DCT
2:10-cv-02352
Abbott Laboratories v. Actavis Elizabeth LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Abbott Laboratories (Illinois) and Fournier Laboratories Ireland Ltd. (Ireland)
- Defendant: Actavis Elizabeth LLC (Delaware/New Jersey), Actavis Inc. (Delaware/New Jersey), and Actavis Group hf. (Iceland)
- Plaintiff’s Counsel: Graham Curtin PA
- Case Identification: 2:10-cv-02352, D.N.J., 05/07/2010
- Venue Allegations: Venue is asserted based on the defendants' principal places of business within New Jersey, as well as their persistent and continuous contacts with the district, including the sale of various products.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for generic choline fenofibrate delayed-release capsules constitutes an act of patent infringement.
- Technical Context: The technology concerns novel, photostable salts of fenofibric acid and pharmaceutical formulations designed to improve the bioavailability of this poorly water-soluble, cholesterol-lowering drug.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following the plaintiffs' receipt of a letter from Actavis dated April 5, 2010, which provided notice of Actavis's ANDA filing and included a Paragraph IV certification alleging that the patent-in-suit is invalid and/or would not be infringed. The patent is listed in the FDA's "Orange Book" in connection with Plaintiff's TRILIPIX® product.
Case Timeline
| Date | Event |
|---|---|
| 2002-12-17 | U.S. Patent No. 7,259,186 Priority Date |
| 2007-08-21 | U.S. Patent No. 7,259,186 Issue Date |
| 2010-04-05 | Actavis sends Paragraph IV certification letter to Plaintiffs |
| 2010-05-07 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,259,186 - "Salts of Fenofibric Acid and Pharmaceutical Formulations Thereof"
- Patent Identification: U.S. Patent No. 7,259,186, titled "Salts of Fenofibric Acid and Pharmaceutical Formulations Thereof," issued on August 21, 2007 (’186 Patent).
The Invention Explained
- Problem Addressed: The patent addresses the technical challenge that fenofibrate, a widely used lipid-regulating agent, is nearly insoluble in water, which compromises its in vivo bioavailability after oral administration (’186 Patent, col. 1:56-61). Furthermore, attempts to improve dissolution by making the drug amorphous are thwarted by its tendency to recrystallize into a less bioavailable form (’186 Patent, col. 2:3-6).
- The Patented Solution: The invention discloses two primary solutions: first, novel salts of fenofibric acid (the active metabolite of fenofibrate) that are inherently more photostable than other known forms, and second, pharmaceutical formulations where fenofibric acid or its salts are embedded as a molecular dispersion within an enteric binder, which prevents recrystallization and ensures release in the intestine for better absorption (’186 Patent, Abstract; col. 2:7-18).
- Technical Importance: This approach provided a method for creating more stable and effective oral dosage forms of a commercially significant drug, overcoming long-standing formulation challenges related to poor solubility (’186 Patent, col. 1:35-37; Compl. ¶19).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, noting that Defendant’s notice letter did not contest infringement of claims 1 and 2 (Compl. ¶¶28, 31). The asserted independent claims appear to be Claim 1 (composition of matter) and Claim 8 (formulation).
- Independent Claim 1:
- A salt of fenofibric acid
- selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine.
- Independent Claim 8:
- A pharmaceutical formulation in a form of a molecular dispersion comprising:
- a salt of fenofibric acid selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine; and
- a binder component comprising at least one enteric binder.
- The complaint reserves the right to assert infringement of other claims of the ’186 Patent (Compl. ¶31).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the generic drug product for which Actavis filed ANDA No. 200920, identified as "choline fenofibrate delayed-release capsules in 45 mg and 135 mg dosages" ("Actavis' DR Capsules") (Compl. ¶23).
Functionality and Market Context
- The accused product is a generic version of Plaintiffs' "highly successful TRILIPIX®" drug, intended for use as a lipid and cholesterol-lowering agent (Compl. ¶¶1, 19). The filing of the ANDA is a request for FDA approval to commercially manufacture and sell this generic drug in the U.S. prior to the expiration of the ’186 Patent (Compl. ¶¶1, 26).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint pleads infringement under 35 U.S.C. § 271(e)(2), where the act of filing an ANDA for a drug claimed in a patent is a statutory act of infringement (Compl. ¶30). The complaint alleges that Actavis's notice letter did not contest infringement of claims 1 and 2 (Compl. ¶28).
