DCT

1:23-cv-00877

Vifor Fresenius Medical Care Renal Pharma Ltd v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00877, D. Del., 08/10/2023
  • Venue Allegations: Venue is based on Defendant Aurobindo Pharma USA, Inc. being a Delaware corporation and Defendant Aurobindo Pharma Limited allegedly having persistent business contacts with Delaware and previously engaging in patent litigation in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s VELPHORO® drug product constitutes infringement of eleven patents related to pharmaceutical compositions containing sucroferric oxyhydroxide.
  • Technical Context: The technology concerns oral pharmaceutical compositions, specifically chewable tablets, that act as phosphate binders to control serum phosphorus levels in patients with chronic kidney disease on dialysis.
  • Key Procedural History: The action arises under the Hatch-Waxman Act, prompted by Defendant’s submission of ANDA No. 218226 to the FDA. The lawsuit follows Plaintiff's receipt of a Paragraph IV Certification letter, dated June 26, 2023, in which Defendant asserted that the patents-in-suit are invalid, unenforceable, and/or would not be infringed by its proposed generic product.

Case Timeline

Date Event
2007-11-16 Priority Date for ’251, ’376, ’367, ’896, ’897, ’090, ’761, ’762 Patents
2013-11-01 VELPHORO® FDA Approval Date (approximate)
2013-11-27 Priority Date for ’855, ’938, ’252 Patents
2017-02-07 ’251 Patent Issue Date
2020-04-21 ’855 Patent Issue Date
2020-06-16 ’376 Patent Issue Date
2020-06-30 ’367 Patent Issue Date
2021-02-23 ’896 Patent Issue Date
2021-02-23 ’897 Patent Issue Date
2021-03-02 ’090 Patent Issue Date
2021-05-25 ’761 Patent Issue Date
2021-05-25 ’762 Patent Issue Date
2022-02-01 ’938 Patent Issue Date
2022-09-20 ’252 Patent Issue Date
2023-06-26 Date of Aurobindo's Paragraph IV Certification Letter
2023-08-10 Complaint Filing Date

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

U.S. Patent No. 9,561,251 - "Pharmaceutical Compositions" (issued Feb. 7, 2017)

The Invention Explained

  • Problem Addressed: The patent describes the difficulty in formulating effective oral phosphate binders for patients with chronic renal insufficiency. Such patients often require high dosages, but existing formulations can result in tablets that are too large to be swallowed, have poor patient compliance due to taste or pill burden, or are limited by low active ingredient loading (U.S. Patent No. 10,682,376, col. 1:15-56).
  • The Patented Solution: The invention is a pharmaceutical composition, particularly a chewable tablet, with a high loading (10-80% w/w) of iron oxy-hydroxide. This active ingredient is combined with specific carbohydrates—saccharose (sucrose), native starch, and pregelatinized starch—which act as stabilizers and excipients to create a palatable, high-dose dosage form (’376 Patent, col. 5:1-12, claim 1). This combination allows for a large amount of the active ingredient (700 mg to 1700 mg) in a single chewable tablet, addressing the high dosage requirements while improving patient experience (’376 Patent, col. 15:43-46).
  • Technical Importance: This approach enabled the creation of a high-dose oral phosphate binder in a chewable format, which can improve patient adherence compared to regimens requiring patients to swallow multiple large pills daily (’376 Patent, col. 1:40-56).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 15, 17, and 27 (Compl. ¶32).
  • Independent Claim 1:
    • A pharmaceutical composition comprising iron oxy-hydroxide, saccharose, native starch, and pregelatinized starch.
    • Wherein the iron oxy-hydroxide is present in an amount of 10 to 80% (w/w) expressed in relation to the total weight of the composition.
    • Wherein the pharmaceutical composition is in a form of a chewable tablet for oral administration.
    • Wherein the amount of iron oxy-hydroxide per dosage form is 700 mg to 1700 mg.
  • The complaint notes that Defendant’s Paragraph IV Certification does not dispute infringement of claims 1, 17, and 27 (Compl. ¶32). The right to assert other claims is implicitly reserved (Compl. ¶37).

