DCT

1:25-cv-15857

Pharmacosmos Holding AS v. Daiichi Sankyo Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-15857, D.N.J., 09/22/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Daiichi Sankyo is incorporated and has its principal place of business in New Jersey. For Defendant American Regent, venue is alleged based on its role as an agent and alter ego of Daiichi Sankyo, its commission of infringing acts within the district, and its history of availing itself of the jurisdiction by filing patent infringement lawsuits in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ intravenous iron-deficiency drug, Injectafer®, infringes four patents covering methods for treating iron deficiency with ferric carboxymaltose while reducing the risk and severity of associated side effects, particularly hypophosphatemia.
  • Technical Context: The lawsuit concerns intravenous iron carbohydrate complexes used to treat iron deficiency anemia, a market where managing treatment-related side effects is a key area of clinical and commercial differentiation.
  • Key Procedural History: The complaint alleges that between March 2021 and January 2022, the parties engaged in discussions regarding the asserted patent family, during which Plaintiff notified Defendants of the patents and their potential infringement. This history is presented to support allegations of pre-suit knowledge for claims of willful infringement.

Case Timeline

Date Event
2018-10-29 Earliest Priority Date for all Asserted Patents
2021-06-01 U.S. Patent No. 11,020,369 Issues
2023-05-31 Defendants revise Injectafer® label ("2023 Injectafer® Label")
2023-11-07 U.S. Patent No. 11,806,329 Issues
2025-01-03 Defendants revise Injectafer® label ("2025 Injectafer® Label")
2025-05-13 U.S. Patent No. 12,295,934 Issues
2025-05-20 U.S. Patent No. 12,303,486 Issues
2025-09-22 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,020,369 - Treating Iron Deficiency with Ferric Carboxymaltose

  • Issued: June 1, 2021

The Invention Explained

  • Problem Addressed: The patent describes that treatment with ferric carboxymaltose (FCM) can cause hypophosphatemia (low serum phosphate), a side effect mediated by the hormone FGF23. Prior to the invention, this side effect was considered transient and clinically irrelevant. The inventors assert they discovered that repeated FCM dosing leads to a "surprising and previously unknown self-amplifying effect" on FGF23 levels, which can cause clinically significant consequences like reduced muscle function and increased bone turnover (Compl. ¶¶37-38; ’369 Patent, col. 2:20-40, col. 3:12-19).
  • The Patented Solution: The patent claims methods of treating iron deficiency with specific, repeated doses of FCM, but only for a selected subgroup of patients who have a "reduced risk for FGF23-mediated side effects." This reduced risk is determined by assessing specific patient characteristics, such as having normal blood or urine parameters (e.g., normal serum phosphate), the absence of certain exclusion criteria (e.g., no history of bariatric surgery), or having normal respiratory capacity (’369 Patent, col. 3:28-42, col. 12:5-52). This patient selection strategy aims to mitigate the auto-synergistic adverse effects of repeat FCM dosing (’369 Patent, col. 3:12-19).
  • Technical Importance: The invention purports to provide a method to safely administer repeat doses of a widely used intravenous iron therapy by identifying and treating only those patients less susceptible to its newly-discovered severe side effects (Compl. ¶48).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶67).
  • The essential elements of independent Claim 1 are:
    • A method of treating iron deficiency, comprising administering a dose followed by a further dose of ferric carboxymaltose to a subject.
    • The dosing regimen is either two 750 mg doses or a 1000 mg dose followed by a 500-1000 mg dose.
    • The subject has a reduced risk for FGF23-mediated side effects.
    • This reduced risk is characterized by the subject meeting at least one of four criteria: (I) having a normal level of a specified blood or urine parameter (e.g., serum phosphate >2.5 mg/dL), (II) having a normal level of a specified blood parameter related to bone turnover, (III) absence of specified exclusion criteria (e.g., obesity, bariatric surgery), or (IV) having normal respiratory capacity.
  • The complaint explicitly reserves the right to assert dependent claims 2-5 and 16 (Compl. ¶¶67, 85).

