Untitled case

This case, 3:24-cv-08760, filed in the New Jersey District Court, involves Regeneron Pharmaceuticals, Inc. as the plaintiff, asserting U.S. Patent 11,084,865 against Sandoz Inc. The patent at issue, US 11,084,865, is titled "VEGF antagonist formulations suitable for intravitreal administration" and broadly covers stable liquid pharmaceutical formulations for inhibiting vascular endothelial growth factor (VEGF), often used for treating angiogenic eye disorders like age-related macular degeneration (AMD). These formulations include specific concentrations of VEGF antagonist fusion protein, buffering agents, and optional stabilizing and tonicity agents, designed for intravitreal injection. The case is likely a biosimilar patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), given that Regeneron is a prominent biopharmaceutical company known for its VEGF-targeting drugs like Eylea (aflibercept), and Sandoz is a well-known developer of biosimilars.

Regeneron Pharmaceuticals, Inc. is an operating biopharmaceutical company that discovers, develops, manufactures, and commercializes medicines. Sandoz Inc. is a subsidiary of Novartis and a global leader in generic pharmaceuticals and biosimilars. The accused product, though not explicitly named in the immediate search results for this specific case number, is almost certainly a biosimilar version of Regeneron's VEGF antagonist drug, likely aflibercept, which Sandoz is seeking to bring to market. The procedural posture places the case in the District of New Jersey, a common venue for Hatch-Waxman and BPCIA litigation due to the presence of many pharmaceutical companies and their generic/biosimilar counterparts. The specific judge for this case is not readily available in the provided search snippets for this particular case number, 3:24-cv-08760.

This case is notable as it represents a common pattern in the pharmaceutical industry where innovator companies like Regeneron defend their blockbuster biologics against biosimilar competition. Such BPCIA cases often involve complex litigation over manufacturing processes, formulations, and methods of use, and their outcomes can significantly impact market access and pricing for crucial medications. The filing itself, under the BPCIA, indicates Regeneron is exercising its right to litigate patent issues before Sandoz's biosimilar product can be commercially launched, a standard practice designed to resolve patent disputes and define the scope of market entry for biosimilar versions.

Key Legal Developments and Outcome for Regeneron Pharmaceuticals, Inc. v. Sandoz Inc. (3:24-cv-08760)

This patent infringement litigation, filed by Regeneron Pharmaceuticals, Inc. against Sandoz Inc. in the District of New Jersey, concerns US Patent 11084865, among others, and arises under the Biologics Price Competition and Innovation Act (BPCIA) related to Sandoz's proposed biosimilar to Regeneron's EYLEA® (aflibercept). The case, filed in August 2024, is one of several parallel litigations Regeneron has initiated to protect its EYLEA® franchise.

Filing & Initial Pleadings

• Complaint Filed (2024-08-26): Regeneron Pharmaceuticals, Inc. filed a complaint against Sandoz Inc. in the U.S. District Court for the District of New Jersey, Case No. 3:24-cv-08760. The complaint alleges that Sandoz failed to comply with its obligations under the BPCIA, specifically by not providing statutorily mandated information regarding its abbreviated Biologics License Application (aBLA) for a biosimilar version of EYLEA® (aflibercept). Regeneron sought a declaratory judgment of non-compliance with the BPCIA and alleged infringement of US Patent 11084865, among other patents.

Pre-Trial Motions of Substance

As of May 21, 2026, specific details regarding motions to dismiss, transfer, or stay within this particular case (3:24-cv-08760) are not publicly available in the provided search results. However, the existence of this district court case has significantly impacted parallel proceedings at the Patent Trial and Appeal Board (PTAB).

Claim Construction (Markman) Outcomes

No information regarding a Markman hearing or claim construction order for this specific case (3:24-cv-08760) is available in the provided search results. Given the recent filing date of August 2024, it is unlikely to have reached this stage yet.

Discovery Milestones

No specific discovery milestones for 3:24-cv-08760 are publicly available in the provided search results.

Trial Events, Verdict, and Post-Trial Motions

The case was filed in August 2024, and as of the current date (May 2026), it is highly unlikely to have reached trial, verdict, or post-trial motions. No information on these stages for this specific case has been found.

Settlement, Dismissal, Judgment, or Appeal

While one snippet briefly mentioned "Status Closed" for 3:24-cv-08760 with the "Last Docket" date as the filing date (August 26, 2024), other, more detailed and recent sources strongly indicate that this case is an ongoing BPCIA litigation. The consistent referencing of 3:24-cv-08760 as a "pending BPCIA litigation" or "ongoing patent litigation" in PTAB decisions from late 2025 and early 2026, which relied on the advanced state of such district court cases, contradicts an early closure. Therefore, the case is presumed to be active. There is no information about a settlement, dismissal, or judgment for this specific case.

