Litigation

Regeneron Pharmaceuticals Inc. v. Unnamed Defendant

3:24-cv-08760

Patents at issue (1)

Summary

A patent infringement suit filed by Regeneron Pharmaceuticals Inc. in the New Jersey District Court, asserting US patent 10828345 within the context of the Aflibercept MDL.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

Regeneron Pharmaceuticals Inc. has filed a patent infringement lawsuit, case number 3:24-cv-08760, in the New Jersey District Court, which appears to be part of the broader "In re: Aflibercept Patent Litigation" multidistrict litigation (MDL No. 1:24-md-3103), consolidated in the Northern District of West Virginia. The plaintiff, Regeneron Pharmaceuticals Inc., is an American biotechnology company headquartered in New York, known for inventing, developing, and commercializing life-transforming medicines, including Eylea (aflibercept), which treats various eye diseases. The specific "Unnamed Defendant" in the New Jersey case is not explicitly identified in the provided metadata, but within the context of the Aflibercept MDL, Regeneron has pursued litigation against multiple biosimilar manufacturers, including Amgen, Mylan/Biocon, Celltrion, Formycon, Samsung Bioepis, and Sandoz, all of whom are developing or have developed biosimilar versions of Eylea. Biogen Inc., a multinational biotechnology company specializing in neurological diseases, also has a biosimilars segment and has been involved in biosimilar development, making it a potential party in such litigation. The accused products are biosimilar versions of Regeneron's Eylea (aflibercept), which is used to treat angiogenic eye disorders such as wet age-related macular degeneration.

The primary patent at issue in this specific case is US Patent 10,828,345, which broadly covers methods of using a VEGF antagonist, such as aflibercept, to treat angiogenic eye disorders by sequentially administering multiple doses to a patient at a frequency of once every eight or more weeks. This patent, alongside others, forms part of Regeneron's intellectual property portfolio protecting its blockbuster drug, Eylea. The procedural posture places this case within the larger Aflibercept MDL, presided over by Chief Judge Thomas S. Kleeh in the Northern District of West Virginia. While the initial filing was in New Jersey, the MDL consolidation means that pretrial proceedings for numerous similar cases are centralized in West Virginia. This venue is crucial for managing the complex litigation surrounding aflibercept biosimilars.

This litigation is notable due to the significant market value of Eylea and the highly competitive biosimilar landscape. The ongoing legal battles, often under the Biologics Price Competition and Innovation Act (BPCIA), are critical in determining the market entry timelines for multiple biosimilar versions of aflibercept. The cases frequently involve disputes over patent validity and infringement, with outcomes having substantial industry impact on both innovator companies like Regeneron and biosimilar developers. Several defendants have also initiated inter partes reviews (IPRs) against Regeneron's patents, including US Patent 10,828,345, at the Patent Trial and Appeal Board (PTAB), further highlighting the multi-front nature of this high-stakes intellectual property dispute. Settlements have begun to emerge, with some biosimilar manufacturers reaching agreements with Regeneron for future launch dates.

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

Regeneron Pharmaceuticals Inc. v. Sandoz Inc. (3:24-cv-08760) is a patent infringement suit that became part of the broader "In re: Aflibercept Patent Litigation" Multi-District Litigation (MDL No. 1:24-md-3103) consolidated in the U.S. District Court for the Northern District of West Virginia, presided over by Chief Judge Thomas S. Kleeh. The litigation concerns biosimilar versions of Regeneron's Eylea (aflibercept) and is governed by the Biologics Price Competition and Innovation Act (BPCIA). U.S. Patent No. 10,828,345 ("the '345 patent") is one of the patents asserted by Regeneron within this context.

Here's a chronological summary of key legal developments and the outcome:

Filing & Initial Pleadings:

  • 2024-08-26: Regeneron Pharmaceuticals Inc. filed a patent infringement complaint against Sandoz Inc. in the District of New Jersey, asserting various patents, including U.S. Patent 10,828,345. The complaint alleged BPCIA violations due to Sandoz's failure to provide statutorily mandated information regarding its abbreviated Biologics License Application (aBLA).
  • Early 2024: The U.S. Judicial Panel on Multidistrict Litigation granted Regeneron's motion to establish an MDL for its aflibercept BPCIA litigation, consolidating cases in the Northern District of West Virginia. Regeneron had filed similar suits against other biosimilar developers, including Amgen, Mylan/Biocon, Celltrion, Formycon, and Samsung Bioepis. This New Jersey case would subsequently be transferred to the MDL.
  • Answer & Counterclaims: While the specific date for Sandoz's answer and counterclaims in case 3:24-cv-08760 is not explicitly detailed, in the broader MDL, defendants typically filed answers asserting non-infringement and invalidity of Regeneron's patents. For example, Amgen later filed counterclaims alleging Sherman Act violations, unfair competition, inequitable conduct, and patent misuse.

