DCT

3:25-cv-15336

Vifor Intl AG v. Orbicular Pharmaceutical Tech Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-15336, D. Del., 05/02/2025
  • Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation not residing in any U.S. judicial district and because Defendant committed acts of infringement related to its Abbreviated New Drug Application (ANDA) with the intent to market its product in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an ANDA to market a generic version of Plaintiffs’ Injectafer® (ferric carboxymaltose) product constitutes an act of infringement of five U.S. patents covering the drug’s composition and methods of use.
  • Technical Context: The technology concerns water-soluble iron-carbohydrate complexes for intravenous treatment of iron deficiency anemia, a condition where the blood lacks adequate healthy red blood cells.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiffs’ receipt of a March 20, 2025 Notice Letter from Defendant. The letter included a Paragraph IV certification against five patents listed in the FDA’s Orange Book for Injectafer®, asserting that the patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture or sale of Defendant’s generic product.

Case Timeline

Date Event
2002-10-23 ’109 Patent Priority Date
2006-01-06 ’702, ’612, ’091, ’502 Patents Priority Date
2009-11-03 ’109 Patent Issue Date
2010-07-13 ’702 Patent Issue Date
2013-07-25 FDA Approval of Injectafer® NDA No. 203565
2014-11-25 ’612 Patent Issue Date
2022-09-06 ’091 Patent Issue Date
2022-10-25 ’502 Patent Issue Date
2025-03-20 Orbicular’s Notice Letter Date
2025-05-02 Complaint Filing Date

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," issued November 3, 2009

The Invention Explained

  • Problem Addressed: The patent describes challenges with existing parenteral iron preparations, such as iron dextran, which could cause dangerous anaphylactic shocks, and iron sucrose, which was difficult to sterilize and had stability issues, limiting its applicability (U.S. Patent No. 7,612,109, col. 1:26-44).
  • The Patented Solution: The invention is a water-soluble iron-carbohydrate complex created by oxidizing one or more maltodextrins with a hypochlorite solution and then reacting the product with an iron (III) salt (U.S. Patent No. 7,612,109, Abstract; col. 2:5-24). This process yields a stable complex with a defined molecular weight, suitable for creating neutral, sterilizable aqueous solutions for parenteral iron therapy.
  • Technical Importance: This approach provided a method for producing stable, high-molecular-weight iron complexes from readily available starting materials, which could be formulated into safer and more effective intravenous iron treatments.

Key Claims at a Glance

  • The complaint asserts "one or more claim of the ’109 patent" without specifying claims (Compl. ¶37). Independent claim 1 is representative of the composition claims.
  • Independent Claim 1 Elements:
    • A water soluble iron carbohydrate complex
    • having a weight average molecular weight (Mw) of 80,000 to 400,000
    • comprising 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
    • wherein, when one maltodextrin is present, it has a dextrose equivalent of between 5 and 20
    • and wherein, when a mixture of more than one maltodextrin is present, the dextrose equivalent of each individual maltodextrin is between 2 and 40, and the dextrose equivalent of the mixture is between 5 and 20.

U.S. Patent No. 7,754,702 - "Methods and Compositions For Administration of Iron," issued July 13, 2010

The Invention Explained

  • Problem Addressed: The patent background describes that conventional parenteral iron therapies required a total dose to be administered over multiple sessions (e.g., 5 to 10) and extended periods, leading to significant expense, nursing time, and patient inconvenience (’702 Patent, col. 1:47-52).
  • The Patented Solution: The invention provides a method for treating iron deficiency anemia by administering a high single dose of an iron carbohydrate complex (at least about 0.6 grams of elemental iron) intravenously in a very short period (about 15 minutes or less) (’702 Patent, Abstract; col. 2:36-43). This allows for rapid and efficient iron repletion in a single clinical visit.
  • Technical Importance: The claimed method represented a significant shift in treatment paradigm, enabling full iron repletion in a single, rapid administrative session, thereby increasing patient compliance and reducing healthcare system costs.

