PureWick v. Sage Products: FEC Patent Battle Ends in Settled Dismissal
PureWick Corporation brought a two-patent infringement action against Sage Products, LLC in Delaware, asserting US10226376B2 and US10390989B2 over the PrimaFit female external catheter line. After 762 days of litigation, the parties reached a confidential settlement and jointly stipulated to dismiss all claims with prejudice.
Two-patent FEC dispute settled after two years in Delaware
PureWick Corporation filed suit against Sage Products, LLC on 26 January 2022 in the Delaware District Court (Case No. 1:22-cv-00102), presided over by Judge Maryellen Noreika. The complaint alleged infringement of two patents — US10226376B2 and US10390989B2 — both directed to female external catheter (FEC) technology marketed under PureWick’s PureWick™ FEC Solution brand. The accused products were Sage’s PrimaFit and PrimaFit 2.0 catheters, which PureWick alleged replicated core aspects of its patented catheter design aimed at reducing catheter-associated urinary tract infections (CAUTI) and skin damage.
The case was resolved by a joint stipulation of dismissal filed on 27 February 2024, citing a confidential settlement agreement. The dismissal was entered with prejudice under Fed. R. Civ. P. 41, meaning PureWick is permanently barred from reasserting these specific claims against Sage. Notably, the court retained jurisdiction to enforce the dismissal order — a provision that typically indicates the underlying settlement contains ongoing obligations, such as licensing terms, royalty arrangements, or product design commitments. Each party agreed to bear its own attorney’s fees and expressly waived any rights under 35 U.S.C. § 285.
At 762 days, the case ran longer than many patent disputes that settle pre-trial, suggesting meaningful litigation activity — likely including claim construction and fact discovery — before the parties reached agreement. The court’s retained jurisdiction clause and the mutual fee waiver are consistent with a negotiated commercial resolution, though the specific financial or licensing terms remain confidential. Whether Sage obtained a license to the asserted patents or agreed to design-around obligations is unknown from the public record.
Filing to dismissal in 762 days
762 days — above median for multi-patent infringement actions reaching settlement in Delaware District Court
What the with-prejudice settlement dismissal means for both parties
Fed. R. Civ. P. 41 dismissal with prejudice — no refiling
A voluntary dismissal with prejudice under Rule 41 is a final adjudication on the merits for the claims dismissed. PureWick permanently surrenders its right to pursue these exact infringement claims against Sage Products. Courts treat this as the equivalent of a judgment — it cannot be undone absent extraordinary circumstances. This is the standard vehicle for converting a confidential settlement into a binding court record.
Permanent bar on re-litigationRetained jurisdiction suggests ongoing settlement obligations
The court’s explicit retention of jurisdiction to enforce the dismissal order is a meaningful drafting choice. It is typically included when the settlement imposes future obligations on one or both parties — such as royalty payments, product modification timelines, or licence milestones. If the matter were a simple walk-away, no retained jurisdiction clause would be needed. This clause gives either party a fast-track enforcement mechanism without refiling.
Likely ongoing commercial termsMutual § 285 waiver — neither side receives attorney’s fees
Both parties expressly waived any claim to attorney’s fees under 35 U.S.C. § 285, which authorises fee-shifting in ‘exceptional’ patent cases. This mutual waiver is characteristic of negotiated settlements where neither party wishes to open a fee dispute or signal the other’s litigation conduct was unreasonable. It does not reflect a judicial finding on the merits — it is a contractual election by both sides to close the matter cleanly.
No fee-shifting orderedSage’s PrimaFit future — license, redesign, or exit?
The public record does not disclose whether Sage obtained a licence to continue selling PrimaFit products, committed to a design modification, or agreed to phase out the accused line. The with-prejudice structure and retained jurisdiction are consistent with a licensing or royalty resolution. Competitors and procurement teams in the FEC space should monitor Sage’s post-settlement product portfolio for any changes to the PrimaFit 2.0 specification.
Product future undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | PureWick Corporation | Company | Medical device company — holder of US10226376B2 and US10390989B2 (female external catheters)Search in Eureka ↗ |
| Defendant | Sage Products, LLC | Company | Sage Products, LLC — manufacturer of the PrimaFit and PrimaFit 2.0 female external cathetersSearch in Eureka ↗ |
| Plaintiff counsel | Andrew Russell | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Bianca A. Fox | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Brian P. Biddinger | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Brianne M. Straka | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | David A. Nelson | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Emily DiBenedetto | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Immanuel R. Foster | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Jared W. Newton | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Jason C. Williams | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | John W. Shaw | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | John Yang | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Matthew A. Traupman | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Nathan Roger Hoeschen | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Nicola Felice | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Raymond N. Nimrod | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Plaintiff counsel | Steven C. Cherny | Attorney | Counsel for PureWick CorporationSearch in Eureka ↗ |
| Defendant counsel | Anne Shea Gaza | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Christopher M. Scharff | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Deborah A. Laughton | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Gene Volchenko | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Madeline P. Paradkar | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Michael J. Weil | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Robert A. Surrette | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Ryan J. Pianetto | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Samantha G. Wilson | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Sandra A. Frantzen | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Sarine R. Hagopian | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | Wilhelm L. Rao | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Presiding judge | Judge Maryellen Noreika | Chief Judge | Delaware District Court — Chief JudgeSearch in Eureka ↗ |
Stipulation of dismissal — official text
The joint stipulation cites a confidential settlement agreement as its basis and invokes Rule 41 to effect a with-prejudice dismissal. The court’s retention of jurisdiction is the legally significant phrase — it converts the dismissal from a mere procedural closure into an enforceable framework for any future breach of the settlement’s terms. The mutual § 285 waiver signals that both parties elected certainty over the possibility of a fee award, consistent with a negotiated commercial resolution rather than a unilateral capitulation by either side.