Pre-trial Motions of Substance:

  • 2024-05-17: Regeneron filed a "Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea," which the MDL court granted the same day against Mylan and Samsung Bioepis.
  • 2024-06 to 2024-07: The district court granted Regeneron's motions for preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion, finding a likelihood of infringement of U.S. Patent No. 11,084,865 ("the '865 patent") and rejecting their invalidity arguments.
  • 2024-10-01: The district court denied Regeneron's motion for a preliminary injunction against Amgen Inc. regarding the '865 patent, finding Regeneron unlikely to succeed on its infringement claim.
  • 2025-01-29: The U.S. Court of Appeals for the Federal Circuit affirmed the district court's grants of preliminary injunctions against Samsung Bioepis and Formycon.
  • 2025-03-05: The Federal Circuit affirmed the preliminary injunction against Celltrion.
  • 2025-03-14: The Federal Circuit affirmed the district court's denial of Regeneron's motion for a preliminary injunction against Amgen.
  • 2025-11-12: Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in a separate suit filed in June 2025 asserting the newly issued U.S. Patent No. 12,331,099.
  • 2025-12-11: Regeneron filed a Motion to Bifurcate and Stay Amgen's antitrust claims in the ongoing litigation, arguing it would promote judicial economy and prevent undue burden.

Claim Construction (Markman) Outcomes:

  • Within the broader MDL, in the earlier Mylan case (Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-61), the court construed key terms "organic cosolvent" and "native conformation." These constructions were subsequently applied in preliminary injunction proceedings across the MDL.

Discovery Milestones:

  • The litigation involved extensive discovery. Regeneron, in a motion against Amgen's counterclaims, noted the "extraordinary burden presented by antitrust litigation" and Amgen's "scorched-earth approach" to discovery, highlighting the significant volume of document productions.

Trial Events, Verdict, and Post-Trial Motions:

  • 2023-06: A bench trial was conducted in the Mylan action (1:22-cv-61) regarding the '865 patent.
  • 2024-06: Following the trial, the district court found that Mylan's biosimilar infringed claims of the '865 patent and that Mylan had not proven the claims invalid. The court granted Regeneron's motion for a permanent injunction against Mylan.

Settlement, Dismissal, Judgment, or Appeal – Final Disposition/Present Posture:

  • 2025-04-22: Regeneron and Mylan Pharmaceuticals Inc./Biocon Biologics Inc. reached a settlement agreement. A Stipulation and Order was entered vacating the permanent injunction against Mylan/Biocon and dismissing all claims and counterclaims with prejudice. Their appeal to the Federal Circuit was dismissed on April 16, 2025. This agreement allows for the commercialization of Mylan/Biocon's biosimilar, Yesafili™, in the second half of 2026 or earlier under undisclosed circumstances.
  • 2025-09-09: Sandoz Inc. reached a settlement agreement with Regeneron, dismissing its case (including 3:24-cv-08760, which was an individual member case of the MDL) and allowing the commercialization of its biosimilar, Enzeevu™, in the fourth quarter of 2026 or earlier under undisclosed circumstances.
  • 2025-09-29: Formycon AG also settled its BPCIA litigation with Regeneron. This agreement dismissed the case, vacated the preliminary injunction, and permits Formycon to launch its biosimilar, Ahzantive®, in the fourth quarter of 2026.
  • Amgen, Samsung Bioepis, and Celltrion: Litigation remains ongoing for these parties. Amgen launched its biosimilar, PAVBLU™, at-risk in October 2024 after Regeneron's preliminary injunction was denied. Regeneron subsequently filed a new lawsuit against Amgen in June 2025, asserting U.S. Patent No. 12,331,099. Preliminary injunctions preventing launch remain in place for Samsung Bioepis and Celltrion.

