DCT
2:10-cv-03241
Abbott Laboratories v. Watson Laboratories
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Abbott Laboratories (Illinois) and Fournier Laboratories Ireland Ltd. (Ireland)
- Defendant: Watson Laboratories, Inc.-Florida (Florida); Watson Pharma, Inc. (Delaware); Watson Pharmaceuticals, Inc. (Nevada)
- Plaintiff’s Counsel: Coffey Burlington, P.L.
- Case Identification: 2:10-cv-03241, S.D. Fla., 04/29/2010
- Venue Allegations: Venue is alleged based on Defendant Watson Laboratories' incorporation in Florida, as well as the collective Defendants' business operations, sales, and distribution activities within the judicial district.
- Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the cholesterol drug TRILIPIX® constitutes an act of infringement of a patent covering specific salts and formulations of fenofibric acid.
- Technical Context: The technology involves pharmaceutical chemistry, specifically creating novel, stable salt forms and formulations of fenofibric acid to improve its bioavailability for use as a lipid-lowering agent.
- Key Procedural History: This action was triggered by Defendants' submission of ANDA No. 200564 to the U.S. Food and Drug Administration (FDA) and their subsequent notification to Plaintiffs via a letter dated March 12, 2010. In that letter, Defendants provided a Paragraph IV certification, asserting that certain claims of the patent-in-suit are invalid or would not be infringed. The patent-in-suit is listed in the FDA's "Orange Book" as being associated with Plaintiffs' TRILIPIX® product.
Case Timeline
| Date | Event |
|---|---|
| 2002-12-17 | Earliest Priority Date for ’186 Patent |
| 2007-08-21 | U.S. Patent No. 7,259,186 Issued |
| 2010-03-12 | Date of Defendant's Letter Notifying Plaintiffs of ANDA Filing |
| 2010-04-29 | 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"
- Issued: August 21, 2007
The Invention Explained
- Problem Addressed: The patent's background describes that fenofibrate, a known lipid-regulating agent, is nearly insoluble in water. This poor solubility can negatively impact its in vivo performance and bioavailability. Furthermore, attempts to use amorphous (non-crystalline) forms of the drug to improve release can be undermined by recrystallization. (’186 Patent, col. 1:56-58, col. 2:1-6).
- The Patented Solution: The invention addresses this problem in two ways. First, it discloses novel, photostable salts of fenofibric acid (the active metabolite of fenofibrate). Second, it describes pharmaceutical formulations where fenofibric acid or its salts are embedded as a "molecular dispersion" within an enteric binder, a structure designed to prevent recrystallization and ensure the drug is released in the intestine for better absorption. (’186 Patent, Abstract; col. 2:7-18).
- Technical Importance: By creating more stable and bioavailable forms of a known therapeutic agent, the invention offers a way to improve the consistency and efficacy of treatment for patients with high cholesterol and triglyceride levels. (’186 Patent, col. 1:34-36).
Key Claims at a Glance
- The complaint alleges infringement of "one or more claims" and specifically notes that Defendants' pre-suit notification letter did not contest infringement of claims 1 and 2 (Compl. ¶35, ¶38). The asserted independent claims appear to be at least Claim 1 and Claim 8.
- 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:
- i. a salt of fenofibric acid selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine; and
- ii. a binder component comprising at least one enteric binder.
- The complaint's general allegation of infringing "one or more claims" reserves the right to assert additional claims, including dependent claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants' proposed "choline fenofibrate delayed-release capsules in 45 mg and 135 mg dosages" ("Watson's DR Capsules"), for which they seek FDA approval via ANDA No. 200564 (Compl. ¶32).
Functionality and Market Context
Watson's DR Capsules are intended to be generic versions of Plaintiffs' "highly successful TRILIPIX®" drug products (Compl. ¶1). The act of infringement alleged is the submission of the ANDA seeking approval to manufacture and sell these generic capsules prior to the expiration of the ’186 Patent, an act defined as infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶37). The accused product is designed to be a lipid and cholesterol-lowering agent for treating adults with increased triglyceride levels (Compl. ¶28).
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 characteristics of the product described in Defendants' ANDA filing.
