DCT
1:18-cv-00555
IBSA Institut Biochimique SA v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: IBSA Institut Biochimique, S.A. (Switzerland), Altergon, S.A. (Switzerland), Mist Acquisition, LLC (Delaware), and Mist Pharmaceuticals, LLC (Delaware)
- Defendant: Teva Pharmaceutical USA, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:18-cv-00555, D. Del., 04/13/2018
- Venue Allegations: Venue is asserted as proper in the District of Delaware on the basis that Defendant Teva is a Delaware corporation.
- Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the thyroid hormone drug Tirosint® constitutes an act of infringement of two patents covering pharmaceutical formulations.
- Technical Context: The technology concerns soft gelatin capsule formulations for thyroid hormones, which are drugs requiring precise dosing due to a narrow therapeutic index, making formulation stability and uniformity critical.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following a February 27, 2018 notification letter from Teva, in which Teva certified that the patents-in-suit are invalid, unenforceable, or will not be infringed by its proposed generic product (a "Paragraph IV certification"). The patents are listed in the FDA's "Orange Book" as covering Plaintiffs' branded Tirosint® product.
Case Timeline
| Date | Event |
|---|---|
| 2001-07-02 | ’390 Patent Priority Date |
| 2002-12-27 | ’411 Patent Priority Date |
| 2010-04-06 | U.S. Patent No. 7,691,411 Issues |
| 2010-05-25 | U.S. Patent No. 7,723,390 Issues |
| 2018-02-27 | Teva sends Paragraph IV certification letter |
| 2018-04-13 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,691,411 - "Pharmaceutical Formulae for Thyroid Hormones and Procedures for Obtaining Them"
The Invention Explained
- Problem Addressed: The patent describes the significant risks associated with the administration of thyroid hormones due to their "very strict therapeutic index" (’411 Patent, col. 2:50-51). Traditional tablet formulations were known to have problems with stability, titre, and bioavailability, leading to inconsistent and potentially dangerous dosing for patients. (’411 Patent, col. 2:47-55).
- The Patented Solution: The invention is a pharmaceutical composition in the form of a "single phase uniform matrix of soft-gel" for oral delivery of thyroid hormones (’411 Patent, col. 51:22-26). Instead of a conventional compressed powder tablet or a two-phase capsule with a distinct liquid fill, the active hormone is integrated into a monolithic, single-phase gel matrix. This matrix is composed of specific percentages of gelatin, glycerol, and water, which is asserted to provide a more stable and reliable dosage form. (’411 Patent, Abstract; col. 3:62-67).
- Technical Importance: The formulation was developed to overcome the long-standing challenge of dosage instability and inconsistency in thyroid hormone therapies, thereby improving patient safety. (’411 Patent, col. 2:55-63).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-32 (Compl. ¶20). Independent claim 1 is central.
- The essential elements of independent claim 1 are:
- A pharmaceutical composition in the form of a single phase uniform matrix of soft-gel for oral administration.
- Comprising thyroid hormones as the active principle.
- The single phase uniform matrix of soft-gel comprising in the dried state:
- 30%-68% by weight of gelatine of bovine, pig or fish origin.
- 31-60% by weight of glycerol.
- 1-10% by weight of water.
- The complaint reserves the right to pursue infringement of dependent claims (Compl. ¶20).
U.S. Patent No. 7,723,390 - "Pharmaceutical Formulations for Thyroid Hormones"
The Invention Explained
- Problem Addressed: Similar to the ’411 patent, the ’390 patent addresses the "great difficulty" of formulating thyroid hormone dosage units with "foreseeable and reproducible release" due to the drug's instability and sensitivity to excipients. (’390 Patent, col. 2:55-63).
- The Patented Solution: The patent claims two alternative formulation types. The first is a "soft elastic capsule" containing a "liquid or semi-liquid inner phase" where the hormone is dissolved, with the inner phase being in direct contact with the capsule shell (’390 Patent, col. 14:32-39). The second is a "swallowable uniform soft-gel matrix" comprising glycerol and the hormone (’390 Patent, col. 14:40-44). Both approaches avoid the physical stresses and chemical interactions of compacted solid tablets.
- Technical Importance: The invention provides different pathways for creating non-solid, non-compacted dosage forms for thyroid hormones, aimed at improving stability and bioavailability over traditional tablets. (’390 Patent, col. 3:34-44).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-10 (Compl. ¶26). Independent claim 1 is foundational.
