DCT

3:25-cv-17822

Vifor Intl AG v. Xiromed Pharma Espana SL

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-17822, D.N.J., 11/21/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Xiromed LLC maintains its principal place of business in the state. Defendant Xiromed Pharma España, S.L. is a foreign corporation, which may be sued in any judicial district. The complaint also notes that both defendants have previously litigated Hatch-Waxman patent disputes in this district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs' iron deficiency anemia treatment, Injectafer®, constitutes an act of infringement of six U.S. patents covering ferric carboxymaltose compositions and methods of administration.
  • Technical Context: The technology relates to parenteral iron-carbohydrate complexes used to treat iron deficiency anemia in patients who cannot tolerate or effectively absorb oral iron supplements.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendants’ Paragraph IV certification letter, which notified Plaintiffs of the filing of ANDA No. 220469. The complaint notes that U.S. Patent No. 7,612,109 has been granted a one-year patent term extension. The complaint's Local Rule 11.2 Certification discloses that the asserted patents have been the subject of other, now-closed and currently pending litigations against different generic manufacturers.

Case Timeline

Date Event
2002-10-23 ’109 Patent Priority Date
2006-01-06 ’702, ’612, ’260, ’091, and ’502 Patents Priority Date
2009-11-03 ’109 Patent Issued
2010-07-13 ’702 Patent Issued
2013-07-25 FDA approved New Drug Application for Injectafer®
2014-11-25 ’612 Patent Issued
2022-06-21 ’260 Patent Issued
2022-09-06 ’091 Patent Issued
2022-10-25 ’502 Patent Issued
2025-10-08 Defendants sent Paragraph IV Notice Letter to Plaintiffs
2025-11-21 Complaint Filed

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

U.S. Patent No. 7,612,109 - "Water-Soluble Iron-Carbohydrate Complexes, Production Thereof, and Medicaments Containing Said Complexes"

The Invention Explained

  • Problem Addressed: The patent addresses the limitations of prior art parenteral iron preparations, noting that dextran-based complexes can cause dangerous anaphylactic shocks and that sucrose-based complexes have stability issues that make sterilization difficult (’109 Patent, col. 1:33-41).
  • The Patented Solution: The invention is a water-soluble iron (III) carbohydrate complex created by reacting an iron (III) salt with the oxidation product of one or more maltodextrins. This process, using an aqueous hypochlorite solution, yields a complex that is described as stable, easy to produce from readily available starting materials, and suitable for parenteral administration (’109 Patent, Abstract; col. 1:44-54).
  • Technical Importance: This approach provided a pathway to create a parenteral iron therapeutic intended to be safer than dextran-based products and more stable for manufacturing and sterilization than other alternatives.

Key Claims at a Glance

  • The complaint alleges infringement of one or more claims without specifying them; independent claim 1 is a representative composition claim (Compl. ¶49).
  • The essential elements of independent claim 1 include:
    • A water-soluble iron carbohydrate complex with a weight average molecular weight between 80,000 and 400,000 daltons.
    • The complex is the reaction product of an aqueous solution of an iron (III) salt and an aqueous solution of oxidized maltodextrin(s).
    • The oxidation is performed using an aqueous hypochlorite solution at an alkaline pH.
    • The starting maltodextrin(s) must have a specified dextrose equivalent.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent but makes a general allegation of infringement.

U.S. Patent No. 7,754,702 - "Methods and Compositions For Administration of Iron"

The Invention Explained

  • Problem Addressed: The patent family specification describes the drawbacks of conventional parenteral iron therapies, which often require multiple, slow, low-dose administrations to deliver a full therapeutic course of iron. This approach is noted as being inconvenient for patients and costly for healthcare providers (’260 Patent, col. 1:48-68).
  • The Patented Solution: The invention is a method for treating iron deficiency anemia by administering a relatively high single dose of an iron carbohydrate complex (such as ferric carboxymaltose) in a short period. This allows for rapid iron repletion in a single session, a method often referred to as a total dose infusion (’260 Patent, Abstract; col. 2:5-12).
  • Technical Importance: The claimed method represented a significant shift in clinical practice, enabling the full therapeutic dose of iron to be administered in one visit, which improves patient compliance and reduces the logistical burden of multiple infusions.

Key Claims at a Glance

  • The complaint asserts claims 4–9, 16–22, 24, 26, 31–40, and 44–57; independent claim 44 is a representative asserted claim (Compl. ¶72, ¶75).
  • The essential elements of independent claim 44 include:
    • A method of treating iron deficiency anemia in a subject.
    • The method comprises intravenously administering an iron carbohydrate complex.
    • The administration is in a single dosage unit containing at least 0.6 grams of elemental iron.
    • The administration occurs in about 15 minutes or less.
    • The iron carbohydrate complex has a molecular weight between about 100,000 and 350,000 daltons.
  • The complaint asserts both independent and dependent claims.

