American Regent Inc v. Zydus Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Zydus Pharmaceuticals (USA) Inc. (New Jersey)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11133, D.N.J., 12/13/2024
• Venue Allegations: Venue is alleged to be proper as Defendant is incorporated in New Jersey, maintains its principal place of business in the district, and has committed acts of infringement in New Jersey.
• Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's Selenious Acid products constitutes infringement of a patent covering stable trace element compositions for parenteral nutrition.
• Technical Context: The technology concerns injectable trace element compositions used in parenteral nutrition, which provides nutrients intravenously to patients who cannot eat or absorb food through their digestive tract.
• Key Procedural History: The complaint notes a "Related Action" (C.A. No. 24-7812) involving the same parties and the same ANDA, but concerning a different patent. The complaint also alleges that Plaintiff provided Defendant with notice of the patent-in-suit's impending issuance on October 11, 2024, which may form the basis for a willfulness claim.

Case Timeline

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

U.S. Patent No. 12,150,957 - Trace element compositions, methods of making and use

The Invention Explained

• Problem Addressed: The patent describes a problem in the field of parenteral nutrition (PN) where admixing trace elements into a PN solution leads to a short stability period (typically 24-48 hours). This necessitates frequent, time-consuming, and costly preparation of PN solutions under aseptic conditions, and can lead to drug supply shortages if prepared solutions must be discarded ('957 Patent, col. 1:49-2:25).
• The Patented Solution: The invention provides a stable, injectable trace element composition that, when added to a PN solution, allows the mixture to remain stable for a longer period. The solution comprises specific concentrations of trace elements such as zinc, copper, selenium, and manganese in water, reducing the need for frequent admixing and improving the quality of life for patients and caregivers ('957 Patent, Abstract; col. 2:31-44).
• Technical Importance: The invention addresses the need for more flexible and cost-effective administration of parenteral nutrition by extending the shelf-life of admixed solutions containing essential trace metals ('957 Patent, col. 2:31-39).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims" but does not specify which ones (Compl. ¶33). Independent claim 1 is representative of the patented composition.
• Essential elements of Independent Claim 1:
  • An injectable composition comprising water, and at least one of:
  • about 800 µg to about 4,000 µg of zinc,
  • about 40 µg to about 400 µg of copper,
  • from about 4 µg to about 90 µg of selenium, or
  • from about 1 µg to about 80 µg of manganese
  • per 1 mL of the injectable composition.
• The complaint does not explicitly reserve the right to assert dependent claims, but the prayer for relief seeks judgment on "at least one claim" of the Asserted Patent (Compl., Prayer for Relief ¶(b)).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant Zydus's generic Selenious Acid products ("the ANDA Products") described in ANDA No. 219322 (Compl. ¶1).

Functionality and Market Context

• The complaint alleges the ANDA Products are generic versions of Plaintiff ARI's Selenious Acid products, intended for intravenous use (Compl. ¶¶27, 28). The specific formulations disclosed in a notice letter are selenious acid solutions at concentrations of 12 mcg/2 mL, 60 mcg/mL, and 600 mcg/10 mL (Compl. ¶28).
• The complaint alleges these products are designed to have the "same or equivalent formulations" and "the same or equivalent chemical and therapeutic properties" as ARI's branded products, which are covered by the '957 Patent (Compl. ¶¶19, 29, 30). Zydus seeks FDA approval to commercially manufacture and sell these products prior to the expiration of the '957 Patent (Compl. ¶1).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart. The following chart summarizes the infringement theory for representative independent claim 1, based on the complaint's allegation that Zydus's ANDA product is a generic equivalent to ARI's patented product.

'957 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A central question will be the interpretation of the term "about" as it modifies the numerical concentration ranges. The infringement analysis will depend on whether the specific concentrations in Zydus's ANDA product, once revealed in discovery, fall within the scope of the claimed ranges, as construed by the court.
  • Technical Questions: A key factual question will be whether Zydus's ANDA product formulation is bioequivalent and contains the same or "equivalent" ingredients in amounts that meet the limitations of the asserted claims. The complaint alleges this equivalence, but the actual formulation of the ANDA product will be subject to discovery and scrutiny (Compl. ¶¶27, 29).

V. Key Claim Terms for Construction

• The Term: "about"
• Context and Importance: This term appears in the preamble of Claim 1 modifying all four trace element concentration ranges. Its construction is critical because the infringement determination will likely depend on whether the precise concentrations in Zydus's ANDA product fall within the patent's claimed numerical boundaries. Practitioners may focus on this term because even a small deviation in the ANDA product's formulation from the recited numbers could avoid literal infringement, making the scope of "about" determinative.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent consistently uses "about" when reciting numerical ranges in the summary, detailed description, and claims, suggesting the patentee did not intend to be limited to the exact numbers recited and contemplated some level of variation ('957 Patent, col. 2:64, col. 3:2, col. 4:8-14).
  • Evidence for a Narrower Interpretation: The patent provides numerous specific, precise numerical values in its examples and tables (e.g., Table 1 lists "13.20 mg" of Zinc Sulfate, not "about 13.20 mg"). A party could argue that these specific embodiments limit the scope of "about" to a very narrow range of equivalents, preventing it from capturing formulations that differ significantly from those explicitly disclosed ('957 Patent, Table 1, col. 11:15-24).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Zydus will induce infringement by providing a proposed package insert with its ANDA Product that will instruct patients and medical practitioners to administer the product in an infringing manner (Compl. ¶33). It further alleges contributory infringement, stating the ANDA Product is especially made for use in an infringing manner and is not suitable for substantial non-infringing use (Compl. ¶34).
• Willful Infringement: The complaint alleges that Zydus has had knowledge of the '957 patent since "at least October 11, 2024," when ARI allegedly informed Zydus that the patent would be issuing (Compl. ¶36). This allegation of pre-suit knowledge forms the basis for the claim of willful infringement and the request for attorneys' fees under 35 U.S.C. § 285 (Compl. ¶37).

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

This Hatch-Waxman action will likely center on two primary questions for the court:

• A central factual question of composition: Following discovery, does the precise formulation of Zydus's ANDA product, particularly the concentrations of zinc, copper, selenium, and manganese, fall within the literal numerical ranges recited in the asserted claims of the '957 patent?
• A key legal question of claim scope: If the ANDA product's formulation does not fall squarely within the recited numbers, how broadly will the court construe the term "about"? The case may turn on whether this term expands the claimed ranges sufficiently to encompass Zydus's formulation, either literally or under the doctrine of equivalents.