DCT
2:25-cv-04439
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: GIBBONS P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:25-cv-04439, D.N.J., 05/16/2025
- Venue Allegations: Plaintiff alleges venue is proper based on Defendant’s business contacts and presence in New Jersey, as well as its stated intent to market and sell the accused product in the district upon receiving FDA approval.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Selenious Acid injection products constitutes an act of infringement of two patents related to trace element compositions for parenteral nutrition.
- Technical Context: The technology concerns injectable trace element formulations, specifically containing selenium, designed as additives for intravenous (parenteral) nutrition solutions for patients who cannot receive nourishment orally.
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s notification to Plaintiff on April 23, 2025, of its ANDA filing containing 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. The patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") as covering Plaintiff’s Selenious Acid products.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's New Drug Application for Selenious Acid approved |
| 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 of ANDA filing to Plaintiff |
| 2025-05-16 | 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"
- Issued: June 4, 2024
The Invention Explained
- Problem Addressed: The patent’s background section describes challenges with existing parenteral nutrition (PN) formulations. When trace elements are added, the resulting PN solution has a short stability period (e.g., 24-48 hours), which requires frequent and costly admixing under aseptic conditions. Furthermore, older all-in-one trace element products contain higher doses of certain elements (e.g., copper, manganese, chromium) than are now recommended and are not easily customizable to individual patient needs. (’565 Patent, col. 1:11-56).
- The Patented Solution: The invention provides stable injectable trace element compositions that, when added to parenteral nutrition, allow the final solution to remain stable for a longer period. This reduces the frequency of admixing, lowers costs, and improves convenience for patients and caregivers. The compositions are also formulated with lower, more modern recommended daily doses of certain trace elements. (’565 Patent, Abstract; col. 2:46-67).
- Technical Importance: The solution addresses a practical clinical need for more stable and customizable intravenous nutritional supplements, particularly for patients requiring long-term parenteral feeding. (’565 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the patent (Compl. ¶29). Independent claim 1 is representative of the asserted composition technology:
- 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. (’565 Patent, col. 71:36-44).
U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"
- Issued: November 26, 2024
The Invention Explained
- Problem Addressed: The technical problem is identical to that described in the ’565 Patent: the short stability and lack of dosage customizability of prior art parenteral nutrition solutions containing trace elements. (’957 Patent, col. 1:12-56).
- The Patented Solution: The ’957 Patent claims methods of providing or administering the stable injectable trace element compositions described in the patent family, thereby addressing the same clinical challenges of cost, convenience, and safety associated with frequent admixing and outdated formulations. (’957 Patent, Abstract; col. 2:46-67).
- Technical Importance: This patent protects the clinical application and use of the novel compositions, extending coverage from the product itself to its method of administration for patient treatment. (’957 Patent, col. 5:11-19).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the patent (Compl. ¶36). Independent claim 1 is representative of the asserted method technology:
- 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. (’957 Patent, col. 72:48-61).
III. The Accused Instrumentality
Product Identification
- Defendant BPI’s proposed generic drug product described in Abbreviated New Drug Application No. 220051 ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The complaint alleges the ANDA Product is a solution for intravenous administration that contains selenious acid, equivalent to 60 mcg/mL of selenium, as its active ingredient (Compl. ¶24). It is intended as a generic version of Plaintiff ARI's Selenious Acid product(s) (Compl. ¶23).
