DCT

2:24-cv-07796

American Regent Inc v. Cipla USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07796, D.N.J., 07/16/2024
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Cipla USA, Inc. has its principal place of business in the district, and Defendant Cipla Limited is a foreign corporation subject to suit in any judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to seek FDA approval for generic versions of Plaintiff's Selenious Acid products constitutes an act of infringement of a patent covering trace element compositions.
  • Technical Context: The technology relates to stable injectable solutions of trace elements, such as selenium, designed for addition to parenteral nutrition for patients who cannot receive nourishment orally.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of an ANDA with a Paragraph IV Certification. Plaintiff’s patent is listed in the FDA’s "Orange Book" with a stated expiration date of July 1, 2041.

Case Timeline

Date Event
2019-04-30 Plaintiff's New Drug Application for Selenious Acid approved
2020-07-02 ’565 Patent Priority Date
2024-06-04 ’565 Patent Issue Date
2024-06-10 Date of Defendants' Paragraph IV Notice Letter
2024-07-16 Complaint Filing Date
2041-07-01 ’565 Patent Expiration Date (as listed in Orange Book)

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

U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use," issued June 4, 2024

The Invention Explained

  • Problem Addressed: The patent describes challenges with providing trace elements to patients receiving parenteral nutrition (PN). Admixing trace elements into PN solutions is time-consuming, and the resulting mixture often has a short stability period (24-48 hours), leading to product waste, increased costs, and frequent trips to healthcare facilities for patients ('565 Patent, col. 2:5-24). Additionally, existing combination products may not allow for easy customization of individual trace element doses ('565 Patent, col. 2:46-56).
  • The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to PN, create a mixture that remains stable for a significantly longer period—from at least three days up to fourteen days ('565 Patent, col. 4:1-5). The compositions are defined by specific concentrations of elements like selenium and, critically, by the near-absence of other elements like chromium, aluminum, and iron, which can cause instability or toxicity ('565 Patent, Abstract; col. 13:58-60). This extended stability facilitates the batch preparation of PN solutions, reducing waste and logistical burdens.
  • Technical Importance: The claimed compositions aim to improve the quality of life for patients on long-term PN and reduce healthcare costs by enabling less frequent admixing and minimizing the disposal of unused, expired PN bags ('565 Patent, col. 2:31-44).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶38). The first independent claim is Claim 1.
  • Independent Claim 1 requires:
    • An injectable composition comprising water
    • 6 µg or 60 µg of selenium
    • no chromium or chromium in an amount not to exceed 1 µg
    • no aluminum or aluminum in an amount not to exceed 6 µg
    • no iron or iron in an amount up to 10 µg
    • and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendants' generic versions of Plaintiff's Selenious Acid products, for which Defendants have filed ANDA No. 218661 with the FDA (Compl. ¶1). The products are identified as "selenious acid injection USP" at concentrations of "eq. 6 mcg selenium/mL" and "eq. 60 mcg selenium/mL" (Compl. ¶33).

Functionality and Market Context

  • The ANDA Products are intended to be generic substitutes for Plaintiff's branded Selenious Acid injection, a reference listed drug (Compl. ¶32). They are formulated to contain the "same or equivalent ingredients in the same or equivalent amounts" as the branded product and are intended for commercial sale in the United States upon FDA approval (Compl. ¶32, ¶34). The complaint alleges these products will have the same chemical and therapeutic properties as Plaintiff's products (Compl. ¶35).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint provides a high-level infringement theory without detailed, element-by-element evidence, which is common in initial ANDA complaints filed before discovery. The infringement allegations are based on the product descriptions in Defendants' notice letter and on "information and belief."

