Facet Tech LLC v. LifeScan Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Facet Technologies, LLC (Delaware)
  • Defendant: LifeScan, Inc. (California)
  • Plaintiff’s Counsel: Witkow | Baskin; Latham & Watkins LLP; Diamond McCarthy LLP
• Case Identification: 2:22-cv-01717, C.D. Cal., 11/22/2022
• Venue Allegations: Venue is alleged to be proper in the Central District of California because Defendant LifeScan, a California corporation, maintains a registered agent in the district and has allegedly committed acts of patent infringement within the district.
• Core Dispute: Plaintiff alleges that Defendant’s OneTouch Delica Plus lancets infringe a patent related to protective sterility caps that feature a dual-receptacle design for safely covering both new and used lancet tips.
• Technical Context: The technology concerns disposable lancets used for capillary blood sampling, a common procedure for individuals managing diabetes, with a focus on improving user safety and ease of handling during use and disposal.
• Key Procedural History: The complaint details a complex prior business relationship where Plaintiff manufactured patented lancets for Defendant to sell under the "Delica" brand. This relationship allegedly involved a temporary patent license granted to Defendant as part of a loan agreement, which Plaintiff claims was terminated upon repayment of the loan. The patent owner has also filed a disclaimer for claims 9 and 10 of the patent-in-suit.

Case Timeline

Date	Event
2008-07-29	'635 Patent Priority Date
2014-09-23	'635 Patent Issue Date
Early 2019	Alleged launch of Accused "Delica Plus" Products
2022-01-19	Plaintiff alleges termination of Defendant's temporary patent license
2022-11-22	First Amended Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,840,635 - "Lancets with Improved Coupling Features and Sterility Caps"

• Patent Identification: U.S. Patent No. 8,840,635, "Lancets with Improved Coupling Features and Sterility Caps", issued September 23, 2014.

The Invention Explained

• Problem Addressed: The patent background describes the common practice of using disposable lancets for blood sampling, which involves removing a sterile cap before use. A technical challenge arises in safely handling and disposing of the used lancet to prevent accidental needle sticks, as the sharp tip is exposed after use. (’635 Patent, col. 1:46-52).
• The Patented Solution: The invention is a protective sterility cap with an integrated, dual-function design. It comprises a "primary sheath" to cover the tip of a new, unused lancet and a separate "secondary sheath" designed specifically to receive and cover the sharp tip of the same lancet after use. These two sheaths are connected by a "gripping handle portion", which improves user handling during both decapping and safe recapping for disposal. (’635 Patent, col. 2:21-35, Abstract).
• Technical Importance: This design aims to enhance safety and usability for patients, including those with limited dexterity or vision, by providing an intuitive, all-in-one component for both sterile deployment and secure disposal of a sharp medical instrument. (’635 Patent, col. 6:62-67).

Key Claims at a Glance

• The complaint asserts independent claims 1 and 14, as well as dependent claims 6, 8, and 18.
• Independent Claim 1 recites:
  • A protective sterility cap for a lancet,
  • comprising a primary sheath for initial embedment of a sharp lancing tip of an unused lancet therein,
  • a secondary sheath for receiving the sharp lancing tip of a used lancet,
  • and a gripping handle portion extending between the primary sheath and the secondary sheath,
  • with the primary sheath attached at a first end of the gripping handle portion and the secondary sheath attached at a second end of the gripping handle portion when the protective sterility cap is removed from the lancet.
• Independent Claim 14 recites a combination of the protective sterility cap and a lancet, adding a dimensional requirement:
  • A protective sterility cap for a lancet... in combination with a lancet having a lancet body defining a lancet thickness, and a sharp lancet tip initially embedded in the primary sheath,
  • wherein the gripping handle portion defines a lateral span of at least 1.5 times the lancet thickness.
• The complaint notes these are preliminary allegations and does not foreclose asserting additional claims. (Compl. ¶60).

III. The Accused Instrumentality

Product Identification

• The accused products are LifeScan’s "OneTouch Delica Plus lancets." (Compl. ¶¶ 3, 40).

Functionality and Market Context

• The complaint alleges the OneTouch Delica Plus lancets are disposable sharps used for blood sampling. They are sold with a protective cap that, according to the allegations, mirrors the patented design. This cap is alleged to have a primary sheath that covers the sterile lancet tip and, at the opposite end of a handle, a secondary receptacle into which the used lancet tip is inserted for safe disposal. (Compl. ¶¶ 43, 63-64). The complaint provides an image from LifeScan’s marketing materials that depicts the process of inserting the used lancet tip into the secondary sheath. (Compl. ¶64). The complaint frames the accused product as a "mimicked" version of Plaintiff's original "Delica" product, intended to "capitalize on the success and popularity" of that product line, which allegedly generated over $90 million in sales for LifeScan in 2018. (Compl. ¶¶ 30, 36).

