DCT
1:24-cv-01248
Convatec Inc v. HR Pharma Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Convatec, Inc. (Delaware)
- Defendant: HR Pharmaceuticals, Inc. d/b/a HR Healthcare (Delaware)
- Plaintiff’s Counsel: Buchanan Ingersoll & Rooney PC; Taft, Stettinius & Hollister LLP
- Case Identification: 1:24-cv-01248, D. Del., 11/13/2024
- Venue Allegations: Venue is asserted in the District of Delaware based on Defendant being a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant’s intermittent urinary catheters, and the methods used to manufacture them, infringe patents related to pre-lubricated catheter packaging technology.
- Technical Context: The technology concerns single-use, pre-lubricated medical devices, specifically focusing on packaging that keeps the insertion portion lubricated while the handling portion remains dry.
- Key Procedural History: The complaint alleges a prior business relationship where Defendant was a lubricant supplier to Plaintiff. Plaintiff alleges it sent Defendant three notice letters regarding the asserted patents prior to filing suit. The complaint also contains an allegation that Defendant admitted to being aware of the patents during product design and admitted to intentional infringement at a face-to-face meeting.
Case Timeline
| Date | Event |
|---|---|
| 2016-04-15 | Priority Date for ’136 and ’061 Patents |
| 2019-05-21 | U.S. Patent No. 10,293,136 Issues |
| 2020-03-17 | U.S. Patent No. 10,589,061 Issues |
| 2021 | Convatec acquires the Asserted Patents |
| 2023-09-13 | First notice letter sent to Defendant |
| 2023-12-12 | Second notice letter sent to Defendant |
| 2024-08-08 | Assignment of patents to Convatec recorded |
| 2024-09-27 | Third notice letter sent to Defendant |
| 2024-11-13 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,293,136 - "Efficiently Packaged Ready to use Intermittent Urinary Catheter"
- Patent Identification: U.S. Patent No. 10,293,136, "Efficiently Packaged Ready to use Intermittent Urinary Catheter," issued May 21, 2019.
The Invention Explained
- Problem Addressed: The patent describes a need for intermittent urinary catheters that are not "large and bulky," which makes them difficult for users to discretely transport for daily use (’136 Patent, col. 1:20-23).
- The Patented Solution: The invention is a hermetically packaged catheter where the packaging film forms a "retention chamber" with a profile that conforms to the shape of the catheter itself (’136 Patent, col. 2:39-44). This design includes a specific arrangement where lubricant is contained within the chamber for contact with "only the first portion" (the insertion end) of the catheter, leaving the fixture end unlubricated for easier handling (’136 Patent, col. 4:43-48).
- Technical Importance: The claimed design seeks to provide a compact, ready-to-use product that improves user convenience and hygiene by selectively lubricating only the necessary portion of the catheter.
Key Claims at a Glance
- The complaint asserts "one or more claims" and specifically recites Independent Claim 1 (Compl. ¶¶27, 29).
- Essential elements of Independent Claim 1 include:
- An intermittent urinary catheter with a first (insertion) portion and a second (fixture) portion.
- The catheter is hermetically packaged between two laminated film layers.
- The packaging forms a "lubricant containing retention chamber" that has a top view profile "conforming to the top view profile of the catheter."
- The lubricant is positioned for contact with "only the first portion" of the catheter.
- The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more claims" (Compl. ¶27).
U.S. Patent No. 10,589,061 - "Packaged Precision-Lubricated Ready-to-Use Intermittent Urinary Catheter"
- Patent Identification: U.S. Patent No. 10,589,061, "Packaged Precision-Lubricated Ready-to-Use Intermittent Urinary Catheter," issued March 17, 2020.
The Invention Explained
- Problem Addressed: This patent addresses a "particular complication" in manufacturing pre-lubricated catheters: "constraining the lubricant to the insertion portion" and preventing its migration to the "fixture end portion... which must be gripped" (’061 Patent, col. 1:27-35).
- The Patented Solution: The patent discloses a multi-step manufacturing method. After injecting lubricant and placing the catheter in a film pocket, the package is partially sealed, leaving an opening (’061 Patent, col. 5:19-26). A vacuum is then drawn through the opening, which compresses the chamber and causes the lubricant to "circumferentially flow around and coat" the insertion portion of the catheter without reaching the fixture end (’061 Patent, col. 5:27-36). The package is then fully sealed.
