Sage Products v. Becton Dickinson: Federal Circuit Affirms Chlorhexidine Patents Unpatentable
Sage Products, LLC lost its appeal at the Federal Circuit after Becton, Dickinson & Company successfully challenged three chlorhexidine article sterilization patents. The court affirmed unpatentability across all three patents in a proceeding spanning 760 days, leaving Sage with no enforceable IP barrier in this antiseptic product space.
Federal Circuit seals Becton Dickinson’s win over Sage’s chlorhexidine IP
Sage Products, LLC filed appeal no. 23-1604 at the Court of Appeals for the Federal Circuit on 17 March 2023, challenging a patentability determination that had invalidated three of its US patents — US10688067B2, US10188598B1, and US10398642B1 — all directed to sterilized chlorhexidine articles and sterilization methods. Becton, Dickinson & Company was the respondent, having successfully pursued invalidity or cancellation proceedings at the underlying tribunal.
On 15 April 2025, the Federal Circuit issued a terse but definitive order: ‘AFFIRMED.’ The affirmance upheld the finding of unpatentability across all three patents, meaning the PTAB’s cancellation or invalidity rulings are now final and binding. For Sage Products, this forecloses any further argument that these patents are valid and enforceable; for Becton Dickinson, it removes a patent barrier that had threatened its chlorhexidine product lines.
The 760-day duration from filing to decision is consistent with complex multi-patent Federal Circuit appeals involving patentability questions, where full briefing cycles and oral argument scheduling routinely extend timelines. The public record does not disclose whether any licensing discussions occurred in parallel. What drove the Federal Circuit’s agreement with the lower tribunal — whether prior art, written description deficiencies, or another ground — is not specified in the available disposition data, suggesting the full opinion warrants close review by practitioners in the antiseptic and medical device space.
Filing to Unpatentable in 760 days
760 days from filing to Federal Circuit decision — longer than the median PTAB appeal timeline
Federal Circuit affirms: what the unpatentability ruling means for both parties
Affirmance means the lower tribunal’s ruling is final
When the Federal Circuit issues an ‘AFFIRMED’ disposition, it has reviewed the record below and found no reversible legal error. The underlying determination of unpatentability — whether from PTAB inter partes review, post-grant review, or ex parte reexamination — now carries the full weight of finality. Sage Products cannot relitigate these patents’ validity in district court on the same grounds.
No reversible error foundSage Products loses all three chlorhexidine patents
The affirmance extinguishes Sage’s ability to assert US10688067B2, US10188598B1, and US10398642B1 against any party. With unpatentability confirmed at the Federal Circuit, these patents cannot be revived through continuation of the same appeal. Sage’s only remaining paths — en banc rehearing petition or Supreme Court certiorari — face extremely high thresholds and are statistically unlikely to succeed.
Three patents cancelledBecton Dickinson secures a clear competitive runway
Becton, Dickinson & Company’s appellate victory, represented by Quinn Emanuel Urquhart & Sullivan, confirms that the three challenged chlorhexidine patents pose no further legal risk to its product portfolio. The Federal Circuit affirmance raises the bar significantly for any future Sage patent assertion in this technology area, and competitors in the antiseptic segment can now operate with greater freedom in the sterilized chlorhexidine article space.
Freedom to operate confirmedSterilized chlorhexidine space opens for device manufacturers
Three cancelled patents covering sterilized chlorhexidine articles and sterilization methods represent a meaningful IP clearance event for the medical antiseptic and infection-prevention device sector. Companies developing chlorhexidine-impregnated products, sterile packaging, or related sterilization processes should note that these specific patent claims are no longer an enforcement risk — though related family members or divisionals held by Sage may still warrant FTO review.
IP barrier removedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Sage Products, LLC | Company | Medical antiseptic products company — holder of US10688067B2, US10188598B1, US10398642B1Search in Eureka ↗ |
| Defendant | Becton, Dickinson & Company | Company | Global medical technology company; successfully challenged Sage’s chlorhexidine sterilization patentsSearch in Eureka ↗ |
| Plaintiff counsel | Ben Mahon | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Deborah Laughton | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Robert Anthony Surrette | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Plaintiff counsel | Sandra A. Frantzen | Attorney | Counsel for Sage Products, LLCSearch in Eureka ↗ |
| Plaintiff law firm | McAndrews, Held & Malloy Ltd. | Law Firm | Representing Sage Products, LLCSearch in Eureka ↗ |
| Defendant counsel | John Yang | Attorney | Counsel for Becton, Dickinson & CompanySearch in Eureka ↗ |
| Defendant counsel | Matthew A. Traupman | Attorney | Counsel for Becton, Dickinson & CompanySearch in Eureka ↗ |
| Defendant counsel | Nicola R. Felice | Attorney | Counsel for Becton, Dickinson & CompanySearch in Eureka ↗ |
| Defendant counsel | Steven Cherny | Attorney | Counsel for Becton, Dickinson & CompanySearch in Eureka ↗ |
| Defendant counsel | William Adams | Attorney | Counsel for Becton, Dickinson & CompanySearch in Eureka ↗ |
| Defendant law firm | Quinn Emanuel Urquhart & Sullivan, LLP | Law Firm | Representing Becton, Dickinson & CompanySearch in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | Court of Appeals for the Federal CircuitSearch in Eureka ↗ |
Official order — verbatim text
The order’s language — ‘THIS CAUSE having been considered, it is ORDERED AND ADJUDGED: AFFIRMED’ — is the Federal Circuit’s standard form for an unqualified affirmance with no remand. The court applied the applicable standard of review to the unpatentability determination below and found no reversible error, whether legal or factual. For Sage Products, this language forecloses further appellate argument on these three patent assets at this court level; for Becton Dickinson, it is a final, unreserved endorsement of the invalidity positions it advanced.
