Litigation
Unified Patents v. Regeneron Pharmaceuticals Inc.
Not Instituted - MeritsIPR2025-01269
Patents at issue (1)
Plaintiffs (1)
Defendants (1)
Summary
An inter partes review filed by Unified Patents against Regeneron Pharmaceuticals Inc. concerning US patent 10828345, which was not instituted on the merits.
Case overview & background
Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.
Unified Patents, a member-based organization focused on deterring patent trolls and reducing frivolous patent litigation, filed an inter partes review (IPR) against Regeneron Pharmaceuticals Inc. concerning U.S. Patent No. 10,828,345. Regeneron is a leading American biotechnology company that invents, develops, and commercializes medicines for serious diseases, including ophthalmic conditions. The patent at issue, US 10828345, broadly covers methods for treating angiogenic eye disorders by administering multiple doses of a Vascular Endothelial Growth Factor (VEGF) antagonist, such as aflibercept, at specific frequencies. This patent is particularly significant as it relates to Regeneron's blockbuster drug, Eylea, which is a VEGF antagonist used to treat conditions like wet age-related macular degeneration and diabetic macular edema.
The IPR, designated IPR2025-01269, was heard before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. The procedural posture indicates that the PTAB reviewed Unified Patents' petition but ultimately did not institute the review on the merits. This means the Board determined that Unified Patents did not demonstrate a reasonable likelihood that at least one challenged claim of the patent was unpatentable, thus allowing Regeneron's patent to remain unchallenged in this specific IPR.
This case is notable due to its connection to the highly lucrative and competitive market for ophthalmic biologics, particularly the biosimilar landscape surrounding Regeneron's Eylea, which has generated significant global sales. Regeneron has been involved in extensive patent litigation, including numerous IPRs and Biologics Price Competition and Innovation Act (BPCIA) lawsuits, defending its Eylea patents against biosimilar developers seeking to enter the market. Unified Patents' challenge, while not instituted, highlights the ongoing efforts by various entities to test the validity of patents covering high-value pharmaceutical products.
Key legal developments & outcome
Major rulings, motions, claim construction, settlements, and the present posture or final disposition.
The inter partes review (IPR) case IPR2025-01269, filed by Unified Patents against Regeneron Pharmaceuticals Inc. concerning U.S. Patent 10,828,345, concluded with a non-institution decision on the merits.
Here's a chronological summary of the key legal developments:
- Filing of IPR Petition (2025-08-19): Unified Patents filed a petition for inter partes review (IPR2025-01269) challenging U.S. Patent No. 10,828,345, owned by Regeneron Pharmaceuticals Inc. [cite: 2 (from previous search output)]. This patent relates to methods for treating angiogenic eye disorders.
- Institution Decision (2026-01-09): The Patent Trial and Appeal Board (PTAB) issued a decision denying institution of the inter partes review. The case status indicates that the petition was "Not Instituted - Merits". This means the PTAB, after reviewing the merits of the petition, determined that Unified Patents did not demonstrate a reasonable likelihood of prevailing with respect to at least one of the challenged claims, which is a statutory requirement for instituting an IPR trial. A general notice from the USPTO Director on the same date listed IPR2025-01269 among proceedings denied institution "after review of discretionary considerations." However, the authoritative status for this specific case as provided indicates a merits-based denial.
- Outcome: The IPR proceeding terminated at the institution stage, as the petition was not instituted on the merits. Consequently, there were no further proceedings such as claim construction, discovery, trial events, or a final written decision. The non-institution means that the validity of U.S. Patent No. 10,828,345 was not subjected to a full trial at the PTAB based on this specific petition.
Plaintiff representatives
Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
- Erise IP
- Jason R. Mudd · Lead Counsel
- Kelly R. Hughes · Back-Up Counsel
- Eric A. Buresh · Of Counsel
- In-house counsel
- Roshan Mansinghani · Legal Head-NPE
- Jordan M. Rossen · Senior Patent Counsel
While specific counsel filings for IPR2025-01269 are not directly available in public search results, Unified Patents, LLC frequently appears as a petitioner in inter partes review (IPR) proceedings. Based on a Power of Attorney filing in a similar IPR (IPR2021-01260, Unified Patents, LLC v. Authwallet LLC), the following attorneys are highly likely to represent Unified Patents in PTAB matters. It is important to note that this information is drawn from a different IPR case but is indicative of Unified Patents' typical legal representation.
Here is the likely counsel for Unified Patents:
Jason R. Mudd
- Role: Lead Counsel (in IPR2021-01260, likely lead in other IPRs)
- Firm: Erise IP, P.A., Overland Park, Kansas
- Experience Note: He successfully argued on behalf of the petitioner in the first-ever inter partes review conducted at the USPTO under the America Invents Act and has substantial experience in patent litigation and post-grant proceedings.
Roshan Mansinghani
- Role: Back-Up Counsel (in IPR2021-01260), Legal Head-NPE
- Firm: Unified Patents LLC, Dallas, Texas
- Experience Note: As Legal Head-NPE at Unified Patents, he oversees numerous USPTO invalidation proceedings, with over a decade of experience in patent litigation and trials.
