Litigation
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al.
Settled1:22-cv-00061
- Filed
- 2022-08
- Terminated
- 2025-04-15
Patents at issue (1)
Plaintiffs (1)
Defendants (2)
Summary
Regeneron secured a district court victory finding Mylan infringed US Patent 11084865. A subsequent settlement between Regeneron and Biocon (Mylan's associate) led to the dismissal of the district court case and a related Federal Circuit appeal (CAFC Appeal No. 24-2002), allowing commercialization of Mylan's biosimilar in 2026.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
Regeneron Pharmaceuticals, Inc. initiated patent infringement litigation against Mylan Pharmaceuticals Inc. and Biocon Biologics Inc., both global generic and biosimilar pharmaceutical manufacturers. Regeneron, a leading U.S. biotechnology company, developed and markets Eylea® (aflibercept), a blockbuster anti-VEGF (vascular endothelial growth factor) therapy for various retinal diseases, administered via intravitreal injection. The defendants' accused product was their proposed aflibercept biosimilar, initially designated M710 and later approved as Yesafili™ (aflibercept-jbvf), which sought to enter the market as a biosimilar to Eylea®. Mylan, a subsidiary of Viatris, Inc., later transferred its biosimilar rights to Biocon Biologics.
The central patent at issue was U.S. Patent 11,084,865 (the '865 patent), though Regeneron initially asserted a portfolio of 24 patents, later reducing them to a subset including the '865 patent, U.S. Patent 10,888,601, and U.S. Patent 11,253,572. The '865 patent generally covers ophthalmic formulations of a VEGF-specific fusion protein antagonist, specifically aflibercept (referred to by amino acid sequence SEQ ID NO:4), suitable for intravitreal administration, encompassing both stable liquid and lyophilizable formulations. The litigation was filed in the U.S. District Court for the Northern District of West Virginia, with Chief District Judge Thomas S. Kleeh presiding. This venue became particularly significant as the case was part of an MDL consolidation (MDL No. 1:24-md-03103), centralizing multiple patent infringement actions brought by Regeneron against various aflibercept biosimilar developers. The District of West Virginia is relevant due to Mylan/Viatris's historical operational presence in Morgantown, West Virginia.
This case is notable for several reasons, primarily its position within the high-stakes Eylea® biosimilar litigation landscape, a multi-billion dollar market segment. Regeneron pursued an aggressive intellectual property enforcement strategy to delay biosimilar market entry, as evidenced by the multiple lawsuits consolidated in the MDL and numerous Inter Partes Reviews (IPRs) filed against its patents, including the '865 patent. Although Regeneron initially secured a district court victory finding infringement of the '865 patent and a subsequent permanent injunction in June 2024, the case ultimately resolved through a confidential settlement. This settlement led to the vacatur of the permanent injunction and the dismissal of the district court case, as well as the related Federal Circuit appeal (CAFC Appeal No. 24-2002), allowing Mylan/Biocon's biosimilar to launch in the U.S. in the second half of 2026. This outcome reflects an industry trend where originator biologic companies often opt for negotiated market access agreements, controlling biosimilar entry timelines, rather than pursuing litigation to a final appellate resolution.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
The patent infringement litigation Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al. (1:22-cv-00061, N.D.W. Va.) concerning Regeneron's Eylea® (aflibercept) product, involved several key legal developments before ultimately settling.
Key Legal Developments and Outcome:
Filing & Initial Pleadings:
- Regeneron Pharmaceuticals, Inc. filed its initial complaint against Mylan Pharmaceuticals Inc. on August 2, 2022, in the U.S. District Court for the Northern District of West Virginia. The complaint asserted infringement of 24 patents related to Eylea®, including US Patent 11084865, against Mylan's proposed biosimilar, M710 (later known as Yesafili™).
- Mylan Pharmaceuticals Inc. filed its First Amended Answer, Defenses, and Counterclaims, broadly denying infringement and asserting that Regeneron's patents were invalid, unenforceable, or not infringed. Mylan also included counterclaims related to inequitable conduct during patent prosecution. Biocon Biologics Inc. was later added as a defendant by stipulation.
