DCT
2:24-cv-07794
American Regent Inc v. Aspiro Pharma Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Aspiro Pharma Ltd. (India)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 2:24-cv-07794, D.N.J., 07/16/2024
- Venue Allegations: Venue is alleged to be proper because the defendant is a foreign company not residing in any U.S. judicial district and has designated an agent for service of process in New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for generic Selenious Acid injectable products infringes a patent on stable trace element compositions for parenteral nutrition.
- Technical Context: The technology concerns injectable formulations of the trace element selenium, which is essential for patients receiving nutrition intravenously (parenteral nutrition) because they are unable to absorb nutrients through the digestive tract.
- Key Procedural History: This is a patent infringement action filed under the Hatch-Waxman Act, triggered by a notice letter dated June 11, 2024, in which Defendant notified Plaintiff of its ANDA filing containing a Paragraph IV certification against the patent-in-suit. The patent is listed in the U.S. Food and Drug Administration's "Orange Book" in connection with Plaintiff's approved Selenious Acid products.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's New Drug Application (NDA) for Selenious Acid approved by FDA |
| 2020-07-02 | U.S. Patent No. 11,998,565 earliest priority date |
| 2024-06-04 | U.S. Patent No. 11,998,565 issue date |
| 2024-06-11 | Defendant sends Paragraph IV Certification notice letter to Plaintiff |
| 2024-07-16 | Complaint filing date |
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 describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting mixture has a very short period of stability, often just 24 to 48 hours. This necessitates frequent and costly preparation of PN bags at healthcare facilities, increases waste, and creates logistical burdens for patients and caregivers (’565 Patent, col. 1:11-24, col. 2:5-18).
- The Patented Solution: The invention is a stable, injectable trace element composition that, when added to a PN solution, allows the final mixture to remain stable for a significantly longer period (e.g., up to 14 days under refrigeration). This is achieved through specific formulations that control for pH and impurity levels, thereby reducing the need for frequent admixing and minimizing waste ('565 Patent, Abstract; col. 2:46-64).
- Technical Importance: By extending the stability of admixed PN solutions, the invention enables the preparation of nutrition bags in larger, more efficient batches, which can reduce healthcare costs and improve the quality of life for patients dependent on long-term intravenous feeding ('565 Patent, col. 2:34-44).
Key Claims at a Glance
- The complaint asserts independent claims 1, 15, and 26, among others (Compl. ¶¶ 22, 28). Independent Claim 1 is representative of the core composition claims focused on selenium.
- Independent Claim 1:
- 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 additional claims, including dependent claims (Compl. ¶29).
III. The Accused Instrumentality
Product Identification
- Defendant’s proposed generic products, identified as "Selenious Acid Injection USP, eq. 600 mcg Selenium/10 mL (eq. 60 mcg Selenium/mL) and eq. 12 mcg Selenium/2 mL (eq. 6 mcg Selenium/mL)," for which Defendant submitted ANDA No. 219633 (Compl. ¶¶ 1, 24).
Functionality and Market Context
- The accused products are intended to be generic versions of Plaintiff's commercial Selenious Acid products and are designed to provide the same or equivalent amounts of selenium for use in parenteral nutrition (Compl. ¶¶ 23, 25). Upon approval, these products would compete directly with Plaintiff’s products as therapeutically equivalent alternatives (Compl. ¶26).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that the submission of the ANDA itself constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A) because the ANDA products, if approved and marketed, would infringe claims 1-25 and 28-29 of the '565 patent (Compl. ¶¶ 22, 28). The complaint does not provide a detailed claim chart, but asserts that the accused products contain the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff's patented products (Compl. ¶25).
