Catilina Nominees Proprietary Ltd v. Stericycle Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Catilina Nominees Proprietary Ltd. (Australia) and Daniels Sharpsmart, Inc. (Delaware)
  • Defendant: Stericycle, Inc. (Delaware)
  • Plaintiff’s Counsel: Nixon Peabody LLP
• Case Identification: 1:15-cv-10734, N.D. Ill., 04/09/2021
• Venue Allegations: Venue is alleged to be proper in the Northern District of Illinois as Defendant Stericycle is a resident of the district with its principal place of business located there.
• Core Dispute: Plaintiffs allege that Defendant’s reusable medical sharps containers infringe a patent related to safety mechanisms that prevent hand access to the container's contents.
• Technical Context: The technology concerns safety features for containers used to dispose of hazardous medical waste, such as needles and syringes, a critical component of infection control in healthcare settings.
• Key Procedural History: The complaint alleges that Defendant gained knowledge of the patent-in-suit during business discussions in 2011 and subsequently used Plaintiffs' commercial product as a "predicate device" in a 2013 FDA 510(k) submission. The asserted claims of the patent-in-suit (claims 22-24) were the subject of an Inter Partes Review (IPR2017-00519), which concluded with a certificate issued on May 30, 2019, confirming the patentability of claims 22-24 and cancelling claim 21. The survival of the asserted claims through an IPR proceeding may be a significant factor in the litigation.

Case Timeline

Date	Event
1998-05-15	’465 Patent Priority Date
2001-06-26	’465 Patent Issue Date
2011	Defendant allegedly receives information on ’465 Patent during business discussions
2011	First accused product ("PGII Lid Version 1") allegedly manufactured
2013-12-27	Defendant receives FDA 510(k) approval for accused product
2014-07	Approximate date of design change to accused product ("PGII Lid Version 2")
2019-05-30	U.S. Patent and Trademark Office issues Inter Partes Review Certificate for the ’465 Patent
2021-04-09	Complaint Filing Date

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

U.S. Patent No. 6,250,465 - “Sharps Container”

The Invention Explained

• Problem Addressed: The patent describes a persistent challenge in the design of sharps containers: the difficulty of providing a large, convenient access opening for disposal while simultaneously ensuring that users are prevented from reaching their hands inside and contacting the hazardous contents (’465 Patent, col. 2:33-39).
• The Patented Solution: The invention is a container featuring a receptacle, a hinged lid, and a pivotal "disposing means" or tray mounted at the opening (’465 Patent, Abstract). When the lid is open, a user places sharps onto the tray. As the tray pivots to drop the waste into the receptacle, its front edge moves toward the opened lid, which reduces or eliminates the access gap. This mechanism, in conjunction with guards, is designed to block hand access throughout the disposal process (’465 Patent, col. 2:4-31).
• Technical Importance: This design aims to enhance the safety of healthcare workers by providing a high level of security against accidental needlesticks and contact with contaminated materials, a significant source of occupational injury and infection (’465 Patent, col. 2:20-28).

Key Claims at a Glance

• The complaint asserts infringement of claims 22, 23, and 24 (’465 Patent, ¶63). Claim 23 is an independent claim.
• The essential elements of independent claim 23 include:
  • A receptacle for storing medical sharps with an opening.
  • A hinged, manually movable lid for closing the opening.
  • A "disposing tray" pivotally mounted at the opening.
  • An operative association between the lid and tray, such that opening the lid moves the tray into an accessible, operative condition.
  • The tray, in the lid's opened position, "impedes hand access into the receptacle."
  • The tray is pivotally movable to dispose of waste from its rear portion.
  • As the tray pivots, its front portion moves toward the lid to "continue to impede hand access."
• Claims 22 and 24 are dependent claims. It is noted that claim 22 depends from claim 21, which was cancelled during Inter Partes Review, raising a question about the viability of asserting claim 22.

III. The Accused Instrumentality

Product Identification

• The Stericycle Sharps Management Service Reusable Sharps Container, also referred to as the "PGII Horizontal Lid Sharps Container" or "Stericycle Products" (Compl. ¶1, ¶22).

Functionality and Market Context

• The accused product is a reusable container for medical sharps, offered as part of a sharps management service (Compl. ¶22). The complaint alleges the existence of at least two versions: "PGII Lid Version 1," used from approximately 2011 to 2014, and "PGII Lid Version 2," used from July 2014 onward (Compl. ¶25).
• Version 2 is alleged to have an "increased 'gap' between the tray/inner door and the outer door" compared to Version 1 (Compl. ¶27). The complaint highlights a key admission from Defendant’s counsel during a 2019 status hearing regarding Version 2: “This is the accused lid, and our position really is that you can fit your hand in here” (Compl. ¶52). This admission is supported by a photographic image provided in the complaint showing a hand reaching into the container. The photograph, reproduced in the complaint, depicts a hand inserted between the lid and tray of the accused container (Compl. ¶53).

