DCT
3:19-cv-12479
Fresenius Medical Care Holdings Inc v. Suven Life Sciences Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Fresenius Medical Care Holdings, Inc. (New York)
- Defendant: Suven Life Sciences Ltd. (India)
- Plaintiff’s Counsel: Foley Hoag LLP
- Case Identification: 3:19-cv-12479, D.N.J., 05/13/2019
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the Defendant, a foreign corporation, maintains its primary U.S. place of business in the district and has previously been sued in the district without objecting to personal jurisdiction.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's PhosLo® GelCaps constitutes an act of patent infringement under the Hatch-Waxman Act, as the proposed generic product is allegedly covered by patents on encapsulated calcium acetate formulations.
- Technical Context: The technology relates to pharmaceutical compositions used to treat hyperphosphatemia (excess blood phosphorus), a common and serious condition for patients with chronic renal disease.
- Key Procedural History: The lawsuit was triggered by Defendant's submission of ANDA No. 211038 to the FDA, which contained a Paragraph IV certification asserting that the patents-in-suit are invalid or would not be infringed by its proposed generic product. The filing of such a certification is a statutory act of infringement. Plaintiff received a notice letter from Defendant regarding the ANDA filing on March 28, 2019. The later-issued '445' Patent is subject to a terminal disclaimer, tying its expiration date to that of the '665' Patent.
Case Timeline
| Date | Event |
|---|---|
| 2001-04-03 | Priority Date for '665' and '445' Patents |
| 2003-06-10 | '665' Patent Issued |
| 2005-04-05 | '445' Patent Issued |
| 2019-03-28 | Plaintiff receives Defendant's ANDA Notice Letter |
| 2019-05-13 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,576,665 - ENCAPSULATED CALCIUM ACETATE CAPLET AND A METHOD FOR INHIBITING GASTROINTESTINAL PHOSPHOROUS ABSORPTION (Issued June 10, 2003)
The Invention Explained
- Problem Addressed: The patent describes that prior calcium acetate treatments for hyperphosphatemia, while effective, were difficult for patients to take. The formulations were bulky, hard to swallow, and had an "unpleasant" "chalky taste," leading to poor patient compliance with necessary dosing regimens ('665' Patent, col. 2:33-43).
- The Patented Solution: The invention identifies that using calcium acetate with a specific bulk density (within a certain range) allows it to be compressed into a smaller, denser "caplet." This caplet can then be placed inside a gelatin capsule, which masks the taste and makes it easier to swallow, thereby "optimizing the volume" for a given dose ('665' Patent, col. 3:30-39). The specification provides a table showing that only calcium acetate within a specific density range can be successfully compressed into caplets without manufacturing defects like "capping" or "picking" ('665' Patent, col. 3:57-col. 4:21, Table 1).
- Technical Importance: This approach aimed to improve patient adherence to a critical therapy by creating a more palatable and physically smaller dosage form ('665' Patent, col. 3:18-27).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-5 (Compl. ¶22).
- Independent Claim 1 recites:
- A composition for binding phosphorous within the gastrointestinal tract of an individual;
- comprising a quantity of calcium acetate having a bulk density of between about 0.55 kg/L and about 0.75 kg/L;
- where the calcium acetate is compressed to form a caplet for fitting within a capsule in a manner which optimizes the volume of the capsule; and
- where at least about 85% of the compressed calcium acetate dissolves in not more than 15 minutes when tested according to a specific USP standard.
U.S. Patent No. 6,875,445 - ENCAPSULATED CALCIUM ACETATE CAPLET AND A METHOD FOR INHIBITING GASTROINTESTINAL PHOSPHOROUS ABSORPTION (Issued April 5, 2005)
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the '665' patent, this patent addresses the same problem of large, unpalatable calcium acetate medications that discourage patient compliance ('445' Patent, col. 2:32-46).
- The Patented Solution: The claims of the '445' patent are directed to the final product itself, described as a "drug delivery vehicle." This vehicle consists of an "outer capsule" that contains an "inner caplet" made from the specifically formulated calcium acetate with the key bulk density and dissolution properties described in the parent patent ('445' Patent, col. 6:42-52, Claim 1). The invention is thus the physical combination of the capsule and the specially compressed caplet.
- Technical Importance: The invention provides a finished dosage form that solves the palatability and size problems of prior art formulations, facilitating better management of hyperphosphatemia in patients with chronic renal disease ('445' Patent, col. 5:1-15).
Key Claims at a Glance
- The complaint asserts independent claims 1, 35, and 36, along with dependent claims 2 and 7 (Compl. ¶28). The complaint reserves the right to assert additional claims.
- Independent Claim 1 recites:
- A drug delivery vehicle for a composition for binding phosphorous;
- comprising an outer capsule defining an inner volume; and
- an inner caplet comprising a quantity of calcium acetate;
- the calcium acetate having a bulk density between about 0.55 kg/L and 0.75 kg/L; and
- being compressed to a caplet form dimensioned for fitting within and optimizing the inner volume of the capsule.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant Suven's proposed generic calcium acetate 667 mg capsules, for which it seeks FDA approval via ANDA No. 211038 (Compl. ¶2).
Functionality and Market Context
- The complaint alleges that Suven's product is a generic version of Plaintiff’s PhosLo® GelCaps calcium acetate drug product (Compl. ¶2). As a generic, it is intended to be a bioequivalent substitute for the branded drug. The filing of the ANDA signals Suven's intent to engage in the commercial manufacture, use, and sale of this product in the United States prior to the expiration of the patents-in-suit (Compl. ¶17, ¶21).
