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)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11138, D.N.J., 12/13/2024
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendants submitted the Abbreviated New Drug Application (ANDA) from their place of business in Somerset, New Jersey, and maintain a regular and established place of business in the state.
• Core Dispute: Plaintiff alleges that Defendants' filing of an ANDA to market a generic version of Plaintiff's Selenious Acid injectable product constitutes an act of infringement of two patents related to trace element compositions for parenteral nutrition.
• Technical Context: The technology concerns stable injectable pharmaceutical compositions containing trace elements like selenium, zinc, and copper, which are critical for patients unable to receive nutrition orally.
• Key Procedural History: The complaint notes this case is related to a prior action, American Regent, Inc. v. Somerset Therapeutics, LLC, C.A. No. 24-7807 (D.N.J.), filed on July 16, 2024. That case addressed Defendants' "Original ANDA," while the current action addresses an "Amended ANDA" for a different dosage formulation of the same drug.

Case Timeline

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

U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use"

The Invention Explained

• Problem Addressed: The patent's background section describes the short stability period (typically 24-48 hours) of parenteral nutrition (PN) solutions after trace elements have been added (Compl., Ex. A, ’565 Patent, col. 2:5-9). This short window for use can lead to drug supply shortages, increased costs from discarded solutions, and logistical burdens for patients and healthcare providers who must admix the solutions frequently (Compl., Ex. A, ’565 Patent, col. 2:10-30).
• The Patented Solution: The invention provides stable injectable compositions of trace elements, particularly selenium, designed to be added to parenteral nutrition solutions. By providing a stable formulation, the resulting admixed PN can be prepared in larger batches and stored for longer periods, reducing waste and improving quality of life for patients and caregivers (Compl., Ex. A, ’565 Patent, Abstract; col. 2:49-57).
• Technical Importance: The invention aims to overcome a key logistical and economic barrier in parenteral nutrition therapy by extending the usable life of admixed solutions containing essential trace elements (Compl., Ex. A, ’565 Patent, col. 2:31-48).

Key Claims at a Glance

• The complaint asserts claims 1, 2-10, 12-19, 21-25, and 27-29 (Compl. ¶35). Independent claims 1, 15, 21, and 27 fall within this range.
• Independent Claim 1 (Composition): An injectable composition comprising:
  • water
  • 6 µg or 60 µg of selenium
  • no chromium or chromium in an amount not to exceed 1 µg
  • no aluminum or aluminum in an amount not to exceed 6 µg
  • no iron or iron in an amount up to 10 µg
  • fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition

U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"

The Invention Explained

• Problem Addressed: As with the ’565 Patent, the technology addresses the instability of parenteral nutrition (PN) solutions once essential trace elements are added, which creates waste and logistical challenges for patients and providers (Compl., Ex. B, ’957 Patent, col. 1:47 - col. 2:30).
• The Patented Solution: The invention provides stable injectable compositions containing specific concentrations of one or more trace elements (zinc, copper, selenium, and manganese) that can be added to PN solutions, thereby extending the stability and shelf-life of the final admixed nutrition product (Compl., Ex. B, ’957 Patent, Abstract; col. 2:49-57).
• Technical Importance: The patented compositions enable more efficient and less wasteful administration of parenteral nutrition by allowing for advance preparation and longer storage times of fully-constituted PN solutions (Compl., Ex. B, ’957 Patent, col. 2:31-48).

Key Claims at a Glance

• The complaint does not specify which claims of the ’957 patent are asserted but reserves the right to assert any claim (Compl. ¶¶ 51-53). Independent claim 1 is a representative composition claim.
• Independent Claim 1 (Composition): 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

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' "Amended ANDA Product," identified as Selenious Acid Injection, USP, (12 mcg Selenium/2 mL (6 mcg Selenium/mL)) (Compl. ¶¶ 33, 40).

Functionality and Market Context

• The Amended ANDA Product is a generic version of Plaintiff's approved Selenious Acid product, which is used as a source of the essential trace element selenium for parenteral nutrition (Compl. ¶¶ 33, 39).
• The complaint alleges that the Amended ANDA Product contains the same or equivalent ingredients in the same or equivalent amounts and features the same or equivalent chemical and therapeutic properties as Plaintiff's reference listed drug (Compl. ¶¶ 39, 41, 42). The act of infringement alleged is the submission of ANDA No. 218780 seeking FDA approval to market this generic product prior to the expiration of the asserted patents (Compl. ¶¶ 1, 33).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or detailed technical comparison mapping elements of the asserted claims to the features of the Amended ANDA Product. The infringement theory is presented narratively. Plaintiff alleges that Defendants’ submission of the Amended ANDA with a Paragraph IV Certification to the FDA constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶ 44, 51). The complaint asserts, on information and belief, that the Amended ANDA Product, if approved and marketed, will have a composition that meets the limitations of the asserted claims of the ’565 and ’957 patents (Compl. ¶¶ 45-46, 52-53).

