DCT
1:23-cv-00212
Single Use Support GmbH v. Entegris Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Single Use Support GmbH (Austria)
- Defendant: Entegris, Inc. (Delaware)
- Plaintiff’s Counsel: Carlson, Caspers, Vandenburgh & Lindquist, P.A.; The Dacus Firm, P.C.
- Case Identification: 1:23-cv-00212, W.D. Tex., 02/24/2023
- Venue Allegations: Venue is asserted based on Defendant maintaining regular and established places of business within the Western District of Texas.
- Core Dispute: Plaintiff alleges that Defendant’s protective freezing shells for biopharmaceutical transport infringe a patent on housings that use compressible foam to prevent damage from liquid expansion during freezing.
- Technical Context: The technology operates within the biopharmaceutical cold chain, where maintaining the integrity of high-value, single-use bags of liquid medicine during freezing and transport is critical.
- Key Procedural History: The complaint alleges a prior business relationship where Plaintiff (SUS) developed a customized version of its patented product for Defendant (Entegris) under non-disclosure agreements. Plaintiff alleges that after this collaboration, during which confidential information was shared, Entegris developed and began marketing its own similar product. The complaint also alleges that Entegris was notified of a pending PCT application and related foreign patent rights prior to the issuance of the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2017-01-16 | '239 Patent Priority Date |
| 2017-08-15 | First Mutual Non-Disclosure Agreement signed between parties |
| 2020-01-10 | Supply agreement signed between parties |
| 2020-01-22 | Second Mutual Non-Disclosure Agreement signed between parties |
| 2020 | Plaintiff's adapted RoSS® Shell introduced to market |
| 2021-12-28 | '239 Patent Issue Date |
| Late 2022 | Defendant announced it would market its own freezing shell |
| 2023 | Alleged commercial launch of Defendant's accused Freezing Shells |
| 2023-02-24 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,207,239 - "Housing for a Flexible Container"
The Invention Explained
- Problem Addressed: When biopharmaceutical liquids in flexible bags are frozen for transport, the liquid expands (by approximately 8%), creating significant pressure on both the bag and its protective outer housing, which can lead to mechanical damage and leaks of high-value products (’239 Patent, col. 1:13-21; Compl. ¶11).
- The Patented Solution: The invention places the flexible container inside a rigid housing that is lined with an elastic foam. This foam is designed to compress and absorb the volume increase during freezing, thereby reducing mechanical stress on the system and preventing damage (’239 Patent, col. 2:25-34, Fig. 1). The patent also describes embodiments where the foam hardens at low temperatures to create a precisely adapted, protective "bed" for the frozen container (’239 Patent, col. 2:46-61).
- Technical Importance: This design addresses a critical failure point in the biopharmaceutical cold chain by providing a mechanism to accommodate the physics of water expansion, thereby reducing product loss and ensuring the integrity of sterile contents (Compl. ¶8, ¶11).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, including at least independent claim 1 (Compl. ¶28).
- Independent Claim 1 of the ’239 Patent recites the following essential elements:
- An arrangement comprising a housing and a flexible container.
- The flexible container is arranged in the housing.
- The container is filled with a liquid from a pharmaceutical production process.
- The housing is at least partially lined with an elastic foam.
- The foam is configured to "completely compensate" for the volume increase that occurs upon freezing.
- The housing comprises "cover layers made of metal."
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the "Entegris Freezing Shells" (Compl. ¶28).
Functionality and Market Context
- The Entegris Freezing Shells are described as protective containers for single-use bags, such as the Entegris Aramus™ bag, intended for the freezing, storage, and shipment of "high-value process fluids" (Compl. ¶34). The complaint alleges the product features an "all-metal, multiuse stainless-steel construction" and is lined with polyurethane foam "to support and protect the product" (Compl. ¶25, ¶36). The complaint includes an annotated image from Defendant's website depicting the accused product and its features. This image from an Entegris advertisement shows the product's "All-metal, multiuse stainless steel design" and notes the presence of "Polyurethane foam to support and protect product" (Compl. ¶25, p. 7).