Pre-trial Motions of Substance:
- On December 16, 2022, Regeneron filed a motion for judgment on the pleadings regarding Mylan's inequitable conduct defenses and counterclaims. This motion was granted by Judge Kleeh a week before trial, clearing these counterclaims.
- The parties filed cross-motions for summary judgment, which the Court denied.
- An earlier motion by Mylan to compel further claim narrowing by Regeneron beyond the scheduling order's stipulations was opposed by Regeneron, arguing it had already complied and Mylan had violated discovery deadlines.
- In April 2024, the Judicial Panel on Multidistrict Litigation granted Regeneron's motion to consolidate six actions against various aflibercept biosimilar applicants, including the Mylan case, in the Northern District of West Virginia for coordinated pretrial proceedings (MDL No. 1:24-md-3103).
Claim Construction (Markman) Outcomes:
- The court held a Markman hearing on January 24, 2023.
- An Order on Claim Construction was issued on April 19, 2023. Following this order, Regeneron narrowed its asserted patents and claims to include claims 4, 7, 9, 11, and 14-18 of the '865 Patent, among others, and stipulated to the invalidity of certain other claims under the court's construction.
Discovery Milestones with Strategic Significance:
- The scheduling order set out various deadlines for claim narrowing and discovery. There were disputes over discovery, including Mylan serving late expert reports.
- Non-party Amgen Inc. moved to intervene for the limited purpose of unsealing certain judicial records, highlighting the public interest in access to sealed filings, particularly claim construction briefs, summary judgment motions, and discovery materials. Judge Kleeh ordered the unsealing of 30 docket entries and some related exhibits in response.
Trial Events, Verdict, and Post-trial Motions:
- A 10-day bench trial commenced on June 12, 2023, and concluded on June 23, 2023.
- On December 27, 2023, the District Court for the Northern District of West Virginia issued a detailed Memorandum Opinion and Order Following Bench Trial, finding that Mylan (and Biocon) infringed certain claims of the '865 patent and that the defendants had not proven the claims invalid.
- Subsequently, the court granted Regeneron's motion for a permanent injunction against Biocon (Mylan's associate) on June 11, 2024, preventing the commercial launch of Yesafili™ until the expiration of the '865 patent in June 2027. A Final Judgment (ECF No. 163) and a Final Order for Injunctive Relief (ECF No. 189) were also issued on June 11, 2024, and June 21, 2024, respectively.
Settlement, Dismissal, Judgment, or Appeal:
- Mylan and Biocon appealed the district court's judgment and permanent injunction to the Federal Circuit (CAFC Appeal No. 24-2002).
- On April 15, 2025, Regeneron and Biocon reached a settlement agreement, leading to the dismissal of the district court case (1:22-cv-00061) and the related Federal Circuit appeal (CAFC Appeal No. 24-2002).
- The settlement allows Biocon to commercialize its Eylea® biosimilar, Yesafili™, in the U.S. in the second half of 2026, or potentially earlier under undisclosed circumstances.
- A critical aspect of the settlement was the stipulated vacatur of the permanent injunction and final judgment orders, meaning these orders no longer establish binding precedent. The district court case was officially closed on April 22, 2025.
Parallel PTAB IPR/PGR Proceedings:
- US Patent 11084865 was the subject of inter partes review (IPR) petitions filed by other biosimilar developers, including Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233).
- In June 2025, a PTAB panel denied institution of these IPR petitions, exercising its discretion under 35 U.S.C. § 314(a) based on the Fintiv factors, citing the advanced state of parallel district court proceedings, including the Mylan litigation. The panel noted the significant investment in the parallel proceedings as weighing heavily in favor of discretionary denial.## Regeneron Prevails in District Court Against Mylan Over Eylea Biosimilar Patent, Case Later Settles
The patent infringement litigation, Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al. (1:22-cv-00061, N.D.W. Va.), concluded with a district court victory for Regeneron on U.S. Patent 11084865, followed by a settlement that dismissed the case and its appeal, permitting Mylan's biosimilar to launch in 2026.
