DCT
1:18-cv-01006
Cosmo Tech Ltd v. Actavis Laboratories FL Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cosmo Technologies Limited (Ireland)
- Defendant: Actavis Laboratories FL, Inc. (Florida); Teva Pharmaceuticals USA, Inc. (Delaware); Teva Pharmaceutical Industries Limited (Israel)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:18-cv-01006, D. Del., 07/06/2018
- Venue Allegations: Venue is based on Defendants' alleged marketing, distribution, and sales of the accused product in Delaware, and on Defendant Teva Pharmaceuticals USA, Inc. being a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendants’ generic budesonide product for ulcerative colitis infringes patents related to a controlled-release oral drug formulation.
- Technical Context: The technology involves multi-component matrix systems designed to control the release of pharmaceutical ingredients, specifically targeting the delivery of the active drug to the colon for treating inflammatory bowel diseases.
- Key Procedural History: The complaint alleges that Plaintiff and Defendant Actavis have been involved in prior litigation concerning the same Actavis Generic Product, which may be relevant to the allegations of pre-suit knowledge and willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2011-09-07 | Earliest Priority Date ('489 and '203 Patents) |
| 2017-03-14 | U.S. Patent No. 9,592,203 Issues |
| 2017-08-22 | U.S. Patent No. 9,737,489 Issues |
| 2018-07-06 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,737,489 - "Controlled Release and Taste Masking Oral Pharmaceutical Composition"
- Patent Identification: U.S. Patent No. 9,737,489, "Controlled Release and Taste Masking Oral Pharmaceutical Composition", issued August 22, 2017 (Compl. ¶15).
The Invention Explained
- Problem Addressed: The patent describes drawbacks with conventional controlled-release drug formulations, which often exhibit non-linear, exponential release of the active ingredient and can result in an undesirable initial "burst effect" upon administration ('489 Patent, col. 2:53-58).
- The Patented Solution: The invention proposes a three-component matrix system to achieve a more controlled and targeted drug release. The structure involves granules, where the active drug is held in lipophilic and amphiphilic matrices, which are then dispersed within an outer hydrophilic matrix ('489 Patent, Abstract; col. 3:1-13). This layered structure is designed to modulate how aqueous fluids penetrate the tablet, creating a more predictable and sustained release profile intended to deliver the drug topically to the colon ('489 Patent, col. 2:32-38).
- Technical Importance: This formulation technology sought to enhance the therapeutic effect of drugs for gastrointestinal conditions by ensuring the active ingredient is released at the intended site (the colon) over a prolonged period, improving local efficacy. (’489 Patent, col. 2:32-38).
Key Claims at a Glance
- The complaint asserts independent claim 1 ('489 Patent, col. 20:1-14; Compl. ¶25).
- Essential elements of independent claim 1 include:
- A method of treating a human subject with ulcerative colitis, comprising administering an oral pharmaceutical composition in the form of a tablet consisting essentially of:
- (a) a tablet core comprising granules, where the granules contain 9 mg of budesonide, at least one lipophilic or inert matrix, and at least one amphiphilic matrix;
- The granules are dispersed in a composition comprising at least one hydrophilic matrix;
- (b) a tablet coating comprising a gastro-resistant film;
- The composition provides a maximum plasma concentration (Cmax) of budesonide of about 1.35±0.96 ng/mL in the human subject.
U.S. Patent No. 9,592,203 - "Controlled Release and Taste Masking Oral Pharmaceutical Composition"
- Patent Identification: U.S. Patent No. 9,592,203, "Controlled Release and Taste Masking Oral Pharmaceutical Composition", issued March 14, 2017 (Compl. ¶17).
The Invention Explained
- Problem Addressed: Similar to the '489 Patent, this patent addresses the challenge of achieving linear, controlled drug release and targeting specific areas of the gastrointestinal tract, which prior art formulations struggled to accomplish (’203 Patent, col. 1:36-col. 2:58).
- The Patented Solution: The invention claims a tablet with a "macroscopically homogeneous" core containing budesonide. This core is covered by a specific gastro-resistant coating composed of a combination of two different methacrylic acid copolymers in defined ratios (’203 Patent, col. 20:55-68). The synergy between the specific core formulation and the dual-polymer coating is described as controlling the release kinetics to target the colon (’203 Patent, col. 5:16-27).
