American Regent Inc v. Long Grove Pharma LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Long Grove Pharmaceuticals, LLC (Delaware)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 2:24-cv-07804, D.N.J., 07/16/2024
• Venue Allegations: Venue is alleged based on Defendant’s business contacts within New Jersey, its registration with the state's Department of Health, and its intent to sell the accused product in the judicial district.
• Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Selenious Acid products constitutes an act of infringement of a patent related to stable injectable trace element compositions.
• Technical Context: The technology concerns pharmaceutical compositions of trace elements, specifically selenium, designed for stable, long-term addition to intravenous parenteral nutrition solutions for patients unable to absorb nutrients orally.
• Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a Paragraph IV Certification notice letter from Defendant, which asserted that the patent-in-suit is invalid or would not be infringed by Defendant’s proposed generic drug product.

Case Timeline

Date	Event
2020-07-02	’565 Patent Priority Date
2024-06-04	’565 Patent Issue Date
2024-06-27	Date of Defendant's Paragraph IV Notice Letter
2024-07-16	Complaint Filing Date

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

• Patent Identification: 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 that adding trace elements to parenteral nutrition (PN) solutions presents stability challenges, often limiting the usable life of an admixed PN bag to 24-48 hours, which necessitates frequent, costly, and wasteful preparation under aseptic conditions (’565 Patent, col. 1:53-col. 2:24). Furthermore, existing multi-element formulations may provide higher-than-necessary daily doses of certain elements, which complicates patient-specific customization (’565 Patent, col. 2:4-10).
• The Patented Solution: The invention is an injectable trace element composition that, when added to PN, remains stable for an extended period (e.g., up to 14 days under refrigeration), thereby reducing admixing frequency, cost, and material waste (’565 Patent, col. 3:1-4). The patented compositions provide specific, and in some cases lower, concentrations of elements like selenium, which allows for more tailored dosing to meet the metabolic needs of individual adult, pediatric, or neonatal patients (’565 Patent, col. 2:57-67).
• Technical Importance: By creating a trace element additive with extended stability after being mixed with parenteral nutrition, the invention sought to improve logistical efficiency and reduce waste in clinical settings for patients requiring long-term intravenous feeding (’565 Patent, col. 2:31-38).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims," which preserves the right to assert various claims as the case proceeds. Independent claim 1 is representative of the core invention.
• The essential elements of independent claim 1 are:
  • 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 instrumentality is Defendant’s proposed generic drug product submitted to the FDA under Abbreviated New Drug Application (ANDA) No. 217850 (Compl. ¶1).
• Functionality and Market Context: The ANDA Product is a generic version of Plaintiff's Selenious Acid injectable products and is intended to be a source of the trace element selenium for patients receiving parenteral nutrition (Compl. ¶¶1, 20). The complaint alleges the ANDA Product contains the "same or equivalent ingredients in the same or equivalent amounts" as the reference listed drug, which includes formulations of Selenious Acid equivalent to 6 mcg/mL and 60 mcg/mL of selenium (Compl. ¶¶20-22). The alleged act of infringement is the statutory filing of the ANDA seeking approval for commercial manufacture, use, and sale of this generic product prior to the expiration of the ’565 patent (Compl. ¶1).

IV. Analysis of Infringement Allegations

The complaint, filed under the provisions of the Hatch-Waxman Act, alleges infringement based on the act of filing the ANDA itself and does not contain a detailed claim chart mapping elements of the asserted claims to specific features of the Defendant's proposed product. The infringement theory is based on the allegation that the product described in the ANDA, if commercially manufactured and sold, would meet all limitations of at least one claim of the ’565 Patent (Compl. ¶¶25, 26).

No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Scope Questions: The asserted claims include both positive limitations (e.g., a specific amount of selenium) and negative limitations (e.g., "no chromium" or a capped amount of other elements). A central issue for the court will be whether the complete formulation specified in Defendant's ANDA falls within these precise boundaries. This raises the question: Does the Defendant's ANDA product, as specified in its FDA submission, contain impurities such as chromium, aluminum, and iron at levels that exceed the strict limits required by the claims?
  • Technical Questions: The infringement analysis will likely depend on a chemical analysis of the ANDA product's formulation. A key technical question is: What do the chemical specifications, manufacturing process descriptions, and quality control data within ANDA No. 217850 reveal about the exact concentration of selenium and the presence and quantity of the other elements recited in the asserted claims?

V. Key Claim Terms for Construction

• The Term: "no chromium"
• Context and Importance: This negative limitation is critical to defining the scope of the claim. The parties may dispute whether "no" requires an absolute absence of the element or an amount below a certain practical threshold, such as the limit of detection. Practitioners may focus on this term because proving absolute absence of a potential trace impurity can be challenging, and the interpretation of this term could be dispositive. The claim's alternative phrasing, "no chromium or chromium in an amount not to exceed 1 µg," suggests the patentee contemplated the potential for trace amounts, which will be a key point of argument (Compl. ¶¶25-27; ’565 Patent, col. 71:38-39).
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (e.g., absolute absence): The plain meaning of "no" could be argued to mean a complete lack of the substance. The specification does not appear to provide an explicit definition of the term "no" that deviates from its ordinary meaning.
  • Evidence for a Narrower Interpretation (e.g., below a detectable or specified limit): The claim structure ("no chromium or chromium in an amount not to exceed 1 µg") may be argued to frame a range, where "no" is the lower bound and 1 µg/mL is the upper bound, implying that "no" means an undetectable or nominal amount rather than absolute zero (’565 Patent, col. 71:38-39). The specification’s Table 2, which lists product specifications, sets an upper limit for chromium impurity at "Not more than 1.0 µg/mL," which may be used to argue the patentee's own understanding of the relevant impurity levels (’565 Patent, Table 2, col. 13).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendant will induce infringement by providing a package insert with its ANDA Product that will instruct medical professionals and patients to use the product in a manner that infringes the ’565 patent (Compl. ¶26). It further alleges contributory infringement, stating that the ANDA Product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶27).
• Willful Infringement: While the complaint does not use the term "willful," it alleges that Defendant has had "knowledge of the '565 patent since at least the date Long Grove submitted the ANDA with a Paragraph IV Certification" (Compl. ¶29). This allegation of pre-suit knowledge provides the basis for the request that the court find the case "exceptional" and award attorneys' fees under 35 U.S.C. § 285 (Compl. ¶30).

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

• A primary factual question will be one of compositional identity: Does the precise formulation of Defendant’s proposed generic drug, as detailed in its confidential ANDA submission to the FDA, fall within the specific quantitative ranges for selenium and, crucially, below the strict upper limits for impurities like chromium and aluminum, as required by the asserted claims?
• A key legal issue will be one of claim scope and negative limitations: How will the court construe the term "no chromium"? Whether this term is interpreted to mean an absolute absence, an amount below a standard detection limit, or simply not intentionally added will be central to the infringement analysis.
• The case will likely focus on an evidentiary deep dive into the ANDA: The dispute will ultimately turn on the contents of ANDA No. 217850. The product specifications, manufacturing controls, and impurity profiles contained therein will constitute the primary evidence for determining whether the proposed generic product, if approved, would infringe the ’565 patent.