DCT
1:19-cv-00913
Ferring Pharma Inc v. Lupin Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Ferring BV Pharmaceuticals Inc. (Delaware), Ferring International Center S.A. (Switzerland), and Ferring BV (Netherlands)
- Defendant: Lupin Ltd (Delaware)
- Plaintiff’s Counsel: Womble Bond Dickinson US LLP
- Case Identification: 1:19-cv-00913, D. Del., 06/17/2020
- Venue Allegations: Venue is alleged to be proper as Defendant Lupin Inc. is a Delaware corporation. Defendant has stipulated it will not contest venue in the District of Delaware for this action.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's CLENPIQ® oral solution constitutes an act of infringement of three patents related to liquid pharmaceutical compositions and methods for their use in colonoscopy preparation.
- Technical Context: The technology concerns ready-to-use liquid formulations for colon cleansing, a market where patient convenience and compliance are critical factors for ensuring the effectiveness of preparatory regimens for colonoscopies.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA seeking FDA approval to market a generic drug. The complaint states Defendant sent notice letters with Paragraph IV certifications for the patents-in-suit, asserting non-infringement or invalidity. The ’231 and ’879 patents are listed in the FDA’s Orange Book as covering the branded CLENPIQ® product. The ’879 patent is a continuation of the application that resulted in the ’231 patent.
Case Timeline
| Date | Event |
|---|---|
| 2011-07-15 | Priority Date for U.S. Patent No. 9,669,110 |
| 2014-03-19 | Priority Date for U.S. Patent Nos. 9,827,231 and 10,624,879 |
| 2017-06-06 | U.S. Patent No. 9,669,110 Issued |
| 2017-11-28 | FDA Approved NDA No. 209589 for CLENPIQ® |
| 2017-11-28 | U.S. Patent No. 9,827,231 Issued |
| 2019-04-04 | Date of Lupin's Notice Letter regarding the '231 Patent |
| 2020-04-21 | U.S. Patent No. 10,624,879 Issued |
| 2020-06-04 | Date of Lupin's Notice Letter regarding the '879 Patent |
| 2020-06-17 | Amended Complaint Filed |
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 issues with colon-cleansing preparations that are sold in powder form. These can be inconvenient for patients and, if pre-mixed with water and stored, the active ingredients can react and precipitate, reducing efficacy. Specifically, citric acid and magnesium oxide react to form magnesium citrate, and leftover magnesium oxide can precipitate over time. Attempts to lower the pH to prevent precipitation can, in turn, destabilize another active ingredient, sodium picosulfate (’231 Patent, col. 1:26-54).
- The Patented Solution: The invention is a stable, ready-to-use liquid pharmaceutical composition that solves the stability and precipitation issues. It achieves this by including not only sodium picosulfate, magnesium oxide, and citric acid, but also malic acid. The addition of malic acid allows the formulation to be maintained within a specific pH range (4.1 to 5.4) that simultaneously prevents the precipitation of magnesium compounds and maintains the chemical stability of the sodium picosulfate (’231 Patent, Abstract; col. 2:7-11, 35-50).
- Technical Importance: This approach offers a ready-to-use liquid formulation that improves patient convenience and dosing accuracy over powder versions, while addressing the underlying chemical stability challenges that previously hindered such liquid products (’231 Patent, col. 1:55-59).
Key Claims at a Glance
- The complaint asserts infringement of independent claim 1, as well as several dependent claims (Compl. ¶¶42-45).
- Independent Claim 1:
- A pharmaceutical liquid composition comprising sodium picosulfate, magnesium oxide, citric acid and malic acid.
U.S. Patent No. 9,669,110 - "Method for Timing a Colonoscopy" (Issued Jun. 6, 2017)
The Invention Explained
- Problem Addressed: The quality of a colonoscopy is highly dependent on the effectiveness of the pre-procedure bowel cleansing. The patent notes that inadequate preparation can lead to incomplete examinations and missed lesions, and that the time interval between administration of the cleansing agent and the procedure is a critical factor, with afternoon colonoscopies historically having higher rates of inadequate preparation (’110 Patent, col. 1:40-54; col. 2:19-27).
