Regeneron Pharmaceuticals, Inc. v. Sandoz Inc.

This patent infringement litigation centers on Regeneron Pharmaceuticals, Inc., a prominent American biotechnology company known for developing and commercializing transformative medicines, particularly for eye diseases, with its blockbuster drug Eylea® (aflibercept). The plaintiff, Regeneron, initiated the suit against Sandoz Inc., a global leader in generic and biosimilar pharmaceuticals that recently spun off from Novartis. Sandoz is the defendant and the maker of the accused product, Enzeevu™ (aflibercept-abzv), a biosimilar referencing Regeneron's Eylea®. Eylea® is a vascular endothelial growth factor (VEGF) inhibitor used to treat various retinal diseases, such as neovascular age-related macular degeneration (nAMD), by blocking abnormal blood vessel growth. The primary patent asserted in this case is US Patent 11084865, which broadly covers ophthalmic formulations of VEGF-specific fusion protein antagonists, ensuring their stability for intravitreal administration to the eye. Specifically, the patent claims formulations where at least 98% of the VEGF antagonist maintains its native conformation after storage.

The procedural posture places this case in the U.S. District Court for the Northern District of West Virginia, under Chief District Judge Thomas S. Kleeh (Case No. 1:24-cv-00085). This venue has become notable as a hub for Biologics Price Competition and Innovation Act (BPCIA) litigation, particularly for disputes concerning aflibercept biosimilars, with several related cases centralized into an MDL (1:24-md-03103-TSK-JPM) overseen by Judge Kleeh. The concentration of these complex biosimilar cases in one district and before a single judge has streamlined, yet intensified, the "aflibercept battle" in the courts.

This litigation is significant within the pharmaceutical industry due to the high stakes surrounding Eylea®, a key revenue driver for Regeneron, and the broader push for affordable biosimilar alternatives. Sandoz's Enzeevu™ received FDA approval in August 2024, prompting the litigation. However, the case was resolved through a settlement agreement between Regeneron and Sandoz, announced in September 2025, leading to the dismissal of all claims and counterclaims without prejudice. Under the terms of the settlement, Sandoz is permitted to launch its aflibercept biosimilar in the U.S. market in the fourth quarter of 2026, or potentially earlier under specific, undisclosed circumstances. This outcome reflects a common trend in BPCIA litigation where settlements often dictate the market entry timelines for biosimilars, influencing patient access and market competition. The '865 patent has been central to Regeneron's defense of Eylea®, facing multiple challenges, including in parallel Inter Partes Review (IPR) proceedings at the PTAB.

Regeneron Pharmaceuticals, Inc. initiated patent infringement litigation against Sandoz Inc. concerning US Patent 11084865, among others, following the FDA approval of Sandoz's biosimilar aflibercept-abzv (Enzeevu). The case was ultimately resolved through a settlement agreement.

Here are the key legal developments and outcome in chronological order:

• Filing & Initial Pleadings (2024-08-26): Regeneron Pharmaceuticals, Inc. filed a Biologics Price Competition and Innovation Act (BPCIA) complaint against Sandoz Inc. in the U.S. District Court for the District of New Jersey. The lawsuit, case number 2:24-cv-08760, was initiated after the FDA approved Sandoz's biosimilar aflibercept-abzv (Enzeevu) on August 9, 2024. Regeneron asserted infringement of up to 46 patents protecting its reference medicine, Eylea.
• Consolidation and Transfer to MDL (2024-09-13): The case was subsequently consolidated into a multi-district litigation (MDL) and transferred to the U.S. District Court for the Northern District of West Virginia, where it was assigned case number 1:24-cv-00085.
• Extension for Regeneron's Response (2025-01-21): Judge Kleeh extended the deadline for Regeneron to respond to Sandoz's First Amended Answer to Complaint, Defenses, and Counterclaims until January 31, 2025. At this point, the Sandoz action was still at the pleading stage.
• Settlement and Dismissal (2025-09-09): Sandoz and Regeneron announced that they had reached an agreement settling all patent disputes between the two companies relating to Sandoz's FDA-approved aflibercept biosimilar. This agreement allows Sandoz to enter the U.S. market with its biosimilar aflibercept in the fourth quarter of 2026, or earlier under certain undisclosed circumstances. A stipulation and order for dismissal were filed on this date, leading to the case's dismissal.

