DCT
0:12-cv-60706
Apotex Inc v. UCB Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Apotex, Inc. (Canadian) and Apotex Corp. (Delaware)
- Defendant: UCB, Inc. (Delaware), Schwarz Pharma Inc. (Delaware), and Kremers Urban Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Broad and Cassel; Katten Muchin Rosenman LLP
- Case Identification: Apotex, Inc. v. UCB, Inc., 0:12-cv-60706, S.D. Fla., 04/20/2012
- Venue Allegations: Venue is alleged to be proper because Defendants committed acts of patent infringement, a substantial part of the events giving rise to the claim occurred in the district, and Defendants are subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendants' hypertension medications are manufactured using a patented process that converts unstable moexipril hydrochloride into a more stable moexipril magnesium form.
- Technical Context: The technology relates to pharmaceutical formulation, specifically a chemical process for improving the stability of moexipril, an Angiotensin Converting Enzyme (ACE) inhibitor drug.
- Key Procedural History: The complaint notes that Apotex Corp. is the exclusive licensee of the patent-in-suit. It also details a series of corporate acquisitions and mergers through which it alleges the named Defendants are successors-in-interest and responsible for the accused manufacturing activities.
Case Timeline
| Date | Event |
|---|---|
| 2000-04-05 | '556 Patent Priority Date |
| 2004-07-27 | U.S. Patent No. 6,767,556 Issued |
| 2012-04-20 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,767,556 - Pharmaceutical Compositions Comprising Moexipril Magnesium
- Patent Identification: U.S. Patent No. 6,767,556 (“the ’556 Patent”), titled “Pharmaceutical Compositions Comprising Moexipril Magnesium,” issued on July 27, 2004.
The Invention Explained
- Problem Addressed: The patent’s background section describes that moexipril, an ACE inhibitor, is susceptible to degradation, rendering it unstable for pharmaceutical use. It notes that prior art methods for stabilization, such as simply mixing the active drug with an alkaline compound, were difficult to control, required large amounts of stabilizing agents, and resulted in products with an uncertain final chemical composition (’556 Patent, col. 2:22-40).
- The Patented Solution: The invention claims a process that solves this stability problem not by merely mixing, but by actively converting the unstable moexipril (or its acid salt, moexipril hydrochloride) into a more stable form, moexipril magnesium. This is achieved by reacting the starting drug with an alkaline magnesium compound in the presence of a solvent, with the specific goal of converting "most or all" of the unstable form to the stable form (’556 Patent, Abstract; col. 2:53-57). This creates a final product with a different, more stable primary ingredient, rather than a simple stabilized mixture.
- Technical Importance: This process offered a method to produce a stable, solid dosage form of moexipril with a more predictable and controlled composition, overcoming prior art limitations (’556 Patent, col. 2:41-44).
Key Claims at a Glance
- The complaint asserts claims 1-15 of the ’556 Patent (Compl. ¶¶ 29, 31). Independent claim 1 is the primary process claim.
- The essential elements of independent claim 1 include:
- A process of making a solid pharmaceutical composition comprising moexipril magnesium;
- comprising the step of reacting moexipril or an acid addition salt thereof;
- with an alkaline magnesium compound;
- in a controlled manner in the presence of a sufficient amount of solvent for a predetermined amount of time;
- so as to convert greater then 80% of the moexipril or moexipril acid addition salt to moexipril magnesium.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are pharmaceutical products sold under the brand names Univasc® and Uniretic®, including versions manufactured or supplied by various entities under the Defendants' control (collectively, the "Accused Univasc® Products" and "Accused Uniretic® Products") (Compl. ¶¶ 21, 26).
Functionality and Market Context
- The complaint alleges that the accused products are made by an infringing process. The central allegation is not based on direct observation of the manufacturing process, which is "not publicly available," but on an inference drawn from the final products' composition (Compl. ¶18).
- Plaintiff alleges that while the product labels for Univasc® and Uniretic® list the starting ingredients of the patented process (moexipril hydrochloride and magnesium oxide), testing of the final products "demonstrates that it contains moexipril magnesium" (Compl. ¶¶ 18, 19, 23). The presence of this resulting compound is presented as evidence that the patented conversion process must have been used. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a formal claim chart. The infringement theory is based on inferring the use of the patented process from the composition of the final product.