’565 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water, 6 µg or 60 µg of selenium... Defendants’ ANDA Products are described as "selenious acid injection USP" containing "eq. 6 mcg selenium/mL" and "eq. 60 mcg selenium/mL." ¶33 col. 71:36-37
...no chromium or chromium in an amount not to exceed 1 µg... The complaint alleges on information and belief that the ANDA Products will meet this limitation, but provides no specific facts regarding the chromium content. ¶37-38 col. 71:38-39
...no aluminum or aluminum in an amount not to exceed 6 µg... The complaint alleges on information and belief that the ANDA Products will meet this limitation, but provides no specific facts regarding the aluminum content. ¶37-38 col. 71:39-40
...no iron or iron in an amount up to 10 µg... The complaint alleges on information and belief that the ANDA Products will meet this limitation, but provides no specific facts regarding the iron content. ¶37-38 col. 71:40-41
...and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. The complaint alleges on information and belief that the ANDA Products will meet this limitation, but provides no specific facts regarding the fluoride content. ¶37-38 col. 71:41-42
  • Identified Points of Contention:
    • Scope Questions: What is the proper construction of the negative limitation "no chromium"? Does this require an absolute absence of the element, or does it mean an amount below a standard limit of detection? The claim's alternative phrasing ("...or chromium in an amount not to exceed 1 µg") suggests a threshold, but the scope of "no" will likely be a point of dispute.
    • Technical Questions: A central question is whether Defendants' ANDA Products, as formulated for the FDA, actually meet the negative limitations for chromium, aluminum, iron, and fluoride. The complaint alleges infringement on "information and belief" and notes that Defendants' notice letter "contained no non-infringement defenses" (Compl. ¶31). The factual accuracy of the infringement allegation for these impurity limitations will depend on evidence obtained during discovery.

V. Key Claim Terms for Construction

  • The Term: "no chromium" (and similar negative limitations for aluminum and iron)
  • Context and Importance: This term is a negative limitation, which is critical to distinguishing the invention from prior art that may have contained such elements as impurities. The definition of "no" will set the infringement threshold. Practitioners may focus on this term because its construction will determine whether the presence of any detectable trace amount of chromium constitutes infringement or if a de minimis exception is permitted.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (favoring infringement): The specification states that in many cases, "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" ('565 Patent, col. 13:58-60). Plaintiff may argue this language supports a construction where any scientifically detectable amount of chromium falls outside the scope of "no chromium."
    • Evidence for a Narrower Interpretation (disfavoring infringement): The claim structure itself provides an alternative ("or chromium in an amount not to exceed 1 µg"), which a defendant might argue contextualizes "no chromium" as a practical, rather than absolute, zero. A defendant could also point to specification discussions of elemental impurities potentially leaching from containers to argue that the patent contemplates the unavoidable presence of trace elements and "no" should be construed to permit such incidental amounts below a certain threshold ('565 Patent, col. 27:36-46).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The basis for this allegation is that Defendants' proposed package insert for the ANDA Products will instruct and encourage medical professionals and patients to administer the products in a manner that directly infringes the ’565 Patent. This conduct is alleged to be done with knowledge and specific intent (Compl. ¶38-39).
  • Willful Infringement: The complaint does not use the term "willful infringement" but does allege the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶42; Prayer for Relief (g)). The basis is the allegation that Defendants had knowledge of the ’565 patent at least as of the date they submitted their ANDA, and that this submission was a known act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶41).

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

  • A core issue will be one of "factual composition": Does Defendants' ANDA product, as confidentially described to the FDA, actually meet the specific negative limitations recited in the asserted claims regarding the maximum allowable amounts of chromium, aluminum, iron, and fluoride? The resolution of this evidentiary question, to be determined in discovery, will be central to the infringement analysis.
  • A key legal question will be one of "claim scope for negative limitations": How will the court construe the term "no chromium" in the context of the full claim language "no chromium or chromium in an amount not to exceed 1 µg"? The interpretation of this phrase will establish the technical boundary for infringement.
  • A third major question will concern "validity": As Defendants' Paragraph IV notice asserted invalidity as an alternative to non-infringement (Compl. ¶30), a central issue for the court will be whether the claimed low-impurity formulation was anticipated or rendered obvious by prior art compositions used in parenteral nutrition.