Regen Labs v. VetStem: Stem Cell Therapy Appeal Voluntarily Dismissed
Regen Labs LLC (dba Regenerative Medical LA) brought a patent infringement appeal at the Federal Circuit against VetStem, Inc., asserting two stem cell therapy patents. The parties filed a joint stipulation of voluntary dismissal after just 75 days, leaving the underlying merits unresolved on the public record.
A swift joint exit from a stem cell IP dispute at the Federal Circuit
Filed on 29 August 2024, Case No. 24-2273 placed two regenerative medicine patents — US9453202B2 and US11129855B2 — before the United States Court of Appeals for the Federal Circuit. Plaintiff Regen Labs LLC, operating as Regenerative Medical LA, alleged infringement by VetStem, Inc. in connection with Regen’s stem cell therapy products. Bryan Cave Leighton Paisner LLP represented Regen, while Friedman, Suder & Cooke, PC acted for VetStem.
The appeal closed on 12 November 2024 via a joint stipulation of voluntary dismissal, terminating the case in its entirety after 75 days. The Federal Circuit’s order is purely procedural: it records the agreement of both parties to end the appeal but issues no ruling on the validity or infringement of either patent. The public record is silent on whether the dismissal was with or without prejudice, and no costs order is reflected in the available docket.
A 75-day resolution at the Federal Circuit is notably brief and is consistent with the parties having reached a private settlement or agreed commercial resolution — though this remains unconfirmed from the public record. The speed at which a joint stipulation emerged suggests both sides had a compelling reason to exit litigation quickly, potentially including licensing discussions, business restructuring, or a negotiated exit from the underlying district court dispute. What drove the resolution, and on what terms, remains undisclosed.
Filing to Voluntary dismissal in 75 days
75-day appeal — resolved well under the Federal Circuit’s typical 12–18-month appellate timeline
Voluntarily dismissed: what the joint stipulation means for both parties
Joint stipulation ends appeal with no merits ruling
A joint stipulation of voluntary dismissal is a procedural instrument by which both parties collectively ask the court to close the case without adjudicating the substance of the dispute. At the Federal Circuit, this means the appellate court issues no opinion on patent validity, claim construction, or infringement — the underlying legal questions remain formally unanswered. The dismissal order itself carries no precedential weight.
No merits adjudicatedWith or without prejudice? The public record is silent
A voluntary dismissal can be with prejudice — permanently barring re-filing of the same claims — or without prejudice, which preserves the right to re-litigate. The joint stipulation in this case does not specify which form applies, and the Federal Circuit’s order does not supply that detail. Without confirmation, practitioners should not assume either outcome; the distinction has material consequences for both parties’ future enforcement and challenge rights.
Prejudice status unconfirmedRegen Labs exits appeal without a favourable ruling on record
Regen Labs voluntarily joined the stipulation, meaning it did not press for a Federal Circuit decision that could have validated its patent claims or reversed any lower-court ruling. The commercial rationale is unknown, but a joint exit typically suggests either that the plaintiff obtained sufficient concessions privately or concluded that continuing appellate litigation was not commercially worthwhile. Patent enforceability against VetStem specifically remains unresolved publicly.
No appellate win on recordVetStem avoids an adverse Federal Circuit ruling — for now
VetStem benefits from the absence of any court finding of infringement or patent validity at the appellate level. A joint stipulation signals VetStem’s participation in whatever private arrangement ended the dispute. However, if the dismissal was without prejudice, VetStem could face future enforcement action under the same stem cell therapy patents. The lack of a public merits ruling also means VetStem cannot leverage a court-validated invalidity finding to deter future suits.
No infringement findingFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | REGEN LABS LLC, dba Regenerative Medical LA | Company | Regenerative medicine company — holder of US9453202B2 and US11129855B2Search in Eureka ↗ |
| Defendant | VETSTEM, INC. | Company | VetStem, Inc. — veterinary regenerative medicine and stem cell therapy companySearch in Eureka ↗ |
| Plaintiff counsel | Erin A. Kelly | Attorney | Counsel for REGEN LABS LLC, dba Regenerative Medical LASearch in Eureka ↗ |
| Plaintiff counsel | K. Lee Marshall Esq. | Attorney | Counsel for REGEN LABS LLC, dba Regenerative Medical LASearch in Eureka ↗ |
| Plaintiff counsel | Kenneth Lee Marshall | Attorney | Counsel for REGEN LABS LLC, dba Regenerative Medical LASearch in Eureka ↗ |
| Plaintiff law firm | Bryan Cave Leighton Paisner LLP | Law Firm | Representing REGEN LABS LLC, dba Regenerative Medical LASearch in Eureka ↗ |
| Defendant counsel | Glenn Schuyler Orman | Attorney | Counsel for VETSTEM, INC.Search in Eureka ↗ |
| Defendant counsel | Jonathan Tad Suder | Attorney | Counsel for VETSTEM, INC.Search in Eureka ↗ |
| Defendant counsel | Richard Wojcio Jr. | Attorney | Counsel for VETSTEM, INC.Search in Eureka ↗ |
| Defendant law firm | Friedman, Suder & Cooke, PC | Law Firm | Representing VETSTEM, INC.Search in Eureka ↗ |
| Presiding judge | Judge Andre Birotte, Jr | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The Federal Circuit’s order adopts the parties’ joint stipulation verbatim, ordering only that ‘the appeal is dismissed.’ This phrasing is purely ministerial — the court exercises no independent judgment on the merits of the underlying infringement claims, the validity of either asserted patent, or the correctness of any lower court ruling. The order creates no precedent and resolves no substantive legal question. Both US9453202B2 and US11129855B2 remain in force, and the dismissal’s silence on prejudice terms means future enforcement cannot be ruled out based on this order alone.
