American Regent Inc v. Accord Healthcare Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Accord Healthcare Inc. (North Carolina)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11108, D.N.J., 12/13/2024
• Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts substantial business in New Jersey, is registered as a drug manufacturer with the state, employs a local sales force, and consented to venue in a related action.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Selenious Acid injection product constitutes an act of infringement of a patent covering trace element compositions and their methods of use.
• Technical Context: The technology concerns stable, injectable trace element formulations used as supplements for patients receiving parenteral nutrition.
• Key Procedural History: This case is related to a prior action (C.A. No. 24-7791, D.N.J.) involving the same parties and the same ANDA, but a different patent. The complaint alleges that Defendant was notified of the patent-in-suit’s impending issuance on October 11, 2024, prior to the filing of this lawsuit.

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 section describes challenges with existing trace element products for parenteral nutrition (PN). Specifically, it notes that admixing these elements into PN solutions is time-consuming and that the resulting admixtures have a short stability period (e.g., 24-48 hours), leading to waste, increased costs, and logistical burdens for patients requiring frequent infusions (U.S. Patent No. 12,150,957, col. 1:4-24). Additionally, existing multi-element formulations may not allow for easy customization to a patient's specific needs ('957 Patent, col. 1:51-56).
• The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to parenteral nutrition, remain stable for a longer duration. This extended stability aims to reduce the frequency of admixing, decrease waste, and improve the quality of life for patients and caregivers ('957 Patent, col. 2:31-39). The patent also describes compositions with specific, and in some cases lower, doses of trace elements like zinc, copper, selenium, and manganese, allowing for more tailored patient treatment ('957 Patent, col. 2:59-68).
• Technical Importance: By creating trace element formulations with longer stability periods post-admixture, the invention addresses a practical need for more efficient and less wasteful administration of long-term parenteral nutrition therapy ('957 Patent, col. 2:31-39).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims" without specifying them (Compl. ¶32). A representative independent claim is Claim 29.
• Essential elements of independent Claim 29 include:
  • A method of providing an injectable composition to a human patient in need thereof, comprising administering the injectable composition to the patient.
  • The injectable composition comprises water and selenious acid 98 µg per 1 mL.
  • The composition has "no chromium" or chromium not exceeding 1 µg per 1 mL.
  • The composition has "no aluminum" or aluminum not exceeding 6 µg per 1 mL.
  • The composition has "no iron" or iron not exceeding 10 µg per 1 mL.
  • The composition comprises fluoride (0.0001 µg to 2.7 µg) or iodine (0.0001 µg to 0.2 µg) per 1 mL.
• The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against the patent.

III. The Accused Instrumentality

Product Identification

The accused products are Accord Healthcare Inc.’s generic Selenious Acid drug products for which it submitted ANDA No. 218655 to the FDA (Compl. ¶1). The products are identified as "Selenious Acid Injection USP, 60 mcg base/mL single-dose vials and 600 mcg base/10 mL (60 mcg base/mL) Pharmacy Bulk Package" (Compl. ¶27).

Functionality and Market Context

The complaint alleges that the ANDA Products are generic versions of Plaintiff's Selenious Acid products and contain the "same or equivalent ingredients in the same or equivalent amounts" (Compl. ¶26). They are intended to be administered to patients as a trace element supplement in parenteral nutrition, according to the directions in a proposed package insert (Compl. ¶¶32, 33). The filing seeks approval for commercial manufacture and sale 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 contain a claim chart. The infringement theory is based on the allegation that Accord’s submission of its ANDA for a generic version of American Regent's Selenious Acid product is an act of infringement under 35 U.S.C. § 271(e)(2) and that future commercialization will constitute direct and indirect infringement (Compl. ¶¶31-33). The following chart summarizes the allegations for representative Claim 29.

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

Identified Points of Contention

• Technical Questions: A primary question will be evidentiary: what proof will be offered to demonstrate that Accord's ANDA product, as would be commercially manufactured, meets the specific negative limitations for chromium, aluminum, and iron, as well as the positive limitation for fluoride or iodine, as required by the claim? The complaint's allegations are conclusory on these points.
• Legal Questions: As the case involves a method-of-use claim asserted in the ANDA context, a central issue will be whether Accord's proposed product labeling and instructions will actively induce medical professionals and patients to perform all the steps of the claimed method, including administration of a product that meets every compositional limitation.

V. Key Claim Terms for Construction

The Term: "no chromium" / "no aluminum" / "no iron"

• Context and Importance: These negative limitations are fundamental to defining the scope of the claimed composition. Infringement will hinge on whether Accord's product contains these elements in amounts exceeding the claimed thresholds. Practitioners may focus on these terms because the presence of even minute, measurable quantities of these impurities in the accused product could be dispositive of non-infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language itself provides a ceiling (e.g., "no chromium or chromium in an amount not to exceed 1 µg"), suggesting "no" is not absolute but rather means below a specified, measurable limit ('957 Patent, col. 74:48-49). This sets a clear, albeit strict, boundary.
  • Evidence for a Narrower Interpretation: A defendant could argue for a very strict interpretation, potentially focusing on the patent's statement that "the trace elements injectable compositions of this application do not contain any detectable chromium" ('957 Patent, col. 17:1-2). This could raise questions about the limits of detection technology and whether any detectable amount, however small, falls outside the claim scope, notwithstanding the explicit 1 µg ceiling in the claim itself.

VI. Other Allegations

Indirect Infringement

The complaint alleges that Accord will induce infringement by providing a product with a proposed package insert containing "directions and instructions" for its administration by patients and medical practitioners (Compl. ¶32). It further alleges Accord will "actively induce, encourage, aid, and abet" the infringing conduct with knowledge and specific intent (Compl. ¶32). The complaint also alleges contributory infringement, stating the ANDA Products are especially made for infringing use and are not suitable for substantial non-infringing use (Compl. ¶33).

Willful Infringement

The complaint alleges that Accord has had knowledge of the ’957 patent "since at least October 11, 2024," based on an email from ARI's counsel informing them of the patent’s impending issuance (Compl. ¶35). This pre-suit notice forms the basis of the willfulness allegation.

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

• A central issue will be one of evidentiary proof: Can Plaintiff demonstrate, through discovery and testing, that Defendant's proposed generic product will, as manufactured, meet the highly specific compositional limitations of the asserted claims, particularly the negative limitations on impurities like chromium, aluminum, and iron? The complaint lacks specific factual allegations on the accused product's precise composition.
• A key legal question will be one of induced infringement: Assuming the compositional elements are met, does the content of Defendant's proposed package insert and other instructional materials direct or encourage medical professionals to administer the product in a manner that satisfies all steps of the asserted method claims, thus establishing the requisite intent for inducement?