation Cases:

  1. Plaintiff: Regeneron Pharmaceuticals, Inc.

    • Defendant(s): Mylan Pharmaceuticals Inc. (and Biocon Biologics Inc.)
    • Jurisdiction: U.S. District Court for the Northern District of West Virginia; U.S. Court of Appeals for the Federal Circuit
    • Case Number(s):
      • District Court: 1:22-cv-00061 (N.D.W. Va.)
      • MDL: 1:24-md-03103 (N.D.W. Va.)
      • CAFC Appeals: 24-2002, along with multiple other related appeals (e.g., 24-1965, 24-1966, 24-2019, 24-2058, 24-2082, 24-2083, 24-2147, 24-2156, 24-2351)
    • Filing Date: August 2022 (District Court)
    • Outcome/Current Status: District court found Mylan infringed and claims were not invalid. Appeals to CAFC were filed. On April 15, 2025, Biocon (for Mylan's biosimilar Yesafili™) settled with Regeneron, dismissing CAFC Appeal No. 24-2002 and District Court Case No. 1:22-cv-00061, allowing commercialization of Yesafili™ in the second half of 2026. CAFC Appeal 24-2351 was dismissed on March 14, 2025.

  2. Plaintiff: Regeneron Pharmaceuticals, Inc.

    • Defendant(s): Samsung Bioepis Co., Ltd.
    • Jurisdiction: U.S. District Court for the Northern District of West Virginia; U.S. Court of Appeals for the Federal Circuit; PTAB
    • Case Number(s):
      • District Court: 1:23-cv-00094 (N.D.W. Va.), 1:23-cv-00106 (N.D.W. Va.)
      • MDL: 1:24-md-03103 (N.D.W. Va.)
      • CAFC Appeals: 24-1965, 24-1966, 24-2082, 24-2083
      • PTAB IPR: IPR2025-00176
    • Filing Date: Late 2023 (District Court); November 20, 2024 (IPR2025-00176)
    • Outcome/Current Status: District court granted preliminary injunction (June 14, 2024). Federal Circuit affirmed preliminary injunction (January 29, 2025). PTAB IPR2025-00176: Not Instituted - Procedural (discretionary denial).

  3. Plaintiff: Regeneron Pharmaceuticals, Inc.

    • Defendant(s): Formycon AG
    • Jurisdiction: U.S. District Court for the Northern District of West Virginia; U.S. Court of Appeals for the Federal Circuit; PTAB
    • Case Number(s):
      • District Court: 1:23-cv-00097 (N.D.W. Va.)
      • MDL: 1:24-md-03103 (N.D.W. Va.)
      • CAFC Appeal: 24-2009
      • PTAB IPR: IPR2025-00233
    • Filing Date: Late 2023 (District Court); December 2, 2024 (IPR2025-00233)
    • Outcome/Current Status: District court granted preliminary injunction (June 21, 2024). Federal Circuit affirmed preliminary injunction (January 29, 2025). PTAB IPR2025-00233: Not Instituted - Procedural (discretionary denial).

  4. Plaintiff: Regeneron Pharmaceuticals, Inc.

    • Defendant(s): Celltrion, Inc.
    • Jurisdiction: U.S. District Court for the Northern District of West Virginia; U.S. Court of Appeals for the Federal Circuit; PTAB
    • Case Number(s):
      • District Court: 1:23-cv-00089 (N.D.W. Va.), 1:24-cv-00053 (N.D.W. Va.)
      • MDL: 1:24-md-03103 (N.D.W. Va.)
      • CAFC Appeal: 24-2058, 24-2147
      • PTAB IPR: IPR2025-00456
    • Filing Date: Late 2023 (District Court); January 15, 2025 (IPR2025-00456)
    • Outcome/Current Status: District court granted preliminary injunction (June-July 2024). Federal Circuit affirmed preliminary injunction (March 5, 2025). PTAB IPR2025-00456: Not Instituted - Procedural (discretionary denial).

  5. Plaintiff: Regeneron Pharmaceuticals, Inc.

    • Defendant(s): Amgen Inc.
    • Jurisdiction: U.S. District Court for the Central District of California (transferred to N.D.W. Va.); U.S. Court of Appeals for the Federal Circuit
    • Case Number(s):
      • District Court: 2:24-cv-00264 (C.D. Cal.), transferred to 1:24-cv-00039 (N.D.W. Va.)
      • MDL: 1:24-md-03103 (N.D.W. Va.)
      • CAFC Appeal: 24-2351
    • Filing Date: January 10, 2024 (District Court)
    • Outcome/Current Status: District court denied preliminary injunction. Federal Circuit upheld the denial of preliminary injunction (March 14, 2025). Amgen launched biosimilar Pavblu™ at-risk in October 2024.

  6. Plaintiff: Regeneron Pharmaceuticals, Inc.

    • Defendant(s): Sandoz Inc.
    • Jurisdiction: U.S. District Court for the Northern District of West Virginia
    • Case Number(s): 1:24-cv-00085 (N.D.W. Va.)
      • MDL: 1:24-md-03103 (N.D.W. Va.)
    • Filing Date: Not explicitly stated, but within the context of other 2024 filings.
    • Outcome/Current Status: Ongoing. Sandoz's biosimilar Enzeevu™ was approved in August 2024.

  7. Plaintiff(s): Fresenius Kabi SwissBioSim GmbH (and related entities)

    • Defendant(s): Regeneron Pharmaceuticals, Inc.
    • Jurisdiction: PTAB
    • Case Number(s): IPR2025-01268
    • Filing Date: Not explicitly stated, but "Effective date: 20250714". (Other sources indicate petitions for IPRs in this timeframe for other parties were filed in late 2024/early 2025).
    • Outcome/Current Status: Not Instituted - Procedural.

  8. Plaintiff: Not specified (implied by "US case filed in New Jersey District Court")

    • Defendant(s): Not specified
    • Jurisdiction: New Jersey District Court
    • Case Number: 3:24-cv-08760
    • Filing Date: Not explicitly found in search results.
    • Outcome/Current Status: Status unknown from current search results.

Note: Several CAFC cases listed in the initial patent document (e.g., 24-1402, 24-1405) were dismissed for lack of jurisdiction. The numerous other CAFC case numbers (e.g., 24-1965, 24-1966, etc.) are generally appeals related to the district court actions and preliminary injunctions against the biosimilar manufacturers listed above, and their outcomes are incorporated into those respective entries.

Generated 5/20/2026, 12:48:08 AM