DCT
1:24-cv-00249
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 (all Delaware)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 1:24-cv-00249, D. Del., 02/23/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because all three defendant entities are organized under the laws of the State of Delaware.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Multrys® drug product constitutes an act of infringement of a patent covering trace element compositions.
- Technical Context: The technology concerns stable, injectable multi-trace element compositions (zinc, copper, selenium, manganese) used for parenteral nutrition in patients, particularly neonates and children, who cannot eat normally.
- Key Procedural History: The lawsuit is a Hatch-Waxman action initiated in response to Defendants' ANDA filing (No. 218823) and an associated Paragraph IV Certification asserting that U.S. Patent No. 11,786,548 is invalid or will not be infringed. Plaintiff was notified via a letter dated January 8, 2024. The patent-in-suit is listed in the FDA's Orange Book for Multrys® and is alleged to expire on July 1, 2041.
Case Timeline
| Date | Event |
|---|---|
| 2020-07-02 | Plaintiff's NDA for Multrys® approved by FDA |
| 2020-07-02 | Earliest Patent Priority Date ('548 Patent) |
| 2023-10-17 | '548 Patent Issue Date |
| 2024-01-08 | Date of Defendants' Notice Letter to Plaintiff |
| 2024-02-23 | Complaint Filing Date |
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. (Compl. ¶36; '548 Patent).
The Invention Explained
- Problem Addressed: The patent's background section describes the problem of instability in parenteral nutrition solutions after trace elements are added. This short stability window (typically 24-48 hours) requires frequent, costly, and time-consuming admixing and leads to waste if not used promptly. Furthermore, existing all-in-one formulations often provide higher-than-needed doses of certain elements, like chromium and manganese, making it difficult to customize treatment for individual patient needs. ('548 Patent, col. 1:46-56, col. 2:5-24).
- The Patented Solution: The invention is a stable, injectable trace element composition that, when added to parenteral nutrition, remains stable for a significantly longer period (e.g., up to 14 days under refrigeration). This reduces waste, cost, and the burden on healthcare providers. The formulation provides specific, lower doses of certain trace elements and omits chromium entirely, allowing for better customization for vulnerable patients like neonates. ('548 Patent, Abstract; col. 2:46-68).
- Technical Importance: This approach provides a safer and more efficient method for delivering essential micronutrients to critically ill patients who depend on intravenous feeding, improving both clinical practice and quality of life. ('548 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims of the '548 patent without specifying which ones. (Compl. ¶49). Based on the non-infringement carve-outs in the Defendants' notice letter, analysis is focused on independent claim 26 as a representative asserted claim. (Compl. ¶42).
- Independent Claim 26 Elements:
- An injectable composition comprising water,
- about 6 µg of selenium per 1 mL of the injectable composition,
- about 1,000 µg of zinc per 1 mL of the injectable composition,
- about 60 µg of copper per 1 mL of the injectable composition,
- 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.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendants' proposed generic drug product described in ANDA No. 218823 ("the ANDA Product"). (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is a generic version of American Regent's Multrys®, an injectable multi-trace element solution. (Compl. ¶¶1, 43).
- As disclosed in the Defendants' notice letter, the ANDA Product's formulation is a single-dose vial (1 mL fill) containing 1000 mcg of Zinc, 60 mcg of Copper, 3 mcg of Manganese, and 6 mcg of Selenium. (Compl. ¶40).
- The product is intended for use in parenteral nutrition for patients for whom oral nutrition is not possible, particularly neonatal and pediatric patients. (Compl. ¶¶33-34). It is alleged that the ANDA Product contains the same or equivalent ingredients in the same or equivalent amounts as Multrys®. (Compl. ¶45).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
- Claim Chart Summary: The complaint does not include a claim chart. The following chart summarizes the infringement theory for representative claim 26 based on the complaint's factual allegations.