Here's a chronological breakdown of the key legal developments:
- 2022-08-02: Complaint Filed. Regeneron Pharmaceuticals, Inc. initiated the lawsuit against Mylan Pharmaceuticals Inc. in the U.S. District Court for the Northern District of West Virginia. The complaint asserted infringement of 24 patents, including U.S. Patent 11084865, against Mylan's proposed Eylea® (aflibercept) biosimilar, M710 (later known as Yesafili™).
- Initial Pleadings. Mylan Pharmaceuticals Inc. filed its First Amended Answer, Defenses, and Counterclaims, denying infringement and alleging that Regeneron's patents were invalid, unenforceable, or not infringed. Mylan also raised counterclaims of inequitable conduct during patent prosecution. Later, Biocon Biologics Inc. was added as a defendant.
- 2022-12-16: Motion for Judgment on Pleadings. Regeneron filed a motion for judgment on the pleadings concerning Mylan's inequitable conduct defenses and counterclaims. This motion was granted prior to trial, dismissing those counterclaims.
- 2023-01-24: Markman Hearing. The court held a Markman (claim construction) hearing.
- 2023-04-19: Claim Construction Order. The court issued its Order on Claim Construction. Following this order, Regeneron narrowed its asserted claims, including claims 4, 7, 9, 11, and 14-18 of the '865 patent, and stipulated to the invalidity of certain other claims.
- 2023-05-23: Amgen Motion to Intervene. Non-party Amgen Inc. moved to intervene for the limited purpose of unsealing judicial records, arguing for public access to various sealed filings, including claim construction briefs and summary judgment motions. In response, Judge Kleeh ordered the unsealing of 30 docket entries and associated exhibits.
- Summary Judgment Motions Denied. The parties filed cross-motions for summary judgment, both of which were denied by the court.
- 2023-06-12 to 2023-06-23: Bench Trial. A 10-day bench trial took place.
- 2023-12-27: District Court Verdict. The District Court for the Northern District of West Virginia issued a detailed opinion finding that Mylan and Biocon infringed certain claims of the '865 patent and had not proven the claims invalid.
- 2024-04-11: MDL Consolidation. The Judicial Panel on Multidistrict Litigation granted Regeneron's motion to consolidate several aflibercept biosimilar cases, including this one, into MDL No. 1:24-md-3103 in the Northern District of West Virginia.
- 2024-06-11: Permanent Injunction Issued. The court granted Regeneron's motion for a permanent injunction against Biocon, prohibiting the commercial launch of Yesafili™ until the '865 patent's expiration in June 2027. A Final Judgment and a Final Order for Injunctive Relief were also entered on June 11, 2024, and June 21, 2024, respectively.
- Federal Circuit Appeal Initiated. Mylan and Biocon appealed the district court's judgment and permanent injunction to the Federal Circuit (CAFC Appeal No. 24-2002).
- 2025-04-15: Settlement and Dismissal. Regeneron and Biocon reached a confidential settlement agreement, leading to the dismissal of the district court case (1:22-cv-00061) and the related Federal Circuit appeal (24-2002). The settlement includes a stipulated vacatur of the permanent injunction and final judgment orders.
- 2025-04-22: Case Terminated. The district court case was officially terminated. The settlement allows Biocon to launch its Eylea® biosimilar in the U.S. in the second half of 2026.
- Parallel PTAB Proceedings (2025-06): IPR Petitions Denied. The Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) petitions filed by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) against U.S. Patent 11084865. The PTAB exercised its discretion under the Fintiv factors, citing the advanced stage and significant investment in the parallel district court litigation, including the Mylan case, as a reason for denial.
In the news
What the press has reported about this case, summarized with links to the source articles.
I'll search for coverage across multiple angles, starting with the provided article list and the case-specific angles.