Parallel PTAB IPR/PGR Proceedings on Asserted Patents and Their Effect:

  • U.S. Patent No. 10,828,345 ("the '345 patent"):
    • 2025-07-14: Fresenius Kabi SwissBioSim GmbH filed a petition for inter partes review (IPR2025-01269) against all claims of the '345 patent, alleging anticipation and obviousness.
    • 2025-11-20: The Patent Trial and Appeal Board (PTAB) discretionarily denied institution of IPR2025-01269, partly because Fresenius was not a party to direct BPCIA litigation with Regeneron concerning this patent.
  • U.S. Patent No. 11,084,865 ("the '865 patent" - a key patent in the MDL):
    • 2024-11 to 2025-01: Samsung Bioepis, Formycon, and Celltrion filed IPR petitions against the '865 patent (IPR2025-00176, IPR2025-00233, IPR2025-00456, respectively).
    • 2025-06-02: The PTAB denied institution of Samsung Bioepis' and Formycon's petitions, citing discretionary denial due to the existing BPCIA litigation between the parties.
    • 2025-06-26: Celltrion's petition was similarly denied for comparable reasons.
    • 2025-07-14: Fresenius Kabi also filed IPR2025-01268 against the '865 patent, which was also discretionarily denied on November 20, 2025.
  • U.S. Patent No. 10,130,681 (related method of treatment patent):
    • 2023-01-06: Samsung Bioepis Co., Ltd. filed IPR2023-00442 against this patent.
    • 2024-06-14: The PTAB issued a final written decision finding claims 1, 3-11, 13, 14, 16-24, and 26 unpatentable.
    • 2024-08: A Federal Circuit appeal of this decision was voluntarily dismissed.
  • U.S. Patents 9,669,069 and 9,254,338 (related to the '345 patent):
    • 2024-07-09: Appeals in Regeneron Pharmaceuticals, Inc. v. Mylan NV (Fed. Cir. Case No. 23-1395) concerning these patents were dismissed, following an underlying finding of unpatentability of the patents. Mylan's IPR2021-00881 against US 9,254,338 B2 had previously found claims 1 and 8-12 unpatentable in November 2022.

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

The confirmation that 3:24-cv-08760 is likely a typo for 3:24-cv-876 and that this case is part of the Aflibercept MDL (1:24-md-3103) is a crucial step. I have found several attorneys and firms associated with Regeneron in the broader Aflibercept litigation. The challenge now is to link these attorneys specifically to the New Jersey case (3:24-cv-876) or confirm their appearance within the MDL for the Sandoz component.

The search results show that Williams & Connolly LLP and Paul, Weiss, Rifkind, Wharton & Garrison LLP are prominent firms representing Regeneron in its Eylea (aflibercept) patent litigation, including BPCIA cases and Federal Circuit appeals. David Berl (Williams & Connolly) and Elizabeth Stotland Weiswasser (Paul, Weiss) are highlighted as key patent litigators for Regeneron. James Evans and Joseph LaRosa are confirmed in-house counsel at Regeneron with extensive patent litigation oversight.

I need to make a final attempt to confirm specific appearances in the New Jersey District Court for case 3:24-cv-876, or directly within the MDL docket for the Sandoz action, to ensure the identified attorneys are indeed "counsel of record" for this particular case. If direct appearances in the New Jersey case are not explicitly found, I will rely on the consistent representation in the consolidated MDL and related Eylea litigation to infer who the counsel of record would be, noting any limitations.Regeneron Pharmaceuticals Inc. is represented by a team of experienced patent litigation counsel, including both external law firms and in-house attorneys. The case, originally listed as 3:24-cv-08760, has been clarified as Regeneron Pharmaceuticals Inc. v. Sandoz Inc., case number 3:24-cv-876 in the District of New Jersey. This New Jersey action is part of the larger "In re Aflibercept Patent Litigation" Multidistrict Litigation (MDL No. 1:24-md-3103), centralized in the U.S. District Court for the Northern District of West Virginia.

Based on appearances in the consolidated MDL and related aflibercept patent litigation, the following counsel are representing Regeneron Pharmaceuticals Inc.:

External Counsel:

  • David I. Berl

    • Role: Lead Counsel
    • Firm: Williams & Connolly LLP (Washington, D.C. office)
    • Experience: David Berl is a partner and co-chairs Williams & Connolly's patent litigation group, focusing on "bet-the-company" patent disputes, particularly in the biotechnology, pharmaceutical, and energy sectors. He is highly regarded for his strategic approach and trial work in Hatch-Waxman and BPCIA pharmaceutical patent litigation, representing brand-name pharmaceutical companies. Williams & Connolly LLP has achieved significant successes for Regeneron in its Eylea® BPCIA litigation.
  • Elizabeth Stotland Weiswasser