U.S. Patent No. 7,259,186 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A salt of fenofibric acid | The accused product is identified as "choline fenofibrate." | ¶23 | col. 30:1-2 |
| selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine. | The accused product is specifically the choline salt of fenofibric acid. | ¶23 | col. 30:2-8 |
U.S. Patent No. 7,259,186 Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation in a form of a molecular dispersion comprising: | The accused product is a pharmaceutical formulation. The "molecular dispersion" characteristic is an asserted technical attribute. | ¶23 | col. 30:15-17 |
| i. a salt of fenofibric acid selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine; and | The accused product is identified as "choline fenofibrate." | ¶23 | col. 30:18-21 |
| ii. a binder component comprising at least one enteric binder. | The accused product is described as "delayed-release capsules," a function achieved by enteric binders as taught in the patent. | ¶23 | col. 30:21-22 |
- Identified Points of Contention:
- Technical Questions: While the complaint alleges the accused product is "choline fenofibrate," which would read on the composition of matter claims, a key question for the formulation claims (e.g., Claim 8) is whether the accused product is in the form of a "molecular dispersion" and whether its "delayed-release" functionality is achieved using "at least one enteric binder" as required by the claim. The complaint does not provide specific factual evidence on these technical details of the accused formulation.
- Scope Questions: The dispute may center on the proper construction of the formulation claim limitations. Actavis's assertion of non-infringement for claims 3-15 suggests its defense may rely on arguing that its formulation does not meet the more specific limitations of the dependent claims, and potentially does not meet all limitations of the independent formulation claim either (Compl. ¶27).
V. Key Claim Terms for Construction
The Term: "molecular dispersion" (preamble, Claim 8)
Context and Importance: This term appears in the preamble of independent claim 8 and defines the overall structure of the claimed formulation. The infringement analysis for the formulation claims will depend on whether Actavis's generic product is properly characterized as a "molecular dispersion." Practitioners may focus on this term because if the accused product achieves its therapeutic effect without forming such a dispersion, it may avoid infringement of claim 8 and its dependents.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party seeking a broader definition may argue that the patent does not provide a single, explicit definition, and the term should be given its plain and ordinary meaning in the context of pharmaceutical formulation.
- Evidence for a Narrower Interpretation: The specification describes a "molecular dispersion" as a system where the drug is "homogeneously dispersed in the binder component," is "free of interfaces," and notes that it is possible to speak of a "solid solution" (’186 Patent, col. 9:5-14, col. 9:48-49). This language, which contrasts with crystalline forms, may support a narrower construction requiring a high degree of molecular-level mixing.
The Term: "enteric binder" (Claim 8)
Context and Importance: This term defines the key functional excipient in the claimed formulation. The accused product is described as "delayed-release," a property that enteric binders provide. The central infringement question for claim 8 is whether the specific delayed-release agent used by Actavis falls within the scope of this term.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines an "enteric polymer" (a type of enteric binder) functionally as "a polymer which is preferentially soluble in the less acid environment of the intestine relative to the more acid environment of the stomach" (’186 Patent, col. 6:35-38). A plaintiff may argue that any polymer meeting this functional definition infringes.
- Evidence for a Narrower Interpretation: The specification provides an extensive list of exemplary enteric polymers, including specific cellulose derivatives (e.g., cellulose acetate phthalate) and acrylic copolymers (e.g., Eudragit®) (’186 Patent, col. 6:49-58, col. 7:1-13). A defendant could argue that the term should be construed as being limited to the classes of polymers expressly disclosed as embodiments.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that the various Actavis entities "participated in, contributed to, aided, abetted and/or induced the submissions to the U.S. Food and Drug Administration ('FDA') of the Actavis ANDA" (Compl. ¶14). This allegation primarily supports holding the parent companies liable for the statutory infringement committed by the ANDA filer.
- Willful Infringement: The complaint alleges that Actavis acted "without a reasonable basis or a good-faith belief that it would not be liable for infringing the '186 patent," which is the standard for willfulness (Compl. ¶32). This allegation is based on Actavis's pre-suit knowledge of the patent, as evidenced by its April 5, 2010 notice letter (Compl. ¶26).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of validity: Actavis's Paragraph IV certification asserts that the ’186 Patent is invalid (Compl. ¶27). While the complaint does not specify the invalidity grounds, the core of the litigation will likely involve Actavis attempting to prove by clear and convincing evidence that the asserted claims are invalid, for instance as obvious over prior art related to formulating poorly soluble drugs.
- A key evidentiary question will be one of technical infringement: Although Actavis reportedly did not contest infringement of the composition claims, the formulation claims remain in dispute. A dispositive question will be whether the specific formulation in Actavis's ANDA constitutes a "molecular dispersion" containing an "enteric binder," as those terms are construed by the court.
- A secondary question will be claim construction: The outcome of the infringement analysis for the formulation claims will hinge on the court's interpretation of "molecular dispersion." The case may turn on whether the court adopts a narrow, structurally-specific definition based on the patent's embodiments or a broader, more functional definition.