'556 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A process of making a solid pharmaceutical composition comprising moexipril magnesium... | Plaintiff alleges that testing of the accused Univasc® and Uniretic® products demonstrates they contain moexipril magnesium, the resulting compound of the claimed process. | ¶18, ¶19 | col. 5:24-31 |
| said process comprising the step of reacting moexipril or an acid addition salt thereof... | The labels of the accused products allegedly list "moexipril hydrochloride," an acid addition salt of moexipril, as an ingredient. | ¶18, ¶23 | col. 2:53-57 |
| with an alkaline magnesium compound... | The labels of the accused products allegedly list "magnesium oxide," an alkaline magnesium compound, as an ingredient. | ¶18, ¶23 | col. 3:1-6 |
| in a controlled manner in the presence of a sufficient amount of solvent...so as to convert greater then 80% of the moexipril or moexipril acid addition salt to moexipril magnesium. | Plaintiff alleges that the presence of moexipril magnesium in the final product is an "indication" that this conversion process was used. The complaint states it will rely on discovery to confirm the exact process. | ¶18, ¶22, ¶27 | col. 5:29-31 |
- Identified Points of Contention:
- Evidentiary Question: The complaint acknowledges that the Defendants' exact manufacturing process is not public and that Plaintiff is not aware of an analytical technique to "definitively establish" infringement from the final product alone (Compl. ¶¶ 22, 27). A central issue will be whether the presence of moexipril magnesium in the accused products is sufficient to prove, by a preponderance of the evidence, that the specific, multi-step process recited in claim 1 was actually performed.
- Quantitative Question: Claim 1 requires converting "greater then 80%" of the starting material. The complaint alleges the accused products "contain" moexipril magnesium but provides no data on the quantity or conversion percentage (Compl. ¶18). A significant point of contention may be whether Plaintiff can prove, through discovery, that the accused process meets this specific quantitative threshold.
V. Key Claim Terms for Construction
The Term: "reacting"
Context and Importance: This term is critical for distinguishing the claimed invention from prior art methods that involved merely mixing a drug with a stabilizer (’556 Patent, col. 2:33-40). The patent frames its contribution as an active conversion, not passive stabilization. Practitioners may focus on this term to dispute whether any incidental chemical conversion that occurs during a standard manufacturing process constitutes "reacting" as claimed.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the process as one that will "convert most or all" of the drug to its magnesium salt, suggesting the outcome (conversion) is the key aspect of the reaction (’556 Patent, col. 2:55-57).
- Evidence for a Narrower Interpretation: The specification details specific process steps, such as wet granulation and the use of solvents for a set time, to achieve the reaction, suggesting "reacting" is not just an outcome but requires performing these specific types of process steps (’556 Patent, col. 3:40-51).
The Term: "in a controlled manner"
Context and Importance: This limitation was included to distinguish the invention from prior art processes that were "difficult to precisely control" (’556 Patent, col. 2:33-34). The definition will be key to determining the scope of the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that any modern, replicable pharmaceutical manufacturing process that yields a consistent product is inherently "controlled."
- Evidence for a Narrower Interpretation: The patent itself describes the "controlled manner" as being "in the presence of a sufficient amount of solvent for a predetermined amount of time" to achieve a high conversion rate, linking the term to specific, deliberate process parameters (’556 Patent, col. 5:27-31).
VI. Other Allegations
- Willful Infringement: The complaint does not contain allegations of willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of proof by inference: As the plaintiff has built its case on analyzing the defendants' final products rather than observing their process, a key question for the court will be whether the presence of moexipril magnesium is sufficient circumstantial evidence to prove that the defendants necessarily used the specific patented process, including its limitations regarding solvents, time, and control.
- The case will also turn on a question of quantitative infringement: Can the plaintiff, through discovery, produce evidence to satisfy the explicit claim requirement that "greater then 80%" of the moexipril hydrochloride was converted? Failure to prove this specific numerical threshold would be fatal to the infringement claim, even if some lesser conversion is shown to have occurred.