DCT
2:25-cv-01278
American Regent Inc v. Meitheal Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Meitheal Pharmaceuticals, Inc. (Delaware) and Kindos Pharmaceuticals Co., LTD (China)
- Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:25-cv-01278, D.N.J., 02/14/2025
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Meitheal has a permanent and continuous presence and does business in the state, and because Defendants intend to market and sell the accused product in New Jersey upon FDA approval. Venue over Kindos, a foreign company, is alleged to be proper in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA to market a generic version of Plaintiff's Selenious Acid injection products constitutes an act of patent infringement.
- Technical Context: The technology concerns stable, injectable trace element compositions, such as selenious acid, used as supplements in parenteral nutrition for patients unable to receive nourishment through normal digestion.
- Key Procedural History: The litigation was triggered by Defendants notifying Plaintiff, via a Paragraph IV Certification letter, of their filing of ANDA No. 219472 with the FDA. This certification asserts that Defendants' generic product would not infringe Plaintiff's patents or that the patents are invalid, creating the basis for this action under the Hatch-Waxman Act.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff’s New Drug Application (NDA) No. 209379 for Selenious Acid approved by FDA |
| 2020-07-02 | Earliest Priority Date for ’565 and ’957 Patents |
| 2024-06-04 | U.S. Patent No. 11,998,565 issues |
| 2024-11-26 | U.S. Patent No. 12,150,957 issues |
| 2024-12-30 | Defendants send Paragraph IV Certification Notice Letter to Plaintiff |
| 2025-02-14 | Complaint for Patent Infringement filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,998,565 - Trace element compositions, methods of making and use, issued June 4, 2024
The Invention Explained
- Problem Addressed: The patent describes challenges with existing parenteral nutrition (PN) solutions, which provide nutrients intravenously. When trace elements like zinc, copper, selenium, and manganese are added to PN solutions, they can have a short stability period (24-48 hours), leading to waste, increased costs, and frequent, inconvenient trips to healthcare facilities for admixing. Additionally, some existing multi-element formulations have higher-than-recommended daily doses of certain elements, limiting customizable patient care (Compl., Ex. A, '565 Patent, col. 1:46 - col. 2:44).
- The Patented Solution: The invention provides stable, injectable trace element compositions with specific concentration ranges that can be added to PN solutions and remain stable for a longer period (e.g., up to 14 days under refrigeration). This allows for the preparation of PN solutions in larger batches, reducing waste and improving patient quality of life. The patent focuses on formulations containing specific amounts of zinc, copper, selenium, and manganese, and notably, compositions that contain little to no chromium, an element whose necessity in daily doses has been questioned ('565 Patent, col. 1:46-54; col. 4:56-65; Abstract).
- Technical Importance: The invention addresses a practical clinical need for more stable and customizable trace element supplements in parenteral nutrition, potentially reducing healthcare costs and patient burden ('565 Patent, col. 2:31-44).
Key Claims at a Glance
- Asserted Independent Claims: The complaint does not specify which claims are asserted, but alleges infringement of "one or more claims" (Compl. ¶37). Claim 1 is representative.
- Claim 1 Elements:
- 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, and
- 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 infringement of other claims, which may include dependent claims (Compl. ¶37).
U.S. Patent No. 12,150,957 - Trace element compositions, methods of making and use, issued November 26, 2024
The Invention Explained
- Problem Addressed: As a divisional of the application leading to the '565 patent, the '957 patent addresses the same technical problems of stability and customization in trace element supplementation for parenteral nutrition (Compl., Ex. B, '957 Patent, col. 1:46 - col. 2:44).
- The Patented Solution: The '957 patent similarly discloses stable injectable compositions containing specific concentrations of trace elements. The claims of this patent are also directed to compositions that solve the stability problem while allowing for more precise dosing and avoiding potentially unnecessary elements like chromium ('957 Patent, Abstract; col. 4:56-65).
- Technical Importance: The invention provides an alternative formulation for stable and customizable trace element supplements, contributing to improved clinical practice in parenteral nutrition ('957 Patent, col. 2:31-44).
Key Claims at a Glance
- Asserted Independent Claims: The complaint does not specify which claims are asserted, but alleges infringement of "one or more claims" (Compl. ¶44). Claim 1 is representative.
- Claim 1 Elements:
- A method of providing an injectable composition to a patient in need thereof,
- the method comprising administering at least the injectable composition to the patient,
- the injectable composition comprising water, 6 µg, 40 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 not to exceed 10 µg, and
- 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 infringement of other claims, which may include dependent claims (Compl. ¶44).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the generic drug product described in ANDA No. 219472 ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
The complaint alleges that the ANDA Product is a generic version of American Regent's Selenious Acid product, specifically Selenious Acid Injection, USP, (600 mcg Selenium/10 mL (60 mcg/mL)) (Compl. ¶30, ¶32). It is alleged to contain the "same or equivalent ingredients in the same or equivalent amounts" as the reference listed drug and will be indicated for the same use (Compl. ¶31, ¶33). As a generic drug intended for parenteral nutrition, the ANDA Product is designed to be a lower-cost, bioequivalent alternative to the Plaintiff's branded product.
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart or detailed, element-by-element infringement allegations. The infringement theory is predicated on the allegation that the ANDA Product is a generic version of Plaintiff's Selenious Acid product and will necessarily have the same or equivalent chemical properties and composition.