Press coverage of Regeneron v. Mylan/Biocon (N.D. W. Va. 1:22-cv-00061; Fed. Cir. 24-2002)
The trial win (Dec. 2023 – Jan. 2024). Coverage of the merits ruling was led by law-firm and trade blogs rather than the wires. Knobbe Martens reported on 2024-02-01 that Judge Thomas S. Kleeh's December 27, 2023 order — following a nine-day bench trial in June 2023 — found that Mylan (Viatris) infringed claims 4, 7, 9, 11 and 14–17 of U.S. Patent No. 11,084,865, that the infringed claims recite a vial containing an ophthalmic VEGF-antagonist formulation with specified two-month stability, and that while the defendants' label would induce infringement of claims of the '572 and '601 patents, those method claims were invalid as obvious. Knobbe noted the supporting opinion was still sealed and that both sides had appealed. Big Molecule Watch had reported the short-form judgment on 2023-12-28, emphasizing the strategic timing: Regeneron had sought and obtained an expedited trial "just 10 months after filing its complaint" to capture the § 271(e)(4)(D) statutory injunction before FDA could approve an aflibercept biosimilar in May 2024, and noting the '865 patent's June 2027 expiry versus the Jan. 11, 2032 expiry of the two invalidated dosing patents. Pearce IP reported on 2024-01-31 that the redacted Memorandum Opinion was unsealed, and that Mylan's BLA (filed October 2021, later transferred to Biocon) was the subject of the findings.
The injunction phase and the Federal Circuit. Pearce IP reported that on 2024-05-17 Judge Kleeh entered a 14-day temporary restraining order barring Mylan/Biocon from making, using, marketing or selling Yesafili® in the U.S., in the run-up to the June 11, 2024 permanent injunction. Venable's BiologicsHQ characterized the resulting posture as a launch enjoined until the '865 patent's June 2027 expiration, and stressed that Yesafili™ was positioned to be the first interchangeable Eylea® biosimilar in the U.S. — with Amgen's Pavblu® already on the market at risk since October 2024 and preliminary injunctions in place against Samsung Bioepis, Formycon and Celltrion. On the appeal, IPWatchdog (Steve Brachmann, 2025-01-30) analyzed the Federal Circuit's January 29, 2025 precedential ruling applying Acorda's minimum-contacts reasoning to aBLA filings, and its rejection of obviousness-type double-patenting and written-description challenges to the '865 patent; its weekly roundup, IPWatchdog's "Other Barks & Bites" (2025-01-31), summarized the same decision in a paragraph. IP Update covered it under the headline "Eye-Catching: Biosimilars Injunction Prevails."
The settlement (April 2025) and the launch (2026). The settlement produced the most substantive press, driven largely by party statements. Biocon Biologics' press release (2025-04-15) announced a "settlement and license agreement" dismissing the Federal Circuit appeal of the '865 patent and the N.D. W. Va. litigation, permitting a U.S. launch "in the second half of calendar year 2026 or earlier in certain circumstances," with terms confidential; CEO Shreehas Tambe was quoted saying the deal "clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the United States." Regeneron's own statement (2025-04-14) confirmed that "[a]ll intellectual property-related litigation in the U.S. with Biocon will be dismissed," that financial terms are confidential, and that Regeneron "remains committed to actively enforcing its intellectual property rights." Big Molecule Watch (2025-04-28) supplied the docket detail the press releases omitted: the stipulation was filed April 21, 2025, the order vacating the injunction and dismissing with prejudice was entered April 22, the appeal was dismissed April 16 pursuant to an April 14 joint stipulation, and the parties told the court they had "reached an agreement that will resolve all issues between them without further litigation." Goodwin later reported the August 3, 2026 U.S. launch of Yesafili (the second aflibercept biosimilar commercially available in the U.S.) and a December 13, 2025 Regeneron–Biocon agreement dismissing ex-U.S. disputes. Notably, no outlet reported a dollar figure: the case was an equitable/injunction action, no damages were awarded, and every reference to the settlement's economics is "confidential." The only market-scale numbers in the coverage are context — Venable noted Regeneron's FY2025 U.S. sales of $2.75 billion for Eylea® and $1.64 billion for Eylea® HD.