US9453202B2 & US11129855B2 — Stem Cell Therapy Compositions and Methods
US9453202B2 (application no. US10/575063) and US11129855B2 (application no. US16/859790) together form a two-patent portfolio asserted by Regen Labs in connection with its stem cell therapy products marketed under the Regenerative Medical LA brand. These patents sit within the rapidly expanding regenerative medicine space, covering cell-based compositions and associated therapeutic methods. The later patent, US11129855B2, suggests continuation-type prosecution activity, indicating Regen Labs has actively worked to extend and refine its claim coverage over time.
The strategic value of this portfolio lies in its breadth across both compositions and methods — a dual-claim structure that complicates design-around attempts and raises the cost of invalidity challenges. For VetStem, which operates in the veterinary stem cell therapy market, and for any adjacent human regenerative medicine company, these patents represent a credible enforcement vector. The fact that litigation reached the Federal Circuit without a merits ruling leaves the enforceability question open and suggests the portfolio retains commercial leverage in licensing discussions.
Should you run an FTO against US9453202B2 and US11129855B2?
Any company developing, commercialising, or distributing stem cell therapy products — whether in veterinary medicine, human regenerative medicine, or adjacent cell therapy applications — should treat this patent family as an active FTO concern. The absence of a court-issued invalidity or non-infringement finding means both patents remain presumptively valid. If your product roadmap involves cell-based therapeutics, autologous or allogeneic stem cell compositions, or related treatment methods, an FTO analysis is warranted before commercialisation or investment decisions are finalised.
PatSnap Eureka’s FTO Search Agent can map your product specifications against the claim scope of US9453202B2 and US11129855B2, identify relevant prior art that could support an IPR petition, and surface related patents in Regen Labs’ broader portfolio that may not yet have been asserted. Eureka’s claim-level analysis allows R&D and legal teams to identify potential design-around paths and assess whether the prosecution history of these patents narrows their enforceability against specific therapeutic approaches.
Run a freedom-to-operate analysis on US9453202B2 to assess your product’s exposure
Run FTO in Eureka →Similar Federal Circuit stem cell and regenerative medicine patent appeals
Cases involving stem cell therapy patents at the Federal Circuit, including voluntary dismissals and infringement appeals in the regenerative medicine sector.
What this case signals for the regenerative medicine IP landscape
A rapid joint exit at the Federal Circuit in a stem cell patent dispute carries implicit signals about enforcement strategy and settlement leverage in regenerative medicine.
Speed of resolution at appeal level suggests private settlement dynamics
Seventy-five days from filing to dismissal at the Federal Circuit is exceptionally fast. This timeline is consistent with a case where the parties had already substantively resolved their differences — possibly at the district court level — or where a licensing or commercial agreement was reached shortly after the notice of appeal was filed. IP professionals monitoring this space should treat the speed as a signal, not a coincidence.
Unresolved patent validity creates ongoing risk for VetStem and competitors
Because neither US9453202B2 nor US11129855B2 was adjudicated on the merits, both patents remain presumptively valid and potentially enforceable. Companies developing or commercialising stem cell therapies — particularly in veterinary and human regenerative medicine — face a live enforcement risk from Regen Labs’ portfolio unless those patents are challenged separately via IPR or ex parte reexamination.
REGEN v VETSTEM — key questions answered
The Federal Circuit appeal was voluntarily dismissed by joint stipulation of both parties on 12 November 2024, 75 days after filing. No merits ruling was issued on the infringement of US9453202B2 or US11129855B2. The court’s order simply records the dismissal without specifying whether it was with or without prejudice.
Regen Labs asserted two patents: US9453202B2 (application US10/575063) and US11129855B2 (application US16/859790). Both relate to stem cell therapy compositions and methods relevant to Regen’s regenerative medicine products marketed under the Regenerative Medical LA brand.
The public record does not specify. The Federal Circuit’s order adopts the joint stipulation of voluntary dismissal without stating whether the dismissal is with or without prejudice. Practitioners should not assume either outcome without access to any underlying agreement between the parties.
A voluntary dismissal at the Federal Circuit means no appellate merits ruling is issued. The patents asserted — here US9453202B2 and US11129855B2 — remain in force and presumptively valid. The patent holder retains the ability to assert them in future proceedings, subject to any private agreement between the parties and applicable res judicata principles depending on the prejudice terms.
Potentially, yes. Because no district court or Federal Circuit merits decision was issued that would estop future challenges, inter partes review (IPR) of either patent at the USPTO may remain available to VetStem or any third party, subject to the one-year statutory bar from service of a complaint. Interested parties should verify their IPR filing eligibility and assess the prior art landscape before the window closes.
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