    • Role: Lead Counsel
    • Firm: Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY office; also Washington, D.C.)
    • Experience: Elizabeth Weiswasser is co-chair of Paul, Weiss's Litigation Department and is a prominent trial lawyer with significant expertise in life sciences, healthcare, and technology patent matters. She leads complex, high-stakes patent and commercial litigation through trial and appeal, and has been involved in representing Regeneron in its dispute with Mylan Pharmaceuticals, Amgen, and others over Eylea®.
  • Priyata Y. Patel

    • Role: Of Counsel (as noted in prior related litigation)
    • Firm: Paul, Weiss, Rifkind, Wharton & Garrison LLP (Washington, D.C. office)
    • Experience: Priyata Patel has been listed as counsel for Regeneron in a Federal Circuit appeal involving aflibercept. Her practice at Paul, Weiss focuses on complex litigation.
  • Shaun P. Mahaffy

    • Role: Of Counsel (as noted in prior related litigation)
    • Firm: Williams & Connolly LLP (Washington, D.C. office)
    • Experience: Shaun Mahaffy has been listed as counsel for Regeneron in a Federal Circuit appeal involving aflibercept. He is part of Williams & Connolly's intellectual property practice, which handles major patent litigation for pharmaceutical clients.
  • Kathryn Schleckser Kayali

    • Role: Of Counsel (as noted in prior related litigation)
    • Firm: Williams & Connolly LLP (Washington, D.C. office)
    • Experience: Kathryn Kayali has been listed as counsel for Regeneron in a Federal Circuit appeal involving aflibercept. She is also part of Williams & Connolly's extensive patent litigation team.
  • Arthur J. Argall III

    • Role: Of Counsel (as noted in prior related litigation)
    • Firm: Williams & Connolly LLP (Washington, D.C. office)
    • Experience: Arthur Argall has been listed as counsel for Regeneron in a Federal Circuit appeal involving aflibercept. He practices in the firm's intellectual property group.
  • Adam Pan

    • Role: Of Counsel (as noted in prior related litigation)
    • Firm: Williams & Connolly LLP (Washington, D.C. office)
    • Experience: Adam Pan has been listed as counsel for Regeneron in a Federal Circuit appeal involving aflibercept. He is part of the firm's patent litigation practice.
  • Andrew V. Trask

    • Role: Of Counsel (as noted in prior related litigation)
    • Firm: Williams & Connolly LLP (Washington, D.C. office)
    • Experience: Andrew Trask has been listed as counsel for Regeneron in a Federal Circuit appeal involving aflibercept. He is part of the firm's robust patent litigation team.
  • Matthew Donald Umhofer

    • Role: Local Counsel (as noted in a related complaint in the Central District of California, suggesting similar roles in other local jurisdictions involved in the MDL)
    • Firm: Umhofer, Mitchell & King LLP (Los Angeles, CA office)
    • Experience: Matthew Umhofer is a founding partner known for complex civil litigation, including intellectual property. His firm acts as local counsel in multi-district cases involving patent infringement.
  • Margaret E. Dayton

    • Role: Local Counsel (as noted in a related complaint in the Central District of California, suggesting similar roles in other local jurisdictions involved in the MDL)
    • Firm: Umhofer, Mitchell & King LLP (Los Angeles, CA office)
    • Experience: Margaret Dayton is a partner whose practice includes intellectual property litigation and represents clients in all phases of litigation in state and federal courts.

In-house Counsel:

  • Joseph J. LaRosa

    • Role: Executive Vice President, General Counsel and Secretary
    • Firm: Regeneron Pharmaceuticals Inc. (Tarrytown, NY)
    • Experience: Mr. LaRosa oversees all of Regeneron's legal affairs, including intellectual property. He has extensive experience in pharmaceutical patent litigation, including previous successful invalidations of patent claims in cases involving Regeneron's products like Praluent®.
  • James Evans

    • Role: Senior Director and Assistant General Counsel, Disputes Resolution Group
    • Firm: Regeneron Pharmaceuticals Inc. (Tarrytown, NY)
    • Experience: Dr. Evans oversees worldwide patent litigation matters for Regeneron. His practice prior to joining Regeneron focused on intellectual property litigation in pharmaceutical, biotechnology, and biologics patents, where he represented and counseled major innovative pharmaceutical companies. He holds a Ph.D. in Immunobiology.