U.S. Patent No. 10,624,855 - "Pharmaceutical Composition, Comprising Phosphate Binder Particles" (issued Apr. 21, 2020)

The Invention Explained

  • Problem Addressed: The patent notes that high-dose drug substances like sucroferric oxyhydroxide have poor physical characteristics for tableting, such as poor flow and cohesion. This makes it difficult to use direct compression, a preferred manufacturing method, to produce tablets with acceptable hardness, friability, and disintegration properties (’855 Patent, col. 5:32-44, col. 6:10-14).
  • The Patented Solution: The invention claims a pharmaceutical composition made from sucroferric oxyhydroxide particles having a specific particle size distribution. By controlling the particle size such that at least 60% of particles (by volume) are within 4 to 200 µm and the median particle size (d50) is between 40 and 80 µm, the resulting powder becomes suitable for direct compression into robust, high-dose chewable tablets with improved physical attributes like hardness and disintegration time (’855 Patent, col. 9:6-24, 46-54). Figure 2 of the patent illustrates an exemplary particle size distribution curve (’855 Patent, Fig. 2).
  • Technical Importance: This invention provides a method to overcome the manufacturing challenges of a high-dose, poorly compressible drug, enabling the use of a more efficient and cost-effective tableting process (direct compression) while achieving a final product with superior physical properties.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 18 and dependent claim 8 (Compl. ¶40).
  • Independent Claim 1:
    • A pharmaceutical composition for oral administration comprising sucroferric oxyhydroxide particles.
    • Wherein at least 60% by volume of said particles have a particle size within the range of 4 µm to 200 µm.
    • Wherein the d50 particle size distribution by volume of said particles is in the range of 40 µm to 80 µm.
    • Wherein the composition is in the form of a chewable tablet.
    • Wherein the chewable tablet has a disintegration time of less than 30 minutes as measured by European Pharmacopoeia 04/2011:20901.
    • Wherein the weight of the chewable tablet is between 2000 mg and 3000 mg.
  • The complaint reserves the right to assert other claims (Compl. ¶45).

U.S. Patent No. 10,682,376 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 10,682,376, “Pharmaceutical Compositions,” issued June 16, 2020 (Compl. ¶8).
  • Technology Synopsis: This patent, a continuation of the application leading to the ’251 patent, covers pharmaceutical compositions of iron oxy-hydroxide, saccharose, and starch in a chewable tablet form with a specified high loading of the active ingredient relative to the total composition weight.
  • Asserted Claims: Independent claims 1 and 40 (Compl. ¶48).
  • Accused Features: The Aurobindo product is alleged to be a chewable tablet containing approximately 800 mg of iron oxy-hydroxide in an amount of 10-80% (w/w), along with saccharose and starch (Compl. ¶48).

U.S. Patent No. 10,695,367 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 10,695,367, “Pharmaceutical Compositions,” issued June 30, 2020 (Compl. ¶9).
  • Technology Synopsis: This patent covers chewable tablets where the total amount of the key ingredients—iron oxy-hydroxide, saccharose, and starch—is greater than 70% of the total weight of the composition.
  • Asserted Claims: Independent claims 1, 66, and 98 (Compl. ¶56).
  • Accused Features: The Aurobindo product is alleged to be a chewable tablet containing iron oxy-hydroxide, saccharose, and starch, where the total amount of these components is greater than 70% (w/w) of the total composition (Compl. ¶56).

