DCT
1:03-cv-10167
Teva Pharma v. Pfizer Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Teva Pharmaceuticals USA, Inc. (Delaware)
- Defendant: Pfizer Inc. (Delaware)
- Plaintiff’s Counsel: Sherin and Lodgen LLP; Kenyon & Kenyon
- Case Identification: 1:03-cv-10167, D. Mass., 01/24/2003
- Venue Allegations: Venue is alleged to be proper in the District of Massachusetts because Defendant Pfizer maintains a regular and established place of business in Cambridge, Massachusetts, and sells the relevant drug product in the state.
- Core Dispute: Plaintiff seeks a declaratory judgment that its generic sertraline hydrochloride product does not infringe U.S. Patent No. 5,248,699, and that the patent is invalid.
- Technical Context: The lawsuit concerns a specific crystalline polymorph of sertraline hydrochloride, the active pharmaceutical ingredient in the widely-prescribed antidepressant drug Zoloft®.
- Key Procedural History: This is a declaratory judgment action arising under the Hatch-Waxman Act. Plaintiff Teva filed an Abbreviated New Drug Application (ANDA) with a "Paragraph IV certification," asserting that Defendant Pfizer's patent is invalid or not infringed. Pfizer received notice of the ANDA but did not file an infringement suit within the statutory 45-day window, prompting Teva to file this action to resolve the controversy and clear a path for its generic product. The complaint notes Pfizer has previously sued other generic manufacturers, including Ivax Corp., over the same patent.
Case Timeline
| Date | Event |
|---|---|
| 1992-08-13 | U.S. Patent No. 5,248,699 Priority Date |
| 1993-09-28 | U.S. Patent No. 5,248,699 Issue Date |
| 2002-01-01 | Teva submitted its ANDA (during 2002) |
| 2002-11-06 | Pfizer received notice of Teva's Paragraph IV certification |
| 2003-01-24 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,248,699 - "Sertraline Polymorph"
- Patent Identification: U.S. Patent No. 5,248,699, "Sertraline Polymorph", issued September 28, 1993 (the "’699 Patent").
The Invention Explained
- Problem Addressed: The patent’s background section notes that while the synthesis of sertraline hydrochloride was known, prior art did not describe specific, distinct crystalline forms (polymorphs) of the compound. Different polymorphs of a drug can have different physical properties, such as stability and solubility, which are critical for manufacturing a consistent and effective pharmaceutical product ('699 Patent, col. 1:46-54).
- The Patented Solution: The invention discloses the discovery of five new polymorphic forms of sertraline hydrochloride, and specifically claims one designated "Form I" ('699 Patent, col. 1:35-39). This Form I is described as having the greatest stability, which is a highly desirable characteristic for an active pharmaceutical ingredient ('699 Patent, col. 1:40-42). The patent defines Form I by its unique analytical characteristics, including its X-ray powder diffraction (XRPD) pattern, as illustrated in Figure 1, and its molecular structure, shown in Figure 3 ('699 Patent, col. 2:62-68; FIG. 1, FIG. 3).
- Technical Importance: Identifying and isolating a thermodynamically stable polymorph of a drug is a critical step in pharmaceutical development, as it ensures product uniformity, predictable performance, and long-term shelf life.
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement and invalidity with respect to all claims of the patent (Compl. ¶¶ 26-27). Independent claim 1 is the primary composition of matter claim.
- Independent Claim 1:
- A crystalline polymorph of the hydrochloride salt of (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
- that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2θ at approximately 7.1, 12.7, 14.1, 15.3, 15.7, 21.2 23.4 and 26.3.
III. The Accused Instrumentality
Product Identification
- Teva’s generic sertraline hydrochloride tablets, as described in its Abbreviated New Drug Application (ANDA) No. 76-465 (Compl. ¶11).
Functionality and Market Context
- The accused product is a generic version of Pfizer’s Zoloft® tablets, intended for use as an antidepressant (Compl. ¶¶ 4, 11). The central technical feature at issue is the specific crystalline form of the active ingredient, sertraline hydrochloride. By filing for a declaratory judgment of non-infringement, Teva implicitly alleges that the crystalline form of sertraline hydrochloride in its product is different from the Form I polymorph claimed in the ’699 Patent (Compl. ¶26).
IV. Analysis of Infringement Allegations
As this is a complaint for declaratory judgment of non-infringement, the allegations are framed to assert that the accused product lacks the features required by the patent claims. The complaint itself does not provide a detailed element-by-element analysis or a claim chart.
’699 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A crystalline polymorph of the hydrochloride salt of (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine... | Teva’s product contains sertraline hydrochloride, but Teva alleges it is not the claimed polymorph. | ¶26 | col. 13:51-54 |
| ...that exhibits an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2θ at approximately 7.1, 12.7, 14.1, 15.3, 15.7, 21.2 23.4 and 26.3. | Teva’s allegation of non-infringement implies its product does not have an XRPD pattern with peaks at these specific locations. Figure 1 of the patent provides the X-ray powder diffraction pattern that defines the claimed Form I polymorph, showing characteristic peaks at specific 2-theta angles. | ¶26 | col. 13:55-58; FIG. 1 |
Identified Points of Contention
- Scope Questions: The dispute will likely focus on the scope of the term "approximately" as it modifies the list of XRPD peak locations. The court will need to determine how much deviation from the enumerated 2θ values is permitted while still falling within the claim’s scope.
- Technical Questions: A central evidentiary question will be whether the XRPD pattern of Teva's generic product is measurably different from the pattern of Form I as claimed in the ’699 Patent. This will involve a direct comparison of analytical data and expert testimony on the significance of any observed differences between the polymorphs.
V. Key Claim Terms for Construction
- The Term: "approximately"
- Context and Importance: This term, appearing in Claim 1, governs how closely the XRPD peaks of an accused product must match the eight specific values listed in the claim. The entire infringement analysis may depend on whether the variance in Teva's product falls inside or outside the boundary set by this term. Practitioners may focus on this term because its construction will define the literal scope of the composition claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent’s use of the word "approximately" without further definition could support an interpretation that allows for normal, expected experimental variation inherent in XRPD analysis, giving the claim a degree of flexibility ('699 Patent, col. 13:57).
- Evidence for a Narrower Interpretation: The patent distinguishes the claimed Form I from four other polymorphs (Forms II-V) based on their distinct XRPD patterns ('699 Patent, col. 6:5-15). Pfizer may argue that "approximately" must be construed narrowly enough to exclude these other disclosed-but-unclaimed forms, suggesting the eight listed peak locations are critical identifiers that do not permit significant deviation.
VI. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope and factual comparison: Does the analytical data for Teva's sertraline hydrochloride product show an X-ray powder diffraction pattern with peaks "approximately" at the locations required by Claim 1? The construction of "approximately" will be determinative.
- A second central question will be patent validity: Can Teva prove, by clear and convincing evidence, that the claimed Form I polymorph was obvious or not novel in light of the prior art methods for synthesizing sertraline hydrochloride? The patent itself states that prior art methods produced a different polymorph (Form II), which may frame the obviousness inquiry around whether discovering a new, more stable form was a routine or inventive step for one skilled in the art.