Regeneron Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc. initiated a patent infringement lawsuit against Mylan Pharmaceuticals Inc. in the U.S. District Court for the Northern District of West Virginia. Regeneron is a leading American biotechnology company that invents, develops, and commercializes life-transforming medicines, including its blockbuster eye drug, Eylea (aflibercept), which treats various retinal diseases such as wet age-related macular degeneration and diabetic macular edema. Mylan Pharmaceuticals Inc., now part of Viatris Inc. following a 2020 merger with Upjohn, is a global pharmaceutical company specializing in generic and biosimilar drugs. The core of the dispute involves Mylan's proposed biosimilar version of aflibercept, known as M710 or YESAFILI™ (aflibercept-jbvf), which Regeneron alleges infringes its patents covering Eylea.

The primary patent at issue in this specific case is U.S. Patent 10,828,345. This patent generally covers methods for treating angiogenic eye disorders by sequentially administering multiple doses of a Vascular Endothelial Growth Factor (VEGF) antagonist, such as aflibercept, at a frequency of once every eight or more weeks. Regeneron asserts that Mylan's biosimilar product infringes this and potentially other patents related to the composition and formulation of aflibercept.

The litigation, filed in the Northern District of West Virginia, is part of a larger Multidistrict Litigation (MDL No. 1:24-md-3103) titled In re: Aflibercept Patent Litigation, which consolidates multiple cases against various biosimilar developers challenging Regeneron's Eylea patents. Chief District Judge Thomas S. Kleeh presides over the MDL. This venue is significant because it centralizes the complex Biologics Price Competition and Innovation Act (BPCIA) litigation surrounding aflibercept, allowing for streamlined pretrial proceedings against multiple biosimilar challengers. The case is notable for its substantial industry impact, as Eylea is a multi-billion-dollar drug, and the entry of biosimilars is expected to increase competition and lower healthcare costs. Although the specific case against Mylan (1:24-cv-00085, previously 1:22-cv-00061) was initially filed in August 2022, it was subsequently resolved through a confidential settlement agreement, leading to a stipulated dismissal of all claims and counterclaims with prejudice in April 2025. This settlement permits Biocon (Mylan's partner) to launch YESAFILI™ in the U.S. in the second half of 2026 or potentially earlier. Despite this settlement, the broader MDL continues to manage litigation against other biosimilar manufacturers.

The patent infringement litigation Regeneron Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., Case number 1:24-cv-00085, in the West Virginia Northern District Court, asserting US patent 10828345, has seen several key legal developments, although it appears there is a discrepancy in the case caption provided in the prompt and the information available in public records. Public dockets and legal news sources strongly indicate that case number 1:24-cv-00085 in the Northern District of West Virginia is actually Regeneron Pharmaceuticals, Inc. v. Sandoz, Inc., not Mylan Pharmaceuticals Inc.. This case was part of the larger Aflibercept MDL (1:24-md-03103-TSK-JPM), which involved Regeneron suing multiple biosimilar applicants for its Eylea® product.

Despite this discrepancy, the following developments are reported for the case identified by the number 1:24-cv-00085 and its associated patent 10828345:

Key Legal Developments and Outcome

1. Filing & Initial Pleadings:

• The complaint for Regeneron v. Sandoz Inc. (case 1:24-cv-00085) was filed on August 26, 2024.
• On September 13, 2024, the case was ordered to be consolidated into the Aflibercept MDL (1:24-md-03103-TSK-JPM) and transferred to the Northern District of West Virginia.
• Regeneron was given an extended deadline until January 31, 2025, to respond to Sandoz's First Amended Answer to Complaint, Defenses, and Counterclaims.

2. Pre-trial Motions of Substance:

• In the broader Aflibercept MDL, which includes numerous actions against biosimilar developers, Regeneron sought preliminary injunctions against several parties. For instance, preliminary injunctions against Samsung Bioepis and Formycon were granted by the district court and later affirmed by the Federal Circuit on January 29, 2025.
• A permanent injunction was granted in favor of Regeneron against Mylan/Biocon on June 11, 2024, with the terms issued on June 21, 2024, in a separate, earlier case (1:22-CV-00061), not 1:24-cv-00085.
• A motion for a preliminary injunction against Amgen was denied by the district court, and this denial was affirmed by the Federal Circuit on March 14, 2025.

