American Regent Inc v. Hikma Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Hikma Pharmaceuticals USA Inc. (Delaware)
  • Plaintiff’s Counsel: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11118, D.N.J., 12/13/2024
• Venue Allegations: Venue is based on Defendant's regular and established place of business in New Jersey, from which it allegedly submitted the Abbreviated New Drug Application (ANDA) at issue and where it intends to market the accused products.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA for generic versions of Plaintiff's Selenious Acid injectable products constitutes an act of infringement of a patent covering methods of using trace element compositions.
• Technical Context: The technology relates to stable, injectable trace element compositions for parenteral nutrition, a method of feeding patients intravenously when oral ingestion is not possible.
• Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendant’s Paragraph IV certification in ANDA No. 217680. The complaint notes a "Related Action" (24-cv-7803, D.N.J.) involving the same ANDA but a different patent. Plaintiff alleges it notified Defendant of the patent-in-suit’s impending issuance on October 11, 2024, prior to filing this complaint.

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, issued November 26, 2024
• The Invention Explained:
  • Problem Addressed: The patent's background describes that parenteral nutrition (PN) solutions mixed with trace elements have a limited stability of only 24 to 48 hours, which necessitates frequent, costly, and resource-intensive admixing under sterile conditions, leading to waste and potential supply shortages (’957 Patent, col. 1:56 - col. 2:24). Furthermore, existing multi-element formulations are not easily customizable and may provide higher-than-necessary doses of certain elements, such as chromium ('957 Patent, col. 2:46-56).
  • The Patented Solution: The invention provides stable, injectable trace element compositions designed to be added to PN solutions, thereby extending their usable life. This solution aims to reduce preparation time and costs, minimize waste, and improve the quality of life for patients and caregivers by reducing the need for frequent trips to healthcare facilities (’957 Patent, col. 2:32-44). The compositions are also formulated to provide lower, more appropriate daily doses of certain trace elements ('957 Patent, Abstract).
  • Technical Importance: By creating longer-lasting, ready-to-use trace element formulations for PN, the invention addresses significant logistical and economic burdens in clinical practice associated with short-stability nutritional admixtures (’957 Patent, col. 2:32-44).
• Key Claims at a Glance:
  • The complaint asserts infringement of "one or more claims" of the '957 Patent, with independent claim 19 being representative of the asserted technology (Compl. ¶29).
  • The essential elements of independent claim 19 are:
    • A method of providing a composition to a patient in need thereof,
    • the method comprising administering at least the composition to the patient,
    • the composition comprising water,
    • 6 µg, 40 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 not to exceed 10 µg, and
    • iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL of the composition.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶29).

III. The Accused Instrumentality

• Product Identification: Defendant’s proposed generic Selenious Acid Injection, USP, products, which are the subject of Abbreviated New Drug Application (ANDA) No. 217680 ("the ANDA Products") (Compl. ¶1, ¶24).
• Functionality and Market Context:
  • The ANDA Products are described as injectable selenious acid solutions in three formulations: 12 mcg/2 mL (6 mcg/mL), 60 mcg/mL, and 600 mcg/10 mL (60 mcg/mL) (Compl. ¶24). They are intended to be administered to a patient as a supplement for parenteral nutrition (Compl. ¶29).
  • The complaint alleges these products are generic versions of Plaintiff's commercial Selenious Acid products, containing the same or equivalent active ingredients and possessing equivalent therapeutic properties (Compl. ¶23, ¶25, ¶26). Infringement is predicated on the future administration of these products according to the instructions in their proposed package inserts (Compl. ¶29).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

• '957 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The complaint alleges infringement but offers no specific facts demonstrating that the ANDA Products meet the negative limitations of claim 19 (i.e., the upper limits for chromium, aluminum, and iron) or the specific range for iodine. The dispute will likely focus on whether the actual composition of Hikma's product, once revealed in discovery, falls within these claimed boundaries.
  • Technical Questions: A primary factual question is the precise chemical makeup of the ANDA Products. Evidence will be required to establish the concentration of not only selenium but also any trace impurities like chromium, aluminum, iron, and iodine that may be present from manufacturing processes or raw materials.

V. Key Claim Terms for Construction

• The Term: "no chromium or chromium in an amount not to exceed 1 µg"
• Context and Importance: This negative limitation is critical for defining the scope of the invention, as the patent distinguishes itself from prior art by reducing or eliminating certain elements like chromium. Practitioners may focus on this term because the infringement analysis will depend on the precise amount of chromium, if any, in the accused product. The construction will determine whether any detectable amount of chromium avoids infringement or if only amounts above the 1 µg threshold are excluded.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (Plaintiff-favored): The claim's structure—"no chromium or chromium in an amount not to exceed 1 µg"—could be read to encompass a range from zero up to and including 1 µg. The specification supports a desire for low chromium levels, stating the goal is "to have no or little chromium" ('957 Patent, col. 13:59-60).
  • Evidence for a Narrower Interpretation (Defendant-favored): A defendant may argue that "no chromium" should be construed as an absolute absence, distinct from the alternative "not to exceed 1 µg." The specification notes, "In many cases, the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" ('957 Patent, col. 13:49-52). This could be used to argue that "no" means either literally zero or below the limit of detection at the time of the invention, potentially creating a non-infringement argument for a product with a minuscule but detectable amount.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendant’s proposed package insert will actively instruct and encourage medical professionals to administer the ANDA Products in a manner that directly infringes the '957 Patent (Compl. ¶29). It also pleads contributory infringement, alleging the ANDA Product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶30).
• Willful Infringement: While not explicitly pleading willfulness, the complaint lays a foundation by alleging Defendant had knowledge of the '957 Patent "since at least October 11, 2024" via an email from Plaintiff (Compl. ¶32). It also seeks a finding that the case is "exceptional" and an award of attorneys' fees, which is often tied to findings of egregious infringement conduct (Compl. ¶33, Prayer (g)).

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

• A central issue will be one of evidentiary proof: can the Plaintiff demonstrate through discovery that the Defendant's ANDA product, as formulated, meets all the specific positive and negative limitations of the asserted claims? The dispute will likely turn on the precise, measured concentration of trace elements and impurities like chromium, aluminum, iron, and iodine in the accused generic product.
• A key legal question will be one of claim construction: how will the court interpret the negative limitation "no chromium or chromium in an amount not to exceed 1 µg"? The outcome may depend on whether "no chromium" is defined as an absolute absence or a level below a given detection threshold, a distinction that could be dispositive for infringement.