DCT

1:25-cv-01236

HQ Specialty Pharma Corp v. Cipla Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01236, D. Del., 10/07/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Cipla USA, Inc. is a Delaware corporation, and Defendant Cipla Ltd. is a foreign entity that may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiffs' calcium gluconate injection constitutes an act of patent infringement.
  • Technical Context: The technology concerns stable, ready-to-use aqueous solutions of calcium gluconate, a drug used to treat hypocalcemia, formulated for intravenous administration in flexible plastic bags.
  • Key Procedural History: The complaint highlights a prior litigation involving the same patent-in-suit against a different defendant, Fresenius Kabi USA, LLC. That case resulted in a final judgment after a jury trial, finding the patent to be not invalid and directly infringed by Fresenius's product. The complaint alleges that the defendant's ANDA product identifies the litigated Fresenius product as its reference listed drug, a fact that may be central to the current infringement allegations.

Case Timeline

Date Event
2017-07-25 ’646 Patent Priority Date
2018-10-29 Plaintiff HQ Specialty Pharma receives FDA approval for its NDA 210906
2018-11-20 ’646 Patent Issue Date
2021-12-03 Plaintiffs file suit against Fresenius USA for infringement of the ’646 Patent
2024-08-26 Jury trial begins in the Fresenius USA litigation
2024-08-30 Jury trial concludes in the Fresenius USA litigation
2025-08-01 Final Judgment entered against Fresenius USA, finding infringement of the ’646 Patent
2025-08-22 Fresenius USA submits the ’646 Patent for listing in the Orange Book
2025-08-25 Defendant Cipla sends Notice Letter to Plaintiffs regarding its ANDA filing
2025-10-07 Complaint Filing Date

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

U.S. Patent No. 10,130,646 - "Calcium Gluconate Solutions in Flexible Containers,"

  • Issued: November 20, 2018

The Invention Explained

  • Problem Addressed: The patent's background section describes challenges with prior methods of administering calcium gluconate, which was typically supplied in glass vials or rigid plastic bottles. These containers posed a risk of breakage, took up significant storage space, and often required hospital staff to dilute the solution into a separate IV bag before administration, a process which created a product with a very limited shelf life of 45 to 70 days (’646 Patent, col. 1:35-64). This created a need for a ready-to-use calcium gluconate solution in a flexible plastic bag with a long shelf life (’646 Patent, col. 2:1-3).
  • The Patented Solution: The invention is a stable, terminally sterilized aqueous solution of calcium gluconate that is pre-packaged in a flexible plastic container, such as an IV bag. The solution includes calcium saccharate as a stabilizing agent and sodium chloride to ensure it is isotonic, making it ready for immediate intravenous administration without further dilution (’646 Patent, Abstract; col. 2:9-16).
  • Technical Importance: This approach provides a commercially sterile, ready-to-use product that simplifies hospital workflow, reduces the risk of contamination from manual preparation, and offers a longer shelf life compared to solutions prepared ad-hoc in a clinical setting (’646 Patent, col. 2:1-3).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1, 2, and 3 (Compl. ¶34). Claim 1 is the sole independent claim.
  • Independent Claim 1:
    • A terminally sterilized aqueous calcium gluconate solution comprising:
    • sodium chloride; and
    • 1 to 15 wt. % calcium gluconate and from 1 to 19 wt. parts of calcium saccharate per 100 wt. parts of calcium gluconate packaged in a flexible plastic container with the remainder water,
    • wherein the flexible plastic container is a bag, and
    • the solution has a pH of from 6 to 8.2.
  • The complaint asserts claims 1-3 generally and does not explicitly reserve the right to assert other dependent claims (Compl. ¶34).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant Cipla's proposed calcium gluconate in sodium chloride injection products, which are the subject of ANDA No. 217891 ("Cipla's ANDA Products") (Compl. ¶1-2).

Functionality and Market Context

The Cipla ANDA Products are generic versions of Plaintiffs' product, intended for the treatment of acute symptomatic hypocalcemia (Compl. ¶8, ¶16). The complaint alleges that by submitting its ANDA, Cipla has represented to the FDA that its products have the same active ingredient, dosage form, route of administration, and strength as the Approved Fresenius Product, which serves as the reference listed drug (RLD) (Compl. ¶30-31). The products are described as solutions of 1 g/50 mL and 2 g/100 mL (Compl. ¶30).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The following summary is based on the narrative allegations.

