DCT
8:25-cv-01470
American Regent Inc v. BPI Labs LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: BPI Labs, LLC (Florida)
- Plaintiff’s Counsel: Sterne, Kessler, Goldstein & Fox p.l.l.c.
- Case Identification: 8:25-cv-01470, M.D. Fla., 06/06/2025
- Venue Allegations: Plaintiff alleges venue is proper because Defendant maintains a regular and established place of business within the Middle District of Florida and has committed, and intends to commit, acts of patent infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of infringement of two patents covering stable trace element compositions for parenteral nutrition.
- Technical Context: The technology relates to injectable solutions containing specific trace elements, such as selenium, which are used as supplements for intravenous parenteral nutrition in patients unable to receive nourishment through normal digestion.
- Key Procedural History: The litigation was triggered under the Hatch-Waxman Act by Defendant’s submission of ANDA No. 220051 with a Paragraph IV Certification. This certification asserts that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product. Plaintiff was notified of the ANDA filing via a Notice Letter dated April 23, 2025.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's New Drug Application 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 |
| 2025-04-23 | Defendant sends Notice Letter to Plaintiff regarding ANDA filing |
| 2025-06-06 | Complaint Filed |
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 solutions, the resulting mixture often has a short stability period of 24 to 48 hours, leading to waste, increased costs, and logistical burdens for patients and healthcare providers (’565 Patent, col. 2:5-18). Furthermore, existing multi-element formulations are often supplied in fixed, higher daily doses that are not easily customized to a patient’s specific needs (’565 Patent, col. 2:46-56).
- The Patented Solution: The invention provides stable injectable compositions containing specific concentrations of trace elements, such as selenium, which can be added to parenteral nutrition. These compositions are designed to allow the final admixed nutrition solution to remain stable for a longer period, reducing the need for frequent admixing and enabling the creation of customized, lower-dose formulations (’565 Patent, Abstract; col. 2:31-45).
- Technical Importance: This approach aims to improve the quality of life for patients on parenteral nutrition by creating more stable and customizable trace element supplements, thereby reducing product waste and the frequency of required trips to healthcare facilities for admixing (’565 Patent, col. 2:31-38).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’565 patent (Compl. ¶29). Independent claim 1 is representative of the patented composition.
- Essential Elements of Independent Claim 1:
- An injectable composition
- Comprising water
- Comprising 6 µg or 60 µg of selenium per 1 mL
- Containing no chromium, or chromium in an amount not to exceed 1 µg per 1 mL
- Containing no aluminum, or aluminum in an amount not to exceed 6 µg per 1 mL
- Containing no iron, or iron in an amount up to 10 µg per 1 mL
- Containing fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL (’565 Patent, col. 71:36-42)
U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"
The Invention Explained
- Problem Addressed: The ’957 Patent addresses the same technical problems as its parent ’565 Patent: the limited stability of parenteral nutrition solutions after the addition of trace elements and the difficulty in customizing doses from existing multi-element products (’957 Patent, col. 2:5-18, col. 2:46-56).
- The Patented Solution: The invention provides stable injectable trace element compositions and methods of administering them to patients. These compositions, like those in the ’565 Patent, are formulated to enhance stability when admixed with parenteral nutrition and to provide specific, customizable doses of elements like selenium (’957 Patent, Abstract; col. 2:46-52).
- Technical Importance: The patented methods and compositions aim to reduce waste and improve convenience for patients and caregivers by enabling longer storage times for admixed parenteral nutrition solutions (’957 Patent, col. 2:31-38).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’957 patent (Compl. ¶36). Independent claim 1 is representative of the patented method.
- Essential Elements of Independent Claim 1:
- A method of providing an injectable composition to a patient
- Comprising administering the injectable composition
- The composition comprising water
- The composition comprising 6 µg, 40 µg, or 60 µg of selenium per 1 mL
- The composition containing no chromium, or chromium in an amount not to exceed 1 µg per 1 mL
- The composition containing no aluminum, or aluminum in an amount not to exceed 6 µg per 1 mL
- The composition containing no iron, or iron in an amount not to exceed 10 µg per 1 mL
- The composition containing iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL (’957 Patent, col. 73:1-11)
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant BPI Labs’ proposed generic Selenious Acid product, filed under ANDA No. 220051 ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is described as a solution for intravenous administration containing selenious acid equivalent to 60 mcg/mL of selenium (Compl. ¶24). The complaint alleges it is a generic version of Plaintiff’s Selenious Acid product and will contain the "same or equivalent ingredients in the same or equivalent amounts" and be indicated for use in the "same or equivalent manner" (Compl. ¶23). By filing the ANDA, BPI seeks to market its product as a direct competitor to ARI’s branded drug before the expiration of the asserted patents (Compl. ¶1, ¶22).
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The following tables summarize the infringement theory based on the complaint's allegations.
No probative visual evidence provided in complaint.