U.S. Patent No. 10,925,896 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 10,925,896, “Pharmaceutical Compositions,” issued February 23, 2021 (Compl. ¶10).
  • Technology Synopsis: This patent claims pharmaceutical compositions of non-bioabsorbable beta iron oxy-hydroxide stabilized by saccharose and a starch mixture (native and pregelatinized), where the total amount of these active and stabilizing agents is greater than 70% of the tablet weight.
  • Asserted Claims: Independent claim 1 (Compl. ¶64).
  • Accused Features: The Aurobindo product is alleged to contain non-bioabsorbable beta iron oxy-hydroxide, saccharose, and a starch comprising native and pregelatinized starch, with the total amount of these ingredients exceeding 70% (w/w) (Compl. ¶64).

U.S. Patent No. 10,925,897 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 10,925,897, “Pharmaceutical Compositions,” issued February 23, 2021 (Compl. ¶11).
  • Technology Synopsis: This patent is similar to the ’896 patent, covering compositions of non-bioabsorbable beta iron oxy-hydroxide stabilized by saccharose and a starch mixture (native and pregelatinized) where the total amount of these ingredients is greater than 70% (w/w).
  • Asserted Claims: Independent claim 1 (Compl. ¶72).
  • Accused Features: The allegations for this patent mirror those for the ’896 patent (Compl. ¶72).

U.S. Patent No. 10,933,090 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 10,933,090, “Pharmaceutical Compositions,” issued March 2, 2021 (Compl. ¶12).
  • Technology Synopsis: This patent claims chewable tablets of non-bioabsorbable beta iron oxy-hydroxide stabilized by saccharose and/or starch, where the total amount of these components exceeds 70% (w/w).
  • Asserted Claims: Independent claims 1 and 14 (Compl. ¶80).
  • Accused Features: The Aurobindo product is alleged to be a chewable tablet where the total amount of iron oxy-hydroxide, saccharose, and starch is greater than 70% (w/w) and is stabilized by saccharose and/or starch (Compl. ¶80).

U.S. Patent No. 11,013,761 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 11,013,761, “Pharmaceutical Compositions,” issued May 25, 2021 (Compl. ¶13).
  • Technology Synopsis: This patent covers chewable tablets containing non-bioabsorbable iron oxy-hydroxide stabilized by saccharose and/or starch, with the total amount of these key ingredients being greater than 70% (w/w).
  • Asserted Claims: Independent claims 1 and 16 (Compl. ¶88).
  • Accused Features: The allegations for this patent mirror those for the ’090 patent (Compl. ¶88).

U.S. Patent No. 11,013,762 - "Pharmaceutical Compositions"

  • Patent Identification: U.S. Patent No. 11,013,762, “Pharmaceutical Compositions,” issued May 25, 2021 (Compl. ¶14).
  • Technology Synopsis: This patent claims compositions for oral administration containing non-bioabsorbable iron oxy-hydroxide, saccharose, and starch, where the total weight percentage of these components is between 10% and 80%, and the active ingredient is stabilized by the saccharose and/or starch.
  • Asserted Claims: Independent claims 1 and 16 (Compl. ¶96).
  • Accused Features: The Aurobindo product is alleged to contain iron oxy-hydroxide, saccharose, and starch, where the total amount of these components is present in an amount of 10% to 80% (w/w) (Compl. ¶96).

U.S. Patent No. 11,234,938 - "Pharmaceutical Composition, Comprising Phosphate Binder Particles"

  • Patent Identification: U.S. Patent No. 11,234,938, “Pharmaceutical Composition, Comprising Phosphate Binder Particles,” issued February 1, 2022 (Compl. ¶15).
  • Technology Synopsis: This patent claims chewable tablets made from sucroferric oxyhydroxide particles with specific physical and compositional properties, including disintegration time (5-18 min), hardness (100-200 N), weight (2000-3000 mg), particle size distribution, and a high concentration (>65%) of the active ingredient.
  • Asserted Claims: Independent claims 1, 6, and 11 (Compl. ¶104).
  • Accused Features: The Aurobindo product is alleged to meet the claimed parameters for disintegration time, hardness, weight, particle size distribution, and high concentration of sucroferric oxyhydroxide (Compl. ¶104).