U.S. Patent No. 11,806,329 - Treating Iron Deficiency with Ferric Carboxymaltose

  • Issued: November 7, 2023

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as its parent '369 patent: repeated dosing of FCM exacerbates FGF23-mediated side effects, including clinically significant hypophosphatemia (’329 Patent, col. 3:15-31).
  • The Patented Solution: The patent claims methods to mitigate this risk through patient selection and monitoring. One method involves administering repeat doses of FCM only to subjects who have a "reduced risk for hypophosphatemia," which is defined in this patent as having a "normal serum phosphate level" (’329 Patent, col. 42:8-13, Claim 1). A second claimed method involves monitoring a patient's serum phosphate level after an initial dose and determining the patient is "eligible" for a further dose only "if the serum phosphate level is normal" (’329 Patent, col. 44:40-45, Claim 16).
  • Technical Importance: This approach provides clinicians with specific biomarkers and decision points (i.e., monitoring serum phosphate) to guide the safe administration of repeat courses of FCM therapy (Compl. ¶53).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claims 1 and 16 (Compl. ¶102).
  • The essential elements of independent Claim 1 are:
    • A method of treating iron deficiency in a human subject by administering a dose followed by a further dose of ferric carboxymaltose.
    • The dosing regimen is either two 750 mg doses or a 1000 mg dose followed by a 500-1000 mg dose.
    • The subject has a reduced risk for hypophosphatemia.
    • This reduced risk is characterized by the subject having a normal serum phosphate level.
  • The essential elements of independent Claim 16 are:
    • A method of monitoring serum phosphate level in a human subject who has been administered a dose of ferric carboxymaltose.
    • The method comprises determining the serum phosphate level in a biological sample from the subject.
    • The subject is eligible for being administered a further dose of ferric carboxymaltose if the serum phosphate level is normal.
  • The complaint explicitly reserves the right to assert dependent claims 2-15, 17-25, 33, and 34 (Compl. ¶¶101, 116, 117).

U.S. Patent No. 12,295,934 - Treating Iron Deficiency with Ferric Carboxymaltose

  • Issued: May 13, 2025
  • Technology Synopsis: This patent claims methods for reducing the severity of hypophosphatemia associated with repeated FCM treatments. The claimed methods require measuring a subject's serum phosphate levels after an initial dose and, if hypophosphatemia is detected, treating it before administering the further dose (Compl. ¶¶55-56). An alternative claimed method involves first treating any hypophosphatemia and then measuring phosphate levels before administering the further dose (Compl. ¶57).
  • Asserted Claims: Claims 1 and 31 are asserted (Compl. ¶134).
  • Accused Features: The complaint alleges infringement based on instructions in the Injectafer® label that direct healthcare providers to check for, monitor, and treat hypophosphatemia in patients receiving repeat courses of therapy (Compl. ¶¶137, 140-141).

U.S. Patent No. 12,303,486 - Treating Iron Deficiency with Ferric Carboxymaltose

  • Issued: May 20, 2025
  • Technology Synopsis: This patent is similar to the ’934 patent but focuses on methods for reducing the risk of symptomatic hypophosphatemia. The claimed methods involve measuring serum phosphate levels after an initial dose and correcting any detected hypophosphatemia before administering a further dose, thereby reducing the risk of clinically significant symptoms (Compl. ¶¶60-61).
  • Asserted Claims: Claim 1 is asserted (Compl. ¶171).
  • Accused Features: Infringement is alleged based on instructions in the Injectafer® label that warn of symptomatic hypophosphatemia and direct healthcare providers to correct pre-existing hypophosphatemia and monitor/treat it during repeat courses of therapy (Compl. ¶¶174, 177-178).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Injectafer® (ferric carboxymaltose injection), a prescription drug for intravenous use (Compl. ¶¶1, 10).

Functionality and Market Context

  • Injectafer® is an intravenous iron carbohydrate complex indicated for the treatment of iron deficiency anemia in adult and pediatric patients who cannot tolerate or have not responded to oral iron, and for adult patients with non-dialysis dependent chronic kidney disease (Compl. ¶10). It is also indicated for treating iron deficiency in adult patients with heart failure to improve exercise capacity (Compl. ¶10).
  • Defendants manufacture, market, distribute, and sell Injectafer® in the United States, with product labels and marketing materials that provide instructions for its administration (Compl. ¶¶7-9, 17). The complaint alleges that Plaintiff's competing product, Monoferric®, is also an iron carbohydrate complex injection for iron deficiency anemia (Compl. ¶6).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,020,369 Infringement Allegations