Parallel PTAB IPR/PGR Proceedings

US Patent 11084865 has been the subject of extensive parallel PTAB inter partes review (IPR) proceedings initiated by various biosimilar manufacturers. The existence and progression of these proceedings, and often their denial, have been directly influenced by the parallel district court litigations, including 3:24-cv-08760.

• IPR2025-00176 (Samsung Bioepis) and IPR2025-00233 (Formycon): Both petitions, filed in November and December 2024 respectively, challenged the validity of US Patent 11084865. The PTAB denied institution for both on June 2, 2025. The denial was based on discretionary factors under 35 U.S.C. § 314(a) (known as Fintiv factors), with the PTAB citing the advanced state of parallel district court proceedings and previous preliminary injunction proceedings related to the '865 patent.
• IPR2025-00456 (Celltrion): Filed on January 15, 2025, also challenging US Patent 11084865. Institution was denied on June 26, 2025, for similar discretionary reasons tied to the pending BPCIA litigation.
• IPR2025-01268 (Fresenius Kabi SwissBioSim GmbH): Filed on July 14, 2025, challenging claims of US Patent 11084865. Institution was denied on November 20, 2025, also based on discretionary denial.
• IPR2025-01269 (Fresenius Kabi SwissBioSim GmbH): Filed on July 14, 2025, challenging a related patent, US Patent 10,828,345. Institution was denied on January 9, 2026.

These PTAB denials underscore the strategic importance and advanced nature of the ongoing district court patent litigations, including Regeneron v. Sandoz (3:24-cv-08760), in Regeneron's defense of its EYLEA® patents.

The '865 patent itself has a prior litigation history, having been asserted by Regeneron in a 9-day bench trial against Mylan Pharmaceuticals Inc. in the Northern District of West Virginia (1:22-cv-61). That trial resulted in a finding of infringement and validity of certain claims of the '865 patent, although the district court's judgment was later appealed and dismissed by joint stipulation as part of a settlement. Additionally, preliminary injunctions based on the '865 patent were granted and upheld on appeal against Celltrion, Samsung Bioepis, and Formycon in early 2025, preventing their biosimilar launches, while an injunction against Amgen was denied.

Regeneron Pharmaceuticals, Inc., the plaintiff in case 3:24-cv-08760 in the New Jersey District Court, is represented by attorneys from Weil, Gotshal & Manges LLP. The counsel of record identified are:

• C. Elizabeth Weiswasser

  • Role: Likely lead counsel or a senior attorney given her listing.
  • Firm: Weil, Gotshal & Manges LLP. While a specific office location for her wasn't immediately found in this search, Weil, Gotshal & Manges has strong patent litigation platforms in New York, Silicon Valley, and Washington, D.C.
  • Relevant Patent Litigation Experience: Weil, Gotshal & Manges LLP is recognized for high-stakes patent litigation, particularly in the life sciences, biotech, and high-tech sectors. The firm has secured significant appellate victories for Regeneron Pharmaceuticals in patent/antitrust disputes related to its eye treatment franchise and has a strong track record in patent cases across major venues. Elizabeth Stotland Weiswasser departed Weil in December 2024.

• Anish Desai

  • Role: Likely a partner or senior attorney.
  • Firm: Weil, Gotshal & Manges LLP. As with Ms. Weiswasser, a specific office for him was not detailed, but the firm operates out of key locations for intellectual property litigation.
  • Relevant Patent Litigation Experience: Anish Desai departed Weil in December 2024. Weil, Gotshal & Manges LLP is known for its comprehensive intellectual property practice, including patent litigation, technology and IP transactions, and strategic IP counseling. They regularly handle complex cases involving cutting-edge technology and have a deep bench of litigators with diverse technical and scientific backgrounds.

As of the current date, May 21, 2026, details regarding the specific counsel of record for Sandoz Inc. in case 3:24-cv-08760 are not extensively detailed in the provided search results.

One attorney, Matthew Sieger, is listed in connection with the case on a patent search platform, noting "Matthew Sieger, patent attorney with..." and associating him with Paul, Weiss, Rifkind, Wharton & Garrison LLP. However, his specific role (lead counsel, local counsel, etc.) is not specified.

The complaint in Regeneron Pharma Inc v. Sandoz Inc, case 3:24-cv-08760, was filed on August 26, 2024. Some search results indicate that, as of their publication, there were "No Attorneys" listed for Sandoz. This could suggest that the initial filings available in the search results did not yet reflect Sandoz's formal appearance of counsel, or that the information has not been updated in all publicly accessible databases.

Given that this is a patent infringement suit under the Biologics Price Competition and Innovation Act (BPCIA), it is highly probable that Sandoz will retain experienced patent litigation counsel, likely from firms with strong life sciences and intellectual property practices. However, without more current docket information, a comprehensive list of Sandoz's counsel of record, including their roles, firms, and specific experience for this particular case, cannot be definitively provided at this time.