- The essential elements of independent claim 1 are a pharmaceutical composition in the form of either:
- a) A soft elastic capsule with a shell of gelatin material containing a liquid or semi-liquid inner phase, where the inner phase comprises the thyroid hormone dissolved in gelatin and/or glycerol and is in direct contact with the shell; OR
- b) A swallowable uniform soft-gel matrix comprising glycerol and the thyroid hormone.
- The complaint reserves the right to pursue infringement of dependent claims (Compl. ¶26).
III. The Accused Instrumentality
Product Identification
- The accused product is Teva's proposed generic version of levothyroxine sodium capsules in 75 mcg and 150 mcg dosage strengths, for which Teva filed Abbreviated New Drug Application (ANDA) No. 211369 with the FDA (Compl. ¶11).
Functionality and Market Context
- The complaint alleges that Teva's ANDA "refers to and relies upon the Tirosint® NDA" and seeks to demonstrate bioequivalence with Plaintiffs' branded Tirosint® product (Compl. ¶12). The core of the infringement allegation is that by seeking to market a product that is therapeutically and pharmaceutically equivalent to Tirosint®, Teva's product will necessarily have the same infringing characteristics and composition as the branded drug, which Plaintiffs assert is covered by the patents-in-suit (Compl. ¶¶1, 12). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed, element-by-element infringement analysis. The infringement theory is predicated on the allegation that Teva’s product is a bioequivalent generic version of Plaintiffs' patented Tirosint® product (Compl. ¶12). The allegations for the independent claims are summarized below based on this theory.
’411 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition in the form of a single phase uniform matrix of soft-gel for oral administration | Teva’s product is a generic version of Tirosint®, which is described as a soft-gel capsule, and allegedly possesses the claimed "single phase uniform matrix" structure. | ¶¶11, 12, 20 | col. 51:22-26 |
| comprising in the dried state: 30%-68% by weight of gelatine... | To be bioequivalent to Tirosint®, Teva's product is alleged to have a composition that falls within the claimed weight percentage of gelatin. | ¶¶11, 12, 20 | col. 51:28-30 |
| 31-60% by weight of glycerol | To be bioequivalent to Tirosint®, Teva's product is alleged to have a composition that falls within the claimed weight percentage of glycerol. | ¶¶11, 12, 20 | col. 51:31-32 |
| and 1-10% by weight of water | To be bioequivalent to Tirosint®, Teva's product is alleged to have a composition that falls within the claimed weight percentage of water. | ¶¶11, 12, 20 | col. 51:31-32 |
’390 Patent Infringement Allegations
| Claim Element (from Independent Claim 1, part a) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a soft elastic capsule consisting of a shell of gelatin material | Teva's product is a generic version of the Tirosint® soft-gel capsule and is alleged to be a soft elastic capsule made of gelatin material. | ¶¶11, 12, 26 | col. 14:32-33 |
| containing a liquid or semi-liquid inner phase | To be bioequivalent to Tirosint®, Teva's product is alleged to contain a liquid or semi-liquid inner phase. | ¶¶11, 12, 26 | col. 14:33-34 |
| comprising said thyroid hormones... dissolved in gelatin and/or glycerol... | To be bioequivalent to Tirosint®, the inner phase of Teva's product is alleged to contain the thyroid hormone dissolved in gelatin and/or glycerol. | ¶¶11, 12, 26 | col. 14:34-37 |
| said liquid or semi-liquid inner phase being in direct contact with said shell without any interposed layers | Teva's product is alleged to have a structure where the inner phase is in direct contact with the capsule shell, consistent with the formulation of the branded Tirosint® product. | ¶¶11, 12, 26 | col. 14:37-39 |
Identified Points of Contention
- Factual Question: The central dispute will be factual: Does the formulation of Teva's proposed generic product, as specified in its confidential ANDA, fall within the compositional ranges claimed in the ’411 patent (e.g., the specific weight percentages of gelatin, glycerol, and water)? The complaint, filed before Plaintiffs could review the ANDA, contains no direct evidence on this point (Compl. ¶14).