Claim Element (from Independent Claim 1) - Alleged Infringing Functionality - Complaint Citation Patent Citation
A method of treating iron deficiency... - The Injectafer® label indicates the product for treating iron deficiency anemia, which constitutes a method of treating iron deficiency. - ¶¶70, 78 col. 29:56-57
...which comprises administering a dose followed by a further dose of ferric carboxymaltose to a subject... - The Injectafer® label identifies the active ingredient as ferric carboxymaltose and instructs that treatment "may be repeated if IDA reoccurs." - ¶¶71, 79 col. 30:7-9
a. the dose of ferric carboxymaltose contains 750 mg of elemental iron and the further dose of ferric carboxymaltose contains 750 mg of elemental iron... - The label’s recommended dosage for patients ≥50 kg is "Injectafer 750 mg intravenously in two doses separated by at least 7 days." - ¶¶72, 80 col. 29:60-63
...wherein the subject has a reduced risk for FGF23-mediated side effects... - The label instructs providers to correct pre-existing hypophosphatemia or treat it as medically indicated, which allegedly reduces the patient's risk of FGF23-mediated side effects. - ¶¶73, 81 col. 12:5-7
(I) has a blood or urine parameter selected from the group consisting of: (1) normal serum phosphate level, in particular >2.5 mg/dL... - By following label instructions to monitor and treat patients at risk for low serum phosphate, providers allegedly identify and treat patients with normal serum phosphate levels, which the complaint asserts is >2.5 mg/dL. ¶¶74, 82 col. 30:1-4

Identified Points of Contention

  • Scope Questions: The complaint alleges that administering Injectafer® to patients who are not at risk (e.g., have normal phosphate levels) satisfies the limitation of treating a subject who "has a reduced risk" (Compl. ¶¶73-74). A central question may be whether selecting a patient who is already at low risk is equivalent to treating a patient who "has a reduced risk," which could imply a change from a higher-risk state.
  • Technical Questions: What evidence does the complaint provide that following the label instructions necessarily results in treating a patient population that meets the specific numerical ranges for blood/urine parameters or the explicit exclusion criteria recited in parts (I)-(IV) of Claim 1? The analysis may focus on whether the label's general instructions to "monitor" or "correct" hypophosphatemia are specific enough to map directly onto the patent's detailed patient selection criteria.

U.S. Patent No. 11,806,329 Infringement Allegations

Claim Element (from Independent Claim 1) - Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating iron deficiency in a human subject... - The Injectafer® label indicates the product for treating iron deficiency anemia, which constitutes a method of treating iron deficiency. - ¶104 col. 1:13-14
...which comprises administering a dose followed by a further dose of ferric carboxymaltose to the subject... - The label instructs that "Injectafer treatment may be repeated" and provides recommended dosages, such as 750 mg in two doses. - ¶¶105-106 col. 1:13-16
...wherein the subject has a reduced risk for hypophosphatemia... - The label instructs healthcare providers to "[c]orrect pre-existing hypophosphatemia" or "[t]reat hypophosphatemia as medically indicated," which allegedly reduces the patient's risk. - ¶107 col. 3:15-31
...wherein the subject having a reduced risk for hypophosphatemia has a normal serum phosphate level. - The complaint alleges that by following the label's instructions to correct or treat hypophosphatemia, providers ensure the patient has a "normal serum phosphate level" before receiving a further dose. ¶108 col. 14:19-30
Claim Element (from Independent Claim 16) - Alleged Infringing Functionality - Complaint Citation Patent Citation
A method of monitoring serum phosphate level in a human subject who has been administered a dose of ferric carboxymaltose... - The Injectafer® label instructs physicians to "[c]heck serum phosphate levels prior to a repeat course of treatment" in certain patients. - ¶110 col. 15:27-35
...comprising determining serum phosphate level in a biological sample obtained from the subject... - The act of checking serum phosphate levels as instructed by the label necessarily requires obtaining and analyzing a biological sample (e.g., blood serum). - ¶111 col. 15:27-29
...wherein the subject is eligible for being administered a further dose of ferric carboxymaltose if the serum phosphate level is normal. - The complaint alleges that by checking levels and treating hypophosphatemia as instructed, providers determine a patient is eligible for a further dose once their level is "normal." - ¶¶112-113 col. 23:13-23

Identified Points of Contention

  • Scope Questions: Claim 1 requires treating a subject who both "has a reduced risk" and "has a normal serum phosphate level." The analysis may question whether these are redundant or distinct requirements and how the complaint's theory satisfies both. Does a patient with a consistently normal phosphate level inherently have a "reduced risk," or does the term require a comparison to a higher-risk state?
  • Technical Questions: For Claim 16, the analysis will question what evidence shows that the label's instruction to "check" phosphate levels constitutes the entire claimed "method of monitoring," which results in a determination of "eligibility." A defendant may argue that the label provides guidance, but the ultimate eligibility decision is a matter of clinical judgment that goes beyond the claimed steps.

