DCT

1:18-cv-01996

Vifor Fresenius Medical Care Renal Pharma Ltd v. Annora Pharma Pvt Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Vifor Fresenius Medical Care Renal Pharma Ltd. v. Annora Pharma Private Ltd., 1:18-cv-01996, D. Del., 12/17/2018
  • Venue Allegations: Venue is alleged to be proper because Defendants are foreign corporations subject to personal jurisdiction in the District of Delaware. Plaintiffs also allege Defendants engage in continuous business and derive substantial revenue from sales in Delaware.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's VELPHORO® drug product constitutes an act of infringement of a patent covering pharmaceutical compositions for phosphate binding.
  • Technical Context: The technology relates to oral phosphate binders, specifically high-dose formulations of iron oxy-hydroxide used to control elevated serum phosphorus levels in patients with chronic kidney disease undergoing dialysis.
  • Key Procedural History: The lawsuit was triggered by Defendants' submission of ANDA No. 212276, which included a Paragraph IV certification asserting that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by the proposed generic product. This filing under the Hatch-Waxman Act is the statutory basis for the infringement claim.

Case Timeline

Date Event
2007-11-16 ’251 Patent Priority Date
2013-11-01 FDA approval for Plaintiff's VELPHORO® drug product (approx.)
2017-02-07 ’251 Patent Issue Date
2018-11-30 Plaintiff received Defendants' Paragraph IV certification letter
2018-12-17 Complaint Filing Date

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

U.S. Patent No. 9,561,251 - "Pharmaceutical compositions"

  • Patent Identification: U.S. Patent No. 9,561,251, "Pharmaceutical compositions", issued February 7, 2017.

The Invention Explained

  • Problem Addressed: The patent describes the difficulty of treating hyperphosphatemia (pathologically high phosphate levels) in chronic renal failure patients. Effective treatment requires oral phosphate adsorbers, but conventional formulations often have low "drug loading," meaning patients must take large or numerous tablets to achieve a therapeutic dose, leading to poor patient compliance (’251 Patent, col. 2:36-54).
  • The Patented Solution: The invention is a pharmaceutical composition containing a "high loading" of iron oxy-hydroxide, which acts as the phosphate binder. By using specific carbohydrates like saccharose (sucrose) and starch as stabilizing agents and excipients, the invention enables the creation of a dosage form (such as a chewable tablet) that contains a large amount of the active ingredient (at least 500 mg) in a manageable size, overcoming the compliance issues of prior art formulations (’251 Patent, Abstract; col. 3:29-44).
  • Technical Importance: The patented technology provides a method for creating a more concentrated and thus more patient-friendly oral dosage form for a critical therapy in managing chronic kidney disease (’251 Patent, col. 2:36-44).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1, 10, 21, 24, 27, 28, 34, 35, 38, 39, and 40 (Compl. ¶33).
  • Independent Claim 1:
    • A pharmaceutical composition comprising an effective phosphate-adsorbing amount of iron oxy-hydroxide
    • in high loading of 10 to 80% (w/w) expressed in relation to the total weight of the pharmaceutical composition,
    • and carbohydrates, said carbohydrates comprising saccharose and starch,
    • in a form suitable for oral administration,
    • wherein the amount of iron oxy-hydroxide per dosage form is at least 500 mg.
  • The complaint does not explicitly reserve the right to assert other dependent claims but lists several.

III. The Accused Instrumentality

Product Identification

  • The "Annora Proposed ANDA Product," identified as a generic version of VELPHORO® described as a "sucroferric oxyhydroxide chewable tablet, 500 mg" (Compl. ¶13).

Functionality and Market Context

  • The proposed product is a phosphate binder intended for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis (Compl. ¶10). The complaint alleges that for the ANDA product to be approved as bioequivalent to VELPHORO®, it must contain "approximately 800 mg of iron oxy-hydroxide and saccharose (sucrose) and a starch" (Compl. ¶33). This allegation forms the core of the infringement theory, suggesting the generic product must necessarily practice the claimed invention to gain FDA approval.

