DCT

3:19-cv-13955

Vifor Intl AG v. Mylan Laboratories Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:19-cv-13955, D.N.J., 06/18/2019
  • Venue Allegations: Venue is alleged on the basis that Defendant is a foreign corporation not resident in any U.S. district and is subject to personal jurisdiction in the District of New Jersey through its business activities and pursuit of regulatory approval for its product in the state.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' iron-deficiency drug, Injectafer®, constitutes an act of infringement of four U.S. patents covering the drug's composition and methods of administration.
  • Technical Context: The technology concerns water-soluble iron carbohydrate complexes for the intravenous treatment of iron deficiency anemia, a condition where the body lacks adequate iron to produce hemoglobin.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendant’s May 7, 2019 Paragraph IV certification letter, which notified Plaintiffs of its ANDA filing. The patents-in-suit are listed in the FDA's "Orange Book" for Injectafer®. Notably, U.S. Patent No. 7,754,702 survived an Inter Partes Review (IPR) proceeding (IPR2015-01490), which resulted in the cancellation of numerous claims but confirmed the patentability of asserted method claims 17 and 47, potentially strengthening their presumption of validity.

Case Timeline

Date Event
2002-10-23 Earliest Priority Date for ’109 and ’505 Patents
2006-01-06 Earliest Priority Date for ’702 and ’612 Patents
2009-11-03 ’109 Patent Issued
2010-07-13 ’702 Patent Issued
2013-07-25 FDA Approves NDA for Injectafer®
2014-11-25 ’612 Patent Issued
2016-06-28 ’505 Patent Issued
2019-05-07 Defendant Sends Paragraph IV Notice Letter
2019-06-18 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"

  • Patent Identification: 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’s background section describes problems with prior art parenteral iron preparations, including the risk of dangerous anaphylactic shocks associated with iron dextran and the instability of other complexes at the high temperatures required for sterilization (U.S. Patent No. 7,612,109, col. 1:31-41).
  • 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 maltodextrin. The specification explains that oxidizing maltodextrin with a hypochlorite solution creates a ligand that forms a highly stable and less toxic iron complex, which can withstand thermal sterilization and allows for higher dosing ('109 Patent, col. 1:45-51, col. 3:45-65).
  • Technical Importance: This approach provided a method for producing a safer and more stable parenteral iron therapeutic that could be manufactured more easily and administered more conveniently than previous generations of iron treatments ('109 Patent, col. 3:50-54).

Key Claims at a Glance

  • The complaint asserts claims 1 through 5 (Compl. ¶33).
  • Independent Claim 1 requires:
    • A water soluble iron carbohydrate complex with a weight average molecular weight (Mw) of 80,000 to 400,000 daltons.
    • The complex comprises the reaction product of an aqueous iron(III) salt and an aqueous solution of an oxidation product of at least one maltodextrin.
    • The oxidation is performed with an aqueous hypochlorite solution at an alkaline pH.
    • The starting maltodextrin(s) must have a specific dextrose equivalent value.
  • The complaint reserves the right to assert additional claims.

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

  • Patent Identification: 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 describes conventional IV iron therapy as being inconvenient and expensive, requiring numerous low-dose sessions over an extended period to achieve iron repletion due to toxicity concerns with higher, faster doses ('702 Patent, col. 2:10-19).
  • The Patented Solution: The invention is a method for treating iron-related conditions by administering a single, high dose of elemental iron (at least 0.6 grams) in a short time frame (15 minutes or less). This is enabled by using a specific type of iron carbohydrate complex that is stable, non-immunogenic, and has low cross-reactivity with anti-dextran antibodies, making such rapid, high-dose administration safe ('702 Patent, Abstract; col. 2:33-38).
  • Technical Importance: This method represented a significant shift in clinical practice, allowing for total dose iron repletion in as few as one or two sessions, which improves patient convenience and reduces healthcare costs ('702 Patent, col. 2:15-19).

Key Claims at a Glance

  • The complaint asserts claims 17, 24, and 47 (Compl. ¶43). Claims 24 and 47 depend from claims that were cancelled during a subsequent IPR proceeding and thus appear to be erroneously asserted.
  • Independent Claim 17, which survived the IPR, requires:
    • A method of treating a condition characterized by iron deficiency or dysfunctional iron metabolism.
    • The method comprises administering an iron carbohydrate complex to a subject in need.
    • The administration is in a single dosage unit of at least about 0.6 grams of elemental iron.
    • The administration occurs in about 15 minutes or less.
    • The complex must have a substantially non-immunogenic carbohydrate component and substantially no cross-reactivity with anti-dextran antibodies.
  • The complaint reserves the right to assert additional claims.