- 11,998,565 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition... | The ANDA Product is a solution for intravenous administration. | ¶24 | col. 71:36 |
| comprising... 60 µg of selenium... per 1 mL | The ANDA Product contains selenious acid equivalent to 60 mcg/mL of selenium. | ¶24 | col. 71:38-39 |
| containing no chromium or chromium in an amount not to exceed 1 µg... | The complaint alleges the ANDA product has the same or equivalent chemical properties as ARI's product, which implies it meets this limitation. | ¶23, ¶26 | col. 71:39-40 |
| containing no aluminum or aluminum in an amount not to exceed 6 µg... | The complaint alleges the ANDA product has the same or equivalent chemical properties as ARI's product, which implies it meets this limitation. | ¶23, ¶26 | col. 71:40 |
| and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL... | The complaint alleges the ANDA product contains the same or equivalent ingredients as ARI's product, which implies it meets this limitation. | ¶23, ¶25 | col. 71:41-42 |
- 12,150,957 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 at least the injectable composition... | Defendant's proposed package insert will instruct medical practitioners and patients to administer the ANDA product. | ¶36 | col. 73:1-4 |
| the composition comprising... 60 µg of selenium... per 1 mL | The ANDA Product contains selenious acid equivalent to 60 mcg/mL of selenium. | ¶24 | col. 73:6-7 |
| the composition containing no chromium or chromium in an amount not to exceed 1 µg... | The complaint alleges the ANDA Product has the same or equivalent chemical properties, implying it meets this limitation. | ¶23, ¶26 | col. 73:7-8 |
| the composition containing no aluminum or aluminum in an amount not to exceed 6 µg... | The complaint alleges the ANDA Product has the same or equivalent chemical properties, implying it meets this limitation. | ¶23, ¶26 | col. 73:8-9 |
| and iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL... | The complaint alleges the ANDA product contains the same or equivalent ingredients, implying it meets this limitation. | ¶23, ¶25 | col. 73:10-11 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the ANDA product, described as a "Selenious Acid" product, meets the additional positive limitations of the claims. For example, does BPI's product specification for its ANDA product require the presence of "fluoride" as claimed in the ’565 Patent or "iodine" as claimed in the ’957 Patent?
- Technical Questions: The complaint relies on allegations that the ANDA Product has the "same or equivalent ingredients" as ARI's branded product (Compl. ¶23, ¶25). A key factual dispute will likely be whether this equivalence extends to the specific trace elements (fluoride, iodine) and purity levels (absence of chromium, aluminum, iron) required by the claims. The infringement analysis will depend on the actual, detailed specifications filed with the FDA in ANDA No. 220051.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for a full claim construction analysis. However, based on the technology, certain terms may become central to the dispute.
- The Term: "no chromium or chromium in an amount not to exceed 1 µg" (’565 Patent, col. 71:39-40).
- Context and Importance: This negative limitation defines a required level of purity. The infringement analysis will depend on whether BPI's ANDA product specification ensures its product meets this standard. Practitioners may focus on this term because the patent emphasizes reducing contaminants as a key feature of the invention.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the plain meaning of the phrase "no chromium or" establishes two distinct, patentable embodiments: one with zero detectable chromium, and another with a measurable but very low amount (≤ 1 µg). The specification's discussion of adjusting dosages for existing contaminants in parenteral nutrition could support the importance of this low-level limitation (’565 Patent, col. 2:49-52).
- Evidence for a Narrower Interpretation: A party might argue that "no chromium" is the primary inventive concept and that the alternative "not to exceed 1 µg" merely defines the threshold for what constitutes "no" in a practical, measurable sense, rather than creating a separate infringing category. The patent's abstract focuses on the primary active ingredients, not the absence of impurities, which might suggest the negative limitations are secondary.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that BPI’s proposed product labeling will instruct medical professionals and patients to administer the ANDA Product in an infringing manner (Compl. ¶29, ¶36). Contributory infringement is based on the allegation that the ANDA Product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶30, ¶37).
- Willful Infringement: The complaint does not explicitly use the term "willful." However, it alleges that BPI has had knowledge of the asserted patents since at least the date it submitted its ANDA and that the case is "exceptional," seeking an award of attorneys' fees (Compl. ¶32-33, ¶39). These allegations may form the basis for a later claim of willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional completeness: does BPI's ANDA specification for its generic "Selenious Acid" product include the additional trace elements positively required by the asserted patents, namely fluoride (for the ’565 Patent) and iodine (for the ’957 Patent)? If not, this could present a straightforward non-infringement defense.
- A key evidentiary question will be one of definitional purity: does the ANDA specification for BPI’s product guarantee that it will meet the stringent negative limitations of the claims, such as containing "no chromium or chromium in an amount not to exceed 1 µg"? The dispute may turn on the precise testing and quality control standards defined in the ANDA filing versus the scope of these claim terms.