DCT
1:18-cv-00665
Fresenius Kabi USA LLC v. Custopharm Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Fresenius Kabi USA, LLC (Delaware) and Fresenius Kabi Deutschland GmbH (Germany)
- Defendant: Custopharm, Inc. (Texas)
- Plaintiff’s Counsel: Connor Lee Shumaker PLLC; Goodwin Procter LLP
- Case Identification: 1:18-cv-00665, W.D. Tex., 04/17/2019
- Venue Allegations: Plaintiff alleges venue is proper as Defendant is incorporated in Texas, has a registered office and established place of business within the district, and conducts substantial business activities in the state.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) filing to market a generic version of Plaintiff’s Naropin® product constitutes an act of infringement of three patents related to connectors for medical fluid packaging.
- Technical Context: The technology concerns specialized connectors for medical infusion bags, designed to ensure sterile fluid transfer and prevent leaks or contamination after use.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 211907 to the FDA. The filing was accompanied by a Paragraph IV Certification, dated June 22, 2018, asserting that the patents-in-suit are invalid, unenforceable, or would not be infringed by the proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2002-05-27 | Priority Date for ’787 and ’802 Patents |
| 2003-03-27 | Priority Date for ’915 Patent |
| 2010-11-09 | Issue Date for U.S. Patent No. 7,828,787 |
| 2012-02-21 | Issue Date for U.S. Patent No. 8,118,802 |
| 2012-04-24 | Issue Date for U.S. Patent No. 8,162,915 |
| 2018-06-22 | Defendant sends Paragraph IV Notice Letter |
| 2019-04-17 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,118,802 - Connector for packaging containing medical fluids and packaging for medical fluids
- Patent Identification: U.S. Patent No. 8,118,802, “Connector for packaging containing medical fluids and packaging for medical fluids,” issued February 21, 2012. (Compl. ¶24).
The Invention Explained
- Problem Addressed: The patent’s specification describes drawbacks in prior art medical bag connectors, including the risk of fluid leakage after a withdrawal spike is removed, insecure connections susceptible to accidental tugging, and piercing membranes that could fail under mechanical stress. (’802 Patent, col. 5:42-58, incorporating by reference the specification of U.S. Patent No. 7,828,787).
- The Patented Solution: The invention proposes a connector with a uniquely designed self-sealing membrane. This membrane features a "circular upper portion, which transforms into a dish-shaped lower portion to form a trough-shaped recess." (’802 Patent, col. 5:63-67). This geometry is intended to guide the insertion spike and, critically, to reliably reseal the port after the spike is withdrawn, preventing leaks and contamination. (’802 Patent, col. 6:33-44).
- Technical Importance: The design aims to improve the safety and integrity of intravenous fluid administration by providing a more robust and reliable seal, which is particularly important after the addition of potent drugs or when preventing post-use contamination. (’802 Patent, col. 5:45-47).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" but does not identify any specific claims. (’802 Patent, Compl. ¶39). Claim 1 is a representative independent claim.
- Independent Claim 1 recites a self-sealing membrane comprising:
- a penetrable section; and
- a flange configured to be clamped between a lower section and an upper section of the connector, the flange having a generally T-shaped cross-sectional profile formed by an inner segment and an outer segment.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,162,915 - Connector for packings containing medical liquids, and corresponding packing for medical liquids
- Patent Identification: U.S. Patent No. 8,162,915, “Connector for packings containing medical liquids, and corresponding packing for medical liquids,” issued April 24, 2012. (Compl. ¶25).
The Invention Explained
- Problem Addressed: The patent identifies inefficiencies in the manufacturing of medical fluid bags, noting that prior art methods often require an additional tube section to join the port to the bag and that filling and sealing occur at different manufacturing stations, adding complexity and cost. (’915 Patent, col. 1:19-30).
- The Patented Solution: The invention describes a one-piece connector with an "elastically deformable pinching-off part" that has a noncircular cross-section. (’915 Patent, col. 1:55-58). This design allows a bag to be filled directly through the integrated connector, which is then temporarily pinched shut. A separate closure part is then fitted, completing the seal. This process simplifies production by eliminating the need for a separate connecting tube and enabling filling and sealing to occur at a single station. (’915 Patent, col. 1:41-54).
