DCT
1:18-cv-00390
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) and Vifor Fresenius Medical Care Renal Pharma France S.A.S. (France)
- Defendant: Lupin Pharmaceuticals, Inc. (Delaware), Lupin Inc. (Delaware), and Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Farnan LLP; Quinn Emanuel Urquhart & Sullivan, LLP
- Case Identification: 1:18-cv-00390, D. Del., 11/25/2020
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant entities are organized and exist under the laws of the State of Delaware.
- Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Applications (ANDAs) to market generic versions of Plaintiff's VELPHORO® drug product constitute an act of infringement of a patent covering pharmaceutical compositions for treating hyperphosphatemia.
- Technical Context: The technology concerns oral phosphate binders used to control serum phosphorus levels in patients with chronic kidney disease, a significant comorbidity requiring ongoing management.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of Paragraph IV certification letters from Lupin (January 2018) and Teva (February 2018). These letters asserted that U.S. Patent No. 9,561,251 is "invalid, unenforceable, and/or will not be infringed" by the proposed generic products. The complaint notes that the patent was the subject of a Certificate of Correction issued in August 2019.
Case Timeline
| Date | Event |
|---|---|
| 2007-11-16 | '251 Patent Priority Date |
| 2013-11-01 | VELPHORO® receives FDA approval (approx. date) |
| 2017-02-07 | '251 Patent Issue Date |
| 2018-01-29 | Plaintiff receives Lupin's Paragraph IV Certification Letter (approx. date) |
| 2018-02-06 | Plaintiff receives Teva's Paragraph IV Certification Letter (approx. date) |
| 2019-08-13 | '251 Patent Certificate of Correction Issue Date |
| 2020-11-25 | Second Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,561,251 - "Pharmaceutical compositions", issued February 7, 2017
The Invention Explained
- Problem Addressed: The patent addresses the challenge of administering high dosages of oral phosphate binders to patients with chronic renal insufficiency. The background notes that existing treatments can be inefficient, have side effects, or present challenges for patient compliance due to the large size or number of tablets required ('251 Patent, col. 1:15-28, col. 2:36-43).
- The Patented Solution: The invention is a pharmaceutical composition that allows for a "high loading" of iron oxy-hydroxide, the active phosphate-binding agent, within a single oral dosage form ('251 Patent, col. 3:9-14). This is achieved by formulating the iron oxy-hydroxide, preferably beta-iron oxy-hydroxide, with specific carbohydrates like saccharose and starch, which act as stabilizers and excipients, enabling the creation of a compact, high-dose tablet ('251 Patent, col. 3:36-44, col. 5:1-8).
- Technical Importance: By enabling a high concentration of the active ingredient in a single tablet, the invention aims to improve patient compliance and therapeutic efficacy for a chronic condition requiring long-term treatment ('251 Patent, col. 2:36-43).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 10, 21, 24, 34, 35, 36, 38, 39, and 40 (Compl. ¶¶ 29, 34).
- Independent Claim 1 requires:
- 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.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the generic sucroferric oxyhydroxide chewable tablets described in Lupin's ANDA No. 211386 and Teva's ANDA No. 211411 (Compl. ¶¶ 11, 15).
Functionality and Market Context
- The proposed generic products are intended to be generic versions of Plaintiff's VELPHORO® drug product (Compl. ¶¶ 11, 15). The complaint alleges that to claim bioequivalence with VELPHORO®, the defendants' products are required to be oral dosage forms containing approximately 800 mg of iron oxy-hydroxide along with saccharose (sucrose) and a starch (Compl. ¶¶ 29, 34). These products are designed to function as phosphate binders for controlling serum phosphorus in patients with chronic kidney disease on dialysis (Compl. ¶8).
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) expressed in relation to the total weight of the pharmaceutical composition... | The proposed ANDA products are alleged to be oral dosage forms that must contain "approximately 800 mg of iron oxy-hydroxide" to be bioequivalent to VELPHORO®. | ¶¶ 29, 34 | col. 5:30-34 |
| and carbohydrates, said carbohydrates comprising saccharose and starch, | The proposed ANDA products are alleged to be required to contain "saccharose (sucrose) and a starch" to establish bioequivalence. | ¶¶ 29, 34 | col. 5:1-8 |
| in a form suitable for oral administration, | The ANDAs seek approval to market "sucroferric oxyhydroxide chewable tablets, 500 mg". | ¶¶ 11, 15 | col. 3:9-14 |
| wherein the amount of iron oxy-hydroxide per dosage form is at least 500 mg. | The proposed ANDA products are alleged to contain "approximately 800 mg of iron oxy-hydroxide". | ¶¶ 29, 34 | col. 5:45-48 |
No probative visual evidence provided in complaint.