- Technical Importance: This method provides a controlled process for "precision-lubrication," using a vacuum to actively and evenly spread lubricant on a targeted area of the catheter during packaging.
Key Claims at a Glance
- The complaint asserts "one or more claims" and specifically recites Independent Claim 1 (Compl. ¶¶40, 41).
- Essential steps of Independent Claim 1 include:
- (a) Obtaining a base film with a pocket.
- (b) Injecting lubricant into the pocket.
- (c) Placing a catheter into the pocket.
- (d) Sealing a cover film to the base film, leaving an unsealed opening.
- (e) Drawing a vacuum through the opening sufficient to compress the chamber and cause lubricant to circumferentially coat the insertion end length "without reaching and coating the fixture end length."
- (f) Sealing the opening to form the final hermetically packaged product.
- The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more claims" (Compl. ¶40).
III. The Accused Instrumentality
- Product Identification: The accused products are HRH's TruCath® Intermittent Catheters (Compl. ¶1).
- Functionality and Market Context: The complaint alleges the Accused Products are intermittent urinary catheters sold for self-catheterization (Compl. ¶16). The infringement allegations focus on the product's physical configuration and packaging. Specifically, the complaint alleges the products consist of a catheter with distinct insertion and fixture ends, packaged in a film that creates a chamber containing lubricant (Compl. ¶¶30-32). A photograph in the complaint shows the Accused Product packaged with annotations identifying a "First Layer of Film," "Second Layer of Film," and a "Lubricant Containing Retention Chamber" (Compl. p. 9). The complaint further alleges that Defendant markets and sells these products through its own website and authorizes their sale on third-party medical supplier websites (Compl. ¶¶22-23).
IV. Analysis of Infringement Allegations
’136 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an intermittent urinary catheter having a longitudinal axial length with a first portion terminating at an insertion end and a second portion longitudinally opposed to the first portion terminating at a fixture end, and a top view profile | The Accused Products are intermittent urinary catheters with a first (insertion) portion and an opposing second (fixture) portion. | ¶30 | col. 2:32-34 |
| the catheter hermetically packaged between laminated first and second layers of film hermetically sealing the catheter within a lubricant containing retention chamber | The accused catheters are hermetically packaged between first and second film layers, forming a lubricant-containing retention chamber. A photograph shows these labeled components. (Compl. p. 9). | ¶31 | col. 2:39-42 |
| having a top view profile conforming to the top view profile of the catheter | The retention chamber has a top view profile that conforms to the catheter's profile. | ¶31 | col. 2:47-49 |
| wherein the lubricant is positioned and arranged within the retention chamber for lubricating contact with only the first portion of the packaged catheter | The lubricant is allegedly positioned to contact only the insertion portion of the catheter. A photograph annotates separate areas of the package as "Lubricant in Retention Chamber" and "Portion of Retention Chamber With No Lubricant." (Compl. p. 9). | ¶32 | col. 4:45-48 |
’061 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) obtaining a base film having a pocket ... configured to retain the intermittent urinary catheter | The manufacturing process allegedly uses a base film with a pocket to hold the catheter. A photograph shows the catheter retained in what is labeled a "Base Film Pocket." (Compl. p. 12). | ¶43 | col. 5:6-11 |
| (b) injecting a limited amount of lubricant into the pocket proximate the first end of the pocket | A limited amount of lubricant is allegedly injected into the pocket. A photograph purports to show "Lubricant Injected Into Pocket." (Compl. p. 13). | ¶44 | col. 5:12-14 |
| (c) placing the intermittent urinary catheter into the lubricant containing pocket | The catheter is allegedly placed into the pocket containing lubricant. | ¶45 | col. 5:15-20 |
| (d) sealing a cover film to the base film with an unsealed opening proximate the second end of the pocket | The manufacturing process allegedly involves sealing a cover film to the base film, leaving an unsealed opening. | ¶46 | col. 5:21-26 |
| (e) drawing a vacuum ... sufficient to compress the retention chamber and cause lubricant to circumferentially flow around and coat a portion of the exterior surface area of the insertion end length ... without reaching ... the fixture end length | Based on information and belief, a vacuum is allegedly drawn on the chamber to compress it and cause the lubricant to flow around and coat the insertion end. | ¶46 | col. 5:27-36 |
| (f) sealing the opening so as to form a hermetically packaged ... catheter having a circumferentially lubricated insertion end length and a lubricant-free fixture end length | The opening is allegedly sealed to create the final product, which is alleged to have a lubricated insertion end and a lubricant-free fixture end. A photograph shows the final product with these distinct sections labeled. (Compl. p. 14). | ¶47 | col. 5:37-41 |
- Identified Points of Contention:
- Scope Questions: For the ’136 Patent, a central question may be the required degree of similarity for the packaging's "top view profile" to be considered "conforming to the top view profile of the catheter." The patent's emphasis on "efficiently packaged" may suggest a tighter fit is required than what is shown in the complaint's photographs (’136 Patent, col. 1:24-28).
