DCT
1:18-cv-00525
iCeutica Pty Ltd v. Teva Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiffs: iCeutica Pty Ltd (Australia) and Iroko Pharmaceuticals, LLC (Delaware)
- Defendants: Teva Pharmaceuticals USA, Inc. (Delaware) and Teva Pharmaceutical Industries Limited (Israel)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:18-cv-00525, D. Del., 04/06/2018
- Venue Allegations: Plaintiffs allege venue is proper in the District of Delaware because Defendant Teva USA is incorporated in Delaware, and Defendant Teva Ltd. has engaged in systematic and continuous contacts with the state and acts in concert with its U.S. subsidiary.
- Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for generic meloxicam capsules constitutes an act of infringement of three patents covering Plaintiffs' branded drug, VIVLODEX®.
- Technical Context: The technology concerns pharmaceutical formulations of meloxicam, a non-steroidal anti-inflammatory drug (NSAID), using nanoparticle technology to achieve specific pharmacokinetic profiles for pain relief at lower dosages.
- Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiffs received a Paragraph IV notice letter from Teva concerning its ANDA to market a generic version of VIVLODEX®. The patents-in-suit are listed in the U.S. Food and Drug Administration's "Orange Book" as covering the VIVLODEX® product.
Case Timeline
| Date | Event |
|---|---|
| 2014-06-09 | Earliest Priority Date for ’734, ’318, and ’468 Patents |
| 2016-12-27 | U.S. Patent No. 9,526,734 Issues |
| 2017-05-16 | U.S. Patent No. 9,649,318 Issues |
| 2017-11-07 | U.S. Patent No. 9,808,468 Issues |
| 2018-02-27 | Alleged date of Teva’s Paragraph IV Notice Letter |
| 2018-04-06 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,526,734 - "Formulation of Meloxicam"
The Invention Explained
- Problem Addressed: The patent addresses the challenge of delivering non-steroidal anti-inflammatory drugs (NSAIDs) like meloxicam effectively while minimizing dose-related side effects such as gastrointestinal bleeding and cardiovascular events. Meloxicam is practically insoluble in water, which can lead to slow or incomplete absorption from the gastrointestinal tract (’734 Patent, col. 1:40-64).
- The Patented Solution: The invention is a solid unit dosage form of meloxicam (e.g., 5 mg or 10 mg) where the drug is formulated into nanoparticles of a specific size distribution. This formulation is designed to increase the surface area of the drug, leading to faster dissolution and more rapid absorption, which in turn provides specific, desirable pharmacokinetic properties (e.g., Cmax and AUC) that allow for effective pain relief at a lower systemic exposure than previously available formulations (’734 Patent, Abstract; col. 2:7-14).
- Technical Importance: This approach allows for the use of the "lowest effective dose for the shortest possible duration," a key safety recommendation for all FDA-approved NSAIDs, by improving the drug's bioavailability (’734 Patent, col. 1:44-47).
Key Claims at a Glance
- The complaint does not identify specific asserted claims. Independent claim 1 is representative of the patented subject matter.
- Essential Elements of Independent Claim 1:
- A capsule form of a pharmaceutical composition comprising 5 mg of meloxicam.
- The meloxicam has a median particle size between 100 nm and 500 nm and a D(0.9) between 1200 nm and 3000 nm.
- A single capsule provides a mean plasma AUC (0-∞) of 7500-20000 h*ng/ml and a mean plasma Cmax of 350-950 ng/ml in healthy adults in a fasted state.
- The capsule has a dissolution rate where at least 80% of the meloxicam dissolves in 10 minutes or less under specified USP testing conditions.
- A single capsule is "effective for treating osteoarthritis pain."
U.S. Patent No. 9,649,318 - "Formulation of Meloxicam"
The Invention Explained
- Problem Addressed: The ’318 Patent addresses the same technical problem as the ’734 Patent: providing a low-dose, effective meloxicam formulation to mitigate the risks associated with NSAIDs by overcoming the drug's poor water solubility (’318 Patent, col. 1:40-64).
- The Patented Solution: The invention, as described in the specification, is a method of treating osteoarthritis pain by administering a capsule containing 5 mg of meloxicam. The formulation is characterized by specific nanoparticle size parameters, which result in a defined pharmacokinetic profile (AUC) upon administration to a patient (’318 Patent, Abstract; col. 2:7-14). This approach is designed to ensure rapid and predictable drug absorption.
- Technical Importance: The claimed method provides a therapeutic regimen for osteoarthritis that aligns with FDA guidance to use the lowest effective NSAID dose, thereby addressing a significant patient safety issue (’318 Patent, col. 1:44-47).
Key Claims at a Glance
- The complaint does not identify specific asserted claims. Independent claim 1 is representative of the patented subject matter.
