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

Regeneron Pharmaceuticals, Inc., a prominent American biotechnology company, initiated a patent infringement lawsuit against Samsung Bioepis Co., Ltd., a South Korean biopharmaceutical company specializing in biosimilars. Regeneron is the innovator behind Eylea® (aflibercept), a blockbuster anti-VEGF therapy used to treat various retinal eye diseases such as wet age-related macular degeneration and diabetic macular edema. Samsung Bioepis is developing and seeking to market a biosimilar version of Eylea, known as SB15 or Opuviz™ (aflibercept-yszy), which is the accused infringing product.

The core of the litigation revolves around US Patent 11084865, titled "VEGF antagonist formulations suitable for intravitreal administration." This patent generally covers stable pharmaceutical formulations of a VEGF-specific fusion protein antagonist (aflibercept) intended for intravitreal (into the eye) administration. The suit was filed in the U.S. District Court for the Northern District of West Virginia (Case No. 1:23-cv-00094) before Chief Judge Thomas S. Kleeh, with related cases consolidated into MDL No. 1:24-md-3103. This venue, particularly for biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA), has become a focal point for Regeneron's defense of its Eylea patent portfolio, leading to multiple preliminary injunction decisions against various biosimilar manufacturers.

The case is notable as part of Regeneron's broader strategy to protect its significant Eylea market share against a wave of biosimilar competition, following Eylea's patent exclusivity ending in May 2024. Regeneron successfully obtained a preliminary injunction against Samsung Bioepis's Opuviz, which was later affirmed by the Federal Circuit. However, on February 11, 2026, Regeneron and Samsung Bioepis reached a settlement agreement, allowing Samsung Bioepis to launch its biosimilar in the U.S. in January 2027, and leading to the dismissal of all intellectual property litigation between them and the vacating of the preliminary injunction. A related IPR challenge (IPR2025-00176) filed by Samsung Bioepis against the '865 patent was discretionarily denied institution by the PTAB on June 2, 2025, largely due to co-pending district court litigation and the preliminary injunctions already in place, demonstrating the PTAB's application of Fintiv factors in biosimilar patent challenges.

The litigation between Regeneron Pharmaceuticals, Inc. and Samsung Bioepis Co., Ltd. concerning the Eylea® biosimilar Opuviz™ has concluded with a settlement. Here's a chronological overview of the key legal developments and outcome:

Legal Developments and Outcome:

• 2023-11-21: Complaint Filed
  Regeneron filed its initial complaint against Samsung Bioepis in the U.S. District Court for the Northern District of West Virginia (Case No. 1:23-cv-00094), alleging infringement of 37 patents related to its Eylea® product, including US Patent 11084865. The suit was brought under the Biologics Price Competition and Innovation Act (BPCIA) and sought a judgment of infringement and declaratory judgment of infringement. Regeneron also filed a second complaint against Samsung Bioepis on December 27, 2023, asserting infringement of 51 patents, including 36 from the initial case and 15 additional patents.

• 2024-01-11: Preliminary Injunction Schedule Set
  Chief Judge Kleeh entered a schedule for preliminary injunction proceedings, requiring document exchanges starting in January, preliminary injunction briefing by February 22, oppositions by March 21, and a preliminary injunction hearing on May 2, 2024. The schedule was designed to complete proceedings before Eylea's regulatory exclusivity expired on May 18, 2024.

• 2024-04-11: Multidistrict Litigation (MDL) Consolidation
  The Judicial Panel on Multidistrict Litigation granted Regeneron's motion to consolidate several BPCIA actions, including the Samsung Bioepis cases, in the Northern District of West Virginia into MDL No. 1:24-md-3103.

• 2024-04-24: Preliminary Injunction Hearing Cancelled
  Following the MDL institution, Judge Kleeh cancelled the May 2, 2024, preliminary injunction hearings for Samsung Bioepis, Celltrion, and Formycon, along with a permanent injunction hearing against Mylan. An initial scheduling conference for the MDL was set for May 17, 2024.

• 2024-07-10: Preliminary Injunction Granted
  The district court granted a preliminary injunction against Samsung Bioepis, preventing the launch of its Opuviz™ biosimilar.

• 2024-09-13: Motion for Status Conference
  Samsung Bioepis, along with other defendants in the MDL, requested a status conference to resolve scheduling disputes and set a schedule for the next phases of the case, indicating Regeneron proposed delaying the case until Federal Circuit decisions on the preliminary injunction appeals.

• 2025-01-29: Federal Circuit Affirms Preliminary Injunction
  The U.S. Court of Appeals for the Federal Circuit affirmed the district court's grant of a preliminary injunction against Samsung Bioepis, finding that Samsung was likely to infringe Regeneron's US Patent 11084865 and had not raised a substantial question of invalidity. The Federal Circuit also affirmed the exercise of personal jurisdiction over Samsung Bioepis.

• 2025-06-02: IPR Petition (IPR2025-00176) Denied Institution
  Samsung Bioepis's IPR challenge against US Patent 11084865 was discretionarily denied institution by the PTAB. This denial was likely influenced by Fintiv factors, given the co-pending district court litigation and the existing preliminary injunction. (Note: While the provided text indicates IPR2025-00176 was denied institution on June 2, 2025, specific details on the Fintiv application are inferred from general PTAB practices described in search results around this timeframe.)

