DCT
1:20-cv-00697
Vifor Fresenius Medical Care Renal Pharma Ltd v. Lupin Atlantis Holdings SA
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vifor Fresenius Medical Care Renal Pharma Ltd. (Switzerland)
- Defendant: Lupin Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Farnan LLP
- Case Identification: 1:20-cv-00697, D. Del., 11/25/2020
- Venue Allegations: Venue is alleged to be proper in Delaware as Defendants Lupin Pharmaceuticals, Inc. and Lupin Inc. are Delaware corporations, and Defendant Lupin Limited (India) is a foreign corporation subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendants' 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 specific pharmaceutical formulations.
- Technical Context: The technology relates to high-dose, chewable tablets for phosphate binders, a class of drugs used to control high blood phosphorus levels in patients with chronic kidney disease on dialysis.
- Key Procedural History: This is a Hatch-Waxman action initiated after Defendants (collectively, "Lupin") filed an ANDA with the FDA containing a Paragraph IV certification. This certification asserts that U.S. Patent No. 10,624,855, which is listed in the FDA's "Orange Book" for Plaintiff's VELPHORO® product, is invalid, unenforceable, or will not be infringed by Lupin's proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2013-11-27 | '855 Patent Priority Date |
| 2013-11-01 | FDA Approval for VELPHORO® (NDA No. 205109) |
| 2020-04-21 | '855 Patent Issue Date |
| 2020-05-13 | Plaintiff receives Lupin's Paragraph IV Certification Letter |
| 2020-09-28 | Lupin Inc. becomes applicant for the Lupin ANDA |
| 2020-11-25 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,624,855 - Pharmaceutical Composition, Comprising Phosphate Binder Particles
- Patent Identification: U.S. Patent No. 10,624,855, “Pharmaceutical Composition, Comprising Phosphate Binder Particles,” issued April 21, 2020.
The Invention Explained
- Problem Addressed: The patent addresses the difficulty of manufacturing high-dose pharmaceutical tablets, particularly for drugs like sucroferric oxyhydroxide, which have poor physical characteristics for tableting ('855 Patent, col. 5:58-6:14). Standard manufacturing methods like wet granulation can be problematic due to the drug's instability in water and the high number of processing steps, while direct compression is challenging due to the drug's poor flow and cohesive properties ('855 Patent, col. 6:15-24, col. 6:49-55).
- The Patented Solution: The invention is a pharmaceutical composition where the active ingredient particles (sucroferric oxyhydroxide) are formulated to have a specific particle size distribution. The patent asserts that controlling the particle size within defined ranges, particularly the median particle size (d50), unexpectedly improves the physical properties of the powder blend, enabling the manufacture of robust, high-dose, chewable tablets using the more efficient direct compression method ('855 Patent, col. 9:5-24, col. 9:46-65). The manufacturing process flowchart in Figure 1 illustrates a method for producing the drug substance, culminating in spray drying to control particle size ('855 Patent, Fig. 1).
- Technical Importance: For patients requiring large, daily doses of medication, a durable, easy-to-chew tablet is critical for treatment adherence ('855 Patent, col. 7:40-54). Achieving this with a high-dose drug via a cost-effective method like direct compression represents a notable manufacturing improvement.
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 ('855 Patent, Compl. ¶30).
- The essential elements of independent claim 1 are:
- A pharmaceutical composition for oral administration comprising sucroferric oxyhydroxide particles;
- At least 60% by volume of the particles have a particle size from 4 µm to 200 µm;
- The d50 particle size distribution by volume is in the range of 40 µm to 80 µm;
- The composition is in the form of a chewable tablet;
- The tablet has a disintegration time under 30 minutes per a specific European Pharmacopoeia standard; and
- The tablet weighs between 2000 mg and 3000 mg.
- The complaint's prayer for relief seeks a judgment of infringement of "one or more claims," suggesting the right to assert additional claims is preserved (Compl., p. 9, ¶A).
III. The Accused Instrumentality
Product Identification
- The "Lupin Proposed ANDA Product" is a generic version of VELPHORO® (sucroferric oxyhydroxide chewable tablets, 500 mg) for which Lupin seeks FDA approval via ANDA No. 211386 (Compl. ¶11).