'565 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality (based on Complaint allegations) | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water | The accused products are described as "Selenious Acid Injection USP," which are aqueous solutions. | ¶24 | col. 10:45-53 |
| 6 µg or 60 µg of selenium | The accused products are identified as containing concentrations equivalent to 6 mcg selenium/mL and 60 mcg selenium/mL. | ¶24 | col. 10:5-9 |
| no chromium or chromium in an amount not to exceed 1 µg | The complaint alleges infringement on information and belief, asserting the products are generic equivalents. The actual chromium level is not specified. | ¶¶ 25, 28 | col. 17:1-2 |
| no aluminum or aluminum in an amount not to exceed 6 µg | The complaint alleges infringement on information and belief. The actual aluminum level is not specified. | ¶¶ 25, 28 | col. 17:1-2 |
| no iron or iron in an amount up to 10 µg | The complaint alleges infringement on information and belief. The actual iron level is not specified. | ¶¶ 25, 28 | col. 17:1-2 |
| and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL... | The complaint alleges infringement on information and belief. The actual fluoride level is not specified. | ¶¶ 25, 28 | col. 17:1-2 |
- Identified Points of Contention:
- Evidentiary Questions (Negative and Purity Limitations): A primary point of contention will be factual. The complaint does not provide any evidence regarding the levels of chromium, aluminum, iron, and fluoride in the accused products. The infringement analysis will depend entirely on discovering the precise formulation of Defendant's products to determine whether they meet these negative and low-level purity limitations required by the claims.
- Scope Questions ("comprising" vs. "consisting essentially of"): Claim 1 uses the open-ended term "comprising", while Claim 26 uses the more restrictive term "consisting essentially of". This raises the question of whether the accused products contain any additional, unrecited ingredients that could alter the "basic and novel characteristics" of the invention, potentially avoiding infringement of Claim 26 even if they fall within the scope of Claim 1.
V. Key Claim Terms for Construction
The Term: "no chromium or chromium in an amount not to exceed 1 µg"
Context and Importance: This is a negative limitation that defines a specific purity threshold. The infringement determination will hinge on the precise amount of chromium, if any, in the accused product. Practitioners may focus on this term because negative limitations can create complex evidentiary and construction issues, especially concerning limits of detection for impurities.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party may argue that the phrase establishes a simple ceiling, where any product with chromium levels below 1 µg/mL meets the limitation. The specification's detailed tables on permitted elemental impurities may be cited to support the view that the patent contemplates the presence of trace contaminants and sets permissible upper limits, rather than demanding absolute absence ('565 Patent, Table 4, col. 16).
- Evidence for a Narrower Interpretation: A party could argue that "no chromium" and "chromium in an amount not to exceed 1 µg" are distinct alternatives. This interpretation, while less probable given the grammar, could suggest that a product with any detectable chromium fails the "no chromium" prong, creating a potential non-infringement argument.
The Term: "selenium"
Context and Importance: Independent claims 1 and 15 recite the element "selenium", while the accused product is a "Selenious Acid Injection" (Compl. ¶24) and dependent claim 12 specifies that the selenium is "elemental selenium from selenious acid" ('565 Patent, col. 22:12-13). The construction of "selenium" will determine if the claim is limited to the specific salt form disclosed.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiff may argue the term should be given its plain meaning, covering the selenium element itself, sourced from any pharmaceutically acceptable salt that provides the claimed amount of elemental selenium.
- Evidence for a Narrower Interpretation: Defendant may argue the term is implicitly limited by the specification, which states that "the elemental selenium is obtained from selenious acid" ('565 Patent, col. 10:51-53). This could be presented as evidence that the inventors defined their invention as using this specific form.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant will induce infringement by providing a product label and package insert that will instruct medical professionals and patients to administer the product in a manner that infringes the patent's claims (Compl. ¶29). Contributory infringement is also alleged, based on the assertion that the accused product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶30).
- Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the '565 patent, which the complaint asserts existed at least as of the date Defendant submitted its ANDA with the Paragraph IV certification (Compl. ¶32). The complaint also seeks a finding that the case is "exceptional" to support an award of attorneys' fees (Compl. ¶33).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: does the chemical composition of Defendant's proposed generic product, upon analysis, actually meet the stringent purity levels required by the asserted claims? The outcome will likely depend heavily on factual discovery regarding the presence and quantity of trace impurities like chromium, aluminum, and iron.
- A key legal question will be one of claim scope: can the negative limitation "no chromium or chromium in an amount not to exceed 1 µg" be satisfied by a product containing any detectable amount of chromium below the 1 µg/mL threshold, or does the "no chromium" phrase create a separate, stricter standard of absolute absence?