US10688067B2, US10188598B1 & US10398642B1 — Sterilized Chlorhexidine Articles
The three patents at issue — US10688067B2 (application US16/557160), US10188598B1 (US15/360037), and US10398642B1 (US16/231034) — all relate to sterilized chlorhexidine articles and methods of sterilizing chlorhexidine-containing products. Chlorhexidine is a broad-spectrum antiseptic widely used in medical device coatings, surgical prep, and infection-prevention consumables. The patents’ application filing sequence suggests a family relationship, with Sage building layered claims across multiple filing dates to create overlapping protection in this product segment.
Strategically, these patents were positioned to protect Sage Products’ commercial position in the hospital infection-prevention market, where chlorhexidine-based products command significant margins. The Federal Circuit’s affirmance of unpatentability signals that the claimed innovations likely lacked sufficient differentiation from prior art — a recurring challenge in the antiseptic formulation space where the core chemistry is mature. For competitors and market entrants, the cancellation removes what had been a potentially significant enforcement risk across a broadly-defined product category.
Should you run an FTO against Sage Products’ chlorhexidine patent portfolio?
If your R&D or product team works on chlorhexidine-impregnated medical devices, antiseptic articles, sterilized packaging, or infection-prevention consumables, these three cancelled patents are no longer an enforcement risk. However, Sage Products may hold related family members, continuation applications, or divisional patents with narrower or differently-scoped claims that remain active. An FTO limited to these three patent numbers is insufficient — a full assignee portfolio search is required.
PatSnap Eureka’s FTO Search Agent can map Sage Products’ entire patent family around the chlorhexidine sterilization technology domain in minutes, flag active related applications, and identify claim elements that may still pose risk. For BD competitors or companies developing similar antiseptic products, running an Eureka FTO now — while prosecution records are current — is the lowest-cost way to validate freedom to commercialise in this space.
Run a freedom-to-operate analysis on US10688067B2 to assess your product’s exposure
Run FTO in Eureka →Federal Circuit PTAB affirmances in medical device & antiseptic patent disputes
Cases where the Federal Circuit affirmed PTAB unpatentability rulings in medical device and antiseptic technology — comparable procedural posture and IP stakes to Case 23-1604.
What this case signals for the medical antiseptic IP landscape
Three cancelled chlorhexidine patents at the Federal Circuit level reshapes enforcement risk for antiseptic device makers and potential entrants.
PTAB remains a powerful tool for clearing blocking patents in medical devices
Becton Dickinson’s success in cancelling three Sage patents — affirmed by the Federal Circuit — underscores that inter partes review or post-grant review remains a commercially efficient route for large device manufacturers facing blocking IP. Challengers with strong prior art arguments can achieve durable patent clearance even across multi-patent portfolios.
Competitors in chlorhexidine products should audit remaining Sage IP family
While these three patents are cancelled, Sage Products may hold continuation patents, divisionals, or related applications covering adjacent claims in the chlorhexidine sterilization space. Any company treating this affirmance as blanket clearance without an updated FTO search risks overlooking active related rights. A targeted family search is warranted now.
Sage v Becton — key questions answered
The Federal Circuit affirmed the unpatentability of all three Sage Products patents — US10688067B2, US10188598B1, and US10398642B1 — on 15 April 2025. The court found no reversible error in the underlying tribunal’s determination, making the cancellation of Sage’s chlorhexidine sterilization patents final.
Three patents covering sterilized chlorhexidine articles and sterilization methods were affirmed as unpatentable: US10688067B2 (application 16/557160), US10188598B1 (application 15/360037), and US10398642B1 (application 16/231034). All three relate to Sage’s chlorhexidine antiseptic product technology.
The affirmance confirms that Becton Dickinson faces no further enforcement risk from these three Sage patents. Becton Dickinson can proceed with its chlorhexidine-related products without exposure to infringement claims under US10688067B2, US10188598B1, or US10398642B1. The ruling is final at the Federal Circuit level.
Sage Products’ remaining options are limited to a petition for rehearing en banc before the full Federal Circuit, or a petition for certiorari to the US Supreme Court. Both paths face very high acceptance thresholds — the Supreme Court grants certiorari in fewer than 2% of petitions — making further reversal statistically unlikely.
Not necessarily. The cancellation of US10688067B2, US10188598B1, and US10398642B1 removes these specific claims from enforcement risk, but Sage Products may hold continuation patents, divisional applications, or related patents with overlapping or adjacent claims that remain active. A full FTO search of Sage’s patent portfolio is recommended before concluding the space is clear.
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