IV. Analysis of Infringement Allegations

'635 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A protective sterility cap for a lancet	The Accused Products are lancets that include a removable protective sterility cap. The complaint provides an image identifying the "Sterility Cap" component of the accused lancet.	¶61	col. 2:21-23
comprising a primary sheath for initial embedment of a sharp lancing tip of an unused lancet therein	The accused cap allegedly includes a "Primary Sheath" that covers the tip of the new lancet before use.	¶62	col. 6:1-4
a secondary sheath for receiving the sharp lancing tip of a used lancet	The accused cap allegedly has a "Secondary Sheath" at its opposite end for covering the used lancet tip. The complaint references LifeScan’s instructions, which allegedly direct users to "push the lancet tip into the flat side of the disk" for disposal.	¶¶63-64	col. 6:35-38
and a gripping handle portion extending between the primary sheath and the secondary sheath	A "Gripping Handle" is alleged to connect the primary and secondary sheaths of the accused cap, as depicted in an annotated image.	¶65	col. 6:50-54
with the primary sheath attached at a first end of the gripping handle portion and the secondary sheath attached at a second end... when the protective sterility cap is removed from the lancet	The complaint alleges that the accused cap is a single, integrated piece where the handle connects the two sheaths, matching the claimed structure. An annotated image shows the alleged primary and secondary sheaths at opposite ends of the handle.	¶¶65, 71; p. 20	col. 8:38-44

• Identified Points of Contention:
  • Scope Questions: A central question may be the proper construction of "gripping handle portion." The patent discloses various embodiments, including forked and solid-panel handles. (’635 Patent, Figs. 5D, 7). The litigation may explore whether the term is limited to specific configurations or dimensions described in the specification, or if it broadly covers any structure connecting the two sheaths.
  • Technical Questions: The primary technical question is whether the feature on the accused cap identified as the "secondary sheath" performs the claimed function of "receiving the sharp lancing tip of a used lancet." While the complaint presents strong evidence from LifeScan’s own instructions (Compl. ¶64), a potential dispute could arise over whether this is the intended, primary function of that structure or an incidental capability.

V. Key Claim Terms for Construction

• The Term: "secondary sheath"

• Context and Importance: This term is critical because it describes the core safety and disposal feature of the invention. The infringement case hinges on whether the accused product's cap includes a structure that meets the definition of a "secondary sheath" for receiving a used lancet tip.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent specification describes this element functionally as a "secondary shroud or sheath portion 514 for receiving and protecting the sharp tip of a lancet in its final or used state." (’635 Patent, col. 6:4-6). This language suggests the defining characteristic is the function of receiving and protecting the used tip.
  • Evidence for a Narrower Interpretation: The specification also describes a specific embodiment as a "cup having an outer rim and a hollow interior chamber" with a depth sufficient to prevent the lancet tip from extending through. (’635 Patent, col. 6:36-49). A party could argue this language limits the term to a "cup-like" structure with specific safety-oriented dimensions.

• The Term: "gripping handle portion"

• Context and Importance: This term defines the element connecting the two functional sheaths and is presented as a key improvement for user handling. Its construction will determine if the connector on the accused device, which the complaint depicts as visually similar to the patented design (Compl. p. 14), satisfies this limitation.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent uses various general terms like "handle or extension arm portion" and describes its function as "assisting in removal of the cap." (’635 Patent, col. 6:6-10). This may support a construction focused on the function of providing a grip, regardless of specific form.
  • Evidence for a Narrower Interpretation: The patent describes specific embodiments with a "forked or split configuration" and provides dimensional limitations, such as a "lateral or transverse span S" that is "at least about 1.5 times... the diameter or thickness of the lancet body." (’635 Patent, col. 6:50-59). A party may argue that these details narrow the scope of the term to structures of a similar form or relative size.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that LifeScan provides instructional materials, including a "Using your OneTouch® Delica® Plus lancing device" video and user manuals, that actively instruct end users to perform the claimed method of using the cap, specifically by directing them to insert the used lancet tip into the secondary sheath for safe disposal. (Compl. ¶¶ 76-77).
• Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge stemming from the parties' extensive history. The complaint alleges LifeScan was "well-acquainted with the Asserted Patent" because it previously sold the original patented product manufactured by Facet and held a temporary license to the '635 patent under a supply and security agreement. (Compl. ¶¶ 4, 34, 85). The complaint further alleges that infringement continued even after the lawsuit was filed. (Compl. ¶85).

VII. Analyst’s Conclusion: Key Questions for the Case

• A central issue will be the impact of the parties' prior commercial and licensing relationship. The allegations that LifeScan previously licensed the patent-in-suit and sold the original patented product before switching to a supplier of an allegedly "mimicked" device raise significant questions that will likely influence the analysis of willfulness and, potentially, infringement itself.
• A key legal question will be one of claim scope: can the term "secondary sheath", which is described in the patent with specific structural details like a "cup," be construed broadly enough to read on the accused product's corresponding feature, which LifeScan's own instructions allegedly identify for receiving the used lancet tip?
• The case may also turn on an evidentiary question of design intent versus function: does the evidence show that the accused cap was designed with distinct primary and secondary sheaths connected by a handle, as claimed, or can the defendant argue that it is a unitary structure where any "secondary sheath" function is merely incidental to its overall design? Evidence from LifeScan's own product documentation will be highly probative on this point.