Identified Points of Contention
- Evidentiary Questions: The complaint's infringement theory rests heavily on the assertion that the defendants' products must contain the claimed components to be bioequivalent to VELPHORO® (Compl. ¶¶ 29, 34). A central question for the court will be what the ANDA filings themselves reveal about the precise formulation of the generic products and whether that formulation literally meets every element of the asserted claims.
- Scope Questions: The complaint alleges that the defendants' Paragraph IV letters do not dispute infringement of at least claim 1 (Compl. ¶¶ 29, 34), suggesting the primary dispute will be over patent validity. However, within the infringement analysis, a question may arise regarding the scope of "iron oxy-hydroxide." The specification emphasizes "beta iron oxy-hydroxide" stabilized by carbohydrates ('251 Patent, col. 3:36-38). The court may need to determine if the claims read on the specific form of iron oxy-hydroxide used in the accused products.
V. Key Claim Terms for Construction
- The Term: "iron oxy-hydroxide"
- Context and Importance: This term defines the active ingredient. While the claim language is broad, the specification repeatedly highlights "beta iron oxy-hydroxide" as a preferred embodiment and discusses its stabilization ('251 Patent, col. 3:37-38). Practitioners may focus on this term because defendants may argue their formulation uses a different iron oxy-hydroxide polymorph that falls outside a narrowly construed definition of the term, potentially leveraging prior art that discloses other forms.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim itself does not specify a particular polymorph (e.g., alpha, beta, gamma), suggesting the term should encompass all forms of iron oxy-hydroxide (FeOOH) ('251 Patent, claim 1). The specification also lists "alpha, beta, gamma, and delta FeOOH and mixtures thereof" as being included in the term ('251 Patent, col. 3:35-37).
- Evidence for a Narrower Interpretation: The specification's repeated emphasis on "beta FeOOH" and the advantages of its stabilization could be argued to limit the scope of the invention to compositions containing this specific form, particularly when read in light of the patent's overall objective ('251 Patent, col. 3:37-38).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that if the defendants commercially make, use, sell, or import their ANDA products, they will induce or contribute to infringement (Compl. ¶¶ 29, 34). This allegation is based on the premise that the product labels and marketing materials will instruct physicians and patients to use the generic drugs for the patented purpose of controlling serum phosphorus levels, thereby causing direct infringement by the end-users.
- Willful Infringement: The complaint alleges that Lupin had knowledge of the '251 Patent at least by the date of service of the original complaint (Compl. ¶30) and that Teva had knowledge at least by the date it submitted its ANDA (Compl. ¶35). The receipt of the Paragraph IV certification letters in early 2018 provides a clear factual basis for alleged pre-suit knowledge of the patent for both defendants (Compl. ¶¶ 13, 17).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of patent validity versus infringement: The complaint states that Defendants' Paragraph IV letters challenge the patent's validity and enforceability while not disputing infringement of claim 1 (Compl. ¶¶ 13, 17, 29, 34). This suggests the case may focus less on whether the generic products fall within the claim language and more on whether the claims are valid over the prior art.
- **A key evidentiary question will be one of compositional identity: While the complaint infers the composition of the accused products from bioequivalence requirements, the ultimate determination of infringement will depend on the actual evidence from the ANDA submissions. The central question is whether the defendants' specific formulations, including the exact polymorph of iron oxy-hydroxide and the nature of the excipients, are proven to fall squarely within the scope of the asserted claims.
- **A secondary issue may be one of claim scope: Should the validity of the patent be seriously challenged, the court's construction of the term "iron oxy-hydroxide" will become critical. The case may turn on whether the claims are interpreted broadly to cover any form of iron oxy-hydroxide in a high-dose tablet, or more narrowly to the "stabilized" beta-iron oxy-hydroxide that the specification describes as the inventive solution.