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PureWick v. Sage Products: Female Urinary Catheter Patent Win | PatSnap
Patent Litigation

PureWick v. Sage Products: Plaintiff wins $26.2M jury verdict on female external catheter patents

PureWick Corporation secured a full plaintiff judgment in the Delaware District Court against Sage Products' PrimaFit product, covering three external female catheter patents. A unanimous jury verdict delivered $26.2M in lost profits, with the court further awarding pre- and post-judgment interest and an ongoing 6.5% royalty on the '407 patent.

Resolution time
1537days
1,537 days — over four years from filing to final judgment, spanning jury trial and post-trial motions
Patents asserted
4
US10226376, US10390989, US10376407 — external female urinary catheter device and method patents
Outcome
Judgment on the merits for Plaintiff
Final judgment on the merits entered for PureWick on infringement, willfulness, and validity of all three asserted patents
Cost ruling
Costs Pending
Costs and attorneys' fees motions (incl. § 285) deferred until after appellate mandate or appeal deadline
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

PureWick's catheter patents survive validity challenge and deliver $26M+ judgment

PureWick Corporation filed suit in the District of Delaware on August 12, 2019, asserting infringement of four patents covering its external female urinary catheter technology against Sage Products, LLC and its PrimaFit product. The case proceeded to a jury trial, and on April 1, 2022 the jury returned a unanimous verdict. The asserted patents — US10226376, US10390989, US10376407, and US8287508 — cover external female catheter device configurations and methods of use marketed under the PureWick FEC brand.

Final judgment was entered on October 27, 2023, amending an earlier April 7, 2022 judgment following post-trial motion practice. The court entered judgment for PureWick on direct, induced, and contributory infringement of the '376 and '989 patents, direct infringement of the '407 patent, and willful infringement of the '376 and '989 patents. Sage's invalidity defenses — including anticipation, obviousness, prior public use, and prior public sale — were all rejected. Damages totaled $26,215,545 in lost profits on the '376 and '989 patents, plus $1,799,193 as a reasonable royalty on the '407 patent, $1,144,734 in pre-judgment interest, and an ongoing royalty of 6.5% of net revenues on the '407 patent. Claims relating to the '508 patent were dismissed with prejudice as moot.

The case took over four years to reach final judgment, reflecting the complexity of the post-trial motion phase — the court's memorandum and order on post-trial motions was not issued until April 6, 2023, nearly a year after the jury verdict. The willfulness findings on two patents and the rejection of all invalidity defenses represent a strong outcome for PureWick. Sage confirmed cessation of all PrimaFit sales after November 30, 2021, which capped the lost-profits exposure on that product. Whether attorneys' fees will be awarded under 35 U.S.C. § 285, and whether any appeal is pursued, remains outside the available record at this filing.

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Case at a glance
CourtDelaware District Court
JudgeMaryellen Noreika
FiledAugust 12, 2019
ClosedOctober 27, 2023
Duration1537 days
OutcomeJudgment on the merits for Plaintiff
Verdict causeInfringement Action
BasisJudgment on the merits for Plaintiff
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Judgment on the merits for Plaintiff in 1537 days

1,537 days — over four years from filing to final judgment, spanning jury trial and post-trial motions

Case timeline: Complaint filed AUG 12 2019 — 1537 days total Horizontal timeline showing the three key events in PureWick Corporation v Sage Products, LLC from filing to resolution. Source: PACER, Delaware District Court. AUG 12 2019 Complaint filed Pre-trial proceedings OCT 27 2023 Judgment on the merits for Plaintiff 1537 DAYS TOTAL
Patent at issue

US10226376, US10390989 & US10376407 — external female urinary catheter patents

Publication No.US10226376B2
Application No.US15/611587
Patent details
ProductExternal female urinary catheter device configurations
Cited in actionAugust 12, 2019

Publication No.US8287508B1
Application No.US12/840475
Patent details
ProductExternal female urinary catheter device configurations and related claims
Cited in actionAugust 12, 2019

Publication No.US10390989B2
Application No.US15/260103
Patent details
ProductExternal female urinary catheter methods of use and assembly
Cited in actionAugust 12, 2019

