DCT
2:19-cv-09335
Sun Pharmaceutical Industries Ltd v. Pfizer Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Sun Pharmaceutical Industries Limited (India)
- Defendant: Pfizer, Inc. (Delaware); PF Prism CV. (Netherlands); Warner-Lambert Company, LLC (Delaware)
- Plaintiff’s Counsel: Rivkin Radler LLP; Katten Muchin Rosenman LLP
- Case Identification: Sun Pharmaceutical Industries Limited v. Pfizer, Inc., 2:19-cv-09335, D.N.J., 04/05/2019
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendants are subject to personal jurisdiction in the district, where they conduct substantial business and have regular and systematic contact.
- Core Dispute: Plaintiff seeks a declaratory judgment that its proposed generic extended-release pregabalin drug does not infringe, and/or that the claims are invalid or unenforceable for, three patents owned by Defendants covering formulations for the branded drug LYRICA® CR.
- Technical Context: The technology relates to extended-release oral pharmaceutical formulations designed to be retained in the stomach, allowing for once-daily dosing of drugs with limited gastrointestinal absorption windows.
- Key Procedural History: This action arises under the Hatch-Waxman Act. Plaintiff Sun Pharmaceutical Industries filed an Abbreviated New Drug Application (ANDA) seeking FDA approval for its generic version of Defendants' LYRICA® CR. As part of the ANDA, Sun filed a "Paragraph IV certification" asserting that its product would not infringe Defendants' Orange Book-listed patents. After Sun provided notice of its certification, Defendants did not file an infringement suit within the statutory 45-day window, prompting Sun to file this declaratory judgment action to establish its right to market its product upon FDA approval.
Case Timeline
| Date | Event |
|---|---|
| 2005-11-02 | Priority Date for ’620, ’559, and ’447 Patents |
| 2015-02-03 | U.S. Patent No. 8,945,620 Issued |
| 2015-03-30 | FDA approves NDA for LYRICA® CR extended-release tablets |
| 2015-09-29 | U.S. Patent No. 9,144,559 Issued |
| 2018-03-31 | Sun files ANDA No. 211889 for generic pregabalin |
| 2018-06-11 | Sun notifies Defendants of Paragraph IV certification for ’620 and ’559 Patents |
| 2018-07-17 | U.S. Patent No. 10,022,447 Issued |
| 2018-09-17 | Sun notifies Defendants of Paragraph IV certification for ’447 Patent |
| 2019-04-05 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,945,620 - Solid Pharmaceutical Compositions Containing Pregabalin, issued February 3, 2015
The Invention Explained
- Problem Addressed: The patent's background section explains that the drug pregabalin is not absorbed uniformly throughout the gastrointestinal (GI) tract and is poorly absorbed beyond the upper small intestine (Compl. ¶23; ’620 Patent, col. 2:1-6). This limited "absorption window" makes it difficult to create an effective once-daily (QD) extended-release (ER) formulation, because any drug released after the dosage form passes this window would be wasted (’620 Patent, col. 2:6-10). The patent also notes that pregabalin can degrade into an undesirable lactam, a process that can be affected by the formulation's other ingredients (’620 Patent, col. 2:3-10).
- The Patented Solution: The invention is a solid oral dosage form designed for gastric retention, meaning it remains in the stomach for a longer time than a conventional immediate-release (IR) dosage form (’620 Patent, col. 2:15-19). This is achieved by a formulation that swells upon contact with gastric fluid to a size of 9 mm or greater, which is too large to pass through the pylorus into the small intestine (’620 Patent, col. 2:40-44). By remaining in the stomach, the tablet can continuously release pregabalin over an extended period within the GI tract's primary absorption region, enabling effective once-daily dosing (’620 Patent, col. 2:19-25). The formulation relies on a combination of a "matrix forming agent" (polyvinyl acetate and polyvinylpyrrolidone) and a "swelling agent" to achieve this effect (’620 Patent, Abstract).
- Technical Importance: This gastric-retentive technology allows for a once-daily dosing schedule, which can improve patient compliance compared to the twice- or thrice-daily regimens required for immediate-release versions of pregabalin (’620 Patent, col. 2:45-53).
Key Claims at a Glance
- The complaint seeks a declaration of non-infringement for any valid claim of the patent; it does not identify specific claims (Compl. ¶49). Independent claim 1 is a representative composition claim.
- Independent Claim 1, Essential Elements:
- A pharmaceutical composition adapted for once-daily oral dosing.
- Comprising pregabalin (5% to 60% by weight).
