DCT
0:18-cv-60846
UCB Inc v. Apotex Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: UCB, Inc. (Delaware) and UCB Biopharma SPRL (Belgium)
- Defendant: Apotex Inc. (Canada)
- Plaintiff’s Counsel: White & Case LLP
- Case Identification: 0:18-cv-60846, S.D. Fla., 04/17/2018
- Venue Allegations: Venue is alleged based on Defendant’s business activities and revenue derived from Florida, its maintenance of a wholly-owned subsidiary in the state for regulatory activities, and its stated intent to market the accused product in Florida.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic levocetirizine solution infringes a patent covering the formulation of the branded drug, Xyzal Allergy 24HR®.
- Technical Context: The dispute concerns liquid pharmaceutical formulations for antihistamines, specifically focusing on the preservative system used to ensure stability and prevent microbial contamination.
- Key Procedural History: The lawsuit was triggered by Defendant’s March 5, 2018 Paragraph IV certification letter, which asserted that the patent-in-suit is invalid, unenforceable, or would not be infringed by its proposed generic product. Subsequent to the filing of this complaint, the patent-in-suit was subject to an Inter Partes Review (IPR) proceeding (IPR2019-00400), which concluded on August 16, 2021, with a determination that claims 1-11 were patentable. This IPR outcome may significantly influence arguments regarding the patent's validity.
Case Timeline
| Date | Event |
|---|---|
| 2004-07-14 | ’194 Patent Priority Date |
| 2014-01-21 | ’194 Patent Issue Date |
| 2018-03-05 | Defendant sends Paragraph IV Certification Letter to Plaintiff |
| 2018-04-17 | Complaint Filing Date |
| 2018-12-13 | Inter Partes Review IPR2019-00400 Filed Against ’194 Patent |
| 2021-08-16 | Inter Partes Review Certificate Issued, Confirming Patentability of Claims 1-11 |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,633,194 - "Pharmaceutical Composition of Piperazine Derivatives," Issued January 21, 2014
The Invention Explained
- Problem Addressed: The patent addresses the risk of microbial contamination in liquid pharmaceutical products, such as oral solutions and drops, after their containers are opened and used repeatedly over time (’194 Patent, col. 1:41-50).
- The Patented Solution: The invention is based on the "unexpected recognition" that certain active ingredients—piperazine derivatives like levocetirizine—possess their own preservative effect in aqueous solutions (’194 Patent, col. 1:51-56). This allows for the creation of a stable liquid formulation that resists microbial contamination while using a "reduced amount of preservatives" compared to what would normally be required (’194 Patent, col. 1:56-61).
- Technical Importance: Reducing the concentration of conventional preservatives, such as parabens, can lower the risk of allergic reactions in sensitive patients and can simplify the manufacturing process by avoiding the need to solubilize large amounts of preservatives (’194 Patent, col. 5:29-38).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-12 of the ’194 patent (Compl. ¶21).
- Independent Claim 1:
- A liquid pharmaceutical composition comprising (i) levocetirizine or a pharmaceutically acceptable salt of levocetirizine, and
- (ii) a preservative mixture consisting essentially of a mixture of methyl parahydroxybenzoate and propyl parahydroxybenzoate in a ratio of 9/1 expressed in weight,
- said mixture being present in an amount of more than 0 and up to 0.75 mg/ml of the composition,
- wherein said composition is substantially free of bacteria.
- The complaint does not specify which dependent claims may be asserted but reserves the right to do so.
III. The Accused Instrumentality
Product Identification
- Defendant’s proposed generic version of levocetirizine dihydrochloride solution, 2.5mg/5ml (0.5mg/ml), for which it seeks FDA approval via ANDA No. 211528 (Compl. ¶11).
Functionality and Market Context
- The accused product is an antihistamine intended to be a generic substitute for the branded drug Xyzal Allergy 24HR® (Compl. ¶1, ¶13). The complaint alleges that the Defendant's ANDA relies on the Xyzal Allergy 24HR® New Drug Application and contains data to demonstrate the bioequivalence of its product to the branded version (Compl. ¶12). The infringement alleged is the technical act of filing the ANDA under 35 U.S.C. § 271(e)(2), which seeks approval to market this generic product prior to the expiration of the ’194 Patent (Compl. ¶1, ¶20).
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart or specific factual allegations mapping elements of the accused product to the patent claims. The infringement theory is predicated on the allegation that the Defendant’s product, as a proposed bioequivalent generic of the Orange Book-listed Xyzal Allergy 24HR®, will necessarily have the same formulation and thus infringe the ’194 patent that covers it (Compl. ¶10, ¶12, ¶21).
