DCT

1:17-cv-00894

Ferring Pharma Inc v. Novel Laboratories Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00894, D. Del., 07/05/2017
  • Venue Allegations: Venue is based on Defendants being domestic Delaware business entities, thus residing in the district for purposes of patent venue.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Prepopik® colonoscopy preparation product constitutes an act of infringement of three patents directed to pharmaceutical compositions, manufacturing processes, and methods of use.
  • Technical Context: The technology concerns formulations of effervescent powders used for cleansing the colon prior to medical procedures like colonoscopies, a standard and high-volume part of diagnostic and preventative medicine.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff’s receipt of a Paragraph IV Notice Letter from Defendant Novel, dated May 19, 2017. The notice asserted that U.S. Patent Nos. 8,450,338 and 8,481,083, which are listed in the FDA’s Orange Book for Prepopik®, are invalid, unenforceable, or will not be infringed by Novel's proposed generic product. The complaint was filed within the 45-day statutory window, triggering a potential 30-month stay of FDA approval for Novel's ANDA.

Case Timeline

Date Event
2007-10-17 Priority Date for '338 and '083 Patents
2011-07-15 Priority Date for '110 Patent
2012-07-16 Ferring's Prepopik® NDA Approved
2013-05-28 U.S. Patent No. 8,450,338 Issued
2013-07-09 U.S. Patent No. 8,481,083 Issued
2017-05-19 Novel's Paragraph IV Notice Letter Sent
2017-06-06 U.S. Patent No. 9,669,110 Issued
2017-07-05 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,450,338, “Granular Compositions of Sodium Picosulphate and Potassium Bicarbonate and Uses Thereof,” issued May 28, 2013

The Invention Explained

  • Problem Addressed: The patent’s background section describes problems in the established process for manufacturing multi-component laxative powders. It notes that mixing ingredients with different physical properties can lead to inhomogeneity, product loss, and dust generation. Specifically, wet-mixing sodium picosulphate with potassium bicarbonate could cause the bicarbonate to dissolve or physically degrade, compromising the final product’s uniformity and quality (Compl. ¶23; ’338 Patent, col. 1:56–col. 2:27).
  • The Patented Solution: The invention claims to solve this problem by creating a more stable intermediate component. It proposes a process where a solution of sodium picosulphate is spray-coated onto a core of potassium bicarbonate, which is then dried. This creates a distinct, coated granule that protects the ingredients and improves homogeneity when mixed with other components of the final drug product (’338 Patent, Abstract; col. 2:42-48).
  • Technical Importance: This process-oriented solution aims to enhance batch-to-batch consistency, reduce manufacturing time, and minimize material waste, which are critical objectives in pharmaceutical production (’338 Patent, col. 2:3-27).

Key Claims at a Glance

  • The complaint asserts claims 8 to 19 (Compl. ¶39).
  • Independent Claim 8 is a process claim with the following essential elements:
    • A process for preparing a composition comprising sodium picosulphate coated granules.
    • The process includes a step of (a) spray coating a solution of sodium picosulphate onto potassium bicarbonate.
    • The process includes a step of (b) drying the sodium picosulphate and potassium bicarbonate.
    • The drying step results in obtaining "sodium picosulphate coated granules" which have a layer of sodium picosulphate coating a potassium bicarbonate core.

U.S. Patent No. 8,481,083, “Granular Compositions of Magnesium Oxide and Citric Acid and Uses Thereof,” issued July 9, 2013

The Invention Explained

  • Problem Addressed: Similar to the ’338 Patent, the background describes manufacturing challenges related to product inhomogeneity. This patent focuses on the "primary mix" of citric acid and magnesium oxide, noting that differences in density and low binding properties can cause the components to separate during mixing, leading to inaccurate dosing and material loss (’083 Patent, col. 1:55–col. 2:16).
  • The Patented Solution: The invention is a pharmaceutical composition containing two distinct types of granules. The first type, central to this patent, comprises a core of citric acid coated with a layer of magnesium oxide. This creates a stable agglomerate. The second type of granule is the sodium picosulphate-coated potassium bicarbonate described in the '338 patent. The patent teaches combining these two distinct, stable granular compositions to form the final homogeneous product (’083 Patent, Abstract; col. 3:45-63).
  • Technical Importance: By creating stable granules of the citric acid and magnesium oxide components, the invention aims to ensure that they remain homogeneously mixed, which is essential for the intended chemical reaction in water that forms magnesium citrate, the product's active osmotic laxative (’083 Patent, col. 1:28-34).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the ’083 patent (Compl. ¶46).
  • Independent Claim 1 is a composition claim with the following essential elements:
    • A pharmaceutical composition comprising two types of granules.
    • (a) "magnesium oxide coated granules which have a layer of magnesium oxide coated on a core of citric acid".
    • (b) "sodium picosulphate coated granules having a spray-coated layer of sodium picosulphate coating a potassium bicarbonate core".

Multi-Patent Capsule: U.S. Patent No. 9,669,110, “Method for Timing a Colonoscopy,” issued June 6, 2017

  • Technology Synopsis: This patent addresses the issue that the quality of colon cleansing is highly dependent on the time interval between the final dose of the preparation agent and the start of the colonoscopy procedure (’110 Patent, col. 2:4-9). The invention is a method of use, claiming that performing the colonoscopy within a specified short timeframe after the patient ingests a picosulfate-based bowel composition—for example, less than four hours—results in superior cleansing and better examination conditions (’110 Patent, Abstract).
  • Asserted Claims: The complaint asserts "one or more claims" (Compl. ¶51). Independent claims 1, 6, and 11 are method claims.
  • Accused Features: Infringement is alleged based on the future use of Novel's ANDA Product. The complaint alleges that the product will be sold with an FDA-approved insert that will direct physicians and patients to use the product in a manner that infringes the claimed timing method (Compl. ¶52).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Novel's ANDA Product," a proposed generic version of Ferring's Prepopik® for Oral Solution, identified in ANDA No. 210306 (Compl. ¶30).