- Technical Importance: This innovation streamlines the manufacturing of sterile fluid packagings, offering a more efficient and potentially less costly method for producing infusion bags. (’915 Patent, col. 1:31-34).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" but does not identify any specific claims. (’915 Patent, Compl. ¶53). Claim 1 is a representative independent claim.
- Independent Claim 1 recites a connector comprising:
- a connecting part with a passage, which includes an "elastically deformable pinching-off part" that reassumes its original shape after pinching and has a "noncircular axial cross section";
- a base part that merges with the pinching-off part and widens to be integrated into the packing; and
- a closure part that can be fitted onto the connecting part.
- The complaint does not explicitly reserve the right to assert dependent claims.
Multi-Patent Capsule
- Patent Identification: U.S. Patent No. 7,828,787, “Connector for packaging containing medical fluids and packaging for medical fluids,” issued November 9, 2010. (Compl. ¶26).
- Technology Synopsis: As the parent to the ’802 Patent, this patent discloses a connector for medical fluid packaging designed to solve the problem of leakage after a withdrawal spike is removed. The invention centers on a self-sealing membrane with a specific geometry—an upper circular portion leading to a lower dish-shaped portion—that is claimed to provide a reliable guide for a spike and an effective reseal upon its removal. (’787 Patent, col. 1:40-47; Abstract).
- Asserted Claims: The complaint alleges infringement of "one or more claims." (Compl. ¶67).
- Accused Features: The complaint alleges that Defendant’s generic Naropin® product, by virtue of its container and ports, will infringe the patent. (Compl. ¶¶ 29-30, 67).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant’s proposed generic ropivacaine hydrochloride injection product, to be sold in 100 mL and 200 mL infusion bags as a generic version of Plaintiff’s Naropin® product. (Compl. ¶¶ 1, 29-30). The act of infringement cited is the filing of Abbreviated New Drug Application (ANDA) No. 211907. (Compl. ¶15).
Functionality and Market Context
- The complaint does not provide technical details, schematics, or descriptions of the accused product's operation. It alleges that the product is a "generic copy" of Naropin®. (Compl. ¶30). The focus of the infringement allegations appears to be the "container and each of the ports proposed for use" in the defendant's product, for which the plaintiff requested samples. (Compl. ¶35). The complaint alleges that upon FDA approval, the defendant will market, sell, and offer for sale this generic product in competition with the plaintiff's branded product. (Compl. ¶16).
IV. Analysis of Infringement Allegations
The complaint does not contain claim charts or detailed infringement theories. The following summary is based on the general allegations that the accused product would infringe representative independent claims of the patents-in-suit.
’802 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A self-sealing membrane disposed within a connector of a medical fluid container | Plaintiff alleges that Defendant’s generic product, which includes infusion bags with ports, would infringe the patent, suggesting the ports contain the claimed membrane. | ¶39 | col. 7:21-23 |
| comprising: a penetrable section; and | The complaint does not provide specific details, but alleges infringement of the claims, which require this feature. | ¶39 | col. 8:27-28 |
| a flange configured to be clamped between a lower section of the connector and an upper section of the connector | The complaint alleges the defendant's product would infringe, implying its connector ports are constructed with a flange clamped between upper and lower sections. | ¶39 | col. 7:26-29 |
| the flange having a generally T-shaped cross-sectional profile formed by an inner segment ... and an outer segment... | The complaint alleges infringement of claims requiring this specific geometric profile, though no direct evidence of the accused product’s flange geometry is provided. | ¶39 | col. 7:30-34 |
’915 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A connector for packings containing medical liquids, comprising: a connecting part that is an injection-molded component with a passage... | Plaintiff alleges infringement by Defendant's generic product, implying its container ports are injection-molded components as claimed. | ¶53 | col. 3:1-6 |
| an elastically deformable pinching-off part, which reassumes its original shape after being pinched ... and is designed as a tubular portion with a noncircular axial cross section that is different... | The complaint alleges infringement of claims requiring this feature, though it provides no detail on the structure or material properties of the accused connector's tubular portion. | ¶53 | col. 3:9-17 |
| and a base part that merges into the pinching-off part, wherein the base part widens to both sides and can be integrated in the packing... | The complaint’s allegations suggest the accused connector has a base part that can be integrated into the infusion bag, consistent with the claim. | ¶53 | col. 3:22-27 |
| and a closure part which can be fitted onto the connecting part and closes the passage in the connecting part. | The complaint does not describe the closure part of the accused product, but alleges infringement of claims that require it. | ¶53 | col. 4:56-67 |
- Identified Points of Contention:
- Technical Questions: The complaint lacks any technical evidence regarding the accused product. Key factual questions will be: (1) Do the ports on Defendant's product contain a self-sealing membrane with the specific "T-shaped cross-sectional profile" recited in the ’802 Patent? (2) Does the tubular part of Defendant's connector function as an "elastically deformable pinching-off part" with a "noncircular" cross-section as required by the ’915 Patent?