Multi-Patent Family Analysis

  • U.S. Patent No. 8,895,612 - "Methods and Compositions For Administration of Iron" (issued November 25, 2014)

    • Technology Synopsis: The ’612 Patent claims methods of treating iron deficiency anemia associated with specific underlying conditions, such as chronic kidney disease or heavy uterine bleeding. The method involves administering a single high dose of an iron carboxymaltose complex characterized as being substantially non-immunogenic and having substantially no cross-reactivity with anti-dextran antibodies (’612 Patent, Abstract).
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶87).
    • Accused Features: The complaint alleges that Defendants' proposed generic product will be labeled for and used in a method of treating iron deficiency anemia associated with chronic kidney disease and/or heavy uterine bleeding by administering a single dosage unit of at least 0.6 grams of elemental iron in 15 minutes or less (Compl. ¶87).

  • U.S. Patent No. 11,364,260 - "Methods and Compositions For Administration of Iron" (issued June 21, 2022)

    • Technology Synopsis: The ’260 Patent claims methods of treating iron deficiency or dysfunctional iron metabolism specifically associated with cardiomyopathy. The method involves administering an iron carboxymaltose complex intravenously in a single high dose over a short time period (’260 Patent, Abstract).
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶99).
    • Accused Features: The complaint alleges that the proposed label for Defendants' generic product will instruct its use for treating iron deficiency associated with cardiomyopathy, via intravenous administration of a single dosage unit of at least 0.6 grams of elemental iron in about 15 minutes or less (Compl. ¶99).

  • U.S. Patent No. 11,433,091 - "Methods and Compositions For Administration of Iron" (issued September 6, 2022)

    • Technology Synopsis: The ’091 Patent claims a method of treating anemia in a human subject by intravenously administering an iron carboxymaltose complex. A key feature of the claimed method is the administration of a single dosage unit of at least 0.7 grams of elemental iron in 15 minutes or less (’091 Patent, Abstract).
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶111).
    • Accused Features: The complaint alleges Defendants' product will be used in a method of treating anemia by administering a single dosage unit of at least 0.7 grams of elemental iron intravenously in 15 minutes or less, per the instructions on its proposed label (Compl. ¶111).

  • U.S. Patent No. 11,478,502 - "Methods and Compositions For Administration of Iron" (issued October 25, 2022)

    • Technology Synopsis: The ’502 Patent claims a method of treating iron deficiency anemia or functional iron deficiency that results in increased transferrin saturation. The method involves administering a specific polynuclear iron (III)-hydroxide complex (ferric carboxymaltose) intravenously in a single high-dose unit over a short duration (’502 Patent, Abstract).
    • Asserted Claims: The complaint alleges infringement of "one or more claims" (Compl. ¶123).
    • Accused Features: The complaint alleges that Defendants' product, identified as the claimed polynuclear iron complex, will be administered to treat iron deficiency anemia in a single dosage of at least 0.6 grams, resulting in increased transferrin saturation (Compl. ¶123).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' proposed generic "Ferric Carboxymaltose Injection" products, for which they submitted ANDA No. 220469 to the FDA (Compl. ¶1, ¶37). The products are identified as being available in 500 mg/10 mL and 1000 mg/20 mL single-dose vials (Compl. ¶37).

Functionality and Market Context

The products are injectable aqueous solutions containing ferric carboxymaltose as the active ingredient (Compl. ¶40, ¶49). The complaint alleges they are bioequivalent to Plaintiffs' Injectafer® product and will be marketed for the same approved indications, including the treatment of iron deficiency anemia (Compl. ¶42-43). The act of infringement is the submission of the ANDA seeking approval to market this generic drug prior to the expiration of the patents-in-suit (Compl. ¶1).

IV. Analysis of Infringement Allegations

’109 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A water soluble iron carbohydrate complex having a weight average molecular weight (Mw) of 80,000 to 400,000, comprising the reaction product of... Xiromed's ANDA Products comprise an aqueous solution of ferric carboxymaltose, an iron carbohydrate complex, having a weight average molecular weight of 80,000 to 300,000 daltons. ¶49 col. 3:10-12
...the reaction product of: (a) an aqueous solution of an iron (III) salt and (b) an aqueous solution of the oxidation product of (i) at least one maltodextrin and (ii) an aqueous hypochlorite solution at an alkaline pH... The complaint alleges that the ferric carboxymaltose in the ANDA product is made by a process covered by one or more claims of the ’109 patent and notes the absence of any allegation in Defendants' notice letter that the product is not made according to the patent's claims. ¶63-64 col. 1:55-67
  • Identified Points of Contention:
    • Technical Questions: A primary evidentiary question will concern the manufacturing process of the accused product. The complaint's allegation of process infringement rests partly on an inference from the defendant's alleged omission in its notice letter (Compl. ¶64). The case may turn on whether discovery shows that the process used to make the accused ferric carboxymaltose meets the specific oxidation and reaction steps required by the patent's claims.