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

  • Patent Identification: U.S. Patent No. 8,895,612, "Methods and Compositions For Administration of Iron," issued November 25, 2014.
  • Technology Synopsis: As a continuation in the same family as the ’702 patent, this patent refines the method of treatment. It claims a method for treating specific conditions, namely iron deficiency anemia associated with chronic kidney disease or heavy uterine bleeding, by administering a high dose (at least 0.6 grams of elemental iron) of an iron carboxymaltose complex in a short duration (about 15 minutes or less) ('612 Patent, Abstract; col. 2:20-34).
  • Asserted Claims: Claims 2, 4, and 5 (all dependent on independent claim 1) (Compl. ¶54).
  • Accused Features: The complaint alleges that Mylan's ANDA product, by copying the approved uses of Injectafer®, will be labeled for and used to treat iron deficiency anemia in patients with chronic kidney disease and heavy uterine bleeding according to the claimed high-dose, rapid-infusion method (Compl. ¶56).

U.S. Patent No. 9,376,505 - "Aqueous Iron Carbohydrate Complexes, Their Production, and Medicaments Containing Them"

  • Patent Identification: U.S. Patent No. 9,376,505, "Aqueous Iron Carbohydrate Complexes, Their Production, and Medicaments Containing Them," issued June 28, 2016.
  • Technology Synopsis: This patent, related to the ’109 patent, claims an aqueous solution containing the iron carbohydrate complex. It specifically claims an aqueous solution comprising an iron(III) carbohydrate complex made with oxidized maltodextrin, where the complex has a weight average molecular weight of 118,000 to 400,000 daltons and the solution has an iron content between 1% and 20% weight/volume ('505 Patent, Abstract; col. 4:16-21).
  • Asserted Claims: Independent claims 1, 10, 19, and 28 (Compl. ¶67).
  • Accused Features: The complaint alleges that Mylan’s ANDA product is an aqueous solution of an iron carbohydrate complex that meets the claimed molecular weight and iron content parameters (Compl. ¶66).

III. The Accused Instrumentality

Product Identification

  • Defendant Mylan’s generic ferric carboxymaltose injection (750 mg/15 ml), for which it filed Abbreviated New Drug Application (ANDA) No. 212572 (Compl. ¶1).

Functionality and Market Context

  • The accused product is an injectable aqueous solution of ferric carboxymaltose, an iron carbohydrate complex, intended for parenteral application to treat iron deficiency anemia (Compl. ¶¶35, 45). The complaint alleges Mylan has represented to the FDA that its ANDA product is bioequivalent, pharmaceutically equivalent, and therapeutically equivalent to Plaintiffs' branded drug, Injectafer® (Compl. ¶35). Mylan seeks approval to market its product for the same indications as Injectafer®, which would place it in direct competition upon launch (Compl. ¶¶1, 29).
  • 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 having a weight average molecular weight (Mw) of 80,000 to 400,000 Mylan's ANDA Product is alleged to have a weight average molecular weight of 80,000 to 300,000 daltons. ¶35 col. 3:8-15
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... Mylan's ANDA Product is an aqueous solution of ferric carboxymaltose, which the complaint alleges is the claimed iron carbohydrate complex made by the patented process. This allegation is based on the product's identity and its bioequivalence to Injectafer®. ¶35 col. 1:45-68

Identified Points of Contention

  • Scope Questions: A central question for these product-by-process claims will be whether Plaintiffs can prove infringement without direct evidence of Mylan's manufacturing process. The dispute may focus on whether the final chemical structure of Mylan's product is unique enough to inherently prove it was made by the claimed process, or if Mylan could have arrived at a bioequivalent product via a different, non-infringing method.
  • Technical Questions: Discovery will likely focus on the precise physicochemical properties of Mylan's product, including the specific weight average molecular weight and the dextrose equivalent of the starting materials used, to determine if they fall within the claimed ranges.