’186 Patent Infringement Allegations (Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A salt of fenofibric acid | The accused product is identified as containing "choline fenofibrate." Fenofibrate is a salt form of fenofibric acid. | ¶32 | col. 35:6-7 |
| selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine. | The accused product is specifically identified as "choline fenofibrate," which is the choline salt of fenofibric acid, an explicitly listed member of the claimed group. | ¶32 | col. 35:7-10 |
’186 Patent Infringement Allegations (Claim 8)
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation in a form of a molecular dispersion | The complaint does not provide sufficient detail for analysis of this element. It does not allege specific facts regarding the physical form of the drug within the proposed generic formulation. | N/A | col. 9:3-10 |
| comprising: i. a salt of fenofibric acid selected from the group consisting of choline... | The accused product is identified as containing "choline fenofibrate," which is the choline salt of fenofibric acid. | ¶32 | col. 35:19-22 |
| and ii. a binder component comprising at least one enteric binder. | The complaint does not provide sufficient detail for analysis of this element, though it notes the accused product is a "delayed-release" capsule, a function often achieved with enteric binders. | ¶32 | col. 5:34-46 |
Identified Points of Contention
- Validity vs. Infringement: The complaint states that Defendants' pre-suit letter did not contest infringement of claims 1 and 2 (Compl. ¶35). This suggests that for the composition claims, the primary dispute may center on validity (i.e., whether the claimed salts are obvious or anticipated by prior art) rather than infringement.
- Technical Questions (Formulation Claims): For formulation claims like Claim 8, a key question will be factual and technical: does the formulation described in the confidential section of Watson's ANDA meet the "molecular dispersion" and "enteric binder" limitations? The complaint does not provide the specific facts Plaintiffs will use to prove these elements are met, which will likely depend on discovery of the ANDA's contents.
V. Key Claim Terms for Construction
- The Term: "molecular dispersion"
- Context and Importance: This term is a critical limitation in independent claim 8. The infringement analysis for the formulation claims will hinge on whether Defendants' proposed product creates a "molecular dispersion" or some other physical form (e.g., a crystalline mixture). Practitioners may focus on this term because it defines the specific physical state of the drug within the formulation, which is central to the patent's claimed solution for enhancing bioavailability.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the term as systems where the drug is "homogeneously dispersed in the binder component" and is "free of interfaces" (’186 Patent, col. 9:5-10). This language could support a construction covering a range of highly uniform, amorphous drug-polymer systems.
- Evidence for a Narrower Interpretation: The patent also refers to the state as a "solid solution" and notes that a molecular dispersion can be identified by the absence of an endothermic melting peak in a DSC analysis, which is characteristic of crystalline material (’186 Patent, col. 5:49-51; col. 9:36-39). This could support a narrower construction requiring a complete, solid-state dissolution of the drug into the binder, a higher standard than a simple amorphous mixture.
VI. Other Allegations
- Indirect Infringement: The complaint includes a general allegation of inducement (Compl. ¶14). In an ANDA case, the primary act of infringement is the statutory one under § 271(e)(2)—the submission of the ANDA itself for a drug claimed in a patent (Compl. ¶37).
- Willful Infringement: The complaint alleges that Defendants acted without a good-faith belief that they would not be liable for infringement (Compl. ¶39). This is based on Defendants' alleged pre-suit knowledge of the ’186 Patent, evidenced by its listing in the FDA's Orange Book for TRILIPIX® and by the fact that Defendants sent a Paragraph IV notification letter concerning the patent (Compl. ¶31, ¶33-34).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of validity: As Defendants have asserted invalidity in their Paragraph IV certification (Compl. ¶34), a central question will be whether the claimed salt compositions, such as choline fenofibrate, were obvious in light of prior art related to fenofibric acid and known salt-formation techniques.
- A second issue will be a technical-factual dispute regarding the formulation claims: Does the specific formulation detailed in the confidential portions of Defendants' ANDA create a "molecular dispersion" as that term is construed? The outcome will depend on evidence concerning the physical chemistry of Defendants' proposed product.
- Finally, the case presents a quintessential Hatch-Waxman remedy question: The core relief sought is not damages for past sales but an order preventing the FDA from approving Defendants' ANDA until after the ’186 Patent expires, thereby preserving the patent-protected market exclusivity for TRILIPIX® (Compl., Prayer ¶(b)).