- The Patented Solution: The invention discloses a method for timing a colonoscopy by administering a second or final dose of a picosulfate bowel composition within a relatively short window before the procedure, specifically "from about 3 hours to about 1 hour" prior to the start of the colonoscopy. The patent presents clinical data suggesting that this shortened interval can result in effective colon cleansing, thereby improving outcomes and potentially offering more flexible patient scheduling (’110 Patent, Abstract; col. 2:53-59; Table 3).
- Technical Importance: This method challenges conventional timing protocols by demonstrating that a shorter interval between the final cleansing dose and the procedure can be effective, which could enhance the quality of colon cleansing, particularly for afternoon appointments (’110 Patent, col. 2:28-38).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" of the patent (Compl. ¶53). Independent claims 1, 6, and 11 are foundational.
- Independent Claim 1: A method comprising:
- administering a picosulfate bowel composition to the patient; and
- performing the colonoscopy procedure from about 3 hours to about 1 hour after the administration of the picosulfate bowel composition.
- Independent Claim 6: A "split-dose" method comprising:
- administering a first picosulfate bowel composition to the patient the day before the colonoscopy procedure;
- administering a second picosulfate bowel composition to the patient on the day of the colonoscopy procedure; and
- performing the colonoscopy procedure from about 3 hours to about 1 hour after the administration of the second picosulfate bowel composition.
U.S. Patent No. 10,624,879 - "Liquid Pharmaceutical Composition" (Issued April 21, 2020)
- Patent Identification: U.S. Patent No. 10,624,879, "Liquid Pharmaceutical Composition", issued April 21, 2020 (Compl. ¶27).
- Technology Synopsis: As a continuation of the application for the ’231 patent, this patent addresses the same technical problem of creating a chemically and physically stable ready-to-use liquid bowel purgative (’879 Patent, col. 1:15-25). The patented solution is a liquid pharmaceutical composition that includes sodium picosulfate, magnesium oxide, citric acid, and malic acid, formulated to have a pH between 4.1 and 5.4 to ensure stability and prevent precipitation (’879 Patent, Abstract; col. 2:23-43).
- Asserted Claims: The complaint alleges infringement of "one of more claims" of the patent (Compl. ¶¶61, 68). Independent claims 1 and 11 are central.
- Accused Features: The accused feature is Lupin Ltd's ANDA Product, a proposed generic liquid oral solution for colon cleansing (Compl. ¶¶12, 61).
III. The Accused Instrumentality
Product Identification
Lupin’s ANDA No. 213029 Product (“Lupin’s ANDA Product”) (Compl. ¶30).
Functionality and Market Context
The accused product is a proposed generic version of Ferring’s CLENPIQ®, which is an oral solution containing sodium picosulfate, magnesium oxide, and anhydrous citric acid (Compl. ¶12). It is intended to be used for cleansing of the colon as a preparation for colonoscopy in adults (Compl. ¶20). The complaint is predicated on Lupin's filing of an ANDA with the FDA, which is a statutory act of infringement if the proposed product, once approved and marketed, would infringe a valid patent (Compl. ¶¶11-12). The commercial importance is that of a generic drug seeking to enter the market established by the branded CLENPIQ® product. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a claim chart. The infringement theory is based on the allegation that Lupin's ANDA Product is a generic version of CLENPIQ® and that its FDA-approved label will instruct users to perform the patented methods. CLENPIQ® is covered by the asserted patents, which are listed in the FDA's Orange Book (Compl. ¶¶24, 29).
'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. | Lupin’s ANDA product is alleged to be a liquid pharmaceutical composition that is a generic version of CLENPIQ®. As such, it is alleged to contain the four required components, including the key stabilizing agent, malic acid. | ¶¶12, 40, 42 | col. 5:61-63 |
- Identified Points of Contention:
- Factual Question: The complaint describes the accused product as containing sodium picosulfate, magnesium oxide, and citric acid, but does not explicitly allege the presence of malic acid (Compl. ¶12). The core of the infringement dispute for the '231 and '879 patents will likely be a factual one: does Lupin’s ANDA formulation, in fact, contain malic acid as required by the claims? Plaintiff's case may depend on proving that the Orange Book-listed CLENPIQ® contains malic acid and that Lupin’s generic must be identical.