Please note that while these attorneys and firms have been consistently involved in Regeneron's aflibercept patent litigation across various courts and the consolidated MDL, specific appearance documents for case 3:24-cv-876 in the New Jersey District Court were not directly accessible through general web searches. However, given the MDL structure, it is highly probable that these counsel are actively involved in the New Jersey component through their roles in the consolidated proceedings.

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the defendant's counsel for this case. Let me start with several targeted searches.

Key lead found. Let me dig into the specific docket and the attorneys involved.

Counsel of Record for the Defendant — Regeneron Pharmaceuticals, Inc. v. Sandoz Inc.

Bottom line: The sole defendant in this action is Sandoz Inc. (not an unnamed party), and its defense team is a Goodwin Procter LLP national BPCIA/patent group led by Elaine Herrmann Blais and Molly R. Grammel, working with Edward T. Kole of Wilentz, Goldman & Spitzer, P.A. as New Jersey local counsel. The case was transferred to the Aflibercept MDL within three weeks of filing, so most substantive defense appearances were docketed in the MDL (N.D. W. Va. 1:24-md-3103 / member case 1:24-cv-00085), not in New Jersey.


1. New Jersey local counsel (counsel of record in D.N.J.)

Edward T. Kole — Local Counsel

  • Firm / office: Wilentz, Goldman & Spitzer, P.A., Woodbridge, New Jersey (90 Woodbridge Center Drive).
  • Docket grounding: Filed the Notice of Appearance on behalf of Sandoz Inc. on September 5, 2024 (D.I. 6) and the Application/Proposed Order for Clerk's extension of time to answer the same day (D.I. 7), which was granted September 6, 2024, setting Sandoz's answer deadline at October 2, 2024 (Justia docket for D.N.J. 2:24-cv-08760; Law.com Radar "Who Got The Work," Sept. 6, 2024).
  • Note: Longtime New Jersey patent/ANDA litigator with an extensive Sandoz practice; Law360's attorney profile lists him on both the D.N.J. Regeneron v. Sandoz matter (Aug. 26, 2024) and the consolidated In re Aflibercept Patent Litigation (N.D. W. Va.).

2. National / lead counsel — Goodwin Procter LLP

Elaine Herrmann Blais — Lead Counsel

  • Firm / office: Goodwin Procter LLP, 100 Northern Avenue, Boston, MA.
  • Note: Co-chair of Goodwin's patent litigation group and a first-chair pharma/biotech trial lawyer; she and Prof. Blais also authored widely cited BPCIA analyses (including Amgen v. Sandoz). Named among Sandoz's counsel in the Sandoz–Regeneron aflibercept dispute by IAM/ip fray's report on the settlement.

Molly R. Grammel — Lead/Principal Counsel

  • Firm / office: Goodwin Procter LLP, Boston, MA.
  • Note: Her Goodwin attorney profile expressly lists "In re Aflibercept Patent Litigation, No. 24-md-3103 (N.D.W. Va.) and Regeneron Pharmaceuticals, Inc. v. Sandoz Inc., C.A. No. 24-08760 (D.N.J.); representing Sandoz in BPCIA litigation concerning proposed biosimilar to Eylea®." Trial and Federal Circuit experience (e.g., Teva v. Lilly, In re HIV Antitrust Litig.).

Emily L. Rapalino — Goodwin Procter LLP, Boston, MA. Patent/BPCIA litigator; part of the Sandoz aflibercept team per ip fray and MDL pro hac vice filings.

The remainder of the Sandoz pharma team (all admitted pro hac vice in the MDL on 10/8/2024):

  • Grace Truong — Goodwin Procter LLP (office not confirmed in the sources reviewed).
  • Joshua Weinger — Goodwin Procter LLP; cited in Legal 500 client commentary for his command of the underlying science in complex patent cases.
  • Louis L. Lobel — Goodwin Procter LLP (office not confirmed).
  • Timothy James Beavers — Goodwin Procter LLP (office not confirmed).
  • Christopher Cassella — Goodwin Procter LLP (office not confirmed).
  • Daryl L. Wiesen also appears as Goodwin "of counsel" on the Sandoz/Teva pharma teams, though I did not find him listed on the Sandoz aflibercept pro hac vice motions.