Publication No.US10376407B2
Application No.US15/238427
Patent details
ProductExternal female urinary catheter system components
Cited in actionAugust 12, 2019
Technical brief · sourced from PatSnap patent database
Patent figurePatent figure
Representative claim (1 of 4 independent)
1. An apparatus comprising: a fluid impermeable casing having a fluid reservoir at a first end, a fluid outlet at a second end, and a longitudinally extending fluid impermeable layer coupled to the fluid reservoir and the fluid outlet and defining a longitudinally elongated opening between the fluid reservoir and the fluid outlet; a fluid permeable support disposed within the casing with a portion extending across the elongated opening, wherein the fluid permeable support is distinct from and at least proximate to the fluid reservoir; a fluid permeable membrane disposed on the support and covering at least the po…
Technical background
CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Patent Application No. 62/414,963, filed Oct. 31, 2016, entitled “Apparatus and Methods for Receiving Discharged Urine,” and U.S. Patent Application No. 62/485,578, filed Apr. 14, 2017, entitled “Apparatus and Methods for Receiving Discharged Urine,” the disclosures of which are incorporated herein by reference in their entirety. This application also is a continuation-in-part of and claims priority to and the benefi…
Patent family
21 family members across 1 jurisdiction (US)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US10226376, US10390989, and US10376407?

Any manufacturer, importer, or distributor of external female urinary catheter or urine collection devices should treat this patent family as a priority FTO target. The Delaware judgment confirms these claims are enforceable, valid, and commercially significant. Healthcare procurement professionals evaluating competing products — including absorbent-wick or non-invasive catheter alternatives — face direct infringement exposure if their products read on the asserted claims. The PrimaFit product was found to infringe; product teams should map their own designs against the specific claim elements of claims 1, 5, and 9 of the '376 patent and claims 1 and 6 of the '989 patent as a starting point.

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Official verdict

Official order — verbatim text

This Final Judgment amends the Judgment entered on April 7, 2022. (D.I. 320). This 27th day of October 2023, the Court having held a jury trial and the jury having rendered a unanimous verdict on April 1, 2022 (see D.I. 316), and the Court having issued its Memorandum and Order resolving the parties’ post-trial motions on April 6, 2023 (D.I. 368, 369), pursuant to Rule 58 of the Federal Rules of Civil Procedure, IT IS HEREBY ORDERED, ADJUDGED and DECREED that: 1. Judgment is entered in favor of Plaintiff PureWick Corporation (“Plaintiff”) and against Defendant Sage Products, LLC (“Defendant”) with respect to Plaintiff’s claim of direct infringement, induced infringement, and contributory infringement of claims 1, 5 and 9 of U.S. Patent No. 10,226,376 (“the ’376 patent”) and claims 1 and 6 of U.S. Patent No. 10,390,989 (“the ’989 patent”) and with respect to direct infringement of claims 1 and 2 of U.S. Patent No. 10,376,407 (“the ’407 patent”) (Counts II, III, IV), as well as Defendant’s declaratory judgment counterclaims for the ’376, ’989, and ’407 patents (Counterclaim Counts II-IV); 2. Judgment is entered in favor of Plaintiff and against Defendant with respect to willful infringement of the ’376 patent and the ’989 patent; Case 1:19-cv-01508-MN Document 381 Filed 10/27/23 Page 1 of 3 PageID #: 28572 2 3. Judgment is entered in favor of Plaintiff and against Defendant as to anticipation of claims 1, 5 and 9 of the ’376 patent and claim 1 of the ’989 patent; 4. Judgment is entered in favor of Plaintiff and against Defendant with respect to obviousness of claims 1, 5 and 9 of the ’376 patent, claims 1 and 6 of the ’989 patent, and claims 1 and 2 of the ’407 patent; 5. Pursuant to the Court’s Order of March 31, 2023, judgment is entered in favor of Plaintiff and against Defendant with respect to anticipation of claim 6 of the ’989 patent and claims 1 and 2 of the ‘407 patent; 6. Pursuant to Plaintiff’s unopposed motion for judgment as a matter of law on prior public use and prior public sale (D.I. 310 at 6-9, D.I. 312 at 2, 5), judgment is entered in favor of Plaintiff and against Defendant as to Defendant’s invalidity counterclaims and defenses based on prior public use and prior public sale relating to the claims 1, 5 and 9 of the ’376 patent and claims 1 and 6 of the ’989 patent; 7. Pursuant to the Court’s Order of March 31, 2023, judgment is entered in favor of Plaintiff and against Defendant as to equitable estoppel, waiver, acquiescence, and unclean hands on Defendant’s declaratory judgment counterclaims for the ’376, ’989, and ’407 patents (Counterclaim Counts II- IV); 8. Judgment is entered in favor of Plaintiff and against Defendant for damages in the amount of $26,215,545 in lost profits for infringement of the ’376 patent and the ’989 patent. Sage has confirmed that it has ceased all making, using, offering to sell, selling within the United States, or importing into the United States of the accused PrimaFit product, and that there are no additional sales of the product after November 30, 2021. Based on this representation by Sage, no further damages are awarded on sales of the PrimaFit product accused of infringement in this matter; Case 1:19-cv-01508-MN Document 381 Filed 10/27/23 Page 2 of 3 PageID #: 28573 3 9. Judgment is entered in favor of Plaintiff and against Defendant for damages in the amount of $1,799,193 as a reasonable royalty for infringement of the ’407 patent; 10. Supplemental damages/ongoing royalty at a rate of 6.5% of net revenues on any sales of the accused PrimoFit product is awarded for any sales after December 31, 2021, until the last date of sale of that product or the expiration date of the ‘407 patent, whichever is later; 11. In the exercise of the Court’s discretion, the Court awards PureWick pre-judgment interest in the amount of $1,144,734; 12. Pursuant to 28 U.S.C. § 1961, the Court awards PureWick post judgment interest at the rate of 1.67% (a) applied to the total amount of damages and supplemental damages ($1,313.05 per day) for the period from April 7, 2022 to the date of entry of this judgment, and (b) applied to the total amount of damages, supplemental damages and prejudgment interest for the period from the date of entry of this judgment until satisfaction of the judgment (e.g., $1,365.42 per day); and 13. All claims and counterclaims relating to claims 1, 3-8 and 17-19 of U.S. Patent No. 8,287,508 are dismissed with prejudice as moot. IT IS STILL FURTHER ORDERED that the deadline for any party to move for costs and attorneys’ fees (including under 35 U.S.C. § 285) is extended to within fourteen (14) days after the time for appeal has expired or within fourteen (14) days after issuance of the mandate from the appellate court on all appeals, and no party shall file any such motion before that time.
Source: PACER Docket, Case 1:19-cv-01508, Delaware District Court