- Scope Questions: Assuming the accused product's structure is revealed in discovery, the dispute may center on the scope of claim terms. For instance, how much deviation from a perfect "T" shape is permitted by the term "generally T-shaped"? And what degree of recovery is required for a component to "reassume its original shape" after pinching?
No probative visual evidence provided in complaint.
V. Key Claim Terms for Construction
For the ’802 Patent:
- The Term: "generally T-shaped cross-sectional profile"
- Context and Importance: This term defines the specific geometry of the flange that secures the self-sealing membrane. The infringement analysis for the ’802 Patent will likely depend on whether the physical structure of the accused product's flange falls within the scope of this term.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the word "generally" may suggest that the profile need not be a perfect geometric "T," but must merely possess the functional characteristics of one, such as providing a surface for clamping between upper and lower connector sections (’802 Patent, col. 7:26-29).
- Evidence for a Narrower Interpretation: The figures provide a specific depiction of the flange (element 11) that has a clear T-shape. (’802 Patent, Fig. 1). A party could argue the term should be construed as being limited to structures closely conforming to this embodiment.
For the ’915 Patent:
- The Term: "elastically deformable pinching-off part"
- Context and Importance: This term is central to the manufacturing advantage claimed by the ’915 Patent. Its construction will be critical, as infringement depends on whether the accused connector's tubular section both deforms to create a seal for filling and possesses the requisite elasticity to "reassume its original shape." (’915 Patent, col. 3:12-14).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the purpose is to allow the part to be "pressed together with relatively slight forces" and to avoid an "undesired reduction of the cross section" after pinching, suggesting a functional definition focused on reversible, low-force clamping. (’915 Patent, col. 3:15-17; col. 2:1-4).
- Evidence for a Narrower Interpretation: The specification discloses the part is made of "polypropylene" and is an "injection-molded" component. (’915 Patent, col. 3:6-8). A party may argue that the term "elastically deformable" should be limited to the material properties characteristic of the specific embodiments and materials disclosed.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement, stating that Defendant’s proposed product labeling will instruct end-users on how to use the product in a manner that infringes the patents. (Compl. ¶¶ 44, 58, 72). It also alleges inducement based on the act of preparing and filing the ANDA with a Paragraph IV certification. (Compl. ¶¶ 42, 56, 70).
- Willful Infringement: Willfulness is alleged based on Defendant having acted "without a reasonable basis for believing that it would not be liable." (Compl. ¶¶ 49, 63, 77). The factual basis for this allegation is Defendant's pre-suit knowledge of the patents, evidenced by its submission of the Paragraph IV certification letter to Plaintiff. (Compl. ¶¶ 43, 57, 71).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue in this case will be an evidentiary one: once the physical characteristics of the accused generic product are revealed through discovery, do its container ports in fact incorporate the specific structures recited in the patents-in-suit? The resolution of the infringement claims depends entirely on this yet-to-be-determined factual record.
- The case will likely turn on claim construction: how the court defines the scope of key terms such as "generally T-shaped cross-sectional profile" (’802 Patent) and "elastically deformable pinching-off part" (’915 Patent) will be dispositive. A narrow construction may place the accused product outside the claims' boundaries, while a broader one may support a finding of infringement.
- A central, though currently unbriefed, question will be that of patent validity. The Defendant’s Paragraph IV certification asserts that the patents are invalid. (Compl. ¶31). The forthcoming invalidity contentions, likely based on prior art, will introduce a critical defensive front that will shape the litigation.