- Comprising a matrix forming agent (5% to 45% by weight) that itself comprises polyvinyl acetate and polyvinylpyrrolidone.
- Comprising a swelling agent (15% to 70% by weight) that itself comprises cross-linked polyvinylpyrrolidone and polyethylene oxide.
U.S. Patent No. 9,144,559 - Solid Pharmaceutical Compositions Containing Pregabalin, issued September 29, 2015
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’620 Patent, this patent addresses the same technical problem: pregabalin's limited absorption window in the GI tract makes it a poor candidate for conventional once-daily extended-release formulations (’559 Patent, col. 2:2-11).
- The Patented Solution: The patent describes the same gastric-retentive solution, where a solid tablet swells in the stomach to a size sufficient to prevent its passage through the pylorus (e.g., 9 mm or greater) (’559 Patent, col. 2:40-44). This prolongs the release of pregabalin in the upper GI tract, making once-daily dosing feasible. The composition uses a specific combination of a matrix forming agent and a swelling agent to control this mechanism (’559 Patent, col. 2:12-28).
- Technical Importance: The invention provides the clinical benefit of a once-daily pregabalin treatment, which is more convenient for patients and may improve adherence to therapy compared to multi-dose daily regimens (’559 Patent, col. 2:45-53).
Key Claims at a Glance
- The complaint seeks a declaration of non-infringement for any valid claim of the patent (Compl. ¶57). Independent claim 1 is a representative composition claim.
- Independent Claim 1, Essential Elements:
- A pharmaceutical composition adapted for once-daily oral dosing.
- Comprising pregabalin (5% to 60% by weight).
- Comprising a matrix forming agent (5% to 45% by weight) that itself comprises polyvinyl acetate and polyvinylpyrrolidone.
- Comprising a swelling agent (15% to 70% by weight) that itself comprises cross-linked polyvinylpyrrolidone.
Multi-Patent Capsule: U.S. Patent No. 10,022,447 - Solid Pharmaceutical Compositions Containing Pregabalin, issued July 17, 2018
- Technology Synopsis: This patent is part of the same family as the ’620 and ’559 patents and is directed to methods of treatment using the described gastric-retentive pregabalin formulations (Compl. ¶26-27). The technology solves the problem of pregabalin's limited absorption window by employing a composition with a matrix-forming agent (polyvinyl acetate and polyvinylpyrrolidone) and a swelling agent (cross-linked polyvinylpyrrolidone) that allows for once-daily oral administration (’447 Patent, col. 2:12-44).
- Asserted Claims: The complaint seeks a declaration of non-infringement of any valid claim (Compl. ¶65). Independent claims 1 and 5 are method of treatment claims.
- Accused Features: The complaint contends that the intended use of Sun's generic pregabalin extended-release tablets, as described in its ANDA, will not infringe the methods claimed in the ’447 patent (Compl. ¶64).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Sun Pharmaceutical's proposed generic pregabalin extended-release tablets in strengths of 82.5mg, 165mg, and 330mg, as described in its Abbreviated New Drug Application (ANDA) No. 211889 (Compl. ¶9, 32, 35).
Functionality and Market Context
- The complaint states that the product is a "generic version" of Pfizer's LYRICA® CR and is "bioequivalent" to it (Compl. ¶2, 32). The purpose of the ANDA filing is to obtain FDA approval to market this product as a lower-cost alternative to the branded drug (Compl. ¶13). The complaint does not provide any specific technical details regarding the composition, excipients, or physical properties of Sun's proposed generic tablets. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement and therefore does not articulate an affirmative infringement theory. It contains only conclusory statements that Sun's ANDA product will not infringe (Compl. ¶48, 56, 64). The infringement controversy arises from Defendants' listing of the patents-in-suit in the FDA Orange Book as covering LYRICA® CR, and Sun's filing of a Paragraph IV certification to the contrary (Compl. ¶9, 30). The following analysis outlines the elements of the patents' independent claims, which would form the basis of any infringement dispute.