- Scope Question: A key legal question will be the distinction between the formulations claimed in the two patents. Does Teva's product meet the definition of a "single phase uniform matrix" under the ’411 patent, or a "soft elastic capsule" with a distinct "inner phase" under the ’390 patent, or neither? The characterization of Teva's product formulation will be a primary battleground.
V. Key Claim Terms for Construction
The Term: "single phase uniform matrix of soft-gel" (’411 Patent, Claim 1)
- Context and Importance: This term defines the core structure of the invention in the ’411 patent and distinguishes it from conventional capsules. Its construction is critical to determining infringement, as Teva's product must be found to have this specific structure, not just be a generic soft-gel capsule.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiffs may argue that any soft-gel formulation where the active ingredient is homogeneously dispersed throughout the gel-forming material, rather than encapsulated as a separate liquid fill, meets the definition. The patent’s general description of overcoming prior art disadvantages could be cited in support. (’411 Patent, col. 3:10-14).
- Evidence for a Narrower Interpretation: The specification describes obtaining "'full' capsules..., that is uniform matrices of soft-gel which are perfectly single-phase," contrasting them with "classic two-phase capsules" (’411 Patent, col. 3:64-67). This language may support a narrower construction requiring a truly monolithic structure with no discernible boundary between a "shell" and a "fill."
The Term: "in the dried state" (’411 Patent, Claim 1)
- Context and Importance: The specific weight percentage limitations of claim 1 are all conditioned on this term. The method of determining the "dried state" of Teva's product will be dispositive of whether it meets these limitations.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties might argue for flexibility in the drying conditions, suggesting that any standard industry method for determining dry weight should suffice.
- Evidence for a Narrower Interpretation: The patent provides a specific definition: "the state reached by the pharmaceutical formula after drying at a temperatures of 20° C.-24° C. and a relative humidity of 20% with a continuous change of the surrounding air until a constant weight is reached" (’411 Patent, col. 3:56-62). A party will likely argue this definition is controlling and must be strictly applied when analyzing the accused product.
The Term: "liquid or semi-liquid inner phase" (’390 Patent, Claim 1)
- Context and Importance: This term is central to distinguishing the first embodiment of claim 1 (part a) from the second (part b, a "uniform soft-gel matrix") and from capsules with solid fills. Whether the fill material in Teva's product qualifies as "liquid or semi-liquid" will be key to infringement under this prong of the claim. Practitioners may focus on this term because the patent was subject to a Certificate of Correction changing "half-liquid" to "semi-liquid" throughout, indicating its importance and potential for ambiguity. (’390 Patent, Certificate of Correction).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification lists vehicle components like glycerol and polyethylene glycol, which can form viscous solutions or pastes, suggesting "semi-liquid" could encompass a wide range of non-solid materials. (’390 Patent, col. 7:45-53).
- Evidence for a Narrower Interpretation: The term could be construed to require some degree of flowability, excluding highly viscous gels or pastes that behave more like solids. The contrast with the "uniform soft-gel matrix" in part (b) of the same claim may suggest that the "inner phase" of part (a) must be a physically distinct and less solid component.
VI. Other Allegations
- Indirect Infringement: The complaint alleges infringement under 35 U.S.C. §§ 271(b) and (c), which cover induced and contributory infringement, respectively (Compl. ¶¶20, 26). However, the complaint provides no specific factual allegations to support the required elements of knowledge and intent for these claims, beyond the general allegation that Teva's actions would cause infringement.
- Willful Infringement: The complaint does not explicitly allege willful infringement. It does request a finding that the case is "exceptional" to support an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶23, 29). The factual basis for this request is not detailed.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case will likely depend on the answers to two fundamental questions that cannot be resolved from the complaint alone.
- A central evidentiary question will be one of factual composition: Once the contents of Teva’s confidential ANDA are produced in discovery, does the proposed generic product’s formulation meet the specific quantitative limitations of the asserted claims, particularly the weight-percent requirements for gelatin, glycerol, and water "in the dried state" as claimed in the ’411 patent?
- A core issue will be one of definitional scope: How will the court construe the key structural terms that differentiate the patents, namely the "'single phase uniform matrix'" of the '411 patent versus the "'soft elastic capsule' containing a 'liquid or semi-liquid inner phase'" of the '390 patent? The infringement outcome may turn entirely on which, if any, of these specific technical definitions accurately describes Teva's product.