The Final Judgment of October 27, 2023 is a comprehensive merits ruling amending and superseding the April 2022 judgment. It confirms jury findings of direct, induced, and contributory infringement, adds a court-level willfulness determination on two patents, and closes out all invalidity and equitable defences in PureWick's favour. The structured damages award — separating lost profits, reasonable royalty, pre-judgment interest, and an ongoing royalty — reflects post-trial motion practice that refined but did not disturb the underlying verdict.

PACER case 1:19-cv-01508 · Public docket record Explore in Eureka ↗
Court ruling

Judgment on the merits: what the plaintiff win means for both parties

Legal mechanism

Final judgment after jury trial and post-trial motions

The court entered final judgment under Fed. R. Civ. P. 58, amending the original April 2022 judgment after resolving post-trial motions. The judgment covers direct, induced, and contributory infringement, willfulness on two patents, and rejection of all invalidity counterclaims. Claims on the '508 patent were dismissed with prejudice as moot, narrowing the operative record to three patents.

Merits judgment — full plaintiff victory
Patent holder outcome

PureWick obtains $26.2M lost profits plus royalties and willfulness findings

PureWick secured $26,215,545 in lost profits on the '376 and '989 patents, $1,799,193 in reasonable royalties on the '407 patent, $1,144,734 in pre-judgment interest, and an ongoing 6.5% royalty on future '407 patent sales. Willfulness findings on two patents open the door to enhanced damages under 35 U.S.C. § 284, subject to any further motion. All three asserted patents survived validity challenge.

Lost profits + ongoing royalty awarded
Defendant outcome

Sage's invalidity and equitable defences comprehensively rejected

Every invalidity theory advanced by Sage — anticipation, obviousness, prior public use, prior public sale — was rejected by the court. Equitable defences including estoppel, waiver, acquiescence, and unclean hands also failed. Sage confirmed cessation of PrimaFit sales after November 30, 2021, which limited ongoing damages exposure but did not reduce the lost-profits award for the infringement period. Attorneys' fees under § 285 remain unresolved in the available record.

All defences failed — damages confirmed
Commercial implications

Strong IP moat established for external female catheter technology

The judgment reinforces PureWick's patent portfolio as a meaningful enforcement barrier in the external female urinary catheter segment. Willfulness findings and the survival of three patents against broad validity challenge signal that competitors seeking to enter this product space face significant litigation risk. The 6.5% ongoing royalty rate and the lost-profits framework established here are commercially significant benchmarks for the sector.