| Claim Element (from Independent Claim 26) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water... and about 1,000 µg of zinc, about 60 µg of copper, about 3 µg of manganese, and about 6 µg of selenium per 1 mL | The ANDA Product is described as a 1 mL fill injectable composition containing 1000 mcg Zinc, 60 mcg Copper, 3 mcg Manganese, and 6 mcg Selenium. | ¶40 | col. 74:51-57 |
| contains 0 µg per 1 mL to about 10 µg per 1 mL of iron | The complaint alleges the ANDA Product is a generic version of Multrys® and will feature the same or equivalent chemical properties. The complaint does not specify the iron content. | ¶¶43, 46 | col. 74:58-59 |
| does not contain any vitamins | The ANDA product is described as a "trace element injection" and alleged to be a generic version of Multrys®, which is not a vitamin product. The disclosed composition does not list vitamins. | ¶¶40, 43 | col. 74:59-60 |
| contains no added chromium | The composition of the ANDA product as disclosed in the complaint does not include chromium. | ¶40 | col. 74:60 |
| no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL | The complaint alleges the ANDA Product is a generic version of Multrys® and will feature the same or equivalent chemical properties. The complaint does not specify the aluminum content. | ¶¶43, 46 | col. 74:60-62 |
- Identified Points of Contention:
- Scope Questions: The infringement allegations for the active ingredients appear to be literally met by the numbers disclosed in the complaint. A potential dispute may arise over the scope of the term "about." The core of the dispute, however, will likely focus on the negative limitations.
- Technical Questions: A primary technical question will be whether the ANDA Product meets the negative limitations regarding impurities. What evidence does the ANDA itself contain regarding the concentration of iron and aluminum, and does it contain what would be construed as "added chromium"? The complaint, as is typical at this stage, does not provide this level of detail, which will be a subject of discovery.
V. Key Claim Terms for Construction
- The Term: "about"
- Context and Importance: This term modifies every specified concentration of the active ingredients. While the ANDA product's disclosed concentrations appear to be an exact match, the construction of "about" is critical for determining the full scope of the claim and its vulnerability to invalidity challenges. Practitioners may focus on this term to understand whether the patentee can capture formulations that deviate slightly from the recited values.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification repeatedly uses "about" in the context of wide numerical ranges (e.g., "about 800 µg to about 4,000 µg of zinc"), suggesting the term is meant to convey a degree of approximation beyond simple rounding. ('548 Patent, col. 3:8-14).
- Evidence for a Narrower Interpretation: The patent discloses very specific formulations in its tables and examples that list exact quantities without the "about" modifier (e.g., Table 1 specifies "3 mg Zn/mL"). A party could argue these precise embodiments limit the scope of "about" to, at most, the precision of the measurement technique. ('548 Patent, col. 12:15).
- The Term: "no added chromium"
- Context and Importance: This negative limitation is a key point of novelty, distinguishing the invention from prior art that included chromium. The definition is critical because if the ANDA Product contains any detectable chromium, the dispute will center on whether its presence constitutes "added" chromium.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (favoring patentee): The patent's focus on creating a chromium-free formulation to align with modern medical recommendations suggests "no added" means not intentionally included as a therapeutic component. The specification distinguishes the invention from older products where chromium was an active ingredient. ('548 Patent, col. 1:46-51).
- Evidence for a Narrower Interpretation (favoring defendant): The patent discloses testing for chromium as a potential elemental impurity and sets a specification limit for it. ('548 Patent, col. 16, Table 4). A defendant could argue that "no added chromium" must be read in this context, and that their product meets the limitation if any chromium present is merely an unavoidable trace impurity below a certain threshold, rather than an "added" component.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Defendants' proposed package insert will instruct and encourage medical professionals and patients to use the ANDA Product in an infringing manner. It also alleges contributory infringement on the basis that the ANDA product is especially made for an infringing use and has no substantial non-infringing use. (Compl. ¶¶49-50).
- Willful Infringement: Willfulness is alleged based on Defendants having knowledge of the '548 patent at least as of the date they submitted the ANDA, which contained a Paragraph IV certification against that patent. (Compl. ¶52). The complaint also pleads that the case is "exceptional" and seeks attorneys' fees. (Compl. ¶53).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: As the concentrations of the active ingredients appear to be a literal match, the dispute will likely turn on the precise impurity profile of the defendants' ANDA product. Does the product, as detailed in the confidential ANDA filing, actually meet the claimed negative limitations for iron, aluminum, and chromium?
- A key legal question will be one of claim construction: How will the court construe the negative limitation "no added chromium"? The case may hinge on whether this term forbids only the intentional inclusion of chromium as a formulation component, or if it sets a stricter standard that could be met by the presence of unavoidable trace impurities originating from the raw materials or manufacturing process.