IV. Analysis of Infringement Allegations

’251 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising an effective phosphate-adsorbing amount of iron oxy-hydroxide in high loading of 10 to 80% (w/w)... The Annora Proposed ANDA Product is a sucroferric oxyhydroxide tablet, which is alleged to be a form of iron oxy-hydroxide. The complaint alleges it contains approximately 800 mg of this active ingredient to achieve bioequivalence with VELPHORO®. ¶13, ¶33 col. 5:31-34
...and carbohydrates, said carbohydrates comprising saccharose and starch... The complaint alleges that to be bioequivalent to VELPHORO®, the ANDA product is required to contain saccharose (sucrose) and a starch. ¶33 col. 5:1-9
...in a form suitable for oral administration... The accused product is described as a "chewable tablet." ¶13 col. 3:56-65
...wherein the amount of iron oxy-hydroxide per dosage form is at least 500 mg. The complaint alleges the proposed ANDA product contains "approximately 800 mg of iron oxy-hydroxide." ¶33 col. 5:46-48
  • Identified Points of Contention:
    • Factual Question: The central issue appears to be factual: does the formulation described in Defendants' confidential ANDA submission meet all the limitations of the asserted claims? The complaint's infringement theory rests heavily on the inference that to be bioequivalent to VELPHORO®, the generic product must have the claimed composition (Compl. ¶33).
    • Scope Question: A potential dispute may arise over whether "sucroferric oxyhydroxide," the active ingredient in the accused product, falls within the definition of "iron oxy-hydroxide" as used and defined in the ’251 patent.
    • Significance of PIV Certification: The complaint alleges that "the Annora Paragraph IV Certification does not dispute that it infringes at least claim 1 of the '251 patent" (Compl. ¶33). If accurate, this suggests Defendants' non-infringement defense may be narrow or focused on other claims, while their primary defense for claim 1 might be patent invalidity.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "iron oxy-hydroxide"
  • Context and Importance: This term is the central active ingredient in the asserted claims. The accused product is identified as containing "sucroferric oxyhydroxide" (Compl. ¶13). The viability of the infringement claim depends on whether this specific compound is properly construed as a species of the genus "iron oxy-hydroxide" as claimed in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification defines the term inclusively, stating it is "usually referred to as FeO(OH) or Fe2O3×H2O" and "includes, in particular, alpha, beta, gamma, and delta FeOOH and mixtures thereof" (’251 Patent, col. 3:28-37). Plaintiffs may argue that "sucroferric oxyhydroxide" is simply a stabilized version of FeO(OH) that falls within this definition.
    • Evidence for a Narrower Interpretation: The specification describes a preferred embodiment where the "iron oxy-hydroxide" is "stabilized by a stabilization agent" such as carbohydrates, which "usually is not bound as a complex compound to the iron oxy-hydroxide" (’251 Patent, col. 3:45-51). Defendants may argue that "sucroferric oxyhydroxide" represents a distinct, complexed chemical entity not encompassed by the patent's definition, or that it falls outside the specific preparative methods described.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement against Defendant Hetero Labs Limited. The factual basis is that Hetero allegedly "made the ultimate decision to file the Annora ANDA," "encouraged and directed Annora to file" it, and will act in concert with Annora to market the product (Compl. ¶16, ¶37). This is asserted to show Hetero's knowledge of the patent and active steps to cause Annora's direct infringement.
  • Willful Infringement: While the complaint does not use the word "willful," it lays the groundwork by alleging pre-suit knowledge. It claims Annora knew of the ’251 patent "since at least the date that Annora submitted the Annora ANDA," and that Hetero was "necessarily aware" when it directed the filing (Compl. ¶34). It further puts Defendants on notice of infringement as of the date of the complaint.

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

  • A primary issue will be one of chemical identity and claim scope: Can the term "iron oxy-hydroxide," as defined and used in the ’251 patent, be properly construed to encompass the "sucroferric oxyhydroxide" active ingredient contained in the Defendants' proposed generic product?
  • A key evidentiary question will be one of compositional fact: Does the formulation detailed in the Defendants' confidential ANDA submission actually contain the combination of "saccharose" and "starch" as the required "carbohydrates" in the amounts recited by the asserted claims? The case may turn on the accuracy of the complaint's assertion that bioequivalence requires this specific combination.
  • The case will also present a question of patent validity: Although not detailed in the complaint, the Defendants' Paragraph IV certification alleges that the ’251 patent is invalid (Compl. ¶14). The nature and strength of this invalidity challenge will be a critical, yet currently unknown, component of the litigation.