Functionality and Market Context

  • The product is a pharmaceutical preparation for cleansing the colon prior to a colonoscopy (Compl. ¶19). As a generic version of Prepopik®, it is expected to contain the same active ingredients: sodium picosulfate, magnesium oxide, and citric acid (Compl. ¶20). The complaint alleges that the submission of the ANDA itself is an act of infringement under 35 U.S.C. § 271(e)(2), as it seeks FDA approval to manufacture and sell a product that allegedly infringes the asserted patents before their expiration (Compl. ¶¶36, 45). The product aims to compete directly with the branded Prepopik® product in the market for colonoscopy preparations.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint, filed at the ANDA stage, does not provide detailed evidence of infringement, as the specifics of the defendant's process and product are confidential. The allegations are based on the act of filing the ANDA and the representations made therein.

U.S. Patent No. 8,450,338 Infringement Allegations

Claim Element (from Independent Claim 8) Alleged Infringing Functionality Complaint Citation Patent Citation
A process for the preparation of a composition...comprising steps of: (a) spray coating a solution of sodium picosulphate on to potassium bicarbonate; The complaint alleges that the process that will be used to manufacture Novel's ANDA Product includes this step. ¶39 col. 2:42-45
and (b) drying the sodium picosulphate and potassium bicarbonate thereby obtaining sodium picosulphate coated granules... The complaint alleges that the manufacturing process for Novel's ANDA Product will result in granules with the claimed coated structure. ¶39 col. 2:45-48

U.S. Patent No. 8,481,083 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising: (a) magnesium oxide coated granules which have a layer of magnesium oxide coated on a core of citric acid; The complaint alleges that Novel's ANDA Product, as described in its ANDA, will be a pharmaceutical composition containing granules with this specific core-shell structure. ¶46 col. 5:42-44
and (b) sodium picosulphate coated granules having a spray-coated layer of sodium picosulphate coating a potassium bicarbonate core. The complaint alleges that Novel's ANDA Product will also contain this second distinct type of coated granule. ¶46 Abstract
  • Identified Points of Contention:
    • Evidentiary Question: The central dispute for the ’338 and ’083 patents will be factual and evidentiary. What does Novel’s confidential ANDA filing reveal about its manufacturing process and final product formulation? The case will depend on whether discovery shows that Novel’s process utilizes "spray coating" and results in the distinct "core-shell" granule structures required by the claims.
    • Technical Question: A key technical question is whether Novel's method of combining ingredients, even if different from the patented process, results in a final product that is structurally and functionally indistinguishable from the one described in the '083 patent's composition claims.

V. Key Claim Terms for Construction

  • The Term: "coated" / "layer ... coated on a core" (from asserted claims of the '338 and '083 patents)
    • Context and Importance: The inventive concept of the formulation patents rests on the creation of specific granular structures with a "core" and a "coating." The infringement analysis for the '338 process patent and the '083 composition patent will hinge on whether Novel’s product is made by a process that creates, and ultimately contains, granules that meet this structural limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discusses the general goal of agglomeration and preventing separation, which could support an argument that any process resulting in one component substantially surrounding another falls within the scope of "coated" (’338 Patent, col. 3:28-32).
      • Evidence for a Narrower Interpretation: The patents repeatedly use terms like "spray coating" and provide SEM images showing a distinct "crystal core" and an outer "shell," suggesting a specific, well-defined layered structure, not merely a heterogeneous mixture or simple agglomerate (’338 Patent, col. 11:15-32; ’083 Patent, col. 11:15-32). Practitioners may focus on this evidence to argue that a specific morphology is required.

VI. Other Allegations

  • Indirect Infringement: The complaint explicitly alleges induced infringement of the ’110 patent. The allegation is based on the assertion that Novel and Gavis will market the ANDA product with an FDA-approved label that instructs and encourages physicians and patients to perform the patented method of timing the colonoscopy procedure relative to the final dose (Compl. ¶¶51-52, 54).
  • Willful Infringement: The complaint does not use the term "willful," but it does allege that Novel had knowledge of the ’110 patent (Compl. ¶55). For the ’338 and ’083 patents, Novel's pre-suit knowledge is established by its own Paragraph IV Notice Letter, which is a required element of the ANDA process (Compl. ¶30). The prayer for relief requests a finding of an exceptional case under 35 U.S.C. § 285, which can be based on litigation misconduct or, in some circumstances, egregious infringement (Compl. p. 12, ¶h).

VII. Analyst’s Conclusion: Key Questions for the Case

  1. An Evidentiary Question of Process and Structure: For the '338 and '083 patents, the case will likely turn on a factual comparison between the patent claims and the confidential details in Novel’s ANDA. Does Novel's manufacturing process in fact involve "spray coating," and does its final product contain the specific "core-shell" granular structures that form the basis of the patents-in-suit?

  2. A Question of Induced Infringement and Label Interpretation: For the '110 patent, a core issue will be whether the final FDA-approved product label for Novel's generic drug will "encourage, aid, and abet" infringement by instructing a method of use that falls within the patent's timing limitations. The dispute will center on the precise language of the label and whether it directs the performance of the claimed steps.