American Regent Inc v. Somerset Therap LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Somerset Therapeutics, LLC, Somerset Pharma, LLC, and Odin Pharmaceuticals, LLC (Delaware / Florida / New Jersey)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11124, D.N.J., 12/13/2024
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Somerset submitted its Abbreviated New Drug Application (ANDA) from its New Jersey place of business and maintains a regular and established place of business in the district.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of infringement of a patent directed to stable trace element compositions for parenteral nutrition.
• Technical Context: The technology involves injectable pharmaceutical compositions containing trace elements like selenium, which are used to supplement parenteral (intravenous) nutrition for patients who cannot receive nourishment orally.
• Key Procedural History: This action arises from Defendant's Paragraph IV Certification in ANDA No. 218780, asserting that the patent-in-suit is invalid or will not be infringed. The complaint notes this case is related to a prior action (C.A. No. 24-7807, D.N.J.) involving the same ANDA but a different patent, U.S. Patent No. 11,998,565.

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"

• 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 describes a problem in parenteral nutrition (PN) where admixing trace elements into a PN solution results in a formulation with a very short stability period, often just 24 to 48 hours. This necessitates frequent, time-consuming, and expensive preparation of PN bags, leading to waste and potential supply shortages if a patient's treatment is paused ('957 Patent, col. 1:10-2:24).
• The Patented Solution: The invention provides an injectable trace element composition that, when added to parenteral nutrition, creates a final mixture that is stable for a longer period. This allows PN solutions to be prepared in larger batches and stored, reducing costs, waste, and the logistical burden on patients and healthcare providers ('957 Patent, Abstract; col. 2:45-58). The core of the solution is a formulation with specific concentrations and low levels of certain impurities, such as chromium.
• Technical Importance: By extending the stability of trace-element-fortified parenteral nutrition, the invention facilitates more efficient and less costly patient care, improving the quality of life for patients requiring long-term intravenous feeding ('957 Patent, col. 2:35-44).

Key Claims at a Glance

• The complaint alleges infringement of "one or more claims" without specifying them (Compl. ¶40). Independent claim 1 is representative of the asserted technology.
• Independent Claim 1 recites a method with the following essential elements:
  • A method of providing an injectable composition to a patient in need thereof, comprising administering the injectable composition to the patient;
  • The injectable composition comprises water;
  • The composition further 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"; and
  • The composition has "fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition."
• The complaint reserves the right to assert additional claims, which may include dependent claims (Compl. ¶41).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is Defendant's generic drug product, identified as "Selenious Acid Injection, USP, (600 mcg Selenium/10 mL (60 mcg Selenium/mL)) in a 10 mL pharmacy bulk package," for which Defendant submitted ANDA No. 218780 to the FDA (Compl. ¶1, ¶35).

Functionality and Market Context

• The ANDA Product is a generic version of Plaintiff's commercial Selenious Acid product and is intended to be administered to patients by medical practitioners according to directions in a proposed package insert (Compl. ¶34, ¶40). The complaint alleges that the ANDA Product contains the same or equivalent ingredients and will have the same or equivalent chemical and therapeutic properties as Plaintiff's reference listed drug (Compl. ¶36, ¶37). The act of infringement alleged is the submission of the ANDA itself, which seeks approval for future commercial manufacture, use, and sale in the United States (Compl. ¶39).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The following summary is based on the narrative allegations for a representative independent claim.

'957 Patent Infringement Allegations

Identified Points of Contention

• Evidentiary Questions: The complaint's infringement theory rests heavily on the selenium concentration, which appears to map directly onto the claim language. However, the complaint is silent on whether the ANDA Product meets the negative limitations concerning chromium, aluminum, iron, and the limitation on fluoride. The central dispute will likely be an evidentiary one, focused on what discovery reveals about the full composition of Defendant's product.
• Scope Questions: The case may raise questions about the scope of the negative limitations. For instance, a key issue could be whether the term "no chromium" requires absolute absence or a level below a certain detection threshold. The patent's explicit provision of a numerical cap ("not to exceed 1 µg") as an alternative to "no chromium" suggests these are distinct standards that will require judicial construction.

V. Key Claim Terms for Construction

• The Term: "no chromium" (and analogous terms "no aluminum," "no iron")
• Context and Importance: These negative limitations are critical to defining the scope of the invention and will be central to the infringement analysis. The defendant will be cleared of infringement if its product contains any of these elements in an amount that falls outside the claim's specified boundaries. Practitioners may focus on this term because the presence of even trace impurities in the accused product could be a dispositive, non-infringement defense.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (e.g., not intentionally added): The patent repeatedly discusses the goal of minimizing impurities and provides maximum allowable limits for various elements, framing the invention in the context of controlling, rather than completely eliminating, contaminants ('957 Patent, col. 13:45-14:65). This context could support a reading where "no" implies the element is not a designated ingredient and is not present in a functionally significant amount.
  • Evidence for a Narrower Interpretation (e.g., absolute absence): Claim 1 presents "no chromium" as a distinct alternative to "chromium in an amount not to exceed 1 µg." A party could argue that to give meaning to both phrases, "no" must mean a complete absence, or at least a non-detectable amount using standard industry techniques. The patent itself states, "In many cases, the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" ('957 Patent, col. 13:50-52), distinguishing between "detectable" and "no."

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendant will induce infringement by providing a proposed package insert with its ANDA Product that will instruct and encourage medical practitioners to administer the drug in an infringing manner (Compl. ¶40). It also alleges contributory infringement, stating that Defendant knows the product is especially adapted for this infringing use and is not suitable for substantial non-infringing uses (Compl. ¶41).
• Willful Infringement: While the complaint does not explicitly use the term "willful," it alleges that Defendant has had "knowledge of the '957 patent since at least October 11, 2024," two months before the suit was filed (Compl. ¶43). This allegation, combined with the request for a finding that the case is "exceptional" for the purpose of awarding attorneys' fees, lays the groundwork for a willfulness claim (Compl. ¶44).

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

• A central issue will be one of evidence: The complaint makes a facial allegation of infringement based on the selenium concentration in the accused product. However, a key evidentiary question is whether discovery will demonstrate that Defendant's product also meets the multiple negative and low-level limitations for impurities (chromium, aluminum, iron, fluoride) required by the asserted claims, a point on which the complaint is silent.
• The case will also turn on a question of claim construction: How will the court interpret the negative limitation "no chromium" in a claim that also provides an alternative quantitative cap ("not to exceed 1 µg")? Whether "no" means an absolute absence or a level below a certain threshold will be a critical legal determination for the infringement analysis.