DCT
2:20-cv-08000
Sage Products LLC v. Becton Dickinson Co
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Sage Products, LLC (Delaware)
- Defendant: Becton, Dickinson and Company (New Jersey)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 2:20-cv-08000, D.N.J., 06/30/2020
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant is a New Jersey corporation that resides in the district and maintains a regular and established place of business there.
- Core Dispute: Plaintiff alleges that Defendant’s ChloraPrep brand pre-operative skin preparation products infringe two patents related to sterilized antiseptic applicators and methods of their use.
- Technical Context: The technology concerns single-use applicators containing a sterilized antiseptic solution, primarily chlorhexidine gluconate (CHG), used in healthcare settings to disinfect a patient's skin before surgical procedures to prevent infection.
- Key Procedural History: The complaint notes that FDA labeling guidelines issued in November 2013 created an industry focus on providing fully sterile antiseptic products. The '067 Patent is a continuation of the application that resulted in the '642 Patent, indicating they share a common specification and priority claim.
Case Timeline
| Date | Event |
|---|---|
| 2015-11-25 | Priority Date for ’642 and ’067 Patents |
| 2016-11-23 | Application date for parent of ’642 and ’067 Patents |
| Early April 2019 | Defendant receives FDA approval for Accused Products |
| 2019-04-30 | Defendant issues press release for Accused Products |
| 2019-09-03 | U.S. Patent No. 10,398,642 issues |
| 2020-06-23 | U.S. Patent No. 10,688,067 issues |
| 2020-06-30 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,398,642 - "Sterilized Chlorhexidine Article and Method of Sterilizing a Chlorhexidine Article," Issued September 3, 2019
The Invention Explained
- Problem Addressed: The patent’s background section identifies the challenge of preventing healthcare-associated infections (HAI's) and notes the difficulty in developing a fully sterilized chlorhexidine article for topical disinfection, as traditional sterilization methods could degrade the active ingredients (’642 Patent, col. 1:16-44, col. 21:10-17).
- The Patented Solution: The invention is a complete, pre-packaged, sterilized product for topical disinfection. It consists of an applicator (e.g., a sponge) and a sealed internal "receptacle" (e.g., an ampule) that contains a sterilized chlorhexidine gluconate (CHG) and alcohol solution. The user breaks the receptacle to release the solution, impregnating the applicator just before use (’642 Patent, Abstract; col. 27:26-39). The patent also describes a method of sterilization, which involves cooling the product to freeze the solution before irradiating it, a process intended to prevent the degradation of CHG while achieving a high sterility assurance level (’642 Patent, col. 19:12-28).
- Technical Importance: This approach provides a terminally sterilized, ready-to-use antiseptic product, addressing the clinical need for products with a validated Sterility Assurance Level (SAL) to minimize the risk of contaminating a surgical site with a non-sterile applicator or solution (’642 Patent, col. 16:38-45).
Key Claims at a Glance
- The complaint asserts independent claims 1 (product) and 12 (method of use) (Compl. ¶33).
- Independent Claim 1: A sterilized chlorhexidine product comprising:
- a sterilized chlorhexidine gluconate composition comprising chlorhexidine gluconate and alcohol;
- an applicator for facilitating application of the composition; and
- a receptacle containing the composition, which can be compromised to impregnate the applicator.
- Independent Claim 12: A method of using a sterilized chlorhexidine article by:
- providing the article (which includes the composition, applicator, and receptacle);
- compromising the receptacle to impregnate the applicator; and
- applying the composition to a patient's skin.
- The complaint does not explicitly reserve the right to assert dependent claims but makes allegations regarding "claims of the 642 patent including at least claims 1 and 12" (Compl. ¶33).
U.S. Patent No. 10,688,067 - "Sterilized Chlorhexidine Article and Method of Sterilizing a Chlorhexidine Article," Issued June 23, 2020
The Invention Explained
- Problem Addressed: As a continuation, the '067 Patent addresses the same technical problem as the '642 Patent: the need for a reliable, terminally sterilized topical antiseptic product to prevent HAI's (’067 Patent, col. 1:16-44).
- The Patented Solution: The solution is structurally identical to that described in the ’642 Patent, involving a sterilized applicator and a sealed antiseptic solution that is released upon activation. The key distinction in the asserted claims is the use of the term "barrier" instead of "receptacle" to describe the element containing the antiseptic solution (’067 Patent, Abstract; col. 27:8-21). The method of sterilization via cooling and irradiation is also disclosed (’067 Patent, col. 19:12-28).
- Technical Importance: This patent provides an alternative claim scope for the same core technology, potentially covering embodiments that might not be read onto the term "receptacle," thereby broadening the proprietary protection for the invention.
Key Claims at a Glance
- The complaint asserts independent claims 1 (product) and 12 (method of use) (Compl. ¶60).
- Independent Claim 1: A sterilized chlorhexidine product comprising:
- a sterilized chlorhexidine gluconate composition comprising chlorhexidine gluconate and alcohol;
- an applicator for facilitating application of the composition; and
- a barrier configured to be compromised to impregnate the applicator with the composition.
- Independent Claim 12: A method of using a sterilized chlorhexidine article by:
- providing the article (which includes the composition, applicator, and barrier);
- compromising the barrier to impregnate the applicator; and
- applying the composition to a patient's skin using the applicator.
- The complaint makes allegations regarding "claims of the 067 patent including at least claims 1 and 12" (Compl. ¶60).
III. The Accused Instrumentality
Product Identification
- The accused products are various versions of Defendant’s "ChloraPrep Patient Preoperative Skin Preparation with Sterile Solution," including the 1 mL, 3 mL, 10.5 mL, and 26 mL applicators, collectively referred to as the "Accused Sterile ChloraPrep Products" (Compl. ¶18).