IV. Analysis of Infringement Allegations

U.S. Patent No. 6,250,465 Infringement Allegations

Claim Element (from Independent Claim 23)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a receptacle for receiving and storing medical sharps and waste, the receptacle having an opening	The accused product is a reusable sharps disposal container with either a 2-gallon or 4-gallon receptacle.	¶22	col. 10:60-65
a lid for closing the opening hingedly connected to the receptacle and manually movable between opened and closed positions	The accused product has a "PGII Horizontal Lid" which is movable.	¶24	col. 15:1-4
a disposing tray for medical sharps and waste pivotally mounted at the receptacle opening	The accused product has a "tray, or 'inner door,'" and a "counterbalanced lid design," suggesting a pivoting mechanism.	¶20, ¶25	col. 15:5-17
the lid and the tray are operatively associated so that the movement of the lid from its closed to its opened position moves the tray from an inoperative condition to an operative condition...	The complaint does not provide sufficient detail for analysis of this element.		col. 15:31-43
in the opened position of the lid the disposing tray impedes hand access into the receptacle through said opening	The complaint alleges Defendant's marketing materials claim the product "prevents access to the contents of the container," but also alleges Defendant has admitted that a person can fit their hand into the device.	¶35, ¶52, ¶53	col. 15:37-43
the disposing tray being pivotally movable such that the medical sharps and waste are disposable therefrom into the receptacle from a rear portion of the disposing tray	The accused product's "counterbalanced lid design" allegedly allows for disposal of sharps waste from the tray into the container.	¶20	col. 15:47-52
whereby said front portion of the tray moves towards said lid to continue to impede hand access into the receptacle	The complaint alleges Defendant's product fails to impede hand access, particularly the "Version 2" product, which allegedly has an increased gap that facilitates sharps access.	¶27, ¶52-54	col. 15:47-52

• Identified Points of Contention:
  • Scope Questions: The central dispute appears to be over the meaning of "impedes hand access." The case may turn on whether this term requires absolute prevention of access or merely makes access more difficult. The complaint highlights Defendant's conflicting positions, contrasting its marketing claims of "preventing access" with its litigation stance that a hand can fit inside (Compl. ¶35, ¶52).
  • Technical Questions: A key factual question is whether the accused product, particularly the "Version 2" with its allegedly wider gap, meets the "impedes hand access" limitation. The complaint puts Defendant's 2019 in-court demonstration and subsequent photographic evidence at the center of its argument that the product does not impede access (Compl. ¶52-53).

V. Key Claim Terms for Construction

• The Term: "impedes hand access"
• Context and Importance: This term is the lynchpin of the infringement dispute. Plaintiffs allege Defendant's product fails this limitation, citing Defendant's own admission and photographic evidence (Compl. ¶52-53). Defendant's position appears to be that its product is non-infringing because access is possible. Therefore, the construction of "impedes"—whether it means to block completely or merely to hinder—will be critical.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (i.e., hindering but not necessarily preventing): The claim itself uses the word "impedes," which is arguably less absolute than "prevents." A party could argue that if the patentee intended to require complete prevention, the word "prevent" would have been used in the claim language itself.
  • Evidence for a Narrower Interpretation (i.e., completely or almost completely blocking): The patent specification repeatedly uses stronger, more absolute language. The abstract states the invention "prevents hand access to within the container," and the Disclosure of the Invention section states an object is to "prevent hand access into the receptacle for all positions of the disposing means" (’465 Patent, Abstract; col. 2:62-64). This language may suggest that "impedes" should be construed to mean something close to complete prevention, creating a high bar for proving infringement.

VI. Other Allegations

• Indirect Infringement: The complaint does not plead specific facts to support distinct counts of induced or contributory infringement, focusing its allegations on direct infringement through making, using, and selling the accused containers (Compl. ¶63).
• Willful Infringement: Willfulness is alleged based on Defendant’s purported pre-suit knowledge of the ’465 Patent. The complaint alleges this knowledge stems from (i) confidential business discussions in 2011 where the patent was identified; (ii) Defendant’s use of Plaintiffs' patented container as a predicate device in its 2013 FDA 510(k) submission; and (iii) the patent marking on Plaintiffs' own commercial products (Compl. ¶65).

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

• A core issue will be one of definitional scope: How should the claim term "impedes hand access" be construed? Will the court define it as requiring near-total prevention, as suggested by the patent's specification and Defendant's alleged marketing, or as a lower standard of mere hindrance, which could favor Plaintiffs' infringement case in light of Defendant's admissions?
• A key evidentiary question will be one of factual infringement: Assuming a construction of "impedes hand access," does the accused Stericycle container—particularly the "Version 2" with its allegedly larger access gap—actually meet that limitation? The outcome may depend heavily on technical evidence and expert testimony comparing the product's operation to the claim requirements.
• The case also presents a question of infringement over time: Does the alleged 2014 design change from "Version 1" to "Version 2" create a substantively different product for infringement purposes? The court may need to consider whether both versions infringe, or only one, which would have significant implications for the damages period.