Parallel PTAB IPR Proceedings:
While Sandoz itself was not reported to have filed an IPR on the '865 patent, other biosimilar developers challenged the patent at the Patent Trial and Appeal Board (PTAB):

• IPR Petitions Against '865 Patent (2024-11-20 to 2025-01-15): Samsung Bioepis (IPR2025-00176), Formycon (IPR2025-00233), and Celltrion (IPR2025-00456) filed petitions for inter partes review (IPR) challenging the validity of U.S. Patent No. 11,084,865.
• Denial of Institution (June 2025): The PTAB denied institution of the IPRs filed by Samsung Bioepis and Formycon on discretionary grounds. The Board cited the advanced state of parallel district court proceedings, including a trial in a related case against Mylan and preliminary injunction proceedings, which had already focused on the validity of the '865 patent.
• Additional IPR Petition (2025-07-14): Fresenius Kabi SwissBioSim GmbH also filed an IPR petition (IPR2025-01268) challenging claims of the '865 patent.

Regeneron Pharmaceuticals, Inc. was represented by a team of attorneys from several law firms in its patent infringement case against Sandoz Inc. concerning US Patent 11084865.

The counsel of record for Regeneron included:

Williams & Connolly LLP

• David I. Berl (Lead Counsel)
• Ellen E. Oberwetter (Lead Counsel)
• Thomas S. Fletcher (Lead Counsel)
• Andrew V. Trask (Lead Counsel)
• Teagan J. Gregory (Lead Counsel)
• Shaun P. Mahaffy (Lead Counsel)
• Kathryn S. Kayali (Lead Counsel)
• Arthur J. Argall (Lead Counsel)
• Adam Pan (Lead Counsel)
• Rhochelle Krawetz (Lead Counsel)
• Jennalee Beazley (Lead Counsel)

Paul, Weiss, Rifkind, Wharton & Garrison LLP

• Elizabeth Stotland Weiswasser (Lead Counsel)
• Christopher M. Pepe (Lead Counsel)
• Priyata Y. Patel (Lead Counsel)
  • Note: Paul Hastings has a strong life sciences and healthcare practice, advising on regulatory, transactional, and litigation matters throughout the product lifecycle. Jane H. Yoon, a partner in their Litigation practice, focuses on healthcare fraud and False Claims Act cases.

Kellogg, Hansen, Todd, Figel & Frederick

• Andrew E. Goldsmith (Lead Counsel)
• Evan T. Leo (Lead Counsel)
• Jacob E. Hartman (Lead Counsel)
• Mary Charlotte Y. Carroll (Lead Counsel)
• Sven E. Henningson (Lead Counsel)

Carey Douglas Kessler & Ruby

• Steven R. Ruby (Local Counsel)
• David R. Pogue (Local Counsel)
• Raymond S. Franks II (Local Counsel)

Additionally, while not explicitly listed as counsel of record for this specific case in the provided search results, Fish & Richardson is known for representing pharmaceutical clients in high-stakes patent litigation, including biosimilar cases, and has a strong life sciences team. Robert C. Sullivan, Jr. and John C. Adkisson from Fish & Richardson have extensive experience in biotechnology, chemistry, and pharmaceutical patent litigation. Craig D. Boyle, also from Fish & Richardson, focuses on patent prosecution in the pharmaceutical and life sciences industries.

I'll research Sandoz's counsel of record in this case. Let me run several targeted searches.

Let me dig into the docket and firm-side confirmations.

Let me verify the Wilentz, Goldman & Spitzer connection and pull the full attorney list from the docket.

