DCT
1:17-cv-00435
Ferring Pharma Inc v. Teva Pharma USA Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Ferring Pharmaceuticals Inc. (Delaware) and Ferring International Center S.A. (Switzerland)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Womble Carlyle Sandridge & Rice, LLP
- Case Identification: 1:17-cv-00435, D. Del., 04/19/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the drug Prepopik® constitutes an act of infringement of patents related to granular pharmaceutical compositions for colon cleansing.
- Technical Context: The technology concerns pharmaceutical formulations for bowel preparation, focusing on methods to create a stable, homogeneous mixture of active ingredients to ensure consistent dosing and reduce manufacturing inefficiencies.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 209960 and a corresponding Paragraph IV Notice Letter, dated March 9, 2017, which asserted that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product. The patents are listed in the FDA's "Orange Book" as covering Plaintiff's Prepopik® drug product. The complaint was filed within the 45-day statutory window, triggering a 30-month stay on the FDA’s approval of the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2007-10-17 | Earliest Priority Date ('338 & '083 Patents) |
| 2012-07-16 | FDA Approves NDA for Prepopik® |
| 2013-05-28 | U.S. Patent No. 8,450,338 Issues |
| 2013-07-09 | U.S. Patent No. 8,481,083 Issues |
| 2017-03-09 | Defendant Sends Paragraph IV Notice Letter |
| 2017-04-19 | 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 describes issues with prior art manufacturing processes for multi-component bowel cleansing powders, where differences in the physical properties of ingredients (e.g., density) lead to poor mixing and product "inhomogeneity" (Compl. ¶18; '338 Patent, col. 1:60-col. 2:11). This inconsistency requires adding excess raw materials ("overage") to compensate for losses, resulting in economic waste and unhealthy dust during manufacturing ('338 Patent, col. 2:11-18).
- The Patented Solution: The invention claims a process for creating a more homogeneous intermediate product, or "pre-mix," used in the final drug formulation. The process involves applying a solution of the active ingredient, sodium picosulphate, onto a core of potassium bicarbonate, for example by "spray coating," and then drying the resulting granules ('338 Patent, col. 2:45-49, Abstract). This technique is designed to distribute the active ingredient more evenly and create granules with consistent properties, reducing processing time and improving product quality ('338 Patent, col. 9:56-col. 10:7).
- Technical Importance: The claimed process provides a method to overcome common manufacturing challenges in producing uniform solid dosage forms from multiple components, aiming for improved dose consistency and manufacturing efficiency.
Key Claims at a Glance
- The complaint alleges infringement of one or more of claims 8 to 19 (Compl. ¶32-35). Independent claim 8 is a process claim.
- Claim 8 (Independent): A process for preparing a composition, comprising the steps of:
- (a) spray coating a solution of sodium picosulphate on to potassium bicarbonate; and
- (b) drying the sodium picosulphate and potassium bicarbonate thereby obtaining sodium picosulphate coated granules,
- wherein the granules have a layer of sodium picosulphate coating a potassium bicarbonate core.
- The complaint reserves the right to assert additional claims (Compl. ¶30).
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: Like its related patent, the ’083 Patent addresses the problem of inhomogeneity in pharmaceutical powders, focusing specifically on the difficulty of uniformly mixing magnesium oxide and citric acid, which together form an osmotic laxative when dissolved in water (Compl. ¶20; '083 Patent, col. 1:60-col. 2:11).
- The Patented Solution: The invention is a final pharmaceutical composition comprising two distinct types of granules that are mixed together. The first type consists of granules with "a layer of magnesium oxide coated on a core of citric acid." The second type consists of the sodium picosulphate-coated granules described in the '338 patent. By creating these two separate, well-defined granular components and then combining them, the invention seeks to ensure a "homogeneous or substantially homogeneous" final product ('083 Patent, Abstract, col. 11:7-14).
- Technical Importance: This two-granule system provides a structural solution to ensure that both the active stimulant laxative and the components of the osmotic laxative are uniformly distributed throughout the final dosage form.
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" of the '083 patent (Compl. ¶39). Independent claim 1 is a composition claim.
- Claim 1 (Independent): A pharmaceutical composition comprising:
- (a) magnesium oxide coated granules which have a layer of magnesium oxide coated on a core of citric acid; and
- (b) sodium picosulphate coated granules having a spray-coated layer of sodium picosulphate coating a potassium bicarbonate core.
- The complaint reserves the right to assert additional claims (Compl. ¶39).
III. The Accused Instrumentality
Product Identification
- Defendant's proposed generic version of Prepopik®, for which it filed Abbreviated New Drug Application (ANDA) No. 209960 with the FDA (Compl. ¶23).
Functionality and Market Context
- The accused product is a pharmaceutical formulation for cleansing of the colon as a preparation for colonoscopy in adults (Compl. ¶14, ¶16). As a generic, it is intended to be bioequivalent to and substitutable for Plaintiff’s branded Prepopik® product (Compl. ¶23). The complaint does not provide specific technical details regarding the formulation or manufacturing process of the accused product, as these allegations are based on the ANDA filing itself, prior to discovery.
