DCT
2:24-cv-11130
American Regent Inc v. Xiromed LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Xiromed, LLC (New Jersey) and Xiromed Pharma España, S.L. (Spain)
- Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
- Case Identification: 2:24-cv-11130, D.N.J., 12/13/2024
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Xiromed, LLC is organized under New Jersey law, maintains its principal place of business in the district, and has committed acts of infringement there, including submitting its Abbreviated New Drug Application (ANDA) and indicating intent to market the accused product in New Jersey.
- Core Dispute: Plaintiff alleges that Defendants' submission of an ANDA to market a generic version of Plaintiff's Selenious Acid products constitutes an act of infringement of a patent covering stable trace element compositions for intravenous use.
- Technical Context: The technology relates to stable, injectable pharmaceutical compositions containing trace elements, such as selenium, which are used as supplements to parenteral (intravenous) nutrition for patients who cannot receive nourishment through normal digestion.
- Key Procedural History: This action is related to a prior case (C.A. No. 24-7811) between the parties involving the same ANDA but a different patent. The patent-in-suit was listed in the FDA's Orange Book after the prior case was filed. Defendants sent a Paragraph IV certification notice letter regarding the patent-in-suit on December 6, 2024, though Plaintiff alleges Defendants had knowledge of the patent since at least October 11, 2024.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's New Drug Application for Selenious Acid product approved |
| 2020-07-02 | ’957 Patent Priority Date (Provisional App. No. 63/047,708) |
| 2024-06-11 | Defendants send First Notice Letter regarding a related patent |
| 2024-10-11 | Plaintiff allegedly informed Defendants of the pending '957 patent |
| 2024-11-26 | U.S. Patent No. 12,150,957 Issues |
| 2024-12-06 | Defendants send Second Notice Letter regarding the '957 patent |
| 2024-12-13 | Complaint Filed |
| 2041-07-01 | ’957 Patent Expiration Date (as per Orange Book) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,150,957 - Trace element compositions, methods of making and use
The Invention Explained
- Problem Addressed: The patent describes a problem with existing parenteral nutrition (PN) therapies where trace elements, when added to PN solutions, result in admixtures that are stable for only a short period (e.g., 24-48 hours) (’957 Patent, col. 1:56-65). This necessitates frequent, time-consuming, and costly preparation of the admixtures, creates waste, and complicates patient care (’957 Patent, col. 2:5-30).
- The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to parenteral nutrition, allow the final admixture to remain stable for a longer period (’957 Patent, col. 2:46-54). This is achieved through specific formulations containing trace elements like zinc, copper, selenium, and manganese, while carefully controlling for the presence of certain impurities, thereby enabling the preparation of PN solutions in larger, more convenient batches (’957 Patent, Abstract; col. 2:31-44).
- Technical Importance: By creating longer-stability formulations, the invention aimed to reduce the logistical burden, cost, and potential for waste associated with daily preparation of parenteral nutrition admixtures for patients requiring long-term intravenous feeding (’957 Patent, col. 2:31-38).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, with independent claim 29 being representative of a method of use.
- Independent Claim 29:
- A method of providing an injectable composition to a human patient in need thereof, comprising administering the injectable composition to the patient.
- The injectable composition comprises water and selenious acid 98 µg per 1 mL.
- The composition has no chromium, or chromium in an amount not to exceed 1 µg per 1 mL.
- The composition has no aluminum, or aluminum in an amount not to exceed 6 µg per 1 mL.
- The composition has no iron, or iron in an amount not to exceed 10 µg per 1 mL.
- The composition has fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL OR iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL.
- The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation of infringement of "one or more claims" (Compl. ¶46).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the generic drug product described in Xiromed’s ANDA No. 219476 ("the ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is described as a generic version of Plaintiff's Selenious Acid products, specifically "Selenious Acid 600 mcg Selenium/10 mL in an intravenous solution" (Compl. ¶¶40-41). This concentration is equivalent to 60 mcg of elemental selenium per mL.