11,998,565 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water... | The ANDA Product is alleged to be an injectable Selenious Acid solution. | ¶32 | col. 4:12-14 |
| 6 µg or 60 µg of selenium... | The ANDA Product is alleged to be a generic version of ARI's Selenious Acid product (eq. 60 mcg Selenium/mL). | ¶31, ¶32 | col. 4:12-14 |
| no chromium or chromium in an amount not to exceed 1 µg... | The ANDA product is alleged to feature the "same or equivalent chemical and therapeutic properties" as ARI's product, which is covered by the patent. | ¶34 | col. 13:55-62 |
| no aluminum or aluminum in an amount not to exceed 6 µg... | The ANDA product is alleged to have the "same or equivalent" properties as ARI's patented product, which has specified low levels of aluminum. | ¶34 | col. 17:5-9 |
| no iron or iron in an amount up to 10 µg... | The ANDA product is alleged to have the "same or equivalent" properties as ARI's patented product, which has specified low levels of iron. | ¶34 | col. 17:10-15 |
| and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. | The ANDA product is alleged to have the "same or equivalent" properties as ARI's patented product, which contains fluoride within the claimed range. | ¶34 | col. 17:5-9 |
12,150,957 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of providing an injectable composition to a patient in need thereof, the method comprising administering... the injectable composition to the patient... | Defendants allegedly will induce infringement by patients and medical professionals who will administer the ANDA product according to its proposed package insert. | ¶44 | col. 3:14-20 |
| the injectable composition comprising water, 6 µg, 40 µg or 60 µg of selenium... | The ANDA Product is alleged to be a generic version of ARI's Selenious Acid product (eq. 60 mcg Selenium/mL). | ¶31, ¶32 | col. 4:12-14 |
| no chromium or chromium in an amount not to exceed 1 µg... | The ANDA product is alleged to feature the "same or equivalent chemical and therapeutic properties" as ARI's product, which is covered by the patent. | ¶34 | col. 13:55-62 |
| no aluminum or aluminum in an amount not to exceed 6 µg... | The ANDA product is alleged to have the "same or equivalent" properties as ARI's patented product, which has specified low levels of aluminum. | ¶34 | col. 17:5-9 |
| no iron or iron in an amount not to exceed 10 µg... | The ANDA product is alleged to have the "same or equivalent" properties as ARI's patented product, which has specified low levels of iron. | ¶34 | col. 17:10-15 |
| and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. | The ANDA product is alleged to have the "same or equivalent" properties as ARI's patented product, which contains fluoride within the claimed range. | ¶34 | col. 17:5-9 |
Identified Points of Contention
- Factual Questions: The complaint does not provide specific details from the ANDA filing. A central question for the court will be whether the precise formulation and manufacturing process described in Defendants' confidential ANDA results in a product that meets every limitation of the asserted claims. This includes not only the concentration of the active ingredient (selenium) but also the specified low or non-existent levels of impurities like chromium, aluminum, and iron.
- Scope Questions: The case may raise questions about the scope of negative limitations, such as "no chromium." The court may need to determine if this requires absolute absence or merely an amount below a certain detectable or functional threshold, especially in the context of unavoidable manufacturing impurities.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for analysis of specific claim construction disputes. However, based on the patent claims, certain terms may become focal points.
- The Term: "no chromium" ('565 Patent, Claim 1; '957 Patent, Claim 1)
- Context and Importance: This negative limitation is critical for distinguishing the claimed invention from prior art that may have included chromium. Infringement will depend on whether the ANDA Product contains any detectable level of chromium. Practitioners may focus on this term because absolute purity is often technically impossible, raising questions of whether trace amounts from manufacturing fall within the claim scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (i.e., allowing for trace impurities): The specification discusses reducing or eliminating daily doses of chromium, which it notes are "not typically needed" ('565 Patent, col. 2:6-8). A defendant might argue this context implies the exclusion of intentionally added, therapeutically dosed chromium, not the absolute absence of unavoidable trace contaminants.
- Evidence for a Narrower Interpretation (i.e., requiring absolute absence): The plain language of the claim is "no chromium." The patent repeatedly emphasizes providing compositions with "little or no chromium" and provides specific, low quantitative limits for other impurities (e.g., aluminum, iron), suggesting that where the patentee meant to permit a small amount, it did so explicitly ('565 Patent, Claim 1).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that if the ANDA is approved, Defendants' proposed package insert will instruct patients and medical practitioners to administer the ANDA Product in a manner that infringes the asserted method claims ('565 Patent, Compl. ¶37; '957 Patent, Compl. ¶44). Contributory infringement is also alleged on the basis that the ANDA Product is especially adapted for an infringing use and is not a staple article suitable for substantial non-infringing use (Compl. ¶38, ¶45).
- Willful Infringement: The complaint alleges that Defendants have had knowledge of the asserted patents at least since submitting the ANDA with a Paragraph IV certification, and that this act of infringement was therefore willful (Compl. ¶40).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional identity: Does the precise formulation detailed in the Defendants' confidential ANDA filing literally meet every limitation of the asserted claims? The analysis will depend heavily on discovery into the ANDA product's exact selenium concentration and, critically, whether it contains any amount of chromium, aluminum, or iron that would exceed the claimed thresholds.
- A secondary issue will be one of definitional scope: How should the court construe the negative limitation "no chromium"? The case may turn on whether this term requires the absolute absence of the element or allows for trace amounts that are not therapeutically significant, a distinction that will be informed by the patent's specification and prosecution history.