’194 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A liquid pharmaceutical composition comprising (i) levocetirizine or a pharmaceutically acceptable salt of levocetirizine... | Defendant's ANDA describes a "levocetirizine dihydrochloride solution," a pharmaceutically acceptable salt of levocetirizine. | ¶11 | col. 2:34-36 |
| ...and (ii) a preservative mixture consisting essentially of a mixture of methyl parahydroxybenzoate and propyl parahydroxybenzoate in a ratio of 9/1 expressed in weight... | The complaint's infringement theory implies that the ANDA product, as a generic version of the drug covered by the patent, contains this specific preservative mixture. | ¶1, ¶21 | col. 3:45-49 |
| ...said mixture being present in an amount of more than 0 and up to 0.75 mg/ml of the composition... | The infringement theory implies the ANDA product contains the claimed concentration of the preservative mixture. Defendant's Paragraph IV letter contests this. | ¶14, ¶21 | col. 8:1-3 |
| ...wherein said composition is substantially free of bacteria. | The infringement theory implies the ANDA product, to be bioequivalent and marketable, must meet the stability criteria taught by the patent and required by the claim. | ¶12, ¶21 | col. 8:1-3 |
- Identified Points of Contention:
- Factual Question: The central dispute will be factual: does the specific formulation detailed in Defendant’s confidential ANDA actually fall within the scope of the asserted claims? Defendant’s Paragraph IV letter suggests a non-infringement defense, raising the possibility that its formulation may have been "designed around" the patent, for instance by using a different preservative, a different ratio of preservatives, or no preservative system of the type claimed (Compl. ¶14).
- Scope Questions: What is the scope of "consisting essentially of"? The parties may dispute whether any additional, unlisted excipients in Defendant's formulation materially alter the "basic and novel" properties of the claimed invention, thereby avoiding infringement.
No probative visual evidence provided in complaint.
V. Key Claim Terms for Construction
- The Term: "consisting essentially of" (Claim 1)
- Context and Importance: This transitional phrase is critical for defining the boundaries of the claimed "preservative mixture." Its construction will determine whether the presence of any other components in Defendant's preservative system, beyond the recited methyl and propyl parahydroxybenzoates, would allow the accused product to avoid infringement. Practitioners may focus on this term because a "design-around" strategy could involve adding an ingredient that Defendant argues materially changes the preservative mixture's characteristics.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A patentee might argue the phrase permits the presence of other components so long as they do not materially affect the basic and novel properties of the invention—namely, the ability to preserve the solution with a reduced amount of parabens due to levocetirizine's inherent properties (’194 Patent, col. 1:51-61).
- Evidence for a Narrower Interpretation: A defendant could argue that the "consisting essentially of" language is narrow and that the mixture must contain only the two specified parabens in their 9:1 ratio for preservative purposes. The claim recites a "preservative mixture consisting essentially of a mixture," which could be interpreted to mean that the components responsible for preservation are limited to those listed (’194 Patent, col. 8:8-12).
VI. Other Allegations
- Indirect Infringement: The complaint includes boilerplate allegations of induced and contributory infringement under 35 U.S.C. § 271(b) and (c) (Compl. ¶21). However, it does not plead specific facts to support the requisite knowledge and intent beyond the act of filing the ANDA itself, which is the basis for the primary infringement count under § 271(e)(2).
- Willful Infringement: The complaint requests attorneys' fees for an "exceptional case" under 35 U.S.C. § 285 (Compl. ¶24). The factual basis for this appears to be that Defendant proceeded with its ANDA filing despite having knowledge of the ’194 patent. This pre-suit knowledge is established by Defendant's own Paragraph IV certification letter dated March 5, 2018 (Compl. ¶14).
VII. Analyst’s Conclusion: Key Questions for the Case
A central evidentiary question will be one of factual correspondence: Does the formulation described in Defendant's confidential ANDA contain a preservative mixture "consisting essentially of" methyl and propyl parahydroxybenzoate in a 9:1 ratio and within the claimed concentration range, or did Defendant successfully "design around" the claim?
A key legal question will be one of validity: Although claims 1-11 survived an IPR challenge, can Defendant present new prior art or arguments to prove by clear and convincing evidence that the claimed formulation was obvious, directly challenging the patent's assertion that the preservative effect of levocetirizine enabling lower paraben use was "unexpected" and "surprising"?
The case may also hinge on a question of claim construction: How will the court construe the term "consisting essentially of"? The outcome will define the permissible boundaries of Defendant's formulation and could be dispositive of the infringement analysis.