US10226376B2 & US10390989B2 — Female External Catheter Technology
US10226376B2 (application US15/611587) and US10390989B2 (application US15/260103) both protect aspects of PureWick’s female external catheter technology — a non-invasive urinary management solution designed for female patients. The patents cover structural and functional features of the FEC device intended to draw urine away from the body without the use of an indwelling catheter, thereby reducing rates of CAUTI and skin breakdown associated with prolonged use of absorbent products. Both patents sit within the growing medtech category of non-invasive continence care.
These patents are commercially significant because the female external catheter market has grown rapidly as hospital infection-control protocols have intensified scrutiny of CAUTI rates. PureWick’s FEC Solution is used across acute care, long-term care, and home health settings. Any competitor offering a functionally similar non-invasive female catheter — particularly one using comparable wicking, fluid-channelling, or body-conforming mechanisms — risks falling within the claim scope of these patents. The litigation against Sage Products demonstrates that PureWick monitors the market actively and is prepared to enforce.
Should you run an FTO against US10226376B2 and US10390989B2?
Any company developing, manufacturing, or distributing a female external catheter — or a non-invasive urinary management device for female patients — should assess freedom-to-operate against PureWick’s portfolio before launch. The PrimaFit litigation shows that physical and functional similarity to the PureWick FEC design is sufficient to trigger enforcement. R&D teams should pay particular attention to fluid-wicking mechanisms, body-contact geometry, and collection chamber design — the features most likely covered by the asserted claims.
PatSnap Eureka’s FTO Search Agent allows product and IP teams to map proposed designs against the independent claims of US10226376B2 and US10390989B2 in minutes, flagging overlap risk and identifying design-around opportunities. Claim monitoring alerts can notify your team if PureWick files continuations or divisionals that extend coverage into adjacent FEC form factors — giving you early warning before a product launch becomes a litigation event.
Run a freedom-to-operate analysis on US10226376B2 to assess your product’s exposure
Run FTO in Eureka →Similar patent cases in female external catheter and medical device technology
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What this case signals for the female external catheter IP landscape
PureWick’s willingness to litigate two patents for over two years before settling signals a determined enforcement posture in the FEC market.
PureWick is an active patent enforcer in the FEC space — budget accordingly
This is not PureWick’s only enforcement action involving its FEC patent portfolio. Companies developing or distributing female external catheter products should treat PureWick’s patent portfolio as a live enforcement risk, not a theoretical one. The two-year litigation duration before settlement suggests PureWick is willing to sustain costly proceedings to protect its market position.
Delaware remains the default venue for medical device patent disputes
Filing in Delaware District Court is a deliberate strategic choice — it is a plaintiff-friendly, experienced patent jurisdiction with predictable claim construction practice. Defendants in this venue face well-developed case management timelines and limited venue transfer options. Medical device companies should ensure their IP counsel has Delaware-specific litigation experience before any enforcement notice arrives.
PureWick v Sage — key questions answered
PureWick asserted two patents: US10226376B2 (application US15/611587) and US10390989B2 (application US15/260103). Both patents cover female external catheter (FEC) technology. The accused products were Sage’s PrimaFit and PrimaFit 2.0 female external catheters.
The case was dismissed with prejudice on 27 February 2024 pursuant to a confidential settlement agreement. The dismissal was entered under Fed. R. Civ. P. 41. The court retained jurisdiction to enforce the dismissal order. Each party agreed to bear its own costs, fees, and expenses, and both parties waived rights to seek attorney’s fees under 35 U.S.C. § 285.
A dismissal with prejudice is a final adjudication on the merits. PureWick is permanently barred from bringing the same infringement claims against Sage Products based on US10226376B2 and US10390989B2 for the accused PrimaFit products. However, PureWick could potentially assert future patents or different claims if new infringing products were introduced.
The retention of jurisdiction signals that the underlying settlement agreement contains ongoing obligations binding on one or both parties — such as licence royalties, product modification requirements, or milestone commitments. Retained jurisdiction allows either party to return to court to enforce those terms without filing a new action. It is a standard feature of patent settlements that are more than a simple walk-away.
PureWick has demonstrated a willingness to enforce its FEC patents through multi-year litigation. Companies developing non-invasive urinary management devices for female patients — particularly those using wicking, fluid-channelling, or body-conforming designs — should conduct freedom-to-operate analysis against US10226376B2 and US10390989B2, and monitor PureWick’s continuation filings for extended claim coverage.
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