- Essential Elements of Independent Claim 1:
- A method for treating osteoarthritis pain in a human subject.
- The method comprises administering a capsule form of a pharmaceutical composition with 5 mg of meloxicam.
- The meloxicam has a median particle size between 100 nm and 1000 nm.
- A single dose provides a mean plasma AUC (0-∞) of 7500-20000 h*ng/ml in healthy adults in a fasted state.
- The particles have a D(0.9) of less than 4000 nm and greater than 1200 nm.
U.S. Patent No. 9,808,468 - "Formulation of Meloxicam"
Technology Synopsis
The ’468 Patent relates to methods of treating osteoarthritis by administering specific low-dose formulations of meloxicam (5 mg or 10 mg). The technology utilizes meloxicam nanoparticles with defined size characteristics to achieve specific pharmacokinetic profiles, enabling effective pain management with reduced systemic drug exposure compared to conventional formulations (Compl. ¶31; ’468 Patent, Abstract).
Asserted Claims
The complaint does not specify which claims of the ’468 patent are asserted.
Accused Features
The complaint alleges that Teva's proposed generic 5 mg and 10 mg meloxicam capsules, as described in its ANDA, will be used according to a label that instructs for the treatment of osteoarthritis, thereby infringing the patented methods (Compl. ¶¶110-111, 116).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are the proposed generic Meloxicam capsules, 5 mg and 10 mg, described in Teva’s ANDA No. 211453 (Compl. ¶40).
Functionality and Market Context
- The accused products are generic versions of Plaintiffs’ VIVLODEX® brand meloxicam capsules, which are approved for the management of osteoarthritis pain (Compl. ¶¶1, 40). The complaint alleges that Teva's products, upon approval, will be sold with a label and/or instructions for use that direct patients to take the capsules for this purpose (Compl. ¶70, 99, 110).
- The complaint identifies Defendant Teva Ltd. as the "largest generic drug maker in the world" and alleges that Defendants are seeking to market a generic competitor to Plaintiffs' branded VIVLODEX® product throughout the United States (Compl. ¶¶5, 45).
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart or detailed infringement contentions mapping specific features of the accused product to claim limitations. The central allegation is that the filing of ANDA No. 211453 is an act of infringement under 35 U.S.C. § 271(e)(2)(A) because the ANDA seeks approval for a generic version of VIVLODEX®, which Plaintiffs allege is covered by the patents-in-suit (Compl. ¶¶37, 50, 79, 108). The following chart summarizes this infringement theory as applied to a representative product claim.
9,526,734 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A capsule form of a pharmaceutical composition comprising 5 mg of meloxicam | Teva's ANDA No. 211453 allegedly seeks approval for a 5 mg meloxicam capsule product. | ¶40 | col. 20:25-30 |
| having a median particle size, on a volume basis, between 100 nm and 500 nm and a D(0.9) that is between 1200 nm and 3000 nm | Teva's proposed generic product is alleged to be a copy of VIVLODEX®, which is covered by the ’734 patent, thereby implying that its formulation meets the claimed nanoparticle size limitations. | ¶¶37, 40, 52 | col. 2:33-40 |
| wherein a single capsule, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-∞) of 7500-20000 h*ng/ml and a mean plasma Cmax of 350-950 ng/ml | Teva’s proposed generic product, by virtue of being a generic version of VIVLODEX®, is alleged to exhibit the pharmacokinetic profile required by the claim. | ¶¶37, 40, 52 | col. 2:15-23 |
| wherein the dissolution rate is such that... at least 80% of the meloxicam dissolves in 10 minutes or less | Teva’s proposed generic product is alleged to be a copy of VIVLODEX®, implying that its formulation meets the claimed rapid dissolution profile. | ¶¶37, 40, 52 | col. 2:40-47 |
| wherein a single capsule is effective for treating osteoarthritis pain. | Teva’s ANDA allegedly seeks approval for the same indication as VIVLODEX®, the management of osteoarthritis pain. | ¶¶1, 40 | col. 7:46-54 |
9,649,318 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating osteoarthritis pain in a human subject comprising administering to the subject a capsule form of a pharmaceutical composition | The complaint alleges Teva will include a label with its generic product that instructs patients and physicians to administer the capsules for the treatment of osteoarthritis pain, thereby inducing infringement of the claimed method. | ¶¶99, 103 | col. 1:31-33 |
| comprising 5 mg of meloxicam having a median particle size, on a volume basis, between 100 nm and 1000 nm, wherein... the D(0.9) of the particles of meloxicam is less than 4000 nm and greater than 1200 nm | The complaint alleges Teva's proposed 5 mg meloxicam capsule is a generic version of VIVLODEX®, which is covered by the ’318 patent, implying its formulation meets the claimed nanoparticle size limitations. | ¶¶37, 40, 81 | col. 4:38-45 |
| wherein a single dose, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-∞) of 7500-20000 h*ng/ml | Teva’s proposed generic product, by virtue of being a generic version of VIVLODEX® which is required to be bioequivalent, is alleged to provide the pharmacokinetic profile required by the claimed method. | ¶¶37, 40, 81 | col. 4:54-61 |
No probative visual evidence provided in complaint.