’646 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A terminally sterilized aqueous calcium gluconate solution The accused product is alleged to be a "terminally sterilized aqueous calcium gluconate solution." ¶24 col. 2:10-12
comprising: sodium chloride The accused product is alleged to be a "calcium gluconate in sodium chloride" solution. ¶30 col. 2:25-26
and 1 to 15 wt. % calcium gluconate and from 1 to 19 wt. parts of calcium saccharate per 100 wt. parts of calcium gluconate The product is alleged to contain the "required amount of calcium gluconate and calcium saccharate." ¶24 col. 2:51-64
packaged in a flexible plastic container with the remainder water, wherein the flexible plastic container is a bag The product is alleged to be packaged "in a flexible plastic container that is a bag." ¶24 col. 3:41-43
and the solution has a pH of from 6 to 8.2 The product is alleged to be "within the required pH range." ¶24 col. 2:30-33

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: This being an ANDA case where the generic product is intended to replicate a reference product, a central question for the court will be whether the product as specified in Cipla's ANDA submission meets every claim limitation, either literally or under the doctrine of equivalents. The complaint's allegations are based on the ANDA submission and the assertion that Cipla's product is bioequivalent to the RLD (Compl. ¶31).
  • Technical Questions: A potential issue may arise if Cipla's manufacturing process, excipients, or container materials, as detailed in its ANDA, differ from those of the reference product in a way that could be argued to fall outside the scope of the claims. The complaint does not provide sufficient detail for analysis of such potential differences.

V. Key Claim Terms for Construction

The complaint does not raise explicit claim construction disputes. However, based on the technology and claim language, certain terms may become focal points.

  • The Term: "terminally sterilized"

    • Context and Importance: The meaning of this term is fundamental to the claimed invention, as it distinguishes the ready-to-use product from solutions prepared ad-hoc in a hospital. Practitioners may focus on this term to determine if it implies a specific method of sterilization.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself does not specify a method, suggesting any process that renders the final packaged product sterile could suffice.
      • Evidence for a Narrower Interpretation: The specification repeatedly mentions sterilization via "moist-heat autoclaving" (’646 Patent, col. 2:11) and provides specific parameters, such as sterilizing at "121° C. for 20 minutes" (’646 Patent, col. 5:17-18). A defendant could argue these examples limit the claim scope to this specific method.

  • The Term: "flexible plastic container"

    • Context and Importance: This term defines the packaging of the claimed invention, which is a key element distinguishing it from prior art glass vials. The composition and structure of the container are relevant to the product's stability and sterility.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim requires only that the container be a "flexible plastic" "bag." The specification lists a wide variety of "primary polymeric materials which may be used," including polysulfone, polycarbonate, polypropylene, and polyethylene (’646 Patent, col. 3:63-col. 4:4).
      • Evidence for a Narrower Interpretation: The specification describes preferred embodiments, such as a bag that is "laminated with the inner most layer comprising copolymerized ethylene and vinyl acetate" and has "from 3 to 7 layers" (’646 Patent, col. 3:44-47). A party could argue these specific details should inform the construction of the broader term.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Cipla will induce and contribute to infringement. The basis for these allegations is that Cipla's proposed product labeling will instruct and direct end-users (e.g., healthcare professionals) to administer the product in an infringing manner (Compl. ¶39, ¶41-42). It is further alleged that the product is not a staple article of commerce and is not suitable for substantial non-infringing use (Compl. ¶42).
  • Willful Infringement: Willfulness is alleged based on Cipla having "acted with full knowledge of the '646 patent and without reasonable basis for believing that it would not be liable for infringing" (Compl. ¶45). The complaint's recitation of the prior successful litigation against Fresenius (Compl. ¶25-26) may be used to support the allegation of knowledge and the objective unreasonableness of any non-infringement or invalidity positions.

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

  • A core issue will be one of procedural impact: to what extent does the final judgment of infringement and validity in the prior litigation against Fresenius preclude Cipla from raising similar non-infringement or invalidity defenses, particularly given the allegation that Cipla’s ANDA designates the adjudicated Fresenius product as its reference listed drug?
  • A key evidentiary question will be one of technical identity: will the evidence show that Cipla's proposed product, as defined in its ANDA, possesses every characteristic required by the asserted claims? The dispute may focus on subtle differences in formulation, pH, sterilization methods, or container materials that Cipla could argue place its product outside the literal scope of the claims.
  • A central legal question will be one of willfulness: given the public record of the prior litigation and final judgment, can Cipla establish a good-faith basis for its assertion in its ANDA certification that the ’646 patent is invalid, unenforceable, or will not be infringed, as required to defend against the claim of willful infringement?