'620 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition... adapted for once-daily oral dosing | The subject of the controversy is Sun's proposed generic pregabalin extended-release tablet, which is intended for once-daily dosing. | ¶32, ¶35 | col. 2:13-16 |
| comprising... a matrix forming agent comprising polyvinyl acetate and polyvinylpyrrolidone | The complaint does not provide details on the composition of Sun's product. The dispute will center on whether Sun's product contains these specific excipients. | ¶32, ¶48 | col. 7:56-65 |
| comprising... a swelling agent comprising cross linked polyvinylpyrrolidone and polyethylene oxide | The complaint does not provide details on the composition of Sun's product. The dispute will center on whether Sun's product contains both of these specific swelling agents. | ¶32, ¶48 | col. 8:21-49 |
'559 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition... adapted for once-daily oral dosing | The subject of the controversy is Sun's proposed generic pregabalin extended-release tablet, which is intended for once-daily dosing. | ¶32, ¶35 | col. 2:12-15 |
| comprising... a matrix forming agent comprising polyvinyl acetate and polyvinylpyrrolidone | The complaint does not provide details on the composition of Sun's product. The dispute will center on whether Sun's product contains these specific excipients. | ¶32, ¶56 | col. 7:62-8:2 |
| comprising... a swelling agent comprising crosslinked polyvinylpyrrolidone | The complaint does not provide details on the composition of Sun's product. The dispute will center on whether Sun's product contains this specific swelling agent. | ¶32, ¶56 | col. 8:31-39 |
- Identified Points of Contention:
- Technical Questions: The complaint provides no technical details about Sun's ANDA product. A primary question for the court will be an evidentiary one: what is the precise formulation of Sun's proposed generic tablet? The infringement analysis for the composition claims of the ’620 and ’559 patents will depend entirely on whether Sun's product contains the specific matrix-forming and swelling agents recited in the claims, and in what quantities.
- Technical Questions: A specific point of contention for the ’620 Patent will be whether Sun's formulation contains polyethylene oxide. Because this element is required by claim 1 of the ’620 Patent but not by claim 1 of the ’559 Patent, its presence or absence in Sun's product could be dispositive for infringement of the ’620 Patent.
V. Key Claim Terms for Construction
The complaint does not offer a basis for claim construction arguments. However, based on the patent claims, the following terms may be central to the dispute.
The Term: "matrix forming agent"
Context and Importance: This term defines a critical functional component of the claimed composition. The claims require this agent to comprise a specific combination of polyvinyl acetate (PVAc) and polyvinylpyrrolidone (PVP). The scope of this term will be important for determining whether Sun's formulation, which is currently undefined in the record, meets this limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is functional. While the claims require PVAc and PVP, the "comprising" language suggests other components could be included without departing from the claim scope.
- Evidence for a Narrower Interpretation: The specification repeatedly identifies the matrix forming agent as a physical mixture of PVAc and PVP and points to a specific commercial product, KOLLIDON® SR, as a useful example, which is described as a specific 80/19 (w/w) mixture (’620 Patent, col. 8:3-16). A party could argue this embodiment limits the scope of the broader term.
The Term: "adapted for once-daily oral dosing"
Context and Importance: This phrase appears in the preamble of the composition claims and in the method of treatment claims. Practitioners may focus on this term because its construction will determine whether it is a limiting feature of the composition itself or merely a statement of intended use.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue this is merely a statement of intended use and not a structural limitation of the composition, meaning any composition with the recited ingredients infringes regardless of its actual performance characteristics.
- Evidence for a Narrower Interpretation: The specification extensively links the composition's structure (e.g., its specific excipients) to the functional outcome of gastric retention and swelling that enables once-daily dosing (’620 Patent, col. 2:12-28). A party could argue that "adapted for" requires the composition to have the structural and physical properties (e.g., swelling to >9mm) necessary to actually achieve this function, making it a positive limitation.
VI. Other Allegations
- Indirect Infringement: The prayer for relief seeks a declaration that the manufacture, sale, or use of Sun's product would not "induce or contribute to the infringement of any valid claim" of the patents-in-suit (Compl., Prayer for Relief ¶B, D, F). The body of the complaint, however, does not allege any specific facts related to the elements of indirect infringement, such as knowledge or specific intent to induce.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional identity: What are the specific excipients and their relative concentrations in Sun's ANDA product? As the complaint provides no technical details, the entire infringement analysis hinges on a factual comparison between this undisclosed formulation and the specific compositional elements required by the patent claims.
- A key evidentiary question for the ’620 Patent will be one of elemental presence: Does Sun’s formulation's swelling agent contain polyethylene oxide? The answer to this binary question could be dispositive for the infringement analysis of claim 1 of the ’620 Patent, which explicitly requires it, and may differentiate the infringement case from that of the ’559 Patent, which does not.
- A central procedural question is one of strategic intent: What considerations led Defendants to forego filing an infringement suit within the 45-day statutory period, thereby compelling Sun to initiate this declaratory judgment action? The court may need to consider the context of this procedural posture in managing the case.