Where accounts differ or go beyond the record. (1) Caption confusion: both IPWatchdog and its Barks & Bites attribute the January 29, 2025 personal-jurisdiction ruling to "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.," but the decision actually resolved Samsung Bioepis's appeal (Fed. Cir. No. 2024-1965; the companion Formycon appeal was No. 2024-2009) — the "v. Mylan" style is the MDL-wide caption, so readers can easily mistake this precedent for a ruling in the Mylan/Biocon case itself. (2) Forum error: Pearce IP's settlement post (also syndicated via Lexology/BioBlast) places the injunction in the "Northern District of Virginia," which is wrong. (3) Claim mix-up: Big Molecule Watch's Dec. 28, 2023 post appears to swap the claim sets, describing claims 6 and 25 of the '865 patent as the formulation claims and claims 4, 7, 9, 11 and 14–17 of the '572 patent as the dosing claims, the reverse of Knobbe's and Venable's accounts and of the judgment; it also dates trial's conclusion to June 15, 2023, while the docket reflects a trial that ran June 12–23, 2023. (4) Framing beyond the record: analyst-type commentary (e.g., Pearce, Venable, Goodwin) reads the settlement as evidence that originators prefer negotiated entry dates to appellate risk, and Venable's observation that Biocon was "the first to settle an EYLEA® biosimilar litigation" is an inference from the docket, not a court finding.
On the supplied article list: several items appear to have no connection to this litigation, and I found nothing in them discussing it — the "Pharmaceutical and Biotechnology Royalty Rates" and [2024 royalty-rate](https://www.globenewswire.com/news-release/2024/03/05/2840764/28124/en/Pharmaceutical-and-Biotechnology-Royalty
Sources
- Legal Matters
- April 14, 2025
- Home / News / BioBlast®
- Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™ - Register now for your free, tailored, daily legal newsfeed service.
- regn-20250630 - On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan Pharmaceuticals Inc
- Regeneron, Mylan, And Biocon Settle In Aflibercept BPCIA Litigation - ARTICLE
- Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation - Big Molecule Watch
- District Court Finds Mylan (Viatris) Infringes Regeneron’s Eylea Patent | Knobbe Martens
- District Court Finds Mylan (Viatris) Infringes Regeneron’s Eylea Patent - Register now for your free, tailored, daily legal newsfeed service.
- 12 Kleeh issued an opinion and judgment holding that one of the three trial patents is
- Regeneron Pharm. v. Mylan Pharm. - Regeneron Pharm. v. Mylan Pharm.
- District Court Publishes Detailed Reasons for Decision in Regeneron’s litigation against Mylan and Biocon regarding aflibercept biosimilar | Pearce IP
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Williams & Connolly
- David I. Berl · Lead Counsel
- Thomas S. Fletcher · Counsel
- Andrew V. Trask · Counsel
- Ellen E. Oberwetter · Counsel
- Teagan J. Gregory · Counsel
- Shaun P. Mahaffy · Counsel
- Kathryn Schleckser Kayali · Counsel
- Arthur J. Argall III · Counsel
- Adam Pan · Counsel
- Rebecca A. Carter · Counsel
- Haylee Bernal Anderson · Counsel
- Renee M. Griffin · Counsel
- Jennalee Beazley · Counsel
- Paul, Weiss, Rifkind, Wharton & Garrison
- Priyata Patel · Counsel
- Elizabeth Weiswasser · Counsel
- Kellogg, Hansen, Todd, Figel & Frederick
- Jacob Hartman · Counsel
- In-house counsel
- Adam J. Bernstein · In-House Counsel
- Arunabha Bhoumik · In-House Counsel
- James Evans · In-House Counsel
- Larry A. Coury · In-House Counsel
- Petra Scamborova · In-House Counsel
Regeneron Pharmaceuticals, Inc. was represented by a robust legal team, including attorneys from Williams & Connolly LLP, Paul, Weiss, Rifkind, Wharton & Garrison LLP, Kellogg, Hansen, Todd, Figel & Frederick, PLLC, and in-house counsel from Regeneron Pharmaceuticals, Inc.. While Carey, Douglas, Kessler & Ruby, PLLC was also mentioned as part of the plaintiff's team, specific attorneys and their roles from this firm were not explicitly detailed in the available records.