- Technical Questions: For the ’061 Patent, the allegation of "drawing a vacuum" to spread lubricant is made "upon information and belief" (Compl. ¶46). A key technical question will be what evidence supports this specific manufacturing step. The complaint's basis for this belief appears to be the allegation that Defendant contracted with Plaintiff's own supplier and requested the "exact same machine" (Compl. ¶17).
V. Key Claim Terms for Construction
Term: "conforming to the top view profile of the catheter" (’136 Patent, Claim 1)
Context and Importance: The scope of this term will define how closely the package must match the catheter's shape. A narrow interpretation might require a near-identical outline, potentially allowing the accused product to be found non-infringing if its packaging is generically shaped. Practitioners may focus on this term because the visual evidence in the complaint shows a package that is visibly wider than the catheter shaft, raising a question of the degree of conformance required by the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the retention chamber has a profile that "generally conforms to the top view profile... of the catheter" (’136 Patent, col. 2:47-49), suggesting that exact correspondence is not required.
- Evidence for a Narrower Interpretation: The patent’s background criticizes prior art catheters as "large and bulky" and states a need exists for an "efficiently packaged" device (’136 Patent, col. 1:20-25). This purpose could support an interpretation that "conforming" requires a shape that closely tracks the catheter to minimize package size.
Term: "drawing a vacuum ... sufficient to ... cause lubricant to circumferentially flow around and coat" (’061 Patent, Claim 1)
Context and Importance: This term defines the central, active mechanism of the claimed method. The infringement analysis will depend on whether the accused manufacturing process includes a vacuum step that performs this specific function.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that any process that uses a vacuum and results in circumferential coating meets the limitation, even if the vacuum's primary purpose is standard package sealing.
- Evidence for a Narrower Interpretation: The patent describes a "novel lubricant placement and spreading technique" and a process where the vacuum is applied "to effect substantially complete circumferential coating" (’061 Patent, col. 4:50-51, col. 5:40-42). This may support a narrower construction requiring that the vacuum step be specifically intended and controlled to manipulate the lubricant, not merely an incidental effect of a generic vacuum-sealing process.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement for both patents. For the ’061 method patent (Count II), the allegation is that Defendant induced its manufacturer(s) to perform the patented steps, with knowledge of the patent (Compl. ¶40). The factual support for this allegation includes the claim that Defendant sought to use the "exact same machine" and "packaging film" as Plaintiff's supplier (Compl. ¶¶17-18). For the ’136 product patent, inducement is alleged against distributors encouraged to sell the accused products (Compl. ¶28).
- Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. It alleges Defendant received actual notice via three separate letters dated September 13, 2023, December 12, 2023, and September 27, 2024 (Compl. ¶20). The willfulness claim is further supported by the allegation that Defendant "admitted intentional infringement to Convatec at a face-to-face meeting" after becoming "aware of the Asserted Patents during the final stages of designing the Accused Products" (Compl. ¶21).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of process verification: can Plaintiff substantiate, through discovery, its "information and belief" allegation that the accused manufacturing process includes a specific vacuum step designed to circumferentially spread lubricant, as required by the ’061 patent? The case may turn on whether the accused process mirrors the claimed method or uses a conventional vacuum sealing technique with only incidental effects.
- A core issue will be one of definitional scope: can the term "conforming," in the context of an "efficiently packaged" catheter, be construed to read on the accused product's packaging, which appears visibly wider than the catheter itself? The resolution will determine the breadth of the ’136 patent's product claims.
- A critical question for damages will be one of intent: can Plaintiff prove its highly specific allegation that Defendant's executives admitted to knowing about the patents and intentionally infringing? The substantiation of this claim would weigh heavily on the determination of willfulness and the potential for enhanced damages.