- The product is designed to be a lower-cost, bioequivalent alternative to ARI's branded drug, intended for the same patient population requiring trace element supplementation via parenteral nutrition (Compl. ¶23). The act of infringement alleged is the filing of the ANDA itself, which seeks FDA approval to market this product before the expiration of the Asserted Patents (Compl. ¶28, ¶35).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
U.S. Patent No. 11,998,565 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water, ... 60 µg of selenium... | The ANDA Product is a solution for intravenous administration containing selenious acid equivalent to 60 mcg/mL of selenium. | ¶24 | col. 15:19-29 |
| no chromium or chromium in an amount not to exceed 1 µg... | The ANDA Product is alleged to be a generic version of ARI's product, containing the same or equivalent ingredients in the same or equivalent amounts. | ¶23 | col. 16:56-62 |
| no aluminum or aluminum in an amount not to exceed 6 µg... | The ANDA Product is alleged to be a generic version of ARI's product, containing the same or equivalent ingredients in the same or equivalent amounts. | ¶23 | col. 18:7-14 |
| no iron or iron in an amount up to 10 µg... | The ANDA Product is alleged to be a generic version of ARI's product, containing the same or equivalent ingredients in the same or equivalent amounts. | ¶23 | col. 17:10-17 |
U.S. Patent No. 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... comprising administering at least the injectable composition to the patient... | Defendant's proposed package insert will allegedly instruct medical practitioners and patients to administer the ANDA Product. | ¶36 | col. 5:11-19 |
| the injectable composition comprising water, ... 60 µg of selenium... | The ANDA Product to be administered contains selenious acid equivalent to 60 mcg/mL of selenium. | ¶24 | col. 15:19-29 |
| no chromium or chromium in an amount not to exceed 1 µg... | The ANDA Product is alleged to be a generic version of ARI's product, containing the same or equivalent ingredients in the same or equivalent amounts. | ¶23 | col. 16:56-62 |
Identified Points of Contention
- Evidentiary Questions: The complaint's infringement theory for the negative limitations (e.g., "no chromium," "no aluminum," "no iron") relies on the allegation that the ANDA Product is a generic equivalent (Compl. ¶23). A central question will be what evidence demonstrates that the final ANDA product formulation, including any manufacturing impurities, actually meets these specific quantitative upper limits as claimed in the patents.
- Scope Questions: The claims require "no chromium or chromium in an amount not to exceed 1 µg." The interpretation of this phrase, particularly whether the presence of any detectable level of chromium as an impurity falls outside the scope of "no chromium," may become a point of contention in claim construction and infringement analysis.
V. Key Claim Terms for Construction
- The Term: "no chromium or chromium in an amount not to exceed 1 µg" (’565 Patent, col. 71:39-40).
- Context and Importance: This is a negative limitation that defines a key feature of the claimed composition, distinguishing it from prior art that may have included chromium. The precise boundary of this limitation is critical, as the presence of even trace amounts of chromium as an impurity in the accused product could be central to the infringement dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that the plain language of the disjunctive "or" creates two distinct possibilities: a composition with absolutely zero chromium, or a composition with a non-zero amount of chromium that is less than or equal to 1 µg. This reading suggests that the claim scope explicitly encompasses compositions with trace amounts of chromium up to the specified limit.
- Evidence for a Narrower Interpretation: The specification states, "In many cases, the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" (’565 Patent, col. 16:56-62). A party could cite this language to argue that the phrase "no chromium" has a distinct meaning of being below detectable limits, potentially creating ambiguity as to how the subsequent clause "or chromium in an amount not to exceed 1 µg" should be interpreted.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement of the method claims of the ’957 Patent. The basis for this allegation is that Defendant’s proposed package insert for the ANDA Product will instruct and encourage medical professionals and patients to administer the product in a manner that performs the steps of the claimed methods (Compl. ¶29, ¶36).
- Willful Infringement: The complaint alleges that Defendant had knowledge of the Asserted Patents "since at least the date BPI submitted the ANDA with a Paragraph IV Certification" (Compl. ¶32). This alleged knowledge forms the basis for the willfulness claim and the request for enhanced damages and attorneys' fees under 35 U.S.C. § 285 (Compl. ¶33, ¶39).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central factual issue will be one of compositional identity: What is the precise formulation of BPI's proposed generic product, including any process-related impurities, and does it meet the specific quantitative limitations—both positive (e.g., 60 µg/mL selenium) and negative (e.g., ≤1 µg/mL chromium)—recited in the asserted claims?
- A key legal question will be one of claim scope: How will the court construe the negative limitation "no chromium or chromium in an amount not to exceed 1 µg"? The resolution of whether this phrase sets a single upper-bound threshold or presents alternative limitations will be critical for determining infringement.
- For the asserted method patent, a core question will be one of induced infringement: Does the specific language in BPI's proposed product labeling constitute active encouragement for medical professionals to administer the generic drug in a manner that practices all steps of the claimed methods, thereby creating liability for inducement?