3. Claim Construction (Markman) Outcomes:

• A scheduling order for a Markman hearing was issued on September 29, 2025, for November 23, 2026, within one of the consolidated MDL cases (specifically involving Amgen). It is unclear from the available information if a specific Markman hearing was held or concluded for patent 10828345 in the Regeneron v. Sandoz case (1:24-cv-00085) prior to its dismissal.

4. Discovery Milestones with Strategic Significance:

• Specific strategic discovery milestones for case 1:24-cv-00085 are not detailed in the available public information, likely due to its early settlement and consolidation into the MDL.

5. Trial Events, Verdict, and Post-Trial Motions:

• The case 1:24-cv-00085 (Regeneron v. Sandoz) did not proceed to trial. An expedited trial was held in June 2023 in a separate, earlier case involving Mylan (1:22-CV-00061), where the court found Mylan infringed claims of US Patent No. 11,084,865, which was found not invalid, while some claims of other patents were found invalid.

6. Settlement, Dismissal, Judgment, or Appeal:

• Regeneron Pharmaceuticals Inc. v. Sandoz Inc. (case 1:24-cv-00085) was ultimately dismissed due to a settlement agreement between the parties. The exact date of dismissal due to settlement is not explicitly stated in the provided snippets, but its status is listed as "Dismissed in view of the parties' settlement."

7. Parallel PTAB IPR/PGR Proceedings on the Asserted Patents:

• US Patent 10,828,345: An Inter Partes Review (IPR) petition, IPR2025-01269, was filed by Fresenius Kabi SwissBioSim GmbH challenging US Patent 10,828,345 on July 14, 2025. Institution of this IPR was denied on January 9, 2026.
• Other Related Patents in Aflibercept Litigation: Numerous other IPRs have been filed challenging patents related to Regeneron's Eylea® product. These include petitions filed by Mylan Pharmaceuticals Inc. (IPR2021-00881, IPR2021-00880), Celltrion, Inc. (IPR2022-00257, IPR2022-00258), and Samsung Bioepis Co., Ltd. (IPR2023-00442, IPR2023-00739).

Counsel of Record for Plaintiff Regeneron Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc. was represented by counsel from several firms in the patent infringement case against Mylan Pharmaceuticals Inc., which was part of the broader In re: Aflibercept Patent Litigation MDL and settled in April 2025.

Here are the identified attorneys representing Regeneron:

• Brian T. Drummond

  • Role: Lead Counsel (Partner)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Brian Drummond is a partner in Goodwin's Litigation Department and a member of the firm's Intellectual Property Litigation practice and Life Sciences Disputes group. He focuses his practice on patent matters, with a concentration on pharmaceuticals and biotechnology. He has participated in all phases of patent litigation, including trials in federal courts and appeals to the Federal Circuit. He is also an editor and contributor to the firm's biosimilars blog, Big Molecule Watch, which frequently covers the Eylea litigation. Drummond was specifically noted in updates regarding Regeneron's BPCIA aflibercept litigation against Mylan.

• Elaine Herrmann Blais

  • Role: Lead Counsel (Partner, Co-Chair of Intellectual Property Litigation)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Elaine Herrmann Blais is Co-Chair of Goodwin's Intellectual Property Litigation practice. She has extensive experience in high-stakes patent disputes for life sciences companies, including securing preliminary injunctions and achieving favorable settlements and appellate relief. Goodwin Procter is recognized for having one of the nation's most active patent litigation practices, and Blais is a key contact for their patent litigation services. She is broadly involved in Regeneron's Eylea patent litigation efforts.

• Frank E. Simmerman, Jr.

  • Role: Of Counsel (likely Local Counsel)
  • Firm: Jackson Kelly PLLC, Charleston, WV
  • Relevant Experience: Frank E. Simmerman, Jr. has been identified as "Of Counsel" for Regeneron in filings related to settlements within the Aflibercept Patent Litigation MDL, suggesting his role as local counsel in the West Virginia District Court. Jackson Kelly PLLC is a prominent law firm in West Virginia with extensive litigation experience.