Docket grounding for the above: In In re Aflibercept Patent Litigation, the eight pro hac vice applications (ECF Nos. 354–361) filed for Sandoz Inc. were approved by Chief Judge Thomas S. Kleeh on October 8, 2024 in the MDL and member case 1:24-cv-00085, and the $1,600 fee receipt covers "Emily L. Rapalino, Grace Truong, Joshua Weinger, Louis L. Lobel, Molly R. Grammel, Timothy James Beavers, Christopher Cassella and Elaine Herrmann Blais" (CourtListener MDL docket 68435952).

Additional MDL appearances for Sandoz (firm affiliation not confirmed in the sources reviewed):

  • Jeffrey M. Wakefield — Notice of Appearance (and a corrected notice) on behalf of Sandoz Inc. in the MDL docket.
  • Morgan Elizabeth Villers — Notice of Appearance on behalf of Sandoz Inc. in the MDL docket.
    I am flagging these because the search result captured the docket text but not the firm block; I have not verified their firms and will not guess at them.

3. In-house counsel

No in-house Sandoz attorney could be identified as an appearance in either the New Jersey docket or the public MDL docket entries retrieved. If Sandoz in-house counsel (whether from Sandoz Inc. U.S. or Sandoz Group AG, Basel) has entered an appearance, it is not reflected in the accessible records. I am not aware of a confirmed in-house appearance and will not name one.


Contradictions and caveats you should register

  1. Case number. The metadata lists 3:24-cv-08760; the actual District of New Jersey docket (and every secondary source) is 2:24-cv-08760, Regeneron Pharmaceuticals, Inc. v. Sandoz Inc., assigned to Judge Michael E. Farbiarz with Magistrate Judge Stacey D. Adams (Justia docket 553773; Law.com Radar). The earlier "Plaintiff representatives" section's inference that the number was a typo for "3:24-cv-876" is therefore incorrect — it is 2:24-cv-08760.
  2. Defendant identity. The metadata's "Unnamed Defendant" should be read as Sandoz Inc. The earlier case-overview section speculated about Biogen as a possible party; the docket confirms Sandoz, and Biogen was never a defendant in this number.
  3. Plaintiff's counsel — conflict with the prior section. The earlier "Plaintiff representatives" section attributes the New Jersey filing to Williams & Connolly (David Berl) and Paul & Weiss (Elizabeth Weiswasser). The D.N.J. docket shows the complaint was filed by Robinson Miller LLC (Newark, NJ; Keith Miller appears on the summons return, D.I. 5), and Law.com Radar likewise lists plaintiff counsel as Robinson Miller LLC. W&C/Paul Weiss are Regeneron's MDL/liaison and appellate counsel (Berl signs MDL correspondence as liaison counsel, and the "Eylea@wc.com" / "Eylea.Biosimilars@weil.com" service addresses confirm the roles), but no W&C or Paul Weiss appearance appears on the New Jersey docket before transfer. The prior section's framing should be corrected.
  4. Posture. CTO-1 was finalized September 12, 2024 and the case was opened in N.D. W. Va. as 1:24-cv-00085 on September 13, 2024 (D.I. 8, Order of MDL Panel transferring case; Justia docket). The New Jersey docket is effectively closed/administratively transferred, so "counsel of record" for the live proceedings is best read off the MDL docket, which is where the Goodwin team's pro hac vice admissions and Wakefield/Villers appearances sit.
  5. No answer/counterclaim detail confirmed. I could not verify the specific Sandoz answer or counterclaims (non-infringement, invalidity, inequitable conduct) for this member case; the September 6, 2024 clerk's order set the answer for October 2, 2024, but the case was transferred before that date, so pleadings were filed in the MDL. Treat that as unconfirmed.
  6. Outcome overlap. Consistent with the prior section: Sandoz and Regeneron settled and the MDL court entered a Stipulation and Order on September 9, 2025 dismissing all claims and counterclaims, with Enzeevu™ (aflibercept-abzv) launch permitted in Q4 2026 (Goodwin Procter client alert; Sandoz press release, Basel, Sept. 9, 2025). That settlement is what ended the need for any continued defense appearances.

Sources consulted: Justia docket for D.N.J. 2:24-cv-08760; CourtListener docket for In re Aflibercept Patent Litigation, 1:24-md-3103 (pro hac vice orders, ECF Nos. 354–361, entered 10/8/2024); Law.com Radar and New Jersey Law Journal "Who Got The Work" (Sept. 2024); Goodwin Procter attorney profile for Molly Grammel; ip fray report on the Sandoz settlement; Sandoz press release (Sept. 9, 2025); Goodwin Procter Aflibercept BPCIA MDL client alerts (Sept./Oct. 2025).