IV. Analysis of Infringement Allegations
U.S. Patent No. 11,207,239 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a housing; and a flexible container | The accused product is a metal shell ("housing") used with single-use Entegris Aramus™ bags ("flexible container"). | ¶32, ¶33 | col. 1:5-9 |
| the flexible container is arranged in the housing and filled with a liquid which occurs in a pharmaceutical production process | The accused shell has a cavity specifically designed to receive the Aramus™ bag for "[b]ulk drug freezing, storage, and shipment" of "high-value process fluids." A provided photograph depicts the open shell with foam inlays and cutouts for receiving the bag (Compl. ¶24). | ¶34 | col. 3:22-24 |
| the housing is at least partially lined with an elastic foam configured to completely compensate for an increase in volume of the flexible container that occurs upon freezing | The accused shell is lined with polyurethane foam, which the complaint asserts is an elastic foam. This foam is allegedly designed to fit the Aramus™ bag and "condense to account for the increase in volume upon freezing." | ¶35 | col. 3:25-28 |
| the housing comprises cover layers made of metal | The accused shell is described and depicted as an "all-metal, multiuse stainless steel design," with metal top and bottom plates. | ¶36 | col. 3:29-30 |
Identified Points of Contention
- Scope Questions: A primary question will be the proper construction of "completely compensate." The infringement analysis will turn on whether the accused polyurethane foam's ability to "condense to account for the increase in volume" (Compl. ¶35) is sufficient to meet the claim’s requirement to "completely compensate" (’239 Patent, col. 3:26-27). The parties may dispute the technical meaning and evidentiary burden associated with the word "completely."
- Technical Questions: A key factual dispute will likely involve the material properties of the accused polyurethane foam. Evidence will be needed to establish whether this foam is "elastic" as claimed and whether it in fact performs the function of compensating for volume expansion as required by the claim. The patent specification also describes a foam that "hardens" at low temperatures (’239 Patent, col. 4:65-67), and it may become a point of contention whether this property is a required, or merely preferred, feature of the claimed "elastic foam."
V. Key Claim Terms for Construction
- The Term: "elastic foam configured to completely compensate for an increase in volume"
- Context and Importance: This term captures the core functional novelty of the invention. The outcome of the infringement analysis will heavily depend on whether the accused product's foam is found to meet this limitation. Practitioners may focus on this term because the word "completely" creates a potential high bar for the patentee to prove infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim requires the foam be "configured to" compensate, which could be interpreted as being designed for that purpose, rather than requiring perfect compensation in every real-world use case. The specification states the foam can "at least partially—preferably substantially completely compensate" for the volume increase, suggesting "completely" may not be an absolute requirement for all embodiments described (col. 2:28-30).
- Evidence for a Narrower Interpretation: The plain meaning of "completely" suggests 100% absorption of the volume increase. A defendant could argue that this language distinguishes the invention from prior art that might have offered only partial protection. The patent also discloses a specific "visco-elastic foam which hardens at certain negative temperatures" (col. 4:65-67), which could be argued as definitional for the type of foam that can achieve the claimed function.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement based on Entegris providing customers with its Freezing Shells along with instructions for use that, when followed, allegedly result in infringement (Compl. ¶38-39). Contributory infringement is alleged on the basis that the Freezing Shells are a material component of the patented invention, are specially designed for an infringing use, and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶41).
- Willful Infringement: The willfulness claim is based on the alleged pre-existing business relationship between the parties, during which Plaintiff allegedly disclosed confidential information and notified Defendant of its pending patent rights (Compl. ¶42). The complaint further alleges that Defendant "copied SUS's RoSS® Shells," which, if proven, would support a finding of deliberate infringement (Compl. ¶43).
VII. Analyst’s Conclusion: Key Questions for the Case
A central issue will be one of functional performance: Can Plaintiff prove, likely through expert testing and testimony, that Defendant's polyurethane foam liner meets the claim requirement to "completely compensate" for liquid expansion during freezing? The case may turn on the technical evidence presented and the court's interpretation of what "completely" means in the context of the patent.
A second core issue will be one of intent and history: Given the extensive allegations of a prior partnership, shared confidential information under NDAs, and subsequent development of a competing product, the court will have to unravel the history of the parties' relationship. The evidence surrounding this history will be critical not only for the patent infringement claim, particularly willfulness, but also for the parallel claims of trade secret misappropriation and breach of contract.