While other firms, such as Finnegan, Henderson, Farabow, Garrett & Dunner LLP, are known for their strong intellectual property litigation practices and expertise in biologics, and have been involved in various aspects of the broader biosimilar landscape, the publicly available information, particularly from Goodwin's own publications regarding the Mylan settlement and specific attorney involvement, strongly points to Goodwin Procter LLP as lead counsel for Regeneron in this particular case.

Based on the provided information, there's a significant discrepancy in the defendant identified for case number 1:24-cv-00085. The prompt initially states the defendant is Mylan Pharmaceuticals Inc., asserting US patent 10828345. However, multiple search results and subsequent sections of the "Previously generated sections" consistently identify the defendant in 1:24-cv-00085 as Sandoz Inc., not Mylan.

The case against Mylan Pharmaceuticals Inc. concerning aflibercept biosimilars was primarily litigated under case number 1:22-cv-00061, which reached a settlement in April 2025. For the purposes of answering the current task, which specifically asks for counsel of record for the defendant(s) in this patent infringement case (referring to 1:24-cv-00085), the following information will focus on Sandoz Inc.

Counsel of Record for Defendant Sandoz Inc. (in 1:24-cv-00085)

Sandoz Inc. was represented by counsel from Wilentz, Goldman & Spitzer, and Goodwin Procter.

• Edward T. Kole

  • Role: Counsel of Record (Partner)
  • Firm: Wilentz, Goldman & Spitzer, Woodbridge, NJ
  • Relevant Experience: Edward Kole is noted as appearing on behalf of Sandoz Inc. in filings for case 1:24-cv-00085. He is known for intellectual property and patent litigation.

• Emily L. Rapalino

  • Role: Counsel of Record (Partner)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Emily Rapalino's admission pro hac vice was approved for Sandoz Inc. in this case. Goodwin Procter has a strong intellectual property litigation practice, particularly in life sciences.

• Grace Truong

  • Role: Counsel of Record (Associate)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Grace Truong's admission pro hac vice was approved for Sandoz Inc. in this case.

• Joshua Weinger

  • Role: Counsel of Record (Associate)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Joshua Weinger's admission pro hac vice was approved for Sandoz Inc. in this case.

• Louis L. Lobel

  • Role: Counsel of Record (Associate)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Louis Lobel's admission pro hac vice was approved for Sandoz Inc. in this case.

• Molly R. Grammel

  • Role: Counsel of Record (Associate)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Molly Grammel's admission pro hac vice was approved for Sandoz Inc. in this case.

• Timothy James Beavers

  • Role: Counsel of Record (Associate)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Timothy Beavers's admission pro hac vice was approved for Sandoz Inc. in this case.

• Christopher Cassella

  • Role: Counsel of Record (Associate)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Christopher Cassella's admission pro hac vice was approved for Sandoz Inc. in this case.

• Elaine Herrmann Blais

  • Role: Counsel of Record (Partner, Co-Chair of Intellectual Property Litigation)
  • Firm: Goodwin Procter LLP, Boston, MA
  • Relevant Experience: Elaine Herrmann Blais, also representing Regeneron in other aflibercept litigation, was granted pro hac vice admission for Sandoz Inc. in this case. This is an interesting dynamic and potentially indicative of the complex and interconnected nature of the broader MDL.

• Jeffrey M. Wakefield

  • Role: Local Counsel (Partner)
  • Firm: Flaherty Sensabaugh Bonasso, PLLC, Charleston, WV
  • Relevant Experience: Jeffrey Wakefield is identified as local counsel for Sandoz Inc. in the stipulation and order dismissing claims.

Discrepancy Flag

As noted above, there is a clear and consistent discrepancy regarding the defendant for case number 1:24-cv-00085. The prompt initially states Mylan Pharmaceuticals Inc., but all available docket and news information confirms the defendant in this specific case number is Sandoz Inc. The litigation involving Mylan Pharmaceuticals Inc. and Biocon Biologics Inc. concerning aflibercept biosimilars concluded in a separate case, 1:22-cv-00061, which settled in April 2025.