’702 Patent Infringement Allegations

Claim Element (from Independent Claim 44) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating iron deficiency anemia in a subject in need thereof, the method comprising intravenously administering an iron carbohydrate complex... The proposed label for Xiromed's ANDA Products will instruct their use in a method of treating iron deficiency anemia. ¶75 col. 3:50-51
...in a single dosage unit of at least 0.6 grams of elemental iron... The proposed label will instruct administration in a single dosage unit of at least 0.6 grams of elemental iron. ¶75 col. 4:2-5
...in about 15 minutes or less... The proposed label will instruct administration intravenously in about 15 minutes or less. ¶75 col. 4:6-9
...wherein the iron carbohydrate complex has a molecular weight between about 100,000 daltons to about 350,000 daltons. Xiromed’s ANDA Products comprise an iron carboxymaltose complex having a molecular weight of about 100,000 daltons to about 350,000 daltons. ¶75 col. 3:45-47
  • Identified Points of Contention:
    • Scope Questions: The infringement theory for this method patent is based on inducement, stemming from the alleged instructions on the proposed product label. A central question will be whether the final, FDA-approved label for the generic product will direct healthcare professionals to perform each and every step of the claimed method, thereby satisfying the legal standard for inducement.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "iron carbohydrate complex" (from ’109 Patent, claim 1; ’702 Patent, claim 44)

    • Context and Importance: This term is foundational to all asserted patents. Its construction will define the universe of compositions and methods covered. Practitioners may focus on this term because its scope will determine whether the accused product, identified as "ferric carboxymaltose," falls within the claims as understood in the context of the patent specifications.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specifications describe the complexes functionally, such as being suitable for parenteral administration and having certain physical characteristics like molecular weight and a near-neutral pH (’260 Patent, col. 4:21-25). This could support a construction based on shared properties rather than a specific chemical formula.
      • Evidence for a Narrower Interpretation: The ’109 Patent defines the complex by its specific manufacturing process (reaction of an iron salt with oxidized maltodextrins) ('109 Patent, claim 1). The specifications for the method patents provide a specific chemical formula and name for a preferred embodiment, polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate (’260 Patent, col. 3:60-65). This may support a narrower construction limited to that specific structure or process.

  • The Term: "single dosage unit" (from ’702 Patent, claim 44)

    • Context and Importance: The novelty of the method patents is rooted in the administration of a large amount of iron in a single session. The definition of "single dosage unit" is therefore critical to determining whether the administration of Defendants' product, which comes in vials of up to 1000 mg (1 gram), would constitute infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification contrasts the invention with conventional therapies that require "5 to 10 sessions over an extended period of time" (’260 Patent, col. 2:1-3). This suggests "single dosage unit" could be construed to mean the total therapeutic dose administered in a single clinical visit or session, regardless of the number of vials used.
      • Evidence for a Narrower Interpretation: The plain meaning of "a single... unit" could be argued to refer to a discrete physical item, such as a single vial or a single pre-mixed IV bag. A defendant might argue that administering the contents of two separate vials, even in the same session, constitutes the administration of two dosage units, not one.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for all asserted patents. The factual basis for inducement is that Defendants' proposed product label will allegedly instruct and encourage healthcare professionals and patients to use the generic product in a manner that directly infringes the claimed methods (Compl. ¶53, ¶79, ¶91, ¶103, ¶115, ¶127). The complaint also alleges contributory infringement of the ’109 patent, stating the ANDA product is a material part of the invention and not a staple article suitable for substantial non-infringing use (Compl. ¶55).
  • Willful Infringement: The complaint does not contain a specific count or prayer for relief related to willful infringement. However, it alleges that Defendants have knowledge of the patents-in-suit, at least as of the date of their Paragraph IV certification letter (Compl. ¶52, ¶78, ¶90, ¶102, ¶114, ¶126). These allegations could potentially form the basis for a future claim of willfulness based on post-suit conduct.

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

  • A core issue will be one of process versus product equivalence: For the '109 composition patent, can Plaintiffs prove that Defendants' generic ferric carboxymaltose is made by the specific maltodextrin oxidation process required by the claims, or will the infringement analysis depend solely on demonstrating structural and functional identity between the patented and accused compositions?
  • A second central issue will be one of infringement by labeling: For the '702 patent and its family members, does the proposed label for the generic product not only describe but actively instruct and encourage physicians to administer the drug in a manner that practices every limitation of the claimed high-dose, rapid-infusion methods, thereby meeting the legal standard for induced infringement under the Hatch-Waxman Act?
  • The case may also turn on a key question of definitional scope: Will the term "single dosage unit," as used in the method patents, be construed broadly to mean a total therapeutic dose administered in one clinical session, or narrowly to mean the contents of a single physical vial, an interpretation that could impact the infringement analysis for doses exceeding the amount in one vial?