DCT
1:10-cv-06431
Hollister Inc v. Convatec Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Hollister Incorporated (Illinois)
- Defendant: ConvaTec Inc. (Delaware)
- Plaintiff’s Counsel: Nixon Peabody LLP
- Case Identification: 1:10-cv-06431, N.D. Ill., 10/07/2010
- Venue Allegations: Venue is alleged to be proper based on Defendant placing the accused products into the stream of commerce throughout the United States, including Illinois, and offering for sale or selling those products within the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s bowel management systems infringe a patent related to a rectal catheter system featuring a specialized retention balloon.
- Technical Context: The technology concerns indwelling medical devices for managing fecal incontinence, primarily for non-ambulatory or critically ill patients, to prevent skin complications and facilitate care.
- Key Procedural History: The asserted patent is a continuation of an earlier application and is subject to a terminal disclaimer, which may limit the patent's enforceable term to that of a related, earlier-expiring patent.
Case Timeline
| Date | Event |
|---|---|
| 2002-08-21 | Priority Date for U.S. Patent No. 7,722,583 |
| 2010-05-25 | Issue Date for U.S. Patent No. 7,722,583 |
| 2010-10-07 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,722,583 - Bowel Management System And Waste Collection Bag Therefor
- Patent Identification: U.S. Patent No. 7722583, Bowel Management System And Waste Collection Bag Therefor, issued May 25, 2010.
The Invention Explained
- Problem Addressed: The patent describes the significant nursing challenges and patient health risks associated with fecal incontinence, such as perianal skin breakdown, infection, and the difficulty of treating wounds continually contaminated by feces (’583 Patent, col. 1:26-40). Existing methods were noted to be limited in their effectiveness due to leakage and anatomical complexities (’583 Patent, col. 1:41-49).
- The Patented Solution: The invention is a rectal catheter system designed for indwelling use. It features a catheter with at least two sections of different durometer hardness: a stiffer section for inside the rectum to ensure an open channel for waste, and a softer, more pliable section to reside in the anal canal to minimize discomfort and tissue damage (’583 Patent, col. 2:32-49). A key component is a "selectively collapsible, substantially spherical retention balloon" at the device's patient-proximal end, engineered to be large enough to anchor the device but not so large as to cause a defecatory response in the patient (’583 Patent, Abstract; col. 2:48-59).
- Technical Importance: This design sought to provide a comprehensive system that could divert fecal matter away from the skin, facilitate colonic irrigation, and be administered for extended periods in non-ambulatory patients (’583 Patent, col. 1:54-65).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim, and reserves the right to assert others (Compl. ¶11). Independent claim 1 is representative of the core system.
- Independent Claim 1 requires:
- A rectally inserted catheter with a first (proximal) and second (distal) section.
- The first section is pliable enough to be folded for insertion but maintains an open passage for waste afterward.
- The second section is soft enough to be retained in a patient's anal canal for extended periods.
- A balloon positioned coaxially with the proximal opening of the first section.
- The balloon has a proximal-most end that is "coincident to a proximal-most first end of the first catheter section."
- The balloon has an inflated size "sufficiently large so as to prevent migration" out of the rectum but not "so large as to trigger a defecatory response."
III. The Accused Instrumentality
Product Identification
- ConvaTec's Flexi-Seal® Fecal Management System and ConvaTec's Flexi-Seal® Signal™ Fecal Management System (Compl. ¶9).
Functionality and Market Context
- The complaint identifies the accused instrumentalities as "bowel management systems" (Compl. ¶9, ¶11). It does not provide specific technical details on the design, materials, or operation of these systems.
- The complaint alleges that Plaintiff Hollister is a "worldwide leader in providing indwelling bowel management devices," suggesting the parties are direct competitors in this market (Compl. ¶8).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint alleges infringement in general terms without providing a detailed breakdown of its theory. The following chart summarizes the likely correspondence between the elements of Claim 1 and the accused products, based on the product category and the infringement allegations.