Identified Points of Contention
- Scope Questions: The complaint does not provide any technical details about Teva’s proposed generic product. A primary point of contention will be whether the specific formulation detailed in Teva's confidential ANDA actually meets every quantitative limitation of the asserted claims, including the specific ranges for particle size (e.g., "median particle size...between 100 nm and 500 nm"), dissolution rate, and pharmacokinetic parameters (e.g., "mean plasma Cmax of 350-950 ng/ml").
- Technical Questions: A key question is whether Teva's formulation can achieve bioequivalence with VIVLODEX®, as required for FDA approval of a generic drug, without literally infringing the specific combination of particle size and pharmacokinetic parameters recited in the patent claims. The dispute will likely focus on whether there are non-infringing formulation methods that result in a product the FDA would consider a legally permissible generic equivalent.
V. Key Claim Terms for Construction
Term: "median particle size, on a volume basis, between 100 nm and 500 nm" (’734 Patent, claim 1)
- Context and Importance: This term defines a core technical feature of the invention. The infringement analysis will depend heavily on whether the particles in Teva’s product fall within this specific nanometer range. Practitioners may focus on this term because even small deviations in Teva's manufacturing process or final product specification from this claimed range could support a non-infringement argument.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses a broader range in its summary, stating the particles "have a median particle size, on a volume average basis, between 100 nm and 5000 nm" (’734 Patent, col. 2:33-35). This could be used to argue that the specific range in claim 1 is one of several possibilities.
- Evidence for a Narrower Interpretation: Claim 1 itself explicitly recites the narrower "100 nm and 500 nm" range, suggesting a specific selection from the broader disclosure. Furthermore, the working examples provide data for attrited blends with a median particle size (D50) of 260 nm and 242 nm, falling squarely within this narrower range, which could be argued to define the core of the invention (’734 Patent, col. 20:1-17).
Term: "effective for treating osteoarthritis pain" (’734 Patent, claim 1)
- Context and Importance: This is a functional limitation that requires the claimed capsule to achieve a therapeutic outcome. Its construction is critical because Defendants may argue the term is indefinite or that their generic product, approved via a bioequivalence pathway, has not been independently proven "effective" in the manner required by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties may argue this term simply means the product is suitable for the approved indication, which would be met by Teva seeking FDA approval for managing osteoarthritis pain (Compl. ¶1).
- Evidence for a Narrower Interpretation: The patent specification links the product's effectiveness to the achievement of the claimed pharmacokinetic and dissolution properties. The description states the dosage forms "provide effective pain relief and have desirable pharmacokinetic properties" (’734 Patent, col. 2:8-10). A narrower construction might require proof that effectiveness is a direct result of the claimed physical and pharmacokinetic characteristics, as demonstrated by the clinical trial data discussed in the specification (’734 Patent, col. 21:21-22:58).
VI. Other Allegations
Indirect Infringement
The complaint alleges active inducement of infringement for all three patents. The basis for this allegation is that Teva, upon receiving FDA approval, will package its generic product with a label and instructions that will inevitably lead medical providers and patients to use the product in a manner that directly infringes the method claims (Compl. ¶¶70, 74, 99, 103, 116). The complaint also alleges contributory infringement of the ’468 patent, asserting that Teva's generic capsules are a material part of the claimed methods and have no substantial non-infringing uses (Compl. ¶¶112-113, 118).
Willful Infringement
The complaint alleges that Teva was aware of the patents-in-suit no later than their issuance dates and their listing in the FDA's Orange Book (Compl. ¶¶72, 101, 114). It further alleges that, upon becoming aware of the patents, Teva "either actually knew of the potential for infringement... or was willfully blind as to the potential for that infringement," which forms the basis for a willfulness claim (Compl. ¶¶73, 102, 115).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical identity: does the specific formulation disclosed in Teva's confidential ANDA meet every numerical limitation of the asserted claims, including the precise nanoparticle size distributions, dissolution rates, and resulting pharmacokinetic parameters? The case will likely depend on a battle of experts analyzing the undisclosed technical details of Teva's product versus the specific boundaries set by the patent claims.
- A second central issue will be one of obviousness: are the claimed ranges of particle size and pharmacokinetic outcomes for a known drug, meloxicam, non-obvious improvements over the prior art? Teva's invalidity defense, mentioned in its Paragraph IV letter, will likely argue that achieving these results was merely the product of routine optimization using known nanoparticle formulation techniques applied to a known drug.