'702 Patent Infringement Allegations

Claim Element (from Independent Claim 17) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a disease, disorder, or condition characterized by iron deficiency or dysfunctional iron metabolism... Mylan's ANDA product is intended to be used for treating iron deficiency anemia. ¶45 col. 2:33-38
comprising administering... an iron carbohydrate complex... in a single dosage unit of at least about 0.6 grams of elemental iron The proposed use of Mylan's ANDA product allegedly involves administration in a single dosage unit of at least about 0.6 grams of elemental iron. ¶45 col. 4:34-38
wherein the single dosage unit of elemental iron is administered in about 15 minutes or less The proposed use of Mylan's ANDA product allegedly involves intravenous administration in about 15 minutes or less. ¶45 col. 3:9-13
and the iron carbohydrate complex has a substantially non-immunogenic carbohydrate component and substantially no cross reactivity with anti-dextran antibodies The complaint alleges Mylan's product will satisfy all limitations of the claim, which implies it possesses these characteristics by virtue of being a bioequivalent copy of Injectafer®, a non-dextran formulation. ¶45 col. 3:19-23

Identified Points of Contention

  • Scope Questions: Infringement of this method claim hinges on inducement. The key legal question will be whether Mylan’s proposed product labeling will actively instruct or encourage healthcare professionals to administer the drug in a manner that meets all the claim limitations, including both the minimum dose (≥0.6 g) and the maximum time (≤15 min).
  • Technical Questions: An evidentiary question will be whether the properties of Mylan’s ANDA product—specifically, being "substantially non-immunogenic" with "substantially no cross reactivity"—are factually met and how those terms are defined in the context of the patent.

V. Key Claim Terms for Construction

The Term: "weight average molecular weight (Mw)" ('109 Patent, Claim 1)

Context and Importance

  • The claimed molecular weight range of 80,000 to 400,000 daltons is a critical limitation defining the scope of the composition claim. Infringement depends entirely on whether Mylan's product falls within this range, and the precise method of measurement could become a point of dispute.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The claim language itself explicitly defines the bounds of the invention as the 80-400 kDa range. The specification refers to gel permeation chromatography as a method for measurement, which could be argued as the established standard for the claim ('109 Patent, col. 3:11-15).
  • Evidence for a Narrower Interpretation: The patent’s examples disclose specific embodiments with molecular weights of 271 kDa, 141 kDa, and 118 kDa ('109 Patent, col. 5-7). A party might argue these examples suggest the core of the invention is narrower than the full claimed range.

The Term: "single dosage unit" ('702 Patent, Claim 17)

Context and Importance

  • This term is central to the method claim, which is premised on replacing multiple, smaller doses with one large one. Practitioners may focus on this term because its definition distinguishes the invention from prior art regimens. The dispute will likely center on whether this term unambiguously means a single, discrete administration event.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: A party could argue for the plain and ordinary meaning, i.e., a single administration of the drug.
  • Evidence for a Narrower Interpretation: The patent’s summary of the invention contrasts the claimed method with prior art models requiring "5 to 10 sessions over an extended period of time" ('702 Patent, col. 2:15-17). This context strongly supports an interpretation that "single dosage unit" means a complete or near-complete therapeutic dose given in one administration event, not merely one injection out of a series.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Mylan will induce infringement of all four patents and contribute to the infringement of the '702 and '612 method patents (Compl. ¶¶38, 46, 57, 67). The inducement allegations are based on the assertion that Mylan's product labeling will necessarily instruct and encourage healthcare professionals and patients to use the generic drug in a manner that directly infringes the method claims (e.g., administering a high dose in a short time) (Compl. ¶¶48, 59). The contributory infringement allegations are based on the assertion that Mylan's product is a material part of the claimed methods and is not a staple article suitable for substantial non-infringing use (Compl. ¶¶50, 61).

Willful Infringement

  • The complaint does not contain a separate count for willful infringement or an explicit request for enhanced damages. However, it alleges that Mylan has knowledge of the patents-in-suit as of its Paragraph IV notice letter, establishing a factual predicate for potential post-suit willfulness allegations (Compl. ¶¶37, 47, 58, 68).

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

  • A core issue for the composition patents ('109 and '505) will be one of evidentiary proof: can Plaintiffs prove that Mylan’s product meets the product-by-process limitations of the '109 patent and the specific physical parameters of both patents, or will the case turn on whether the accused product's bioequivalence to Injectafer® is sufficient to establish infringement?
  • A key question for the method patents ('702 and '612) will be one of induced infringement: will the language of Mylan's final, FDA-approved label actively instruct or merely describe a course of administration that meets every limitation of the asserted method claims, particularly the specific dose-over-time parameters?
  • A central validity question, particularly for the '702 patent, will be the impact of the prior IPR: how will the court view the patentability of the surviving claims (e.g., Claim 17) in light of the arguments and outcomes of the IPR proceeding, and can Mylan raise new invalidity arguments based on art or theories not previously considered by the Patent Trial and Appeal Board?