IV. Analysis of Infringement Allegations
The complaint alleges that the submission of ANDA No. 209960 is an act of infringement under 35 U.S.C. § 271(e)(2) and that the future commercial manufacture, use, or sale of the product will infringe under § 271(a) (Compl. ¶29-30, ¶38-39). The complaint does not provide claim charts; the following tables summarize the infringement theories that can be inferred from the allegations.
No probative visual evidence provided in complaint.
'338 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| spray coating a solution of sodium picosulphate on to potassium bicarbonate | The process for manufacturing Defendant's ANDA Product, as described in its ANDA, is alleged to include the step of spray coating a sodium picosulphate solution onto potassium bicarbonate. | ¶32 | col. 11:21-23 |
| drying the sodium picosulphate and potassium bicarbonate thereby obtaining sodium picosulphate coated granules, wherein the ... granules have a layer of sodium picosulphate coating a potassium bicarbonate core | The manufacturing process for Defendant's ANDA Product is alleged to include a drying step that results in granules with a sodium picosulphate layer on a potassium bicarbonate core. | ¶32 | col. 11:24-28 |
'083 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| magnesium oxide coated granules which have a layer of magnesium oxide coated on a core of citric acid | Defendant's ANDA Product is alleged to be a composition that contains granules comprising a layer of magnesium oxide coated on a core of citric acid. | ¶39 | col. 11:8-10 |
| sodium picosulphate coated granules having a spray-coated layer of sodium picosulphate coating a potassium bicarbonate core | Defendant's ANDA Product is alleged to be a composition that contains granules comprising a spray-coated layer of sodium picosulphate on a potassium bicarbonate core. | ¶39 | col. 11:11-14 |
Identified Points of Contention
- Scope Questions: A primary issue for the ’083 Patent will be whether the term "a layer ... coated on a core" reads on the specific structure of the granules in Defendant's proposed product. The dispute may center on whether Defendant's formulation achieves a similar result through a structure that is not technically a "coated core."
- Technical Questions: A key question for the ’338 Patent is whether Defendant’s manufacturing process, as detailed in its ANDA, in fact uses the "spray coating" technique recited in claim 8. The infringement analysis will depend on whether Defendant employs an alternative, non-infringing method to combine the sodium picosulphate and potassium bicarbonate.
V. Key Claim Terms for Construction
Term: "a layer of magnesium oxide coated on a core of citric acid" (’083 Patent, Claim 1)
- Context and Importance: This term defines the fundamental structure of one of the two key granular components. The infringement analysis for the '083 patent will hinge on whether Defendant's product contains granules meeting this structural definition. Practitioners may focus on this term because designing around such specific structural limitations is a common strategy for generic manufacturers.
- Intrinsic Evidence for a Broader Interpretation: The specification's focus is on solving the problem of "inhomogeneity" arising from different particle densities, which might support an interpretation that covers any structure achieving this functional goal, not just a perfect concentric coating ('083 Patent, col. 2:1-11).
- Intrinsic Evidence for a Narrower Interpretation: The detailed description refers to a "crystal core of Citric Acid and a white shell of MgO" and provides an exemplary layer thickness of "5-10 µm," suggesting a distinct, layered structure rather than a simple agglomerate ('083 Patent, col. 11:32-37).
Term: "spray coating" (’338 Patent, Claim 8)
- Context and Importance: This term recites the specific process step for applying the active ingredient. The infringement analysis for the process claims will depend on whether Defendant's manufacturing method falls within the scope of this term.
- Intrinsic Evidence for a Broader Interpretation: The specification sometimes uses the more general phrase "applying (e.g. spraying)," which could suggest that "spray coating" is merely an example of a broader class of "applying" techniques ('338 Patent, col. 2:46-47).
- Intrinsic Evidence for a Narrower Interpretation: Claim 8 itself uses the specific term "spray coating." The description of the invention also details the use of specific equipment like a "tumble coater" to perform this step, which could support a narrower construction limited to the conventional meaning of the term in pharmaceutical manufacturing ('338 Patent, col. 10:35-44).
VI. Other Allegations
- Willful Infringement: While the complaint does not use the term "willful," it requests a finding that this is an "exceptional case" under 35 U.S.C. § 285, which can be predicated on willful conduct (Compl., p. 9, ¶g). The basis for this allegation appears to be Defendant's pre-suit knowledge of the patents, evidenced by its Paragraph IV Notice Letter of March 9, 2017, which explicitly referenced the patents-in-suit (Compl. ¶23-24).
VII. Analyst’s Conclusion: Key Questions for the Case
This case, typical of early-stage ANDA litigation, presents questions whose answers lie within the confidential details of the Defendant's FDA filing. The litigation will likely center on two key issues:
A core issue for the '083 patent will be one of structural identity: does the formulation described in Teva’s ANDA contain the specific two-granule architecture required by the claims, particularly granules with a "layer of magnesium oxide coated on a core of citric acid," or has Teva developed a formulation that avoids this precise structure?
A key evidentiary question for the '338 patent will be one of process equivalence: does the manufacturing process disclosed in Teva's ANDA utilize the "spray coating" method required by the process claims, or does it employ a technically distinct and therefore non-infringing alternative for combining the active ingredient with its carrier?