Below is a breakdown of the counsel of record for the plaintiff:
Williams & Connolly LLP
David I. Berl
- Role: Lead Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: David Berl is a highly experienced trial lawyer specializing in intellectual property litigation, particularly in pharmaceutical and biotechnology cases, including Hatch-Waxman and BPCIA disputes.
Thomas S. Fletcher
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Thomas Fletcher focuses on complex civil litigation, with significant experience in patent and intellectual property matters.
Andrew V. Trask
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Andrew Trask's practice includes patent litigation, particularly in the life sciences and technology sectors.
Ellen E. Oberwetter
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Ellen Oberwetter is involved in patent litigation, with experience in the pharmaceutical industry.
Teagan J. Gregory
- Role: Counsel (Admitted Pro Hac Vice)
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Teagan Gregory's practice includes intellectual property disputes and complex commercial litigation.
Shaun P. Mahaffy
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Shaun Mahaffy practices complex civil litigation, including patent and antitrust matters.
Kathryn S. Kayali (listed as Kathryn Schleckser Kayali)
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Kathryn Kayali is involved in intellectual property and complex commercial litigation.
Arthur J. Argall, III
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Arthur Argall's practice includes patent and intellectual property litigation.
Adam Pan
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Adam Pan focuses on intellectual property and complex civil litigation.
Rebecca A. Carter
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Rebecca Carter's practice includes patent litigation and other complex commercial disputes.
Haylee Bernal Anderson
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Haylee Bernal Anderson is involved in patent litigation and other complex civil matters.
Renee M. Griffin
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Renee Griffin's practice includes intellectual property litigation.
Jennalee Beazley
- Role: Counsel
- Firm & Office: Williams & Connolly LLP, Washington, DC
- Experience Note: Jennalee Beazley is involved in patent and complex commercial litigation.
Paul, Weiss, Rifkind, Wharton & Garrison LLP
Priyata Patel
- Role: Counsel
- Firm & Office: Paul, Weiss, Rifkind, Wharton & Garrison LLP, Washington, DC
- Experience Note: Priyata Patel has experience in patent litigation, particularly in the pharmaceutical and life sciences sectors.
Elizabeth Weiswasser
- Role: Counsel
- Firm & Office: Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY
- Experience Note: Elizabeth Weiswasser is a leading patent litigator with extensive experience in pharmaceutical patent disputes, including Hatch-Waxman and BPCIA cases.
Kellogg, Hansen, Todd, Figel & Frederick, PLLC (listed as Kellogg Huber Hansen Todd Evans & Figel PLLC in some sources)
- Jacob Hartman
- Role: Counsel
- Firm & Office: Kellogg, Hansen, Todd, Figel & Frederick, PLLC, Washington, DC
- Experience Note: Jacob Hartman's practice includes intellectual property litigation, particularly in high-stakes patent disputes.
Regeneron Pharmaceuticals, Inc. (In-House Counsel)
Adam J. Bernstein
- Role: In-House Counsel
- Firm & Office: Regeneron Pharmaceuticals, Inc., Tarrytown, NY
- Experience Note: As in-house counsel, Adam Bernstein manages intellectual property strategy and litigation for Regeneron.
Arunabha Bhoumik
- Role: In-House Counsel
- Firm & Office: Regeneron Pharmaceuticals, Inc., Tarrytown, NY
- Experience Note: Arunabha Bhoumik contributes to Regeneron's intellectual property and patent litigation efforts.
James Evans
- Role: In-House Counsel
- Firm & Office: Regeneron Pharmaceuticals, Inc., Tarrytown, NY
- Experience Note: James Evans is involved in intellectual property and patent enforcement strategies for Regeneron.
Larry Coury (listed as Larry A. Coury)
- Role: In-House Counsel
- Firm & Office: Regeneron Pharmaceuticals, Inc., Tarrytown, NY
- Experience Note: Larry Coury works on patent matters and litigation for Regeneron.
Petra Scamborova
- Role: In-House Counsel
- Firm & Office: Regeneron Pharmaceuticals, Inc., Tarrytown, NY
- Experience Note: Petra Scamborova contributes to Regeneron's in-house intellectual property legal team.