Functionality and Market Context
- The complaint alleges the accused products are single-use applicators containing a sterile solution of 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol (Compl. ¶27). The complaint describes that users "pinch the wings on the applicator to compromise an ampule within the applicator containing the sterilized antiseptic solution," which then "impregnates the applicator" for application to a patient's skin (Compl. ¶28, 38). The complaint highlights Defendant's marketing of the products as "fully sterile," with an "All-New Sterility Assurance Level of 10⁻⁶" (Compl. ¶23). Figure 4 in the complaint is an image of the accused product's label, which explicitly states "Sterile Solution" and "Applicator is sterile if package is intact" (Compl. p. 8).
IV. Analysis of Infringement Allegations
'642 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a sterilized chlorhexidine gluconate composition...comprising chlorhexidine gluconate and alcohol | The accused products contain a "sterile solution" of "2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol." | ¶¶27, 36, 39 | col. 28:2-3 |
| an applicator for facilitating application of the sterilized chlorhexidine composition | The accused products include a "sterile applicator" with a sponge tip used to apply the antiseptic solution to a patient's skin. | ¶¶35, 37 | col. 9:6-8 |
| a receptacle containing the sterilized chlorhexidine gluconate composition to provide the...composition to impregnate the applicator when the receptacle is compromised | The accused products include an "ampule containing sterilized CHG" which, when compromised by pinching wings, releases the antiseptic to impregnate the applicator's sponge. Figure 6 shows the wings being pinched to release the fluid. | ¶¶38, 43 | col. 9:32-37 |
'067 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a sterilized chlorhexidine gluconate composition...comprising chlorhexidine gluconate and alcohol | The accused products contain a "sterile solution" of "2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol." | ¶¶27, 62 | col. 27:14-15 |
| an applicator for facilitating application of the sterilized chlorhexidine composition | The accused products include a "sterile applicator" with a sponge tip used to apply the antiseptic. | ¶62 | col. 27:12-13 |
| a barrier configured to be compromised to impregnate the applicator with the sterilized chlorhexidine gluconate composition | The accused products include an ampule that is compromised (broken) by pinching wings, which serves as a barrier that, once broken, allows the solution to impregnate the applicator. | ¶¶38, 62 | col. 9:43-46 |
- Identified Points of Contention:
- Scope Questions: A primary question may be whether the accused product's internal glass "ampule" constitutes a "receptacle" as required by the ’642 Patent and a "barrier" as required by the ’067 Patent. A defendant could argue that the terms, in the context of the specification, imply a structure distinct from the ampule used in its product.
- Technical Questions: While the complaint alleges the accused products are "fully sterile," a key question for the court will be what evidence confirms this. The complaint's citation to Defendant's own advertisement of a "Sterility Assurance Level of 10⁻⁶" (Compl. ¶23) suggests that Defendant's own data may support Plaintiff's infringement theory on the "sterilized" limitation, which is a core feature of the patents. Figure 3 in the complaint depicts the product being applied to a patient, which is direct evidence of the use alleged to infringe the method claims (Compl. ¶44).
V. Key Claim Terms for Construction
The Term: "receptacle" (’642 Patent)
- Context and Importance: This term's definition is central to infringement of the ’642 Patent. The case may turn on whether the accused product's frangible glass ampule, which contains the CHG solution, falls within the scope of "receptacle."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the applicator as potentially comprising "a receptacle for receiving the antiseptic composition" ('642 Patent, col. 9:32-33). This general language could be argued to encompass any container, including the accused ampule.
- Evidence for a Narrower Interpretation: The use of "for receiving" could be argued to imply a component that is filled just prior to use, rather than a pre-filled, sealed ampule. A defendant may argue the term implies a refillable or separate component from the applicator body itself.
The Term: "barrier" (’067 Patent)
- Context and Importance: This term appears in the ’067 Patent in place of "receptacle," suggesting a deliberate attempt to claim a different scope. Practitioners may focus on this term because its construction will determine if the ’067 Patent successfully covers embodiments that the ’642 Patent might not.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The common meaning of "barrier" is anything that separates or obstructs. The glass wall of the ampule acts as a barrier separating the liquid from the applicator sponge until it is broken.
- Evidence for a Narrower Interpretation: The specification states that "a barrier may be positioned between the applicator and the receptacle" (’067 Patent, col. 9:43-44, emphasis added). A defendant could argue this requires three separate components (applicator, receptacle, and a barrier between them), whereas the accused product's ampule is a single component that is both the container and the barrier.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant’s product labels and instructions direct customers on how to perform the patented methods, such as compromising the ampule and applying the solution (Compl. ¶¶46, 66). It further alleges contributory infringement, asserting the accused products are especially adapted for infringing use and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶¶51, 71).
- Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the patents "at least as early as Defendant's receipt of this Complaint" (Compl. ¶¶48, 68). The claim is based on continued infringement after receiving notice via the lawsuit.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "receptacle" from the '642 patent and the arguably broader term "barrier" from the '067 patent be construed to read on the internal, frangible glass ampule used in Defendant’s ChloraPrep applicators? The outcome of this claim construction battle will be critical for infringement.
- A key evidentiary question will be one of technical proof: what evidence will substantiate that the accused products meet the "sterilized" limitation and achieve the specific "Sterility Assurance Level" (SAL) of 10⁻⁶ as advertised by Defendant? While the complaint makes a strong allegation based on Defendant's own marketing, the technical details of the sterilization process used for the accused products will be a central focus of discovery.