V. Key Claim Terms for Construction

  • The Term: "a subject [who] has a reduced risk for FGF23-mediated side effects" (’369 Patent, Claim 1) / "the subject has a reduced risk for hypophosphatemia" (’329 Patent, Claim 1).

  • Context and Importance: This term is the central feature of the patient-selection invention. Its construction will determine whether the patents cover the treatment of patients who are simply not in a high-risk group or if they are limited to patients whose risk profile has been actively lowered. The complaint's infringement theory depends on the broader interpretation (Compl. ¶¶73, 107).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that the therapeutic methods are "suitable for patients at reduced risk for FGF23-mediated side effects, which can be determined by them having a normal serum phosphate level" (’329 Patent, col. 14:26-30). This language may support the view that simply having a normal phosphate level is sufficient to meet the "reduced risk" criterion.
    • Evidence for a Narrower Interpretation: The problem solved by the patent is the "auto-synergistic impact" of repeat dosing (’369 Patent, col. 3:15-19). This context may suggest that "reduced risk" implies a comparison against the heightened risk that would otherwise occur with a repeat dose, potentially limiting the claim to methods that actively mitigate that specific, newly-discovered risk.

  • The Term: "normal serum phosphate level" (’329 Patent, Claims 1 and 16).

  • Context and Importance: This term provides the specific, objective metric for the patient selection and monitoring methods. Its definition is critical for determining infringement, as the complaint alleges that the accused label instructions lead providers to treat patients who meet a specific numerical threshold for "normal" (Compl. ¶¶108, 113).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term is used generally throughout the specification. A party might argue that in the absence of a specific definition in the claims, the term should be given its plain and ordinary meaning as understood by a person of ordinary skill in the art, which could encompass a range of values.
    • Evidence for a Narrower Interpretation: The ’329 patent specification, in a section defining "hypophosphatemia," provides specific grades, with Grade 1 being "<LLN-2.5 mg/dL" and Grade 2 being "<2.5-2.0 mg/dL" (’329 Patent, col. 7:55-8:5). This suggests that a "normal" level is one that is not hypophosphatemic, i.e., at or above 2.5 mg/dL, providing a specific numerical threshold that could limit the scope of the term.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b) for all four patents. The theory is that Defendants, with knowledge of the patents, actively and knowingly encourage direct infringement by healthcare providers through the instructions on the Injectafer® product labels and other marketing materials that allegedly instruct providers to perform the claimed methods (Compl. ¶¶64, 86-87, 95, 118-119).
  • Willful Infringement: The complaint alleges willful infringement for all four patents. The basis for willfulness is alleged actual knowledge of the patents and their infringement, stemming from pre-suit communications between the parties from March 2021 to January 2022, during which Plaintiff allegedly put Defendants on notice (Compl. ¶¶66, 97, 129, 166). The complaint further alleges that Defendants have known of or been willfully blind to the existence and infringement of the patents since their issuance dates (Compl. ¶¶89, 100, 132, 169).

VII. Analyst’s Conclusion: Key Questions for the Case

This dispute appears to center on whether the general safety warnings and monitoring instructions on a drug label can be mapped directly onto the specific, multi-part patient selection and treatment-protocol claims of Plaintiff's patents. The resolution will likely depend on the following key questions:

  • A core issue will be one of definitional scope: Does the claim term "a subject [who] has a reduced risk," in the context of the patent's disclosure, mean any patient who is not at high risk, as Plaintiff alleges? Or does it require a more active step of identifying and mitigating a pre-existing or treatment-induced risk, potentially narrowing the claim scope?
  • A key question of causation for inducement will be: Do the Injectafer® label's instructions to "monitor," "check," and "treat" hypophosphatemia provide specific directions that would necessarily lead a healthcare provider to perform all the steps of the claimed methods, or do they constitute general medical guidance that leaves the ultimate infringement decision to the provider's independent clinical judgment?
  • An evidentiary question will be one of knowledge and intent for willfulness: What was the precise content of the pre-suit communications between the parties, and did those communications provide notice of infringement that was specific enough to support a finding that Defendants' subsequent conduct was objectively reckless?