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Rakoczy, Molino, Mazzochi, Siwik
- Deanne M. Mazzochi · lead counsel
- William A. Rakoczy · lead counsel
- Heinz J. Salmen · lead counsel
- Eric R. Hunt · lead counsel
- Neil B. McLaughlin · lead counsel
- Lauren M. Lesko · lead counsel
- Lawrence Scott Beall · lead counsel
- Steven J. Birkos · lead counsel
- Thomas H. Ehrich · lead counsel
- Jeffery A. Marx · lead counsel
- Katie A. Boda · lead counsel
- Abraham J. Varon · lead counsel
- Jake R. Ritthamel · lead counsel
- Steptoe & Johnson
- Gordon H. Copland · local counsel
- William J. O'Brien · local counsel
- John D. Pizzo · local counsel
- Garrett Matthew Spiker · local counsel
- Stephenee Raychel Gandee · local counsel
The following counsel represented the defendant(s), Mylan Pharmaceuticals Inc. and Biocon Biologics Inc., in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al., Case No. 1:22-cv-00061:
Rakoczy, Molino, Mazzochi, Siwik LLP (Chicago, IL) - Lead Counsel (admitted pro hac vice)
- Deanne M. Mazzochi (Partner)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Founding partner specializing in life sciences law, with a focus on pharmaceutical patent litigation, including Hatch-Waxman cases. She has extensive trial and appellate experience, including appearances before the U.S. Court of Appeals for the Federal Circuit, and has been recognized as a "Top Lawyer" in Intellectual Property, Copyright & Trademark, and Patent Law.
- William A. Rakoczy (Partner)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Co-founder of Rakoczy, Molino, Mazzochi, Siwik LLP.
- Heinz J. Salmen (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Regularly appears on dockets for patent infringement cases.
- Eric R. Hunt (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Regularly appears on dockets for patent infringement cases.
- Neil B. McLaughlin (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Involved in patent litigation and Patent Trial and Appeal Board (PTAB) proceedings.
- Lauren M. Lesko (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Involved in patent litigation.
- Lawrence Scott Beall (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Involved in patent litigation.
- Steven J. Birkos (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Involved in patent litigation.
- Thomas H. Ehrich (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Involved in patent litigation.
- Jeffery A. Marx (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Regularly appears on dockets for patent infringement cases.
- Katie A. Boda (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Regularly appears on dockets for patent infringement cases.
- Abraham J. Varon (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Regularly appears on dockets for patent infringement cases.
- Jake R. Ritthamel (Attorney)
- Firm & Office: Rakoczy, Molino, Mazzochi, Siwik LLP, Chicago, IL.
- Experience: Regularly appears on dockets for patent infringement cases.
Steptoe & Johnson PLLC (Bridgeport, WV) - Local Counsel
- Gordon H. Copland (Attorney)
- Firm & Office: Steptoe & Johnson PLLC, Bridgeport, WV.
- Experience: Admitted to the West Virginia State Bar (WVSB #828). Represented Mylan Pharmaceuticals Inc.
- William J. O'Brien (Attorney)
- Firm & Office: Steptoe & Johnson PLLC, Bridgeport, WV.
- Experience: Admitted to the West Virginia State Bar (WVSB #10549). Represented Mylan Pharmaceuticals Inc.
- John D. Pizzo (Attorney)
- Firm & Office: Steptoe & Johnson PLLC, Bridgeport, WV.
- Experience: Listed as counsel for defendants.
- Garrett Matthew Spiker (Attorney)
- Firm & Office: Steptoe & Johnson PLLC, Bridgeport, WV.
- Experience: Listed as counsel for defendants.
- Stephenee Raychel Gandee (Attorney)
- Firm & Office: Steptoe & Johnson PLLC, Bridgeport, WV.
- Experience: Listed as counsel for defendants.
Bernstein-Burkley, P.C.
- While Bernstein-Burkley, P.C. was identified as being retained by Mylan, specific attorneys from this firm were not consistently listed in the provided docket excerpts as counsel of record for the defendants. Therefore, no individual attorneys from this firm can be definitively identified with roles and specific experience based on the provided search results.