American Regent Inc v. Sun Pharmaceutical Industries Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Sun Pharmaceutical Industries Limited (India) and Sun Pharmaceutical Industries, Inc. (Delaware)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11126, D.N.J., 12/13/2024
• Venue Allegations: Plaintiff alleges venue is proper because Defendant Sun Pharmaceutical Industries, Inc. has a principal place of business in New Jersey, has committed acts of infringement in the district by submitting its Abbreviated New Drug Application (ANDA) to the FDA, and maintains a regular and established place of business in the district.
• Core Dispute: Plaintiff alleges that Defendants’ filing of an ANDA to market a generic version of Plaintiff's Selenious Acid injection products constitutes an act of infringement of a patent covering stable trace element compositions for parenteral nutrition.
• Technical Context: The technology concerns injectable trace element formulations used as nutritional supplements for patients who cannot receive nourishment orally, a critical component of parenteral care.
• Key Procedural History: This is a Hatch-Waxman action triggered by Defendants’ submission of an ANDA with a Paragraph IV certification, asserting non-infringement or invalidity of a related patent. The patent-in-suit was recently issued and listed in the FDA's "Orange Book" in connection with Plaintiff's approved Selenious Acid products. The complaint also notes a related action involving the same ANDA and a different patent.

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 identifies a need for improved injectable trace element compositions for patients receiving parenteral (intravenous) nutrition (’957 Patent, col. 1:10-14). Existing solutions have short stability once trace elements are admixed, requiring frequent preparation under sterile conditions, which is costly, time-consuming, and can lead to waste and drug shortages (’957 Patent, col. 2:3-23). The background also notes that existing all-in-one formulations are not easily customizable to a patient's specific needs and may contain trace elements at higher-than-recommended daily doses (’957 Patent, col. 2:46-56).
• The Patented Solution: The invention is a stable injectable composition containing specific concentrations of trace elements like zinc, copper, selenium, and manganese that can be added to parenteral nutrition solutions (’957 Patent, Abstract). This formulation is designed to be stable for a longer period, which allows for batch preparation, reduces waste, and improves the quality of life for patients and caregivers by avoiding frequent trips to healthcare facilities for admixing (’957 Patent, col. 2:32-44).
• Technical Importance: The invention addresses the clinical and logistical challenges of parenteral nutrition by providing a stable, customizable trace element additive, potentially reducing healthcare costs and improving patient care safety and convenience (’957 Patent, col. 2:35-44).

Key Claims at a Glance

• The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶38). Independent claim 1 is representative of the core composition invention.
• Independent Claim 1: An injectable composition comprising:
  • water
  • at least one of:
    • about 800 µg to about 4,000 µg of zinc
    • about 40 µg to about 400 µg of copper
    • about 4 µg to about 90 µg of selenium, or
    • about 1 µg to about 80 µg of manganese
  • per 1 mL of the injectable composition
• The complaint does not explicitly reserve the right to assert dependent claims, but the broad allegation of infringing "one or more claims" preserves this option (Compl. ¶38).

III. The Accused Instrumentality

Product Identification

• Defendants’ generic Selenious Acid product, identified as "Selenious Acid Injection, USP, 600 mcg/10 mL (60 mcg/mL) of selenium in a 10 mL pharmacy bulk package," which is the subject of ANDA No. 219547 (Compl. ¶1, ¶33).

Functionality and Market Context

• The complaint alleges that the accused ANDA Product is a generic version of Plaintiff’s approved Selenious Acid products and, as such, contains the "same or equivalent ingredients in the same or equivalent amounts" and will feature the "same or equivalent chemical and therapeutic properties" (Compl. ¶32, ¶34, ¶35). The product is intended for use as a supplement to parenteral nutrition (Compl. ¶38). The complaint does not provide specific details on the full formulation of the accused product beyond its selenium concentration.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or detailed, element-by-element infringement allegations. The infringement theory is based on 35 U.S.C. § 271(e)(2), which makes the submission of an ANDA for a generic drug an act of infringement if the commercial manufacture, use, or sale of that drug would infringe a valid patent (Compl. ¶37). The complaint alleges that because the ANDA Product is a bioequivalent generic, it will necessarily contain the elements of at least one claim of the ’957 Patent and will be used in an infringing manner once approved (Compl. ¶32, ¶38).

No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Factual Scope Question: The complaint identifies the accused product by its selenium concentration but does not allege that it contains the other trace elements recited in independent claim 1 (zinc, copper, manganese) (Compl. ¶33). A primary issue for discovery will be to determine the full composition of the accused ANDA Product and whether it contains these other elements within the claimed concentration ranges.
  • Technical Question: The patent places significant emphasis on achieving a "stable" composition, as described in Section II. An open question is whether Defendants’ formulation, even if bioequivalent for regulatory purposes, meets the specific stability characteristics defined and claimed in the patent. The complaint alleges the product will have equivalent properties, but this will be a key area for technical evidence and expert testimony (Compl. ¶35).

V. Key Claim Terms for Construction

• The Term: "a stable injectable composition" (from Claim 1)
• Context and Importance: The patent’s primary stated contribution is solving the stability problems of prior art admixtures. The definition of "stable" will therefore be central to determining the scope of the claims and whether the accused product infringes. Practitioners may focus on this term because if Defendants can show their product does not meet the patent's specific definition of "stable," they may have a viable non-infringement argument.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification provides a general definition that stability refers to the "capability of a pharmaceutical active ingredient or pharmaceutical composition to remain within a specific criteria or specification(s)" (’957 Patent, col. 6:47-49). This could be argued to encompass any formulation that meets its own FDA-approved specifications.
  • Evidence for a Narrower Interpretation: The specification also provides a more specific, exemplary definition: "a stable composition is one which retains at least 85% of the original amount of the injectable composition in that state (e.g., not precipitated, degraded, or adsorbed to the container) for a period of at least 72 hours" (’957 Patent, col. 7:1-5). This quantitative and time-based definition could be used to argue for a narrower construction limited to compositions meeting this specific performance threshold.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendants’ proposed package insert will instruct and encourage patients and medical practitioners to administer the ANDA Product in a manner that directly infringes the patent claims (Compl. ¶38).
• Willful Infringement: The complaint alleges that Defendants have had knowledge of the ’957 patent since at least October 11, 2024, when Plaintiff allegedly informed them via email that the patent would issue (Compl. ¶41). This allegation of pre-suit knowledge forms the basis for the willfulness claim.

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

• A central issue will be one of factual composition: Does the accused generic product, identified in the complaint only by its selenium content, contain the other trace elements (zinc, copper, manganese) at the specific concentrations required by the asserted independent claims of the ’957 patent? The answer, which will depend on discovery, will be dispositive for the literal infringement analysis of a key composition claim.
• The case will also turn on a question of claim construction and technical scope: How will the court construe the term "stable," and does the accused product meet that definition? The dispute may focus on whether mere bioequivalence is sufficient to infringe, or if infringement requires meeting the specific, enhanced stability metrics described as a key advantage in the patent’s specification.
• A key evidentiary question for damages and injunctive relief will be one of intent: Does the proposed product label for the accused generic provide sufficient evidence of Defendants' specific intent to encourage or instruct medical professionals to use the product in a manner that infringes the patent's claims, thereby supporting the allegation of induced infringement?