PureWick Lawsuit: Patent Fight, $28M Verdict, and PrimaFit 2.0

The PureWick lawsuit was a patent-infringement fight between PureWick Corporation, a Becton, Dickinson subsidiary, and Sage Products, a Stryker subsidiary, over competing external urinary catheters. A Delaware jury sided with PureWick in April 2022 and awarded more than $28 million, finding that Sage’s PrimaFit and PrimoFit catheters infringed three PureWick patents and that two of the infringements were willful. A second suit followed over an updated Sage product, and both cases ended in confidential settlements in 2024.

Who Sued Whom and Over What

PureWick filed the first case on August 12, 2019, in the U.S. District Court for the District of Delaware, before Judge Maryellen Noreika.1CourtListener. PureWick Corporation v. Sage Products, LLC The complaint targeted two Sage products that had entered the external catheter market after PureWick’s commercial success: the PrimaFit female external catheter and the PrimoFit male external catheter.

PureWick asserted four patents: U.S. Patent Nos. 10,226,376; 10,390,989; 10,376,407; and 8,287,508.2GovInfo. PureWick Corp. v. Sage Products, LLC, No. 19-1508-MN3Quinn Emanuel. Steven Cherny4Quinn Emanuel. Jason C. Williams

The $28 Million Jury Verdict

The case went to a five-day jury trial from March 28 through April 1, 2022. The jury found that Sage’s PrimaFit infringed the ‘376 and ‘989 patents and that Sage’s PrimoFit infringed the ‘407 patent. It also found that the PrimaFit infringements were willful, meaning Sage had knowingly copied PureWick’s protected technology.2GovInfo. PureWick Corp. v. Sage Products, LLC, No. 19-1508-MN

Damages broke down into two pieces. The jury awarded PureWick $26,215,545 in lost profits on Sage’s PrimaFit sales and $1,799,193 as a reasonable royalty at a 6.5% rate on PrimoFit sales, for a combined total over $28 million.5Quinn Emanuel. Jury Awards PureWick Corp. $28 Million in Patent Infringement Case Against Sage Products6Law360. PureWick Wins $28M Jury Verdict in Catheter Patent Suit The jury also rejected all of Sage’s invalidity defenses.

Sage had argued the PureWick patents were anticipated or obvious in light of prior art, relying on a reference called Van Den Heuvel for the ‘376 and ‘989 patents and one called Suzuki for the ‘407 patent. Sage’s own expert conceded on cross-examination that Van Den Heuvel lacked a key element required by the patent claims. PureWick’s expert testified that adding a wicking material to the Suzuki design would have defeated its purpose. The jury was also entitled to weigh secondary considerations of nonobviousness, including long-felt need in the market, the failure of others to solve the problem, and Sage’s copying of the PureWick design.2GovInfo. PureWick Corp. v. Sage Products, LLC, No. 19-1508-MN

What Happened After the Verdict

On March 31, 2023, Judge Noreika denied Sage’s motions for judgment as a matter of law and for a new trial, finding substantial evidence supported the jury on both infringement and validity. The court granted PureWick supplemental damages, pre- and post-judgment interest, and an ongoing 6.5% royalty on continued PrimoFit sales.7Bloomberg Law. Becton Dickinson Unit Wins Royalties on PrimoFit Men’s Catheters

Sage appealed to the U.S. Court of Appeals for the Federal Circuit. One appeal (No. 23-1868) was dismissed in June 2023 for lack of jurisdiction after PureWick moved to terminate it and the court denied Sage’s request for a stay.8Justia. PureWick Corporation v. Sage Products, LLC, No. 23-1868 A second appeal (No. 24-1184) was voluntarily dismissed on March 1, 2024, on mutual agreement of the parties, with each side bearing its own costs. No merits ruling issued on appeal, so the trial court’s findings of infringement and validity stood, though the dismissal created no binding appellate precedent.9PatSnap. Sage Products v. PureWick Voluntary Dismissal in Medical Device Urinary Patent Dispute The voluntary dismissal strongly suggests the parties reached a settlement, though no terms were made public.

The Second Lawsuit Over PrimaFit 2.0

While the first trial was still ahead, PureWick filed a second suit in the same court on January 26, 2022, targeting Sage’s updated PrimaFit 2.0. Case No. 1:22-cv-00102 reasserted two of the same patents, the ‘376 and ‘989.10Bloomberg Law. Becton Dickinson’s PureWick Sues Stryker’s Sage Over Catheter Sage had launched the PrimaFit 2.0 in 2021, and PureWick alleged the newer version also infringed.11Bloomberg Law. Becton Dickinson’s PureWick Wins $28 Million From Stryker’s Sage

Two pretrial rulings shaped the case. In a claim construction order dated March 30, 2023, Judge Noreika construed the disputed term “fluid reservoir” to mean simply “a space where urine can collect,” rejecting Sage’s argument that the patent required the reservoir to actively hold urine.12U.S. District Court for the District of Delaware. PureWick Corporation v. Sage Products, LLC, No. 22-102 (MN) Memorandum Order The next day, in a separate opinion, the court ruled that collateral estoppel applied to Sage’s anticipation and obviousness defenses, barring Sage from re-litigating those issues even with different prior art. The court did let Sage pursue defenses under Section 112 of the patent statute, such as indefiniteness and lack of written description, because those had not been litigated in the first case.13Justia. PureWick Corporation v. Sage Products, LLC, Memorandum Opinion

The second case never reached trial. On February 27, 2024, the parties filed a joint stipulation of dismissal with prejudice, ending the litigation permanently and preventing PureWick from reasserting these specific claims against Sage. Settlement terms are confidential. The court retained jurisdiction to enforce the agreement, a provision that typically signals ongoing obligations such as licensing, royalty payments, or product-design commitments.14PatSnap. PureWick v. Sage Products Female External Catheter Patent Dispute

Where Things Stand Now

Both companies still sell external catheters. Stryker’s Sage PrimaFit product page remains active as of mid-2026, with the PrimaFit 2.0 available for ordering.15Stryker. Sage PrimaFit Whether Sage obtained a license under the PureWick patents or redesigned the product to avoid infringement is not disclosed in the public record. BD has continued to build out the PureWick line since the litigation, and the three patents that survived trial remain valid and enforceable.