IV. Analysis of Infringement Allegations
The complaint alleges that Suven's proposed generic product, by virtue of being a copy of PhosLo® GelCaps, will infringe the patents-in-suit (Compl. ¶16). The infringement theory is based on "information and belief" pending discovery of the contents of Suven's confidential ANDA. No probative visual evidence provided in complaint.
'665 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a quantity of calcium acetate ... having a bulk density of between about 0.55 kg/L and about 0.75 kg/L | Suven's proposed generic drug is a calcium acetate composition that, upon information and belief, contains calcium acetate with a bulk density meeting the claimed range. | ¶2, ¶16, ¶22 | col. 5:36-37 |
| where the quantity of calcium acetate is compressed to form a caplet for fitting within a capsule in a manner which optimizes the volume of the capsule | Suven's product is alleged to be a capsule containing a compressed caplet of calcium acetate, mirroring the formulation of Plaintiff's patented product. | ¶2, ¶16, ¶22 | col. 5:38-40 |
| and where at least about 85% of said compressed calcium acetate dissolves in not more than 15 minutes when tested according to USP standard #24, test #711 at 50 to 100 RPM, apparatus 1 or 2 | The proposed generic product, upon information and belief, must meet the claimed dissolution profile to be bioequivalent to the branded drug. | ¶2, ¶16, ¶22 | col. 5:41-45 |
'445 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A drug delivery vehicle... comprising: an outer capsule defining an inner volume; and an inner caplet comprising a quantity of calcium acetate | Suven's proposed product is alleged to be a drug delivery vehicle consisting of a capsule containing a calcium acetate caplet. | ¶2, ¶16, ¶28 | col. 6:42-46 |
| the calcium acetate having a bulk density between about 0.55 kg/L and 0.75 kg/L | The calcium acetate used in Suven's inner caplet is alleged to have a bulk density that falls within the claimed range. | ¶2, ¶16, ¶28 | col. 6:48-49 |
| and being compressed to a caplet form dimensioned for fitting within and optimizing the inner volume of said capsule | Suven's caplet is alleged to be compressed and dimensioned to fit within its capsule in a manner that optimizes the volume, consistent with the patented technology. | ¶2, ¶16, ¶28 | col. 6:50-52 |
- Identified Points of Contention:
- Technical Questions: A primary factual dispute will concern the physical characteristics of Suven's product as described in its confidential ANDA. Does Suven's calcium acetate formulation in fact have a bulk density between "about 0.55 kg/L and about 0.75 kg/L"? Does it meet the dissolution rate of "at least about 85% in not more than 15 minutes"? The litigation will depend on evidence produced from the ANDA during discovery.
- Scope Questions: The interpretation of "about" as applied to the numerical limitations for bulk density and dissolution rate may become a central issue of claim construction. The meaning of the phrase "optimizes the volume of the capsule" may also be disputed, potentially raising questions of indefiniteness under 35 U.S.C. § 112.
V. Key Claim Terms for Construction
The Term: "a bulk density of between about 0.55 kg/L and about 0.75 kg/L"
Context and Importance: This numerical range is a cornerstone of the claimed invention. Whether Suven's product literally infringes will depend on if its bulk density falls within this range. The scope of "about" is critical.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses that a composition with a bulk density "of between 0.50 kg/L and 0.80 kg/L" is administered to patients, suggesting a slightly wider functional range than what is claimed ('665' Patent, col. 5:7-9). The use of the word "about" in the claim itself suggests the patentee did not intend to be limited to the exact numerical endpoints.
- Evidence for a Narrower Interpretation: The specification explicitly states that a bulk density "of between 0.55 kg/L and 0.75 kg/L is desirable as it has optimal pharmaceutical properties" ('665' Patent, col. 3:49-51). Furthermore, Table 1 suggests these boundaries are not arbitrary, as material with a density "<0.55" could not meet the target weight, and material with a density ">0.75" displayed "picking" defects ('665' Patent, Table 1, col. 3:57). This could support a narrow reading of "about."
The Term: "optimizes the volume of the capsule"
Context and Importance: Practitioners may focus on this term because it could be challenged as indefinite. Its construction will determine how full the capsule must be and what functional result must be achieved for infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that the caplet "fills the internal volume of the capsule substantially completely" ('665' Patent, col. 3:12-14). This could be interpreted broadly to mean any configuration that makes efficient use of the space inside the capsule.
- Evidence for a Narrower Interpretation: The patent's objective is to solve the problem of large, hard-to-swallow pills ('665' Patent, col. 2:33-43). "Optimizes" could therefore be construed more narrowly to mean compressing a standard dosage (e.g., 667 mg) into a standard-sized capsule (e.g., size #0) that was previously not feasible, thereby tying the term to a specific, functional achievement disclosed in the patent ('665' Patent, col. 3:52-56).
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement (Compl. ¶22, ¶28). The basis for this allegation is that Suven, by seeking to market its generic drug with labeling instructing its use for treating hyperphosphatemia, would be intentionally encouraging and instructing physicians and patients to use the product in an infringing manner.
- Willful Infringement: The complaint alleges that Suven's infringement has been and will be "willful and deliberate" (Compl. ¶24, ¶30). This allegation is based on Suven having notice of the patents-in-suit, as evidenced by its Paragraph IV certification and the Notice Letter sent to Fresenius (Compl. ¶17).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of empirical fact-finding: Does the calcium acetate formulation described in Suven's confidential ANDA actually possess a bulk density and dissolution rate that fall within the specific numerical ranges recited in the asserted claims? The outcome will turn heavily on technical data revealed during discovery.
- A key legal question will be one of claim construction and validity: Can the term "optimizes the volume," which describes the spatial relationship between the inner caplet and outer capsule, be construed with sufficient objective clarity based on the patent's specification? The court's interpretation will be critical, and the term may be vulnerable to a defense of indefiniteness.