- The complaint alleges the ANDA Product contains the same or equivalent ingredients and exhibits the same or equivalent chemical and therapeutic properties as Plaintiff's branded product, intended for use as a supplement to parenteral nutrition (Compl. ¶¶42-43). The infringement is predicated on the future manufacture, use, and sale of this product in the United States upon FDA approval (Compl. ¶46).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
Claim Chart Summary
The complaint does not contain a claim chart. The following table summarizes the infringement theory for claim 29 based on the complaint's narrative allegations.
| Claim Element (from Independent Claim 29) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of providing an injectable composition to a human patient... comprising administering... the injectable composition... | The ANDA Product, if approved, will be administered to patients by medical practitioners according to the directions in the proposed package insert, which will constitute direct infringement. | ¶46 | col. 74:45-49 |
| the injectable composition comprising... selenious acid 98 µg... per 1 mL | The complaint alleges the ANDA Product is a "Selenious Acid 600 mcg Selenium/10 mL" solution, which is equivalent to 60 mcg/mL. The patent equates 98 µg of selenious acid with 60 µg of elemental selenium. | ¶¶40, 41 | col. 12:15-20, T.1 |
| 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... not to exceed 10 µg | The complaint alleges that the ANDA Product, if approved, will be administered to patients and that this use will infringe one or more claims of the '957 patent, implying the product meets these negative limitations. | ¶46 | col. 74:50-57 |
| fluoride in an amount of 0.0001 µg to 2.7 µg or iodine in an amount of 0.0001 µg to 0.2 µg per 1 mL | The complaint alleges that use of the ANDA Product will infringe the '957 patent, implying the product meets this limitation. The complaint does not provide specific detail for analysis of the fluoride or iodine content in the ANDA Product. | ¶46 | col. 74:57-61 |
Identified Points of Contention
- Technical Questions: A primary factual dispute will concern the precise composition of Xiromed's ANDA Product. What evidence will discovery reveal about the actual concentration of chromium, aluminum, iron, and fluoride or iodine in the product? The complaint's allegations are general, making the product's exact formulation a central evidentiary issue.
- Scope Questions: Do the specific impurity levels in Xiromed's ANDA product fall within the claimed ranges? The case may turn on whether the accused product meets the negative limitations (e.g., "no chromium or... not to exceed 1 µg"), which are often strictly construed.
V. Key Claim Terms for Construction
- Term for Construction: "no chromium or chromium in an amount not to exceed 1 µg"
- Context and Importance: This is a negative limitation defining an upper bound for an impurity. The construction of "no" and the precision of the numerical limit will be critical. Practitioners may focus on this term because infringement hinges on whether the accused product's composition, including trace impurities, falls outside the excluded scope. The interpretation will determine whether any detectable amount of chromium below 1 µg infringes or if "no" creates a separate, stricter standard.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (favoring Patentee): The disjunctive "or" could be read to define two separate paths for infringement: having literally "no" chromium, or having an amount that is greater than 1 µg. This reading might suggest that any detectable amount between zero and 1 µg does not infringe, but it is an unusual construction. A more likely argument for the patentee is that the claim covers any product that does not meet the condition of having chromium at a level of 1 µg or less.
- Evidence for a Narrower Interpretation (favoring Accused Infringer): The specification states in one embodiment, "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" (’957 Patent, col. 11:49-51). An accused infringer may argue this suggests a very strict, zero-tolerance standard for "no chromium." Conversely, Table 2 lists "Chromium (Cr): Not more than 1.0 µg/mL" as a specification for an exemplary composition, which supports reading the claim as simply setting a 1.0 µg/mL ceiling (’957 Patent, col. 13). An accused infringer would argue its product does not infringe if its chromium level is at or below 1 µg.
VI. Other Allegations
Indirect Infringement
The complaint alleges that Xiromed will induce infringement by patients and medical practitioners. The basis for this allegation is that Xiromed’s proposed package insert will contain "directions and instructions" that will cause end-users to administer the ANDA Product in a manner that directly infringes the method claims of the ’957 Patent (Compl. ¶46).
Willful Infringement
The complaint alleges that Xiromed has had knowledge of the ’957 patent "since at least October 11, 2024, when ARI emailed all defendants in the Related Action to inform them that the '957 patent would issue in due course" (Compl. ¶49). This allegation of pre-suit knowledge forms the basis for the request for a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶50).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual proof: Can Plaintiff demonstrate through testing and discovery that Defendants' ANDA Product, as formulated, meets not only the affirmative element for selenious acid but also the precise negative limitations for chromium, aluminum, and iron, and the specific range for fluoride or iodine, as recited in the asserted method claim?
- 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 will define the exact boundary between infringement and non-infringement for trace impurities, which may be dispositive if the accused product contains any detectable amount of chromium.
- A key procedural question will relate to inducement: Assuming the ANDA product itself does not directly infringe a composition claim, does the language of Defendants' proposed package insert provide sufficient instruction and encouragement to medical professionals to perform all steps of the asserted method claim, thereby supporting a finding of induced infringement?