American Regent Inc v. Aspiro Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Aspiro Pharma Ltd. (India)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11109, D.N.J., 12/13/2024
• Venue Allegations: Venue is alleged on the basis that Defendant is a foreign corporation that may be sued in any judicial district. The complaint also alleges personal jurisdiction based on Defendant's systematic contacts with New Jersey, plans to sell the accused product in the state, and the designation of a U.S. Agent for service of process located in Piscataway, New Jersey.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of Plaintiff's Selenious Acid injection products constitutes an act of infringement of a patent covering trace element compositions for parenteral nutrition.
• Technical Context: The technology relates to stable, injectable trace element compositions used in parenteral nutrition, a critical method for providing nutrients to patients who cannot ingest food orally.
• Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendant's Paragraph IV certification in its ANDA No. 219633. This case is related to a prior action (C.A. No. 24-7794) between the parties involving the same ANDA but a different patent. The complaint alleges that Defendant was notified of the patent-in-suit's impending issuance approximately two months before this complaint was filed.

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 describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixture often has a short stability period of only 24 to 48 hours at room temperature, leading to waste and increased costs (’957 Patent, col. 2:5-18). Furthermore, existing all-in-one formulations make it difficult to customize doses for a patient's specific needs, particularly as recommended daily doses for elements like chromium have been reduced (’957 Patent, col. 1:46-58).
• The Patented Solution: The invention provides stable, injectable compositions containing specific concentrations of trace elements like zinc, copper, selenium, and manganese. These compositions are designed to be stable for longer periods (e.g., at least 3 to 14 days) when added to PN solutions, which reduces waste and allows for the preparation of daily doses in larger, more efficient batches (’957 Patent, Abstract; col. 2:46-61). The patent also describes formulations with lower or no amounts of certain elements like chromium, allowing for more tailored patient therapy (’957 Patent, col. 13:46-52).
• Technical Importance: The patented approach aims to provide more stable, flexible, and cost-effective methods for administering essential micronutrients to patients dependent on intravenous feeding (’957 Patent, col. 2:31-44).

Key Claims at a Glance

• The complaint does not identify specific claims but alleges infringement of "one or more claims" ('Compl. ¶29). Independent claim 19 is a representative method of use claim.
• Independent Claim 19 includes the following essential elements:
  • A method of providing a composition to a patient in need thereof.
  • The method comprises administering the composition to the patient.
  • The composition comprises water.
  • The composition comprises "6 µg, 40 µg or 60 µg of selenium."
  • The composition has "no chromium or chromium in an amount not to exceed 1 µg."
  • The composition has "no aluminum or aluminum in an amount not to exceed 6 µg."
  • The composition has "no iron or iron in an amount not to exceed 10 µg."
  • The composition comprises "iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL."
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

• Defendant’s Abbreviated New Drug Application (ANDA) Products, identified as "Selenious Acid Injection USP, eq. 600 mcg Selenium/10 mL (eq. 60 mcg Selenium/mL) and eq. 12 mcg Selenium/2 mL (eq. 6 mcg selenium/mL)" (Compl. ¶¶ 1, 24).

Functionality and Market Context

• The accused products are generic versions of Plaintiff's Selenious Acid products and are intended to be used as supplements in parenteral nutrition (Compl. ¶¶ 1, 23). The complaint alleges the ANDA Products contain the "same or equivalent ingredients in the same or equivalent amounts" and will have the "same or equivalent chemical and therapeutic properties" as the reference listed drug (Compl. ¶¶ 25-26). The act of infringement alleged is the submission of the ANDA itself, which seeks approval for a use that is covered by the patent (’957 Patent, Compl. ¶28).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’957 Patent Infringement Allegations

Identified Points of Contention

• Evidentiary Question: The complaint's infringement theory relies heavily on the assertion that the ANDA Product is a generic equivalent (Compl. ¶23, ¶26). It does not, however, provide direct factual allegations from the ANDA itself confirming that the product meets the specific quantitative limitations for chromium, aluminum, iron, and iodine required by Claim 19. The actual contents of the ANDA filing will be a critical piece of evidence.
• Technical Question: A key question is whether Defendant's product formulation contains the required trace amount of iodine (0.0001 µg to 0.2 µg/mL). The complaint is silent on this element, and its absence from the ANDA product would present a direct challenge to literal infringement of Claim 19.

V. Key Claim Terms for Construction

• The Term: "no chromium," "no aluminum," "no iron"
• Context and Importance: These negative limitations are central to distinguishing the invention from prior art formulations that may have contained these elements. Practitioners may focus on these terms because their construction will determine the standard of proof for infringement. A dispute may arise over whether "no" requires absolute absence or can be satisfied if the element is not intentionally added and is present only as an unavoidable impurity below a certain threshold.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification's background discusses the reduction of daily doses for certain elements, suggesting the primary goal is avoiding intentional addition of clinically unnecessary components (’957 Patent, col. 1:46-54). This may support an interpretation that "no" means "not intentionally added."
  • Evidence for a Narrower Interpretation: The claims themselves provide an alternative quantitative limit (e.g., "no chromium or chromium in an amount not to exceed 1 µg") (’957 Patent, col. 47:24-25). This structure suggests that "no" is intended to be a distinct, and likely stricter, standard than the numerical cap. The patent also provides extensive tables of permissible elemental impurity levels, indicating a focus on specific, measurable quantities (’957 Patent, Table 2; Table 4).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b) on the basis that Defendant's proposed package insert for the ANDA Product will instruct and encourage medical practitioners to administer the product in a manner that directly infringes one or more claims of the ’957 patent (Compl. ¶29). It also alleges contributory infringement, stating the product is especially made or adapted for an infringing use and is not suitable for substantial non-infringing use (Compl. ¶30).
• Willful Infringement: The complaint alleges Defendant has had knowledge of the ’957 patent since at least October 11, 2024, when it was informed by Plaintiff's counsel of the patent's impending issuance (Compl. ¶32). This allegation of pre-suit knowledge forms the basis for the willfulness claim and the request for enhanced damages and a finding that the case is "exceptional" under 35 U.S.C. § 285 (Compl. ¶33).

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

• A central issue will be one of evidentiary proof: does Defendant's ANDA specification, once produced in discovery, disclose a product that meets every limitation of the asserted claims? The infringement analysis will depend entirely on whether the ANDA product contains the claimed selenium concentrations while also satisfying the specific quantitative caps for impurities (chromium, aluminum, iron) and, critically, including the required trace amount of iodine.
• The case may also turn on a question of claim construction: how should the court interpret the negative limitation "no chromium"? The answer will define the infringement standard, establishing whether the claim requires the absolute absence of the element or is satisfied if the element is merely not an intentionally-added ingredient.