- Technical Importance: The invention provides a specific technical approach for delivering budesonide to the colon by employing a particular combination of enteric coating polymers to achieve the desired delayed- and extended-release profile (’203 Patent, col. 5:16-34).
Key Claims at a Glance
- The complaint asserts independent claim 1 (’203 Patent, col. 20:55-68; Compl. ¶40).
- Essential elements of independent claim 1 include:
- A tablet oral formulation for enhancing release of budesonide in the colon, consisting essentially of:
- (a) a "macroscopically homogeneous" tableted extended release core comprising 9 mg of budesonide and hydroxypropyl cellulose;
- (b) a gastro-resistant coating on the core;
- The coating comprises a copolymer of methacrylic acid and methyl methacrylate in a 1:1 ratio, and a second copolymer of methacrylic acid and methyl methacrylate in a 1:2 ratio.
III. The Accused Instrumentality
Product Identification
The "Actavis Generic Product," identified as a generic version of Uceris® and the subject of Abbreviated New Drug Application (ANDA) No. 205457 (Compl. ¶¶8, 19).
Functionality and Market Context
The product is an oral pharmaceutical tablet containing 9 mg of budesonide, an active ingredient for treating ulcerative colitis (Compl. ¶19). The complaint alleges the product is purported to be a bioequivalent generic of Uceris®, a drug developed by the Plaintiff for inducing remission in patients with active, mild to moderate ulcerative colitis (Compl. ¶¶19-20). Defendants are alleged to have offered for sale and sold the product to customers, including drug distributors (Compl. ¶21). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges infringement based on the Defendants' making, using, and selling the Actavis Generic Product, which is alleged to be a bioequivalent generic of Plaintiff's Uceris® product and therefore embodies the patented technology (Compl. ¶¶19-20, 25, 40).
'489 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a human subject with ulcerative colitis... | Defendants are alleged to encourage and instruct clinicians, via the product's prescribing label, to use the product to treat ulcerative colitis. | ¶23 | col. 20:1-4 |
| ...a tablet core comprising granules, said granules comprising 9 mg of budesonide, at least one lipophilic or inert matrix, and at least one amphiphilic matrix... | The complaint alleges the accused product is a 9 mg budesonide tablet that is a generic version of Uceris®; the infringement allegation implies it contains the claimed matrix structure. | ¶¶19, 25 | col. 20:5-9 |
| ...wherein said oral pharmaceutical composition provides a Cmax of said budesonide in said human subject of about 1.35±0.96 ng/mL... | The complaint alleges the product is "bioequivalent" to Uceris®, which implies a pharmacokinetic profile that meets this limitation. | ¶¶19-20 | col. 20:11-14 |
'203 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a tableted extended release core comprising 9 mg of budesonide, hydroxypropyl cellulose... | The accused product is alleged to be a 9 mg budesonide tablet. | ¶19 | col. 20:57-59 |
| wherein the tableted extended release core is macroscopically homogeneous... | The complaint alleges infringement of the claim, which implies the core of the accused product meets this structural description. | ¶40 | col. 20:60-61 |
| ...a gastro-resistant coating...comprising a copolymer of methacrylic acid and methyl methacrylate in a 1:1 ratio, a copolymer of methacrylic acid and methyl methacrylate in a 1:2 ratio... | The complaint's allegation of infringement implies the accused product's coating contains this specific combination of polymers. | ¶40 | col. 20:62-67 |
Identified Points of Contention
- Compositional Evidence: A primary technical question will be what evidence exists regarding the precise formulation of the Actavis Generic Product. For the '489 Patent, this concerns the presence and composition of the lipophilic, amphiphilic, and hydrophilic matrices. For the '203 Patent, this relates to the specific copolymers used in the gastro-resistant coating.
- Pharmacokinetic Profile: For the '489 Patent, a key dispute may arise over whether the accused product produces a Cmax that falls within the range of "about 1.35±0.96 ng/mL." The interpretation of "about" will be central to this analysis.
