Harbour Antibodies v. Leveragen: Six-Patent Antibody IP Suit Voluntarily Dismissed
Harbour Antibodies BV brought an infringement action in the District of Massachusetts against Leveragen, Inc., asserting six patents covering its HCAb platform and Harbour Mice® single-domain antibody technology. The case — targeting Leveragen’s NANOBODIES® offering — was voluntarily dismissed without prejudice in just 36 days, leaving all rights expressly reserved.
Six-Patent Antibody Platform Suit Ends in 36 Days — With Rights Reserved
On 14 October 2025, Harbour Antibodies BV filed suit against Leveragen, Inc. in the United States District Court for the District of Massachusetts (Case No. 1:25-cv-13004), before Judge Jessica D. Hedges. The complaint asserted six patents — US9346877B2, US8921524B2, US9353179B2, US8921522B2, US10906970B2, and US9365655B2 — all directed to Harbour Antibodies’ proprietary HCAb platform and Harbour Mice® technology for generating single-domain antibodies, commercially relevant to Leveragen’s NANOBODIES® services.
The case closed on 19 November 2025, just 36 days after filing, via a voluntary dismissal without prejudice under Federal Rule of Civil Procedure 41(a)(1)(A)(i). Critically, the dismissal order expressly states that Harbour Antibodies reserved all rights and that no costs or fees were awarded to any party. A dismissal without prejudice means the plaintiff retains the ability to re-file the same claims against Leveragen in the future — this is not a final resolution on the merits.
A 36-day lifespan before any substantive court rulings suggests the parties may have entered early-stage settlement or licensing negotiations, or Harbour Antibodies may have chosen to regroup its legal strategy before re-asserting. The express reservation of all rights — unusual language even for without-prejudice dismissals — strengthens the inference that Harbour views this as a tactical pause rather than a withdrawal. The public record does not disclose whether any agreement was reached, and the underlying infringement claims remain formally unresolved.
Filing to Voluntary dismissal in 36 days
36 days — significantly shorter than the median D. Mass. patent case lifespan
Voluntarily dismissed: what the Rule 41 exit means for both parties
Rule 41(a)(1)(A)(i): a unilateral, pre-answer exit
Under FRCP 41(a)(1)(A)(i), a plaintiff may dismiss its complaint without a court order before the defendant serves an answer or a motion for summary judgment. This procedural route — used here within 36 days — requires no judicial approval and produces no merits ruling. The case closes, but the legal questions it raised are entirely unresolved. Courts treat this as a reset, not a resolution.
No merits adjudicationWithout prejudice — but the distinction matters enormously
A voluntary dismissal ‘without prejudice’ means Harbour Antibodies may re-file identical infringement claims against Leveragen at any time within the applicable statute of limitations. A ‘with prejudice’ dismissal would bar re-filing permanently. The verdict text here is explicit: dismissed without prejudice, all rights reserved. The public record does not reveal whether any side agreement constrains future re-filing — that information, if it exists, is private.
Re-filing remains possibleHarbour Antibodies retains full enforcement optionality
By dismissing without prejudice and expressly reserving all rights, Harbour Antibodies has preserved its ability to re-assert all six patents against Leveragen. The no-costs provision means no financial penalty for the early exit. This posture is consistent with a plaintiff pursuing parallel licensing negotiations, reassessing claim construction, or awaiting a more favourable litigation window. Nothing in the public record forecloses a second action.
Rights fully preservedLeveragen faces unresolved patent exposure on NANOBODIES®
Leveragen achieved dismissal without incurring a costs award, but this outcome provides no legal protection against re-filing. The six asserted patents remain in force and the infringement allegations were never tested on the merits. Any product or service within the scope of Harbour Antibodies’ HCAb or Harbour Mice® portfolio — including the advertised NANOBODIES® offering — carries continuing IP risk until either a licence is secured or the patents are successfully challenged.
Continued exposure riskFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Harbour Antibodies, BV | Individual | Biopharmaceutical IP licensor — holder of HCAb single-domain antibody platform patentsSearch in Eureka ↗ |
| Defendant | Leveragen, Inc. | Company | Leveragen, Inc. — single-domain antibody services provider, offering NANOBODIES® technologySearch in Eureka ↗ |
| Plaintiff counsel | Samuel J. Sussman | Attorney | Counsel for Harbour Antibodies, BVSearch in Eureka ↗ |
| Plaintiff counsel | Susan G. L. Glovsky | Attorney | Counsel for Harbour Antibodies, BVSearch in Eureka ↗ |
| Plaintiff law firm | Hamilton, Brook, Smith & Reynolds PC | Law Firm | Representing Harbour Antibodies, BVSearch in Eureka ↗ |
| Defendant counsel | Philip K. Chen | Attorney | Counsel for Leveragen, Inc.Search in Eureka ↗ |
| Defendant law firm | Fish & Richardson PC (Bos) | Law Firm | Representing Leveragen, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Jessica D. Hedges | Judge | Massachusetts District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal was entered pursuant to FRCP 41(a)(1)(A)(i), a unilateral plaintiff mechanism requiring no court order and producing no adjudication on the merits. The explicit reservation of ‘all rights’ in the dismissal language, combined with the without-prejudice designation, means this proceeding has no preclusive effect on Harbour Antibodies’ ability to re-assert any of the six patents. For Leveragen, the absence of a costs award provides short-term financial relief, but offers no substantive shield against a future infringement action on identical claims.