Counsel of Record for Defendant Sandoz Inc.

Sandoz's defense team in this case is a two-tier structure: a Goodwin Procter LLP life-sciences IP litigation team admitted pro hac vice, anchored by West Virginia local counsel at Flaherty Sensabaugh Bonasso PLLC, plus New Jersey counsel carried over from the original D.N.J. filing.

Lead / trial counsel — Goodwin Procter LLP (IP Litigation / Life Sciences Disputes)

Docket grounding: In In re Aflibercept Patent Litigation, MDL No. 1:24-md-03103-TSK-JPM, "associated cases 1:24-md-03103-TSK-JPM, 1:24-cv-00085-TSK," Sandoz filed PHV applications on Oct. 2, 2024 for Lobel (ECF 357), Grammel (ECF 358), Beavers (ECF 359), Cassella (ECF 360), Blais (ECF 361), and (per the docket's fee entry) Rapalino, Truong, Weinger, and Lobel. Chief Judge Kleeh granted all applications on Oct. 8, 2024 (orders at ECF 354–361).

Local counsel — West Virginia

New Jersey counsel (from the original D.N.J. action)

In-house counsel

No Sandoz in-house attorney appears as counsel of record in the filings I retrieved for 1:24-cv-00085. (By contrast, Regeneron's team includes in-house attorneys such as Adam Bernstein, Arunabha Bhoumik, James Evans, Larry Coury, and Petra Scamborova appearing as lead counsel PHV in the parallel MDL cases — so the absence for Sandoz is notable, not merely a search gap.)

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Important caveats and cross-checks

1. The dismissal submission is the best evidence of the final appearance roster. The parties' Stipulated Dismissal (Sept. 9, 2025) bears the Sandoz signature block of Jeffrey M. Wakefield (Flaherty Sensabaugh Bonasso) plus Goodwin Procter's Rapalino, Blais, Grammel, Weinger, and Lobel. Edward T. Kole and Keith J. Miller do not appear on that block — meaning either they never formally entered in the N.D. W. Va. track (their role was the D.N.J. action, No. 2:24-cv-08760) or they withdrew. I could not retrieve a withdrawal order for them; this specific point is not fully sourced and should be verified against the PACER docket for 1:24-cv-00085.
2. Some Sandoz filings are sealed. The docket reflects a Sandoz motion for leave to file under seal and a memorandum in support (Oct. 30, 2024), so portions of Sandoz's submissions (and any counsel signature blocks in sealed exhibits) are not publicly viewable.
3. Case-transfer nuance. The complaint was filed in D.N.J. on Aug. 26, 2024 (2:24-cv-08760) and the track in the Northern District of West Virginia appears as 1:24-cv-00085 within MDL 1:24-md-03103-TSK-JPM (docket's first local entries Sept. 13, 2024). This is consistent with the previously generated sections; no contradiction found.
4. Contradiction to flag in the prior sections: the earlier "Plaintiff representatives" section appended an unsourced note about Paul Hastings and attorney Jane H. Yoon under the Paul, Weiss heading. That note is not supported by any filing I retrieved and appears to be search noise — it should be removed. Also, the earlier IPR narrative stating Sandoz "was not reported to have filed an IPR on the '865 patent" is consistent with, not contradicted by, what I found (Bioepis/Formycon/Celltrion/Fresenius Kabi petitions only).

Key sources: Stipulated Dismissal, N.D. W. Va. (Sept. 9, 2025) (via biologicshq.com); In re Aflibercept Patent Litigation, 1:24-md-03103 (CourtListener docket, ECF 354–361, 378); Docket sheet for Regeneron Pharms., Inc. v. Sandoz, Inc., 1:24-cv-00085 (dockets.justia.com, Filing 11); Law.com Radar card for No. 2:24-cv-08760; IPFray, "Regeneron makes strides in global Eylea patent enforcement campaign" (counsel summary); Goodwin Procter and BTI profiles for Emily L. Rapalino.