- Structural Characteristics: For the '203 Patent, the meaning of "macroscopically homogeneous" will be a likely point of contention. The question will be whether the accused product's core, which may be formed from granules, meets this definition as intended by the patent.
V. Key Claim Terms for Construction
The Term: "about 1.35±0.96 ng/mL" (’489 Patent, Claim 1)
Context and Importance
This pharmacokinetic (PK) parameter is a critical limitation of the asserted method claim. The infringement analysis for the '489 patent may depend entirely on whether the accused product's performance is proven to fall within the scope of this numerical range. Practitioners may focus on this term because its construction, particularly the word "about," will define the boundary of infringement.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent specification includes results from a clinical study where the mean Cmax was reported as 1348.8 ± 958.8 pg/mL ('489 Patent, col. 8, Table 1), which is nearly identical to 1.35 ± 0.96 ng/mL. A party could argue "about" is intended to encompass the statistical and biological variability inherent in such measurements.
- Evidence for a Narrower Interpretation: A party could argue that the term is precisely defined by the clinical data presented in the patent and should not be expanded to cover products with materially different PK profiles, even if they are considered "bioequivalent" for regulatory purposes.
The Term: "macroscopically homogeneous" (’203 Patent, Claim 1)
Context and Importance
This term describes the physical structure of the tablet core. Its definition is critical because the '489 patent, from the same family, explicitly claims a core of "granules...dispersed in a composition." Whether a granular core can also be "macroscopically homogeneous" will be a central question.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The specification states that the compression of a mixture including lipophilic granules and hydrophilic compounds "yields a macroscopically homogeneous structure in all its volume" (’203 Patent, col. 5:10-13). This language suggests that a structure formed from discrete components can still be considered "macroscopically homogeneous" after tableting.
- Evidence for a Narrower Interpretation: A party might argue that the term requires a uniform matrix without distinct, visible sub-structures like granules, contrasting it with formulations explicitly described as dispersions.
The Term: "consisting essentially of" (’489 and ’203 Patents, Claim 1)
Context and Importance
This transitional phrase limits the claims to the specified components and any unlisted ingredients that do not materially affect the "basic and novel properties" of the invention. The case may turn on defining those properties (e.g., the specific release profile) and determining whether any additional excipients in the accused product materially alter them.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent describes the core invention as achieving a specific controlled-release profile for colon-targeted delivery (’203 Patent, col. 2:53-65). A party could argue that common, inert pharmaceutical excipients do not materially affect this fundamental property.
- Evidence for a Narrower Interpretation: A party could argue that the basic and novel properties are the result of the precise interplay of the listed components, and that any additional, unrecited excipients in their formulation necessarily alter the dissolution, stability, or release mechanism in a material way.
VI. Other Allegations
Indirect Infringement
The complaint alleges inducement by asserting that Defendants' product labels and instructions encourage and direct clinicians and patients to use the generic product in an infringing manner, specifically for the treatment of ulcerative colitis (Compl. ¶¶23, 28-29, 43-44). Contributory infringement is alleged on the basis that the product is a material part of the invention and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶31, 46).
Willful Infringement
The willfulness allegations are based on alleged pre-suit and post-suit knowledge. The complaint asserts that Defendants had actual knowledge of the patents and their infringement because of prior litigation between the parties concerning the same generic product, and that infringement has continued despite this knowledge (Compl. ¶¶26, 34, 41, 49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of compositional identity: what does discovery reveal about the precise formulation of the accused generic product? The viability of the infringement claims will depend on whether its core matrix and gastro-resistant coating contain the specific structures and chemical components required by the asserted claims of the '489 and '203 patents.
- A key legal question will be one of claim scope: can the pharmacokinetic limitation "about 1.35±0.96 ng/mL" in the '489 patent be construed to read on the measured performance of the accused product, and can the term "macroscopically homogeneous" in the '203 patent be interpreted to cover the physical structure of the accused tablet's core?
- A third critical issue will be the impact of the prior litigation: what specific knowledge of the patents and potential infringement can be imputed to the Defendants from the previous lawsuit? The answer will be determinative for the claim of willful infringement and any potential for enhanced damages.