'110 Patent Infringement Allegations
| Claim Element (from Independent Claim 6) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| administering a first picosulfate bowel composition to the patient the day before the colonoscopy procedure; | The complaint alleges that Lupin will induce infringement by marketing its product with an FDA-approved insert that directs physicians and patients to use a split-dosing regimen, with the first dose administered the day before the procedure. | ¶¶53-55 | col. 12:51-52 |
| administering a second picosulfate bowel composition to the patient on the day of the colonoscopy procedure; | The product insert is alleged to instruct users to take a second dose on the day of the procedure. | ¶¶53-55 | col. 12:53-54 |
| performing the colonoscopy procedure from about 3 hours to about 1 hour after the administration of the second picosulfate bowel composition. | The product insert is alleged to instruct a timing for the procedure that falls within the claimed window of approximately one to three hours after the second dose is administered. | ¶¶53-55 | col. 12:56-59 |
- Identified Points of Contention:
- Evidentiary Question: What will the final, FDA-approved label for Lupin’s product actually instruct users to do regarding the timing of the second dose relative to the colonoscopy? The infringement case for the ’110 patent will depend on whether those instructions direct a use that falls within the scope of the claims.
- Scope Question: How broadly will the court construe the term "about"? The answer will determine whether Lupin's instructed timing, if close to but not exactly within the 1-to-3-hour window, constitutes infringement.
V. Key Claim Terms for Construction
- The Term: "from about 3 hours to about 1 hour" (from '110 Patent, Claim 1, 6, 11)
- Context and Importance: This temporal limitation is the central feature of the method claims in the ’110 patent. The scope of "about" is critical, as it defines the boundary of infringement. Practitioners may focus on this term because whether the dosing instructions on Lupin’s product label fall inside or outside this window will likely decide the infringement question for this patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification discusses a clinical study where patients who received the final dose at 3.67 hours and 1.78 hours prior to the procedure were both deemed successful "responders," which may suggest the claimed range is exemplary, not absolute (’110 Patent, col. 9:12-42, Table 3). The abstract also uses the broader phrase "less than about 4 hours" (’110 Patent, Abstract).
- Evidence for a Narrower Interpretation: The inventors chose the specific "from about 3 hours to about 1 hour" range for the independent claims, which could be argued as a deliberate narrowing from the broader disclosure. A party could argue that the term "about" should only cover minor, insignificant variations from the stated 1- and 3-hour endpoints.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement for all three patents. The factual basis is the allegation that Lupin will market its ANDA product with an FDA-approved product insert that "will direct physicians and patients" to use the product in an infringing manner (Compl. ¶¶43, 54-55). For the ’231 patent, contributory infringement is also alleged on the basis that Lupin's product is designed for an infringing use and "lacks a substantial non-infringing use" (Compl. ¶45).
- Willful Infringement: The complaint does not explicitly plead "willful infringement." However, it alleges that Lupin has pre-suit "knowledge" of the patents, based on its notice letters, and that its use of the product will be infringing (Compl. ¶¶43, 56). The complaint also seeks a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which are often associated with findings of willfulness or other litigation misconduct (Compl. ¶¶48, 59, 71).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual composition: Do Lupin's proposed generic drug formulations actually contain malic acid, the key stabilizing ingredient required by the composition claims of the '231 and '879 patents? The complaint's infringement theory relies on the accused product being a generic equivalent to the Orange Book-listed CLENPIQ®, but it provides no direct evidence of malic acid's presence.
- A second core issue will be one of evidentiary proof: Will the final, FDA-approved instructions for use for Lupin's product direct a split-dosing regimen where the colonoscopy is performed within the time window claimed by the '110 patent? The inducement case hinges entirely on the content of this future product label.
- The dispute will also involve a key question of definitional scope: How will the term "about," as used in the timing limitations of the '110 patent (e.g., "from about 3 hours to about 1 hour"), be construed? The breadth of this term will be critical in determining whether the instructions on Lupin's product label fall within the bounds of the claims.