American Regent Inc v. Gland Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Gland Pharma Limited (India)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11116, D.N.J., 12/13/2024
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign company not residing in any U.S. judicial district and may be sued in any judicial district.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of infringement of a patent directed to trace element compositions for parenteral nutrition.
• Technical Context: The technology concerns stable, injectable pharmaceutical formulations containing trace elements, such as selenium, for use as a supplement in intravenous parenteral nutrition for patients who cannot receive nourishment orally.
• Key Procedural History: The complaint notes this case is related to a prior action (C.A. No. 24-7802, D.N.J.) involving the same defendant and the same ANDA, but a different patent. The current action was filed after Plaintiff notified Defendant of the issuance of the patent-in-suit. Plaintiff alleges Defendant has had knowledge of the patent since at least October 11, 2024.

Case Timeline

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

• Patent Identification: 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 section describes challenges with parenteral nutrition (PN), where nutrients are delivered intravenously. Specifically, when trace elements are added to PN solutions, the mixture often has a short stability period (e.g., 24-48 hours), requiring frequent, costly, and time-consuming admixing under aseptic conditions. This can also lead to drug shortages and waste if a patient's treatment is put on hold (’957 Patent, col. 2:5-24).
• The Patented Solution: The invention is a stable, injectable trace element composition that can be added to PN. This composition is designed to be stable for a longer period, which reduces the frequency of admixing, minimizes waste, and improves the quality of life for patients and caregivers by reducing trips to healthcare facilities (’957 Patent, col. 2:31-44). The composition contains specific concentrations of trace elements like selenium, zinc, copper, and manganese (’957 Patent, Abstract).
• Technical Importance: By creating a more stable formulation, the invention sought to reduce the logistical burdens, costs, and potential for waste associated with preparing parenteral nutrition solutions requiring trace element supplementation (’957 Patent, col. 2:31-44).

Key Claims at a Glance

• The complaint asserts infringement of one or more claims without specifying them (Compl. ¶29). Independent claim 19 is representative of the asserted method claims.
• Independent Claim 19 requires:
  • 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, which may include dependent claims (’957 Patent, col. 74:1-12; Compl. ¶29).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is Gland Pharma's generic selenious acid product described in ANDA No. 219629 ("the ANDA Product") (Compl. ¶1).

Functionality and Market Context

• The complaint alleges the ANDA Product is a generic version of American Regent's Selenious Acid products and is described as "selenious acid (trace elements injection selenious acid, USP) in 10 mL pharmacy bulk package vial" (Compl. ¶23-24).
• The product is alleged to contain "60 mcg Selenium/mL," which is the same or an equivalent amount as the reference listed drug (Compl. ¶25).
• The complaint alleges the ANDA Product will have the same or equivalent chemical and therapeutic properties as Plaintiff's product and will be administered to patients by medical practitioners according to a proposed package insert (Compl. ¶26, ¶29).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint pleads infringement generally without providing a detailed, element-by-element analysis. The following chart summarizes the infringement theory for representative Claim 19 based on the facts alleged in the complaint.

U.S. Patent No. 12,150,957 Infringement Allegations

• Identified Points of Contention:
  • Factual Questions: A central dispute will be factual, centering on the precise composition of the ANDA Product. The complaint does not allege any facts regarding the presence or absence of chromium, aluminum, iron, or iodine in Gland Pharma’s formulation. Discovery will be required to determine if the product meets these positive and negative claim limitations.
  • Scope Questions: The infringement analysis will depend on whether Gland's proposed product label instructs administration in a manner that falls within the scope of the term "administering... to the patient" as used in the patent.

V. Key Claim Terms for Construction

• The Term: "no chromium"
• Context and Importance: This is a negative limitation, and its construction is critical for determining infringement. If the accused product contains any amount of chromium, even as an unintended impurity, infringement could be avoided depending on the term's definition. Practitioners may focus on this term because the patent appears to use it inconsistently, creating ambiguity.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (e.g., "not intentionally added" or "below a certain threshold"): The patent specification states in some embodiments that "the chromium content will not exceed about 0.3 µg/mL" and includes tables listing acceptable limits for impurities, suggesting the invention tolerates some level of chromium (’957 Patent, col. 17:5-7; Table 4). This may support an argument that "no chromium" does not mean absolute zero.
  • Evidence for a Narrower Interpretation (e.g., "absolute absence"): The claim uses the plain word "no," which could be argued to mean a complete absence. Elsewhere, the specification states the composition "does not contain any detectable chromium or no chromium at all," which could be read to require either non-detectability or absolute absence, distinguishing it from compositions that merely have a low amount (’957 Patent, col. 13:50-51).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Gland Pharma's proposed package insert will instruct and encourage medical practitioners to administer the ANDA Product in an infringing manner. It further alleges Gland knows or should know this conduct would cause infringement and that Gland possesses the specific intent to cause infringement (Compl. ¶29). The complaint also pleads contributory infringement, alleging the ANDA Product is especially made for an infringing use and is not suitable for substantial non-infringing use (Compl. ¶30).
• Willful Infringement: The complaint alleges Gland has had knowledge of the ’957 patent "since at least October 11, 2024," when Plaintiff allegedly emailed Defendant to inform it that the patent would issue (Compl. ¶32). This alleged pre-suit notice forms the basis for the willfulness claim.

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

• A primary issue will be one of evidentiary proof: Can Plaintiff demonstrate through discovery that Defendant’s ANDA product meets the patent’s numerous negative limitations (e.g., "no chromium," "no aluminum," "no iron") and positive limitation for iodine? The complaint’s silence on these compositional facts makes this the central and unresolved factual question.
• The case may also turn on a question of claim construction: How will the court interpret the negative limitation "no chromium"? The resolution of whether this term means an absolute absence of the element, or merely an amount below a certain de minimis or non-functional threshold, will be critical to the infringement analysis.