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-01030, D.N.J., 02/22/2024
• Venue Allegations: Venue is alleged based on Defendants' established and regular places of business in New Jersey, where Defendants are alleged to have prepared and submitted the Abbreviated New Drug Application (ANDA) that gives rise to the suit.
• Core Dispute: Plaintiff alleges that Defendants’ filing of an ANDA to market a generic version of Plaintiff’s Multrys® injectable drug constitutes an act of patent infringement under the Hatch-Waxman Act.
• Technical Context: The technology involves stable, multi-trace element compositions for parenteral (intravenous) nutrition, a critical therapy for neonatal and pediatric patients unable to get adequate nutrition orally.
• Key Procedural History: This action was triggered by Defendants' submission of ANDA No. 218823 to the U.S. Food and Drug Administration (FDA). The ANDA included a Paragraph IV Certification asserting that U.S. Patent No. 11,786,548 is invalid or will not be infringed by the proposed generic product. The patent is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for the branded drug Multrys®.

Case Timeline

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

U.S. Patent No. 11,786,548 - "Trace element compositions, methods of making and use"

• Patent Identification: U.S. Patent No. 11,786,548, "Trace element compositions, methods of making and use," issued October 17, 2023.

The Invention Explained

• Problem Addressed: The patent's background section describes the short stability of existing parenteral nutrition (PN) admixtures once trace elements are added, typically lasting only 24 to 48 hours ('548 Patent, col. 2:7-17). This short window leads to product waste, increased healthcare costs, and requires frequent, burdensome admixing for patients and caregivers ('548 Patent, col. 2:17-24). Additionally, existing all-in-one formulations make it difficult to customize doses for individual patient needs, particularly for neonatal and pediatric patients ('548 Patent, col. 1:46-57).
• The Patented Solution: The invention is a stable, injectable composition containing specific concentrations of four essential trace elements—zinc, copper, selenium, and manganese—while specifically excluding or limiting others like chromium, aluminum, and iron ('548 Patent, col. 3:41-48; Abstract). This formulation is designed to be stable for longer periods when added to PN, thereby reducing waste and simplifying administration ('548 Patent, col. 2:31-44).
• Technical Importance: By providing a more stable and customizable trace element supplement, the invention addresses a significant logistical and clinical challenge in administering parenteral nutrition, a life-sustaining therapy for vulnerable patient populations ('548 Patent, col. 1:10-14, col. 2:35-39).

Key Claims at a Glance

• The complaint alleges infringement of one or more claims, with the Notice Letter specifically failing to provide non-infringement positions for claims 26-33, 38-39, 42-43, 47, 49-50, 53-54, and 57-58 (Compl. ¶35, 42). Independent claim 26 is representative of the asserted composition claims.
• Independent Claim 26:
  • An injectable composition comprising water,
  • about 6 µg of selenium,
  • about 1,000 µg of zinc,
  • about 60 µg of copper, and
  • about 3 µg of manganese per 1 mL of the injectable composition,
  • wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron,
  • does not contain any vitamins,
  • contains no added chromium and
  • no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL of the injectable composition.
• The complaint reserves the right to assert additional claims (Compl. ¶42).

III. The Accused Instrumentality

Product Identification

• The accused product is Defendants' generic version of "trace elements injection 4*, USP," which is the subject of ANDA No. 218823 ("the ANDA Product") (Compl. ¶1, 33).

Functionality and Market Context

• The ANDA Product is a generic version of Plaintiff's Multrys® and is alleged to contain the "same or equivalent ingredients in the same or equivalent amounts" (Compl. ¶36). According to the complaint, Defendants' notice letter disclosed that the ANDA Product's formulation includes 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium in single-dose vials with a 1 mL fill (Compl. ¶37). The product is intended for commercial manufacture and sale in the United States upon FDA approval, positioning it to compete directly with Multrys® (Compl. ¶1, 18). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,786,548 Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A central question will concern the negative limitations of the claims. The infringement analysis will depend on whether Defendants' ANDA Product truly contains "no added chromium," "no... vitamins," and falls within the specified low limits for iron and aluminum, as required by the claims. The complaint's allegation of equivalence (Compl. ¶36) will need to be substantiated with evidence during discovery.
  • Technical Questions: The complaint's infringement theory appears to rely on the exact match between the concentrations of the four main active ingredients in the ANDA product and those specified in claim 26. The key factual dispute may be whether Defendants can demonstrate that their formulation includes a disqualifying feature, such as a level of aluminum impurity exceeding the claimed threshold or the presence of a vitamin, thereby taking it outside the literal scope of the claims.

V. Key Claim Terms for Construction

• The Term: "about"

  • Context and Importance: This term modifies every specified concentration of the active ingredients in claim 26. Its construction is critical because it defines the permissible range of deviation from the recited values (e.g., "1,000 µg of zinc"). The infringement analysis hinges on whether the exact concentrations in the ANDA Product fall within the scope of the claimed "about" ranges.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification frequently uses ranges to describe the invention (e.g., "from about 800 µg to about 4,000 µg of zinc") ('548 Patent, col. 4:13-14). This repeated use of ranges suggests "about" is intended to afford some flexibility beyond mere experimental error.
    • Evidence for a Narrower Interpretation: The patent discloses specific formulations with precise values, such as in Table 1, which lists "3 mg Zn/mL" and "0.3 mg Cu/mL" for one embodiment ('548 Patent, col. 12:12-15). A defendant may argue that these precise values, along with the specific values in claim 26, indicate that "about" should be construed narrowly to cover only minor manufacturing or measurement variability.

• The Term: "no added chromium"

  • Context and Importance: This negative limitation is a key distinguishing feature of the invention. Practitioners may focus on this term because proving the complete absence of an "added" substance can be complex. The dispute will likely center on what constitutes "added" versus an unavoidable background impurity from raw materials.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (favors Plaintiff): The patent repeatedly contrasts the invention with prior art that included chromium as a necessary or desirable element ('548 Patent, col. 1:46-50, col. 2:45-50). This context suggests "no added chromium" means chromium is not included as an intentional, functional ingredient, distinguishing it from unavoidable trace contaminants.
    • Evidence for a Narrower Interpretation (favors Defendant): The claim language is absolute ("no added..."). A defendant could argue that if any raw material used in its process contains chromium that carries over into the final product, that chromium has been "added," regardless of intent. The patent’s emphasis on providing a formulation with specific, low levels of impurities could be used to support a very strict interpretation of this limitation ('548 Patent, col. 14:1-12).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendants' future commercial activities will induce infringement by medical practitioners and patients who administer the ANDA Product according to its package insert and instructions (Compl. ¶42). It also alleges contributory infringement, stating that the ANDA Product is especially made for infringing use and is not suitable for a substantial non-infringing use (Compl. ¶43).
• Willful Infringement: While the complaint does not use the word "willful," it pleads that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶46). The basis for this allegation appears to be that Defendants had knowledge of the '548 patent at least as of the ANDA submission date, which required a certification regarding the patent (Compl. ¶45).

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

• A core issue will be one of evidentiary proof for negative limitations: Can Plaintiff demonstrate, and what level of evidence will be required to prove, that Defendants' ANDA Product meets the negative limitations of claim 26, such as containing "no added chromium" and falling below the specified thresholds for iron and aluminum? The outcome may depend on the analytical chemistry data presented by both sides.
• A second key question will be one of definitional scope: How broadly will the court construe the term "about" as it applies to the claimed concentrations, and how will it define "added" in the context of the "no added chromium" limitation? The resolution of these claim construction issues will likely determine the outcome of the literal infringement analysis.