’583 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a rectally inserted catheter having a first catheter section... and a second catheter section... | The accused products are alleged to be bowel management systems that include a rectally inserted catheter with multiple sections. | ¶11 | col. 11:7-11 |
| the first catheter section being sufficiently pliable to permit folding for insertion into a patient's rectum but following insertion permits flow of bowel waste through the patient proximal opening | The catheter of the accused products is alleged to have a section that is foldable for insertion and subsequently allows for the passage of waste. | ¶11 | col. 11:13-16 |
| the second catheter section permitting passage of bowel waste from the patient and being sufficiently soft to permit retention within a patient's anal canal for extended periods of time | The catheter of the accused products is alleged to have a soft section that resides in the anal canal for extended periods while allowing waste to pass. | ¶11 | col. 11:17-21 |
| a balloon coaxial with, and extending radially outward relative to, the patient proximal opening of the first catheter section... | The accused products are alleged to include a retention balloon positioned coaxially at the proximal end of the catheter. | ¶11 | col. 11:22-24 |
| the balloon having a proximal-most end coincident to a proximal-most first end of the first catheter section... | The balloon of the accused products is alleged to have a proximal end that is aligned with the proximal end of the catheter section. | ¶11 | col. 11:25-27 |
| the balloon having an inflated size sufficiently large so as to prevent migration of the first catheter section out of the patient's rectum...without being so large as to trigger a defecatory response... | The balloon of the accused products is alleged to inflate to a size that anchors the device in the rectum without stimulating a defecatory response. | ¶11 | col. 11:27-31 |
- Identified Points of Contention:
- Scope Questions: A central question will be whether the accused systems, in operation, possess a retention balloon with the specific placement characteristics required by the claims. The interpretation of "coincident to" will be critical in determining whether the alignment of the balloon and catheter in the accused products meets this limitation.
- Technical Questions: The complaint does not provide sufficient detail for a technical analysis. A key evidentiary question for the court will be whether the accused products meet the negative limitation of having a balloon that does not "trigger a defecatory response in the patient," a functional property that may require clinical or technical evidence to prove or disprove.
V. Key Claim Terms for Construction
The Term: "coincident to"
Context and Importance: This term defines the precise physical relationship between the retention balloon and the catheter's proximal end. Its construction is critical because a narrow definition could allow a defendant to design around the claim by creating even a small offset between the two components.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is not explicitly defined in the patent, which might support an argument for applying its plain and ordinary meaning of being adjacent or occurring at the same place or time.
- Evidence for a Narrower Interpretation: The specification provides language suggesting a more exact alignment, stating that "the extreme ends of each element are substantially flush (or at least closely adjacent to) with one another" (’583 Patent, col. 5:55-58). This description of a "flush" arrangement may be used to argue for a narrower construction that requires a precise, edge-to-edge alignment.
The Term: "a balloon... having an inflated size... without being so large as to trigger a defecatory response in the patient"
Context and Importance: This is a negative functional limitation that defines the upper boundary of the balloon's permissible size based on a physiological effect. Infringement requires that the accused device's balloon operate below this threshold.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the "defecatory response" is patient-dependent and the claim should not be limited to a specific volume, but rather to the functional outcome in an average patient.
- Evidence for a Narrower Interpretation: The specification provides explicit numerical guidance, stating that "a volume of 90 cc is sufficient to trigger a defecatory response" and that the "optimal size for balloon 24 for the normal adult patient is between 44 cc and 69 cc" (’583 Patent, col. 5:61-65). This language provides a potential basis for arguing that the claim scope is bounded by these disclosed volumes, giving the term a more defined and limited meaning.
VI. Other Allegations
- Indirect Infringement: The prayer for relief seeks an injunction against inducing infringement (Compl., Prayer for Relief B). However, the complaint does not allege specific facts to support a claim of inducement, such as the provision of instructions or user manuals that would encourage infringing acts.
- Willful Infringement: The complaint requests that damages be trebled pursuant to 35 U.S.C. § 284, which is the statutory basis for enhancement of damages upon a finding of willful infringement (Compl., Prayer for Relief D). The complaint does not, however, plead any facts regarding Defendant’s alleged pre- or post-suit knowledge of the patent or its alleged infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute may turn on the following central questions:
A central issue will be one of definitional precision: how narrowly will the court construe the term "coincident to" when describing the alignment of the retention balloon and catheter tip, and does this require the "substantially flush" arrangement described in the specification, or does it permit a broader range of adjacent configurations?
A key evidentiary question will concern a functional limitation: what evidence will be required to establish that the accused device's balloon is sized to prevent migration without triggering a "defecatory response," and to what extent will the specific volumes disclosed in the patent (e.g., 44-69 cc as optimal, 90 cc as triggering) define the boundaries of this claim limitation?