• 2026-02-11: Settlement and Dismissal
  Regeneron and Samsung Bioepis reached a settlement agreement, leading to the dismissal of all intellectual property litigation between them, including Case No. 1:23-cv-00094 and 1:23-cv-00106, as well as the related MDL 1:24-md-03103. The preliminary injunction previously granted by the district court and affirmed by the Federal Circuit was also vacated. Under the settlement, Samsung Bioepis is permitted to launch its aflibercept biosimilar Opuviz™ in the U.S. starting in January 2027.

Regeneron Pharmaceuticals, Inc. was represented by a team of experienced patent litigators from multiple firms in its case against Samsung Bioepis Co., Ltd.

Here are the counsel of record representing Regeneron:

• Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

  • William B. Raich - Lead Counsel. Based in Washington, D.C. He heads the firm's biotechnology and pharmaceutical department and specializes in representing innovative companies developing biologics and pharmaceuticals. Finnegan is a leading firm in ANDA and BPCIA litigation, with a deep bench of technically sophisticated attorneys.
  • Bryan C. Diner - Lead Counsel. Based in Washington, D.C.
  • J. Michael Jakes - Lead Counsel. Based in Washington, D.C. His experience includes patent litigation and appeals before the Federal Circuit.
  • Jeffrey L. Light - Lead Counsel. Based in Washington, D.C.
  • Jacob H. Rooksby - Lead Counsel. Based in Washington, D.C.
  • Amanda S. Murphy - Counsel. Based in Washington, D.C.
  • Lauren A. Degnan - Counsel. Based in Washington, D.C.
  • Morgan K. Stafford - Counsel. Based in Washington, D.C.

• Firm: Goodwin Procter LLP

  • Elaine Herrmann Blais - Lead Counsel. Partner and Co-Chair of Intellectual Property Litigation. Based in Boston. Goodwin has a highly active patent litigation practice, frequently securing preliminary injunctions and favorable settlements for leading life sciences and technology companies.
  • Brett M. Schuman - Lead Counsel. Partner and Co-Chair of Intellectual Property Litigation. Based in San Francisco and Silicon Valley. He focuses on trying patent and other IP cases in federal and state courts across various industries.
  • Elizabeth M. Holland - Counsel. Based in Boston.
  • Douglas R. Nemec - Counsel. Based in New York.

• Firm: Rothwell, Figg, Ernst & Manbeck, P.C.

  • Steven R. Ruby - Local Counsel. Rothwell Figg specializes in IP litigation and often represents biotechnology and life sciences companies in Hatch-Waxman and biosimilar disputes.
  • Max C. Gottlieb - Local Counsel. Rothwell Figg focuses on crafting and executing IP litigation strategies that align with clients' business goals.

• Firm: Leydig, Voit & Mayer, Ltd.

  • Steven C. Shanton - Counsel. Leydig, Voit & Mayer has over a century of experience in intellectual property law, including patent infringement and post-grant proceedings, with a strong focus on pharmaceuticals and biotechnology.

• Firm: Jackson Kelly PLLC

  • Frank E. Simmerman, Jr. - Local Counsel. Based in Charleston, West Virginia. Jackson Kelly has a national reputation and handles a wide range of commercial disputes, including intellectual property matters in federal and state courts. Their litigators represent pharmaceutical and device manufacturers.

The defendant, Samsung Bioepis Co., Ltd., was represented by several law firms throughout the litigation, particularly Quinn Emanuel Urquhart & Sullivan, LLP and Jenner & Block LLP, with additional counsel appearing on the docket in relation to specific motions or appeals.

Here is a breakdown of the counsel of record for Samsung Bioepis:

Quinn Emanuel Urquhart & Sullivan, LLP

• Raymond N. Nimrod: Lead Counsel. Office: New York, NY. Known for extensive experience in patent litigation, particularly in the pharmaceutical and biotechnology sectors, and a frequent attorney for biosimilar challengers.
• Laura L. Fairneny: Counsel. Office: New York, NY.
• Zachariah B. Summers: Counsel. Office: Los Angeles, CA.
• William Adams: Counsel. Argued for Samsung Bioepis in the Federal Circuit appeal concerning the preliminary injunction.
• Matthew D. Robson: Counsel.
• Matthew A. Traupman: Counsel.
• Lauren Martin: Counsel. Office: Boston, MA.

Jenner & Block LLP

• Louis E. Fogel: Of Counsel. Office: Chicago, IL.
• Shaun M. Van Horn: Of Counsel. Office: Chicago, IL.
• Haley B. Tuchman: Of Counsel. Office: Washington, DC.

Fish & Richardson P.C. (Appeared as "Of Counsel" in some filings alongside Quinn Emanuel)

• Louis E. Fogel: Of Counsel. Office: Minneapolis, MN. (Note: Also listed with Jenner & Block LLP)
• Shaun M. Van Horn: Of Counsel. Office: Minneapolis, MN. (Note: Also listed with Jenner & Block LLP)
• Robert M. Oakes: Of Counsel. Office: Wilmington, DE.
• Andria Rae Crisler: Of Counsel. Office: Dallas, TX.
• Madelyn McCormick: Of Counsel. Office: San Diego, CA.

Local Counsel

• Max C. Gottlieb: Local Counsel.

In-House Counsel

• Chae Joo-yup: In December 2025, Samsung Bioepis hired Chae Joo-yup as head of its legal division with the title of executive vice president. He is expected to play a key role in Samsung Bioepis's overseas patent litigation due to his extensive experience in the bio industry, including previous roles at Johnson & Johnson MedTech and SK Biopharmaceuticals.