DCT
1:25-cv-00810
Ferring Pharma Inc v. Alkem Laboratories Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Ferring Pharmaceuticals Inc. (Delaware) and Ferring International Center S.A. (Switzerland)
- Defendant: Alkem Laboratories Ltd. (India)
- Plaintiff’s Counsel: Womble Bond Dickinson (US) LLP
- Case Identification: 1:25-cv-00810, D. Del., 07/02/2025
- Venue Allegations: Venue is asserted based on Defendant being a foreign corporation not residing in the United States, and on the basis of Defendant’s alleged systematic and continuous business contacts with Delaware.
- Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs’ CLENPIQ® oral solution constitutes an act of infringement of three U.S. patents.
- Technical Context: The technology concerns liquid pharmaceutical compositions for colonic cleansing, commonly used in preparation for colonoscopies, which are formulated to be chemically and physically stable for storage.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s notification to Plaintiffs of its ANDA filing with a Paragraph IV certification, asserting that Plaintiffs' patents are invalid, unenforceable, or will not be infringed. The patents-in-suit form a family, with the '879' patent being a continuation of the application that issued as the '231' patent, and the '753' patent being a continuation of the application that issued as the '879 patent. All three patents are listed in the FDA's "Orange Book" as covering the CLENPIQ® product. The complaint was filed within the 45-day window provided by statute, which typically triggers an automatic 30-month stay of FDA approval for the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2014-03-19 | Priority Date for '231, '879, and '753 Patents |
| 2017-11-28 | FDA Approval for CLENPIQ® New Drug Application |
| 2017-11-28 | U.S. Patent No. 9,827,231 Issued |
| 2020-04-21 | U.S. Patent No. 10,624,879 Issued |
| 2021-12-07 | U.S. Patent No. 11,191,753 Issued |
| 2025-05-19 | Date of Alkem's Notice Letter |
| 2025-07-02 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,827,231 - "Liquid Pharmaceutical Composition," Issued Nov. 28, 2017
The Invention Explained
- Problem Addressed: The patent describes the challenges with purgative medicines that come in powder form. Such powders are inconvenient for patients to dissolve and can be used improperly. If pre-dissolved in water for storage, the active ingredients (citric acid and magnesium oxide) can react and form a precipitate, which reduces the efficacy of the dose. Attempts to prevent this precipitation by lowering the solution's pH can, in turn, cause another active ingredient, sodium picosulfate, to become unstable. (’231 Patent, col. 1:32-57).
- The Patented Solution: The invention is a ready-to-use, stable liquid pharmaceutical composition. Stability is achieved by adding malic acid to the formulation of sodium picosulfate, magnesium oxide, and citric acid. The patent asserts that this combination, maintained within a specific pH range, prevents both the precipitation of magnesium citrate and the degradation of sodium picosulfate, solving the dual problems of the prior art. (’231 Patent, Abstract; col. 2:5-10, 40-51).
- Technical Importance: This innovation provides a shelf-stable, ready-to-drink bowel preparation, which can improve patient compliance and convenience compared to powder-based kits. (’231 Patent, col. 2:20-25).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 16.
- Claim 1: A pharmaceutical liquid composition with four essential components:
- sodium picosulfate
- magnesium oxide
- citric acid
- and malic acid
- Claim 16: "A pharmaceutical composition comprising sodium picosulfate, magnesium oxide, citric acid and malic acid."
- The complaint reserves the right to assert other claims, including dependent claims 2-15 and 17-20. (Compl. ¶¶ 33-36).
U.S. Patent No. 10,624,879 - "Liquid Pharmaceutical Composition," Issued Apr. 21, 2020
The Invention Explained
- Problem Addressed: As a continuation of the '231 patent's application, the '879 Patent addresses the identical problem: the inconvenience and chemical instability of prior art powder-based purgatives when stored in liquid form. (’879 Patent, col. 1:32-58).
- The Patented Solution: The patented solution is the same stable liquid formulation containing sodium picosulfate, magnesium oxide, citric acid, and malic acid. The claims of this patent add further specificity regarding the solution's pH and, in some claims, the precise weight ratios of the components. (’879 Patent, Abstract; col. 2:40-51).
- Technical Importance: This patent further protects the specific formulation parameters that allegedly confer the unique stability to the liquid bowel preparation. (’879 Patent, col. 2:20-26).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 11.
- Claim 1: A pharmaceutical composition comprising the four key ingredients, further limited by two properties:
- the composition is a solution
- with a pH in the range from 4.1 to 5.4
- Claim 11: A pharmaceutical composition comprising the four key ingredients, further limited by:
- the composition is a liquid with a pH ranging from 4.1 to 5.4
- the components are present in a specific weight ratio of about 0.005:1.75:6:4.19
- The complaint reserves the right to assert other claims, including dependent claims 2-10 and 12-19. (Compl. ¶ 43).
U.S. Patent No. 11,191,753 - "Liquid Pharmaceutical Composition," Issued Dec. 7, 2021
- Technology Synopsis: This patent, a continuation in the same family, claims methods of treatment using the stable liquid formulation. It addresses the problem of ensuring proper and convenient administration of a bowel-cleansing agent by claiming a method of cleaning a colon that involves orally administering the specific liquid composition containing sodium picosulfate, magnesium oxide, citric acid, and malic acid. (’753 Patent, col. 1:28-59; col. 7:1-5).
- Asserted Claims: The complaint asserts independent claims 1 and 12, along with dependent claims. (Compl. ¶¶ 50-51).