U.S. Patent No. 11,446,252 - "Pharmaceutical Composition, Comprising Phosphate Binder Particles"

  • Patent Identification: U.S. Patent No. 11,446,252, “Pharmaceutical Composition, Comprising Phosphate Binder Particles,” issued September 20, 2022 (Compl. ¶16).
  • Technology Synopsis: This patent is similar to the ’938 patent, claiming chewable tablets made from sucroferric oxyhydroxide particles with specific physical and compositional properties, including disintegration time, hardness, weight, particle size distribution, and high concentration of the active ingredient.
  • Asserted Claims: Independent claims 1, 6, and 11 (Compl. ¶112).
  • Accused Features: The allegations for this patent mirror those for the ’938 patent (Compl. ¶112).

III. The Accused Instrumentality

  • Product Identification: The "Aurobindo Proposed ANDA Product," identified as a generic version of VELPHORO® (sucroferric oxyhydroxide chewable tablets, 500 mg) for which Aurobindo seeks FDA approval via ANDA No. 218226 (Compl. ¶20).
  • Functionality and Market Context: The accused product is a pharmaceutical chewable tablet designed to control serum phosphorus levels in patients with chronic kidney disease on dialysis (Compl. ¶17). The complaint alleges, on information and belief, that the product possesses the specific combination of ingredients, weight percentages, particle size distributions, and physical characteristics (e.g., tablet weight, disintegration time, hardness) required by the various asserted patent claims (Compl. ¶¶32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112). By filing an ANDA, Aurobindo seeks to enter the U.S. market and compete with Plaintiff's branded VELPHORO® product prior to the expiration of the patents-in-suit (Compl. ¶20).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising iron oxy-hydroxide, saccharose, native starch, and pregelatinized starch, The accused product is a pharmaceutical composition containing iron oxy-hydroxide, saccharose (sucrose), and a starch. ¶32 U.S. 10,682,376, col. 15:1-14
wherein the iron oxy-hydroxide is present in an amount of 10 to 80% (w/w) expressed in relation to the total weight of the composition, The iron oxy-hydroxide is present in a high loading of 10 to 80% (w/w). ¶32 U.S. 10,682,376, col. 5:31-33
wherein the pharmaceutical composition is in a form of a chewable tablet for oral administration, The accused product is formulated as a chewable tablet suitable for oral administration. ¶32 U.S. 10,682,376, col. 15:43-44
and wherein the amount of iron oxy-hydroxide per dosage form is 700 mg to 1700 mg. The accused product contains approximately 800 mg of iron oxy-hydroxide per dosage form. ¶32 U.S. 10,682,376, col. 15:43-46
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition for oral administration comprising: sucroferric oxyhydroxide particles; The accused product is a pharmaceutical composition for oral administration containing sucroferric oxyhydroxide particles. ¶40 col. 3:26-33
wherein at least 60% by volume of said sucroferric oxyhydroxide particles have a particle size within the range of 4 μm to 200 μm; At least 60% by volume of the sucroferric oxyhydroxide particles in the accused product have a particle size in the range of 4 μm to 200 μm. ¶40 col. 10:29-34
wherein the d50 particle size distribution by volume of said sucroferric oxyhydroxide particles is in the range of 40 μm to 80 μm; The d50 particle size distribution by volume of the sucroferric oxyhydroxide particles in the accused product is in the range of 40 μm to 80 μm. ¶40 col. 9:20-24
wherein said pharmaceutical composition is in the form of a chewable tablet; The accused product is a chewable tablet. ¶40 col. 7:35-36
wherein the chewable tablet has a disintegration time of less than 30 minutes as measured according to the European Pharmacopoeia 04/2011:20901; The accused product has a disintegration time of less than 30 minutes as measured according to the specified European Pharmacopoeia standard. ¶40 col. 9:45-47
and wherein the weight of said chewable tablet is between 2000 mg and 3000 mg. The accused product has a weight between 2000 mg and 3000 mg. ¶40 col. 9:48-50
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges infringement "upon information and belief," as the precise details of the Aurobindo ANDA are confidential. A central question will be whether the specific formulation in the ANDA—including the exact types and ratios of starch, the precise chemical form of the iron oxy-hydroxide, and the manufacturing process—falls within the scope of the asserted claims.
    • Technical Questions: The infringement analysis for the ’855 patent and related patents will depend heavily on factual evidence regarding physical properties. A key question for the court will be: What are the actual, measured particle size distribution, disintegration time, and tablet weight of the Aurobindo product, and were these properties measured using methodologies consistent with those disclosed in the patents or otherwise accepted in the art? The complaint does not provide sufficient detail for analysis of how these properties were determined for the accused product.