Key Claims at a Glance

  • The complaint asserts claims 4–9, 16–22, 24, 26, 31–40, and 44–57 (Compl. ¶48). Independent claim 4 is representative of the asserted method claims.
  • Independent Claim 4 Elements:
    • A method of treating iron deficiency anemia
    • comprising administering to a subject in need thereof an iron carbohydrate complex in a single dosage unit
    • wherein the single dosage unit comprises at least about 0.6 grams of elemental iron
    • and wherein the single dosage unit is administered intravenously in about 15 minutes or less.

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

  • Patent Identification: U.S. Patent No. 8,895,612, "Methods and Compositions For Administration of Iron," issued November 25, 2014 (Compl. ¶18).
  • Technology Synopsis: This patent, related to the ’702 patent, claims methods of treating specific types of iron deficiency anemia, such as those associated with chronic kidney disease or heavy uterine bleeding. The method involves administering an iron carboxymaltose complex with specific characteristics (e.g., substantially non-immunogenic) in a high single dose (at least about 0.6 grams) over a short duration (about 15 minutes or less) (’612 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" without specification (Compl. ¶63).
  • Accused Features: The accused feature is the intended use of Orbicular’s ANDA Product to practice the claimed method of treating iron deficiency anemia (Compl. ¶63).

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

  • Patent Identification: U.S. Patent No. 11,433,091, "Methods and Compositions For Administration of Iron," issued September 6, 2022 (Compl. ¶19).
  • Technology Synopsis: This patent, also related to the ’702 patent, claims methods of treating anemia by administering an iron carboxymaltose complex intravenously to a human subject. The method specifies a single dosage unit of at least about 0.7 grams of elemental iron administered in 15 minutes or less (’091 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" without specification (Compl. ¶75).
  • Accused Features: The accused feature is the intended use of Orbicular’s ANDA Product to practice the claimed high-dose, rapid-infusion method of treating anemia (Compl. ¶75).

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

  • Patent Identification: U.S. Patent No. 11,478,502, "Methods and Compositions For Administration of Iron," issued October 25, 2022 (Compl. ¶20).
  • Technology Synopsis: This patent, also in the same family, claims methods of treating iron deficiency anemia or functional iron deficiency. The method involves administering a specific chemical entity, polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate, in a single high-dose unit (at least about 0.6 grams) intravenously in about 15 minutes or less (’502 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" without specification (Compl. ¶87).
  • Accused Features: The accused feature is the intended use of Orbicular’s ANDA Product, which allegedly comprises the claimed chemical entity, to practice the specified treatment method (Compl. ¶87).

III. The Accused Instrumentality

Product Identification

  • Orbicular’s ANDA Product, a generic ferric carboxymaltose injection (750 mg Iron/15 mL) for which Orbicular seeks FDA approval under ANDA No. 212136 (Compl. ¶1).

Functionality and Market Context

The complaint alleges that Orbicular’s ANDA Product is a generic version of Plaintiffs’ Injectafer® product and is represented to the FDA as having the same active ingredient, dosage form, strength, and bioequivalence (Compl. ¶30). The product is described as an aqueous solution of ferric carboxymaltose formulated for parenteral application (Compl. ¶37). As an ANDA product, its proposed labeling is required to be substantially the same as the FDA-approved labeling for Injectafer®, which is approved to treat iron deficiency anemia (Compl. ¶¶24, 37). The complaint alleges the product is intended for the same approved indications as Injectafer® (Compl. ¶31).

No probative visual evidence provided in complaint.

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... Orbicular's ANDA Product comprises an aqueous solution of ferric carboxymaltose, which is an iron carbohydrate complex. ¶37 col. 1:12-14
...having a weight average molecular weight (Mw) of 80,000 to 400,000... The ferric carboxymaltose in the ANDA Product has a weight average molecular weight of 80,000 to 300,000 daltons. ¶37 col. 4:9-11
...comprising 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 does not provide sufficient detail for analysis of the specific manufacturing process used for the accused product, but alleges the resulting complex satisfies the claim limitations. ¶37 col. 1:46-56