- Accused Features: The complaint alleges that Defendant will induce and contribute to infringement by marketing its ANDA Product with an FDA-approved label that instructs physicians and patients to use it for colon cleansing, a use covered by the patent’s method claims. (Compl. ¶ 50).
III. The Accused Instrumentality
- Product Identification: Defendant’s proposed generic version of CLENPIQ® (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution, which is the subject of ANDA No. 220428 ("Alkem's ANDA Product"). (Compl. ¶¶ 2, 24).
- Functionality and Market Context: The accused product is an oral solution intended for cleansing of the colon as a preparation for colonoscopy in adults. (Compl. ¶¶ 13, 26). The complaint alleges that by filing its ANDA, Defendant has represented to the FDA that its product has the same active ingredients, dosage form, strength, and route of administration as the branded CLENPIQ® product and is bioequivalent to it. (Compl. ¶ 26).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The infringement allegations are based on the premise that Alkem's ANDA Product is a generic copy of CLENPIQ® and will therefore have the same formulation and properties, which are protected by the patents-in-suit.
'231 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical liquid composition comprising sodium picosulfate, magnesium oxide, citric acid and malic acid. | Alkem's ANDA filing for a generic version of CLENPIQ® constitutes an act of infringement because the product, if approved, would be a liquid composition that necessarily contains these components to be bioequivalent to the branded drug, which embodies the patent. | ¶¶ 26, 31, 33 | col. 1:20-25; col. 2:5-10 |
'879 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising sodium picosulfate, magnesium oxide, citric acid, and malic acid, | As a proposed bioequivalent generic of CLENPIQ®, Alkem's ANDA Product is alleged to be a composition containing these four ingredients. | ¶¶ 26, 41, 43 | col. 2:5-10 |
| wherein the pharmaceutical composition is a solution with a pH in the range from 4.1 to 5.4. | The complaint's infringement theory rests on the basis that Alkem's ANDA Product, to be a stable and effective generic, must be formulated as a solution within the same pH range as CLENPIQ®, which is the range claimed by the patent. | ¶¶ 26, 41, 43 | col. 2:40-51 |
- Identified Points of Contention:
- Evidentiary Question: The central question will be factual: does the formulation described in Alkem's confidential ANDA filing actually contain all four claimed components, including malic acid, and does it have a pH that falls within the 4.1 to 5.4 range? The complaint proceeds on the inference that it must, but the litigation will depend on the actual evidence of the proposed generic product's composition.
- Invalidity Question: A primary defense in ANDA litigation is invalidity. A question for the court will be whether the combination of malic acid with the other known purgative ingredients to achieve stability at a specific pH would have been obvious to a person of ordinary skill in pharmaceutical formulation at the time of the invention.
V. Key Claim Terms for Construction
The Term: "malic acid"
- Context and Importance: This is the key ingredient that the patents identify as the solution to the long-standing stability problem. Its presence or absence in Alkem's ANDA Product is likely dispositive for infringement. Practitioners may focus on this term because the patents' own background distinguishes the invention from prior art compositions that lacked it.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that "The malic acid may include both 1-malic acid and d-malic acid," suggesting the term is not limited to a specific isomer. (’231 Patent, col. 2:38-39). The use of the open-ended term "comprising" in the claims may also support a broader reading that allows for the presence of other ingredients.
- Evidence for a Narrower Interpretation: A defendant could argue that the term "malic acid" should be construed to require its presence in an amount sufficient to perform the claimed stabilizing function within the specified pH range, potentially importing functional limitations from the specification. The '879 patent's claim 11, which recites a specific weight ratio, could be used to argue that the term has a more limited, functional meaning in the context of the invention.
The Term: "a pH in the range from 4.1 to 5.4"
- Context and Importance: The '879 and '753 patents explicitly claim this pH range, which the specification describes as critical for achieving superior stability by preventing both precipitation and degradation. Whether Alkem's product meets this numerical limitation will be a central factual issue for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The language itself is a clear numerical range. A plaintiff would likely argue for its plain and ordinary meaning.
- Evidence for a Narrower Interpretation: The specification heavily links this pH range to the invention's success, stating that outside this range, the composition is less stable. (’879 Patent, col. 2:41-51). A party might raise questions regarding measurement precision or whether a product whose pH temporarily deviates from this range meets the limitation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement of the '231 and '753 patents based on the assertion that Alkem's product, upon approval, will be sold with an FDA-approved product insert that will instruct physicians and patients to use the product in an infringing manner. (Compl. ¶¶ 34, 50). Contributory infringement is alleged on the basis that Alkem's product is designed for an infringing use and lacks a substantial non-infringing use. (Compl. ¶¶ 35, 51).
- Willful Infringement: While the complaint does not use the word "willful," it alleges that this is an "exceptional one" and seeks an award of attorneys' fees under 35 U.S.C. § 285. (Compl. ¶¶ 39, 46, 54). The factual basis for knowledge includes Alkem's Paragraph IV certification notice letter and the listing of the patents-in-suit in the FDA's Orange Book. (Compl. ¶¶ 17, 24).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of factual evidence: Does the specific formulation detailed in Alkem's confidential ANDA submission fall within the scope of the asserted claims? This will turn on whether discovery reveals that Alkem's product contains malic acid and is formulated to a pH between 4.1 and 5.4.
- A second critical issue will be patent validity: Can Alkem prove by clear and convincing evidence that the claimed invention—specifically the use of malic acid to create a stable, liquid, multi-component purgative within a specific pH range—was obvious to a skilled formulator at the time of the invention? The case will likely involve competing expert testimony on the predictability of achieving the claimed stability.