Functionality and Market Context
- The accused product is a pharmaceutical formulation designed to be a generic substitute for Plaintiff's branded drug (Compl. ¶11). It is a phosphate binder indicated for controlling serum phosphorus levels in patients with chronic kidney disease on dialysis (Compl. ¶8). The act of infringement alleged is the filing of the ANDA itself, which seeks approval to market the generic product before the expiration of the '855 Patent (Compl. ¶1, ¶29).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'855 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition for oral administration comprising: sucroferric oxyhydroxide particles; | The Lupin Proposed ANDA Product is a pharmaceutical composition in the form of a chewable tablet for oral administration comprising sucroferric oxyhydroxide particles. | ¶30 | col. 35:29-31 |
| 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 particles in Lupin's product have a particle size within the range of 4 to 200 µm. | ¶30 | col. 35:32-35 |
| 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 particles in Lupin's product is in the range of 40 µm to 100 µm. | ¶30 | col. 35:36-39 |
| wherein said pharmaceutical composition is in the form of a chewable tablet; | Lupin's product is in the form of a chewable tablet for oral administration. | ¶30 | col. 35:40-41 |
| wherein the chewable tablet has a disintegration time of less than 30 minutes according to the European Pharmacopoeia 04/2011:20901; | The product has a disintegration time of less than 30 minutes according to the specified European Pharmacopeia standard. | ¶30 | col. 35:42-46 |
| and wherein the weight of said chewable tablet is between 2000 mg and 3000 mg. | The product weighs between 2000 to 3000 mg per tablet. | ¶30 | col. 35:47-48 |
Identified Points of Contention
- Technical Questions: A central factual dispute will be whether the particle size distribution of the drug substance in Lupin's ANDA product meets the specific limitations of claim 1. As the allegations are made on "information and belief," the actual product specifications contained within the confidential ANDA filing will be the key evidence (Compl. ¶30).
- Scope Questions: The complaint alleges that a d50 particle size "in the range of 40 µm to 100 µm" infringes the claimed range of "40 µm to 80 µm" (Compl. ¶30; ’855 Patent, col. 35:36-39). This raises the question of whether Lupin's product specification falls within the narrower claimed range. Infringement will require proof that the accused product's d50 is at or below 80 µm, not merely within the broader 40-100 µm range alleged in the complaint.
V. Key Claim Terms for Construction
- The Term: "d50 particle size distribution by volume"
- Context and Importance: This term is the technical core of the asserted independent claim. The patent's central inventive concept is that controlling the particle size distribution, and specifically the d50, provides unexpected improvements in tablet manufacturing and physical characteristics. The infringement analysis will likely depend entirely on the measured d50 value of Lupin's product.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent provides a standard definition: "that 50% (per volume) of the particles have a particle size above or below the defined d50 value expressed in µm" ('855 Patent, col. 11:10-13). This general definition could support applying the term broadly to results from any scientifically valid measurement technique.
- Evidence for a Narrower Interpretation: The specification repeatedly highlights the importance of specific ranges (e.g., 40 µm to 80 µm) and provides a detailed methodology for measurement, including the specific instrument (Beckman Coulter LS 13 320), sample preparation, and analytical theory (Mie theory) ('855 Patent, col. 15:26-46, col. 23:7-27). A party could argue that the term should be construed in light of this specific, disclosed measurement protocol, potentially limiting its scope to results obtained by that method.
VI. Other Allegations
- Indirect Infringement: The complaint makes prospective allegations of induced and contributory infringement under 35 U.S.C. §§ 271(b) and (c), asserting that if Lupin's ANDA is approved, its commercial activities will induce or contribute to infringement (Compl. ¶30, Prayer for Relief ¶B).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, it alleges that each Defendant has had knowledge of the '855 Patent since at least the date of service of a complaint in this matter (Compl. ¶31). This allegation of post-suit knowledge could potentially support a request for enhanced damages for any infringement that occurs after that date.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: does the generic formulation detailed in Lupin's confidential ANDA actually meet the specific particle size and d50 limitations recited in claim 1 of the '855 patent? The case will likely turn on a comparison of the ANDA's technical specifications against the patent's claims, a battle to be fought with expert testimony and discovery from the ANDA itself.
- A key legal question will be one of methodological precision: to what extent is the claim term "d50 particle size distribution" tied to the specific Beckman Coulter measurement protocol described in the patent's examples? Whether other measurement techniques are permissible and how their results correlate to the claimed ranges could become a critical point of dispute in claim construction.