’702 Patent Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating iron deficiency anemia comprising administering to a subject in need thereof an iron carbohydrate complex... The proposed use of Orbicular's ANDA Product is for treating iron deficiency anemia by administering an iron carboxymaltose complex. ¶51 col. 2:36-40
...in a single dosage unit wherein the single dosage unit comprises at least about 0.6 grams of elemental iron... Orbicular's ANDA Product will be administered in a single dosage unit containing at least about 0.6 grams of elemental iron. ¶51 col. 8:22-26
...and wherein the single dosage unit is administered intravenously in about 15 minutes or less. The ANDA Product will be administered intravenously in about 15 minutes or less. ¶51 col. 8:46-51
  • Identified Points of Contention:
    • Scope Questions: A potential point of contention for the ’109 Patent may be whether the term "reaction product of" limits the claim to complexes made by the specific recited process. This raises the question of whether a composition claim can be limited by the process steps used to create it. For the method patents, a key question will be whether Orbicular's proposed label instructs physicians to administer the product to the specific patient populations defined in various dependent claims, should those be asserted later.
    • Technical Questions: A central factual question for the ’109 Patent will be whether Orbicular's ANDA Product actually has the physicochemical properties (e.g., weight average molecular weight) falling within the ranges claimed in the patent. For the method patents (’702, ’612, ’091, ’502), the dispute will center on the content of Orbicular’s proposed label. The question will be what evidence exists that the label will induce infringement by instructing administration of "at least about 0.6 grams" of elemental iron in "about 15 minutes or less."

V. Key Claim Terms for Construction

  • The Term: "iron carbohydrate complex" (’109 Patent, Claim 1)

    • Context and Importance: This term defines the core composition of the ’109 Patent. Its construction is critical because the infringement analysis depends on whether Orbicular’s ferric carboxymaltose product is properly classified as the claimed "complex." Practitioners may focus on this term to determine if its scope is limited to complexes made by the patent's disclosed manufacturing method.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent title and abstract refer to "Water-Soluble Iron-Carbohydrate Complexes" generally, suggesting the term could be read broadly to cover a class of substances, not just one specific formulation (’109 Patent, Title).
      • Evidence for a Narrower Interpretation: Claim 1 defines the complex as the "reaction product of" a specific multi-step process. The specification provides detailed examples of this process, which could support an argument that the term is limited to complexes possessing the structural and chemical attributes resulting from that particular synthesis pathway (’109 Patent, col. 2:5-24; Examples 1-8).

  • The Term: "single dosage unit" (’702 Patent, Claim 4)

    • Context and Importance: The novelty of the method patents hinges on administering a large amount of iron in a single session. The definition of this term will determine whether an administration protocol constitutes a "single" unit as claimed. The dispute will likely focus on whether this term refers to a single vial, a single infusion, or a single course of treatment completed within one visit.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discusses delivering a "total dose of iron in fewer sessions," which could support a reading where a "single dosage unit" means a single clinical session designed to achieve full iron repletion, regardless of how many vials are used (’702 Patent, col. 2:34-36).
      • Evidence for a Narrower Interpretation: The specification provides an example where "1000 mg of elemental iron" is described as a single unit dose and can be introduced "in a concentrated form over, for example, two minutes" (’702 Patent, col. 8:4-8). This may support a narrower definition tied to a specific quantity of drug administered in one continuous, uninterrupted event.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is based on allegations that Orbicular, with knowledge of the patents, will instruct and encourage healthcare professionals and patients to use its ANDA Product in an infringing manner through its product labeling (e.g., Compl. ¶¶41-42, 55-56). Contributory infringement is based on allegations that the ANDA Product is a material part of the claimed inventions, is not a staple article of commerce, and is specifically labeled for an infringing use (e.g., Compl. ¶¶43, 57).
  • Willful Infringement: The complaint does not explicitly allege willful infringement or request enhanced damages.

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

  • A core issue will be one of induced infringement: does Orbicular's proposed product label, which must substantially copy the label of the brand-name drug, constitute active inducement by instructing or encouraging healthcare providers to perform the patented methods of administering a high, rapid, single dose of ferric carboxymaltose?
  • A second key question will be one of compositional identity: does the ferric carboxymaltose complex in Orbicular’s ANDA product possess the specific physicochemical properties, such as the weight average molecular weight, recited in the claims of the ’109 patent, and will this determination be limited by the manufacturing process described in the patent?