Sector: medical device / continence care
Legal analysis based on PACER docket records for case 1:19-cv-01508 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffPureWick CorporationCompany/Search in Eureka ↗
DefendantSage Products, LLCCompany/Search in Eureka ↗
Plaintiff counselAmanda K. AntonsAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselAndrew RussellAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselAthena D. DaltonAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselBrian P. BiddingerAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselJason C. WilliamsAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselJohn W. ShawAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselKaren Elizabeth KellerAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselMatthew A. TraupmanAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselRaymond N. NimrodAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff counselSteven C. ChernyAttorneyCounsel for PureWick CorporationSearch in Eureka ↗
Plaintiff law firmShaw Keller LLPLaw FirmRepresenting PureWick CorporationSearch in Eureka ↗
Defendant counselAnne Shea GazaAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselBradley P. LorenAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselBryce R. PersichettiAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselChristopher M. ScharffAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselDeborah A. LaughtonAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselJenna SaundersAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselRobert A. SurretteAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselRyan J. PianettoAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselSamantha G. WilsonAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant counselSandra A. FrantzenAttorneyCounsel for Sage Products, LLCSearch in Eureka ↗
Defendant law firmYoung Conaway Stargatt & Taylor, LLPLaw FirmRepresenting Sage Products, LLCSearch in Eureka ↗
Presiding judgeJudge Maryellen NoreikaJudgeDelaware District CourtSearch in Eureka ↗
R&D signals

R&D signals in the external female catheter IP space

Forward-looking patent and innovation intelligence derived from PureWick's enforcement of its external female catheter portfolio against Sage Products in Delaware.

Patent portfolio

PureWick's external catheter filing activity signals continued IP build-out

PureWick successfully asserted three patents filed between 2016 and 2017, all of which survived validity challenge. This suggests a deliberate, layered filing strategy around external female catheter technology. Monitoring PureWick's subsequent applications in this family — including continuations and divisionals — is essential for any R&D team working in continence care device design.

PureWick patent family watch
Technology landscape

Non-invasive female urine collection is an active and contested filing domain

The commercial success and enforcement activity around PureWick's FEC product suggests growing patent density in external female urinary collection devices. R&D teams developing absorbent-wick, vacuum-assisted, or anatomically shaped collection devices should conduct a landscape analysis to identify white space and avoid the claim perimeter established by the PureWick portfolio.

Filing density — continence care
Competitor IP posture

Sage Products' IP position in continence care post-judgment

Sage Products confirmed cessation of PrimaFit sales after November 2021 and lost comprehensively on invalidity. Understanding Sage's own patent filings in the catheter and continence care space — and whether it has pursued alternative designs since withdrawal — provides intelligence on competitive repositioning in this product category.

Sage Products patent posture
White space opportunity

Adjacent innovation opportunities near the PureWick claim perimeter

With PureWick's core device and method claims now confirmed as valid and infringed, adjacent R&D opportunities may lie in collection system integration, sensor-enabled monitoring of fluid volumes, or antimicrobial materials for external catheters — areas not specifically addressed by the asserted claims. A targeted patent landscape search can identify whether these adjacencies are already populated or represent genuine white space.

Design-around white space
Related litigation

Similar patent infringement cases in external female catheter & medical device IP

Explore comparable patent infringement cases involving medical device IP asserted in the Delaware District Court, particularly in continence care and non-invasive catheter technology.

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PureWick Corporation patent enforcement history, Delaware District Court case history, PureWick Corporation's full IP portfolio, and comparable case analysis
Continence care device casesDelaware medical device verdictsLost profits in device IPWillfulness in medical patents
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Strategic implications

What this case signals for the external female catheter IP landscape

A $26M+ verdict with willfulness findings confirms PureWick's patents as high-value enforcement assets in a fast-growing medical device category.

Willfulness findings raise the stakes for any competitor in this space

The court's willfulness findings on the '376 and '989 patents signal that Sage's conduct was assessed as more than inadvertent. Competitors in the external female catheter market should treat these patents as live enforcement risks requiring proactive FTO clearance, not background noise.

Three patents survived every invalidity theory Sage could bring

Anticipation, obviousness, prior public use, and prior public sale were all rejected. For R&D teams designing around PureWick's portfolio, the breadth of the validity challenge — and its failure — suggests these claims are robustly drafted and will be difficult to engineer around without a clear non-obviousness argument.

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Frequently asked questions

PureWick v Sage — key questions answered

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Track external catheter IP enforcement and FTO risks in real time

PureWick's $26M+ judgment confirms these external catheter patents as active enforcement assets. Use PatSnap Eureka to monitor new filings in this family, run FTO clearance against US10226376 and related patents, and track any appellate developments.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

Nothing on this page constitutes legal advice or a legal opinion on the validity, infringement, enforceability, or scope of any patent or case, and no attorney‑client relationship is created by its use. Any description of an outcome (such as a dismissal, settlement, or consent judgment) is a general summary, not a legal determination. All patents, trademarks, and company or law‑firm names are the property of their respective owners. PatSnap makes no warranty as to the accuracy or completeness of this content and disclaims, to the fullest extent permitted by law, all liability for reliance on it. For advice on a specific matter, consult qualified legal counsel.

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