US9346877B2 and five further patents — HCAb single-domain antibody platform
The six patents asserted in this action — US9346877B2, US8921524B2, US9353179B2, US8921522B2, US10906970B2, and US9365655B2 — collectively cover Harbour Antibodies’ proprietary HCAb (heavy-chain-only antibody) platform and Harbour Mice® transgenic animal system. The patents span claim families directed to antigen-specific VH binding domains, single-domain antibody generation methods, and related nucleic acid and expression technologies, with application priority dates ranging from late 2009 (US12/645684) through 2018 (US15/953622), reflecting a decade of platform development.
The HCAb platform is commercially significant because single-domain antibodies — including VHH fragments marketed as nanobodies — are increasingly deployed in therapeutic, diagnostic, and research tool applications due to their small size, stability, and ease of engineering. Harbour Antibodies’ Harbour Mice® system enables in vivo generation of fully human single-domain antibodies, directly competing with or complementing alternative nanobody discovery platforms. The assertion of this portfolio against a commercial single-domain antibody services provider signals that Harbour views its patent estate as an active competitive moat in the growing antibody discovery services market.
Should you run an FTO against Harbour Antibodies’ HCAb patent portfolio?
Any company offering single-domain antibody generation services — including nanobody discovery, VHH library construction, or HCAb-based therapeutic development — should treat Harbour Antibodies’ six-patent portfolio as a material FTO risk. This case demonstrates active enforcement intent; the without-prejudice dismissal means all six patents remain in force and fully assertable. R&D teams developing antigen-specific VH binding domains or deploying transgenic animal platforms for antibody discovery should map their workflows against the claim scope of each asserted patent before commercialising services.
PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to run structured claim-by-claim freedom-to-operate analysis across all six Harbour Antibodies patents simultaneously. Eureka surfaces prior art, identifies claim overlaps with your technology, and flags related family members and PTAB proceedings — enabling a defensible FTO opinion before your next product launch or licensing negotiation. Given that this enforcement action targeted a commercial nanobody services provider, any comparable business should prioritise this analysis now.
Run a freedom-to-operate analysis on US9346877B2 to assess your product’s exposure
Run FTO in Eureka →Similar single-domain antibody patent infringement cases in US federal courts
Related infringement actions involving HCAb, VHH, and nanobody platform patents litigated before US district courts, including the District of Massachusetts.
What this case signals for the single-domain antibody IP landscape
A six-patent assertion dropped in 36 days rarely means the dispute is over — especially when rights are expressly reserved.
Voluntary dismissals with reserved rights are enforcement signals, not retreats
When a patentee files, then dismisses without prejudice while explicitly reserving all rights, the operative message to the market is that the patents remain live threats. Competitors and licensees in the single-domain antibody space — particularly those offering nanobody generation services — should treat this case as a marker of Harbour Antibodies’ enforcement intent, not its abandonment.
Six-patent portfolios in HCAb technology create layered FTO complexity
Harbour Antibodies asserted patents spanning multiple application numbers and claim families covering the HCAb platform and Harbour Mice®. Companies operating in the single-domain antibody or VHH/nanobody space should conduct layered FTO analysis across all six patents — claim-by-claim — before launching or expanding antibody generation services, particularly where those services mirror Leveragen’s advertised NANOBODIES® offering.
BV v Leveragen — key questions answered
Harbour Antibodies asserted six patents: US9346877B2, US8921524B2, US9353179B2, US8921522B2, US10906970B2, and US9365655B2. All relate to the HCAb single-domain antibody platform and Harbour Mice® transgenic system for generating antigen-specific VH binding domains, directly targeting Leveragen’s NANOBODIES® services.
The case was voluntarily dismissed under FRCP 41(a)(1)(A)(i) — a mechanism available before the defendant serves an answer, requiring no court order. The 36-day timeline and express reservation of all rights suggest possible early licensing negotiations or a strategic decision to reposition before substantive litigation. The public record does not disclose any underlying agreement.
No. A voluntary dismissal without prejudice under Rule 41(a)(1)(A)(i) has no preclusive effect. Harbour Antibodies expressly reserved all rights in the dismissal text and may re-file identical infringement claims against Leveragen on any or all of the six asserted patents within the applicable limitations period. The underlying patents remain in force.
The six patents cover heavy-chain-only antibody (HCAb) technology, including antigen-specific VH single-domain antibody compositions, methods for generating single-domain antibodies using transgenic Harbour Mice®, related nucleic acid sequences, and expression methods. Application priority dates range from 2009 to 2018, spanning over a decade of platform development relevant to the nanobody and VHH antibody discovery market.
This case signals active enforcement intent by Harbour Antibodies against commercial nanobody service providers. All six asserted patents remain in force and the infringement claims were never adjudicated. Companies offering VHH discovery, single-domain antibody generation, or HCAb-based services should conduct freedom-to-operate analysis against each patent’s claim scope and consider whether PTAB inter partes review proceedings offer a viable defensive strategy.
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