• Identified Points of Contention:
  • Evidentiary Questions: A central question will be what evidence, presumably contained within the confidential ANDA submission, demonstrates the precise formulation of the accused product. The dispute will turn on whether that formulation, including its active ingredients, excipients, and any potential impurities, falls within the specific quantitative and qualitative limitations of the asserted claims.
  • Scope Questions: The analysis will likely focus on whether the accused product's composition meets every limitation of the asserted claims. For the ’565 Patent, this includes not only the presence and amount of selenium but also the absence or near-absence of other specified elements like chromium, aluminum, and iron, as required by claim 1.

V. Key Claim Terms for Construction

• The Term: "no chromium" (from ’565 Patent, claim 1)
• Context and Importance: The claim requires "no chromium or chromium in an amount not to exceed 1 µg." The construction of this negative limitation will be critical. Practitioners may focus on this term because the parties will likely dispute whether it means an absolute absence of chromium or an amount below a certain limit of detection or quantification, and what test methodology is appropriate for making that determination. The outcome could determine whether trace impurities in the accused product are sufficient to avoid infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (i.e., allowing for some trace amount): The claim itself provides an alternative quantitative limit ("not to exceed 1 µg"), which may suggest that "no chromium" is not intended to be an absolute, zero-molecule standard but rather a practical limit below a specified threshold (Compl., Ex. A, ’565 Patent, col. 45:38-40).
  • Evidence for a Narrower Interpretation (i.e., closer to absolute zero): The specification repeatedly distinguishes the invention from prior art multi-element compositions that included chromium, framing the removal of chromium as a key feature (Compl., Ex. A, ’565 Patent, col. 2:42-45, col. 36:40-44). The patent also describes specific compositions as having "no detectable chromium," which could be argued to set the standard for the term "no chromium" (Compl., Ex. A, ’565 Patent, col. 36:50-51).
• The Term: "about" (from ’957 Patent, claim 1)
• Context and Importance: Claim 1 of the ’957 patent uses the term "about" to qualify all four recited concentration ranges (e.g., "about 800 µg to about 4,000 µg of zinc"). Practitioners may focus on this term because its scope will determine the permissible range of deviation from the stated numerical values. Whether the concentrations in the accused product fall within the claimed ranges could depend entirely on how much flexibility the term "about" provides.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification uses numerical ranges throughout, and the use of "about" in the claims could be argued to signify that the inventors did not intend to be limited to the precise endpoints, consistent with general practice in the chemical arts where some measurement variability is inherent (Compl., Ex. B, ’957 Patent, col. 3:1-12).
  • Evidence for a Narrower Interpretation: The patent provides numerous specific numerical examples and embodiments (e.g., "3,000 µg of zinc, 300 µg of copper, 60 µg of selenium, and 55 µg of manganese per 1 mL") without using the term "about" (Compl., Ex. B, ’957 Patent, col. 4:26-29). A defendant may argue that these specific examples limit the scope of "about" to a narrow range of equivalents.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendants' proposed package insert will instruct and encourage medical practitioners and patients to administer the Amended ANDA Product in a manner that directly infringes the patents (Compl. ¶¶ 45, 52). Contributory infringement is also alleged on the basis that the product is especially made for an infringing use and is not a staple article suitable for substantial non-infringing use (Compl. ¶¶ 46, 53).
• Willful Infringement: Willfulness is alleged for the ’565 Patent based on Defendants' knowledge of the patent since at least the date they submitted the Amended ANDA with its Paragraph IV Certification (Compl. ¶48). For the ’957 Patent, willfulness is alleged based on pre-suit knowledge stemming from an email Plaintiff sent on October 11, 2024, informing Defendants that the patent would be issuing (Compl. ¶55).

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

• A primary issue will be one of claim scope and interpretation: Can the negative limitation "no chromium" in the ’565 Patent be construed to read on a product that may contain trace impurities of chromium, and what is the proper evidentiary standard for determining the presence or absence of such an element?
• A central evidentiary question will be one of factual correspondence: Based on the contents of the confidential ANDA, does the precise chemical composition of the accused generic product—including its active ingredients, their concentrations, and any impurities—fall squarely within the numerical ranges and component limitations recited in the asserted claims of the ’565 and ’957 patents?
• A key legal and factual issue regarding the ’957 patent will be willfulness: Does Plaintiff’s pre-issuance notice to Defendants regarding the forthcoming ’957 patent, provided in the context of a related litigation, establish the predicate knowledge and intent required for a finding of willful infringement from the moment the patent issued?