V. Key Claim Terms for Construction

  • The Term: "iron oxy-hydroxide" (from claim 1 of the ’251 Patent)

    • Context and Importance: This term defines the active pharmaceutical ingredient. Its construction is important because any ambiguity in its chemical definition, such as required crystal structure or degree of hydration, could create a non-infringement argument if the accused product uses a variant not covered by the claim's scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification of the related ’376 patent states that the term "includes, in particular, alpha, beta, gamma, and delta FeOOH and mixtures thereof," suggesting the term is not limited to a single polymorphic form (’376 Patent, col. 4:35-38).
      • Evidence for a Narrower Interpretation: The specification repeatedly identifies "beta-iron oxy-hydroxide" as a preferred or specific embodiment (’376 Patent, col. 16:16-21, claim 16). A defendant may argue that the invention is implicitly limited to this preferred form, despite the broader definition provided elsewhere.

  • The Term: "sucroferric oxyhydroxide particles" (from claim 1 of the ’855 Patent)

    • Context and Importance: The claims of the ’855 patent recite specific size distributions for these "particles." The definition of what constitutes a "particle"—whether it is the pure active ingredient or a composite material formed with stabilizers—is central to determining if the size limitations are met. Practitioners may focus on this term because the method of measurement and the definition of the object being measured are critical for infringement.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification explicitly defines "sucroferric oxyhydroxide" as "a mixture of iron(III) oxyhydroxide, sucrose and starches" (’855 Patent, col. 3:26-33). This supports a construction where the "particle" is the composite material resulting from the manufacturing process, such as spray drying, which combines these ingredients.
      • Evidence for a Narrower Interpretation: A defendant might argue that "particles" should refer only to the discrete iron oxy-hydroxide component within the broader mixture, potentially altering the infringement analysis if the size of that component differs from the size of the composite granule. However, the patent's description of creating the particles via spray-drying an aqueous suspension of all three components supports the composite view (’855 Patent, col. 14:10-18).

VI. Other Allegations

  • Indirect Infringement: The complaint includes boilerplate allegations of induced and contributory infringement for all asserted patents (e.g., Compl. ¶¶32, 40). However, it does not plead specific facts to support the knowledge and intent elements required for these claims beyond the act of filing the ANDA itself.

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

  • A core issue will be one of factual correspondence: does the confidential formulation and manufacturing process detailed in Aurobindo's ANDA result in a final product that meets every compositional and physical limitation of the asserted claims? As this is a Hatch-Waxman action, the dispute will center on a technical comparison of the proposed generic product against the patent claims, the details of which will emerge during discovery.
  • A key evidentiary question will be one of methodological consistency: are the testing methods used to characterize the accused product's properties (e.g., particle size analysis, tablet hardness, disintegration time) legally and scientifically equivalent to the methods disclosed in the patents or otherwise required for an infringement analysis? Any discrepancy in measurement techniques could become a central point of contention.
  • A third major question will be one of validity: can Aurobindo prove by clear and convincing evidence that the asserted claims, which cover specific combinations of well-known pharmaceutical ingredients and formulation parameters, are invalid as obvious over the prior art? This will likely involve arguments that achieving the claimed compositions and physical properties would have been a matter of routine optimization for a person of ordinary skill in the art.