Jordan M. Rossen
- Role: Back-Up Counsel (in IPR2021-01260), Senior Patent Counsel
- Firm: Unified Patents, LLC, Washington, D.C.
- Experience Note: He is an experienced intellectual property litigator who has represented clients before the Patent Trial and Appeal Board (PTAB), International Trade Commission (ITC), district courts, and the Federal Circuit.
Kelly R. Hughes
- Role: Back-Up Counsel (in IPR2021-01260), Senior Patent Counsel
- Firm: Erise IP, P.A., Greenwood Village, Colorado
- Experience Note: She handles PTAB filings, including inter partes reviews and ex parte reexaminations, with prior experience as a patent litigator focusing on software and electronics.
Eric A. Buresh
- Role: Of Counsel (listed alongside lead and backup counsel in IPR2021-01260)
- Firm: Erise IP, P.A., Overland Park, Kansas
- Experience Note: A founding member of Erise, he is a highly recognized patent litigator with a track record of success in district courts and has filed over 115 inter partes review proceedings.
Defendant representatives
Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).
It appears there was an error in the tool code execution. I will attempt to identify the counsel for Regeneron Pharmaceuticals Inc. in IPR2025-01269 using the previously outlined search strategy.
Given that the IPR was not instituted on the merits, the public record for counsel might be less extensive than for a fully litigated case. However, I will endeavor to find any publicly available information regarding Regeneron's legal representation in this specific PTAB proceeding.
Counsel of Record for Regeneron Pharmaceuticals Inc.
I will now attempt to find the counsel for Regeneron Pharmaceuticals Inc. in IPR2025-01269. If information is not readily available due to the case status (not instituted), I will explicitly state that.It is important to note that the provided case is an inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB), not a traditional patent infringement case in district court. In IPRs, the patent owner (Regeneron in this instance) defends its patent against a petitioner's challenge.
Based on the search results, directly identifying counsel of record specifically for Regeneron in IPR2025-01269 is challenging because the IPR was not instituted on the merits. This means the case did not proceed to the substantive trial phase where extensive legal filings and appearances by counsel would typically be made public. The initial search results indicated that IPR2025-01269 was filed by Fresenius Kabi SwissBioSim GmbH, not Unified Patents, against Regeneron Pharmaceuticals Inc. and was denied institution on January 9, 2026. There seems to be a contradiction with the case metadata provided, which states the plaintiff is Unified Patents. However, the search results consistently identify IPR2025-01269 as Fresenius Kabi SwissBioSim GmbH v. Regeneron Pharmaceuticals Inc.
While specific counsel for IPR2025-01269 is not explicitly listed as a result of its non-institution, Regeneron is a very active participant in patent litigation, especially concerning its Eylea product. They frequently engage outside counsel for these matters, in addition to having an in-house patent department.
Here's an overview of attorneys and firms that have represented Regeneron in similar patent litigation and PTAB proceedings, which provides insight into their typical legal representation:
Likely Counsel for Regeneron Pharmaceuticals Inc. in PTAB Proceedings (based on similar cases):
Firm: Paul, Weiss, Rifkind, Wharton & Garrison LLP
- Attorneys:
- Elizabeth S. Weiswasser (Lead Counsel)
- Office Location: New York, NY
- Experience: Elizabeth S. Weiswasser is a partner at Paul, Weiss, Rifkind, Wharton & Garrison LLP and has represented Regeneron in other significant patent cases, including IPRs and BPCIA litigation concerning Eylea. She was counsel for Regeneron in IPR2025-00176, another PTAB case related to an Eylea patent.
- Priyata Y. Patel (Counsel)
- Office Location: Washington, DC
- Experience: Priyata Y. Patel is also an attorney at Paul, Weiss, Rifkind, Wharton & Garrison LLP and was listed as counsel for Regeneron in IPR2025-00176.
- Elizabeth S. Weiswasser (Lead Counsel)
- Notable Experience: Paul, Weiss, Rifkind, Wharton & Garrison LLP has a strong track record of representing Regeneron in various intellectual property disputes, including defending Eylea patents. They were involved in district court cases and Federal Circuit appeals related to Eylea biosimilars.
- Attorneys:
In-House Counsel (Regeneron Pharmaceuticals Inc.):
- James Evans (Senior Director and Assistant General Counsel, Disputes Resolution Group)
- Role: In-house counsel, overseeing worldwide patent litigation matters.
- Experience: Dr. Evans has extensive experience in intellectual property litigation in the pharmaceutical, biotechnology, and biologics fields, representing and counseling major innovative pharmaceutical companies.
- Regeneron also has a Patent Department with various patent attorneys and agents, including Adam Gastonguay, Brandon Schurter, David Mellman, and Shing-Yi Cheng, who handle the development, protection, and management of Regeneron's intellectual property.
- James Evans (Senior Director and Assistant General Counsel, Disputes Resolution Group)
It is important to reiterate that while Paul, Weiss, Rifkind, Wharton & Garrison LLP and Regeneron's in-house team are consistently involved in their patent defense, the specific appearance of these attorneys in the non-instituted IPR2025-01269 cannot be confirmed without access to the full, non-public docket entries that might show initial filings or correspondence before the institution decision. The publicly available information for non-instituted IPRs is often limited.