DCT

2:19-cv-09330

Sun Pharmaceutical Industries Ltd v. Pfizer Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-09330, D.N.J., 04/05/2019
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants are subject to personal jurisdiction in the District of New Jersey, conduct substantial business there, and derive substantial revenue from products sold in the District.
  • Core Dispute: Plaintiff alleges that Defendants’ LYRICA® CR extended-release tablets infringe a patent related to gastroretentive drug delivery formulations for the active ingredient pregabalin.
  • Technical Context: The technology concerns pharmaceutical formulations designed to remain in the stomach for an extended period, thereby improving the absorption of drugs that are primarily absorbed in the upper gastrointestinal tract.
  • Key Procedural History: Plaintiff alleges it sent a letter to Defendant Pfizer, Inc. on February 6, 2019, providing notice of the alleged infringement. The complaint also notes that Defendants have not sought to list the patent-in-suit in the FDA's "Orange Book," a registry of patents a brand-name manufacturer asserts could reasonably be infringed by a generic equivalent.

Case Timeline

Date Event
2012-01-30 U.S. Patent No. 9,393,205 Priority Date
2016-07-19 U.S. Patent No. 9,393,205 Issued
2017-10-12 Defendants announce FDA approval of LYRICA® CR
2019-02-06 Plaintiff sends notice letter to Defendant regarding '205 Patent
2019-04-05 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,393,205 - "Gastroretentive Tablets"

  • Patent Identification: U.S. Patent No. 9,393,205, issued July 19, 2016.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge that the active drug pregabalin has an "absorption window" and is poorly absorbed in the lower gastrointestinal tract. This makes conventional once-daily, extended-release formulations inefficient, as much of the drug is released after the tablet has passed the area where it can be effectively absorbed, necessitating inconvenient multiple daily doses (’205 Patent, col. 1:30-49).
  • The Patented Solution: The invention is a "gastroretentive" tablet that includes at least one "swellable polymer." When ingested, the tablet absorbs gastric fluid and swells to a size that prevents it from quickly passing out of the stomach. By retaining the dosage form in the upper gastrointestinal tract for a prolonged period, the tablet can release pregabalin over time within its primary absorption window, enabling an effective once-daily dosage (’205 Patent, col. 2:1-5, 2:47-54).
  • Technical Importance: This gastroretentive approach aims to improve patient compliance by enabling a once-daily dosing regimen and may reduce side effects by maintaining more stable plasma concentrations of the drug (’205 Patent, col. 1:35-39).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶19, 24).
  • The essential elements of independent claim 1 are:
    • A gastroretentive tablet
    • comprising pregabalin,
    • at least one swellable polymer,
    • and other pharmaceutically acceptable excipients.
  • The complaint reserves the right to assert additional claims of the '205 Patent (Compl. ¶24).

III. The Accused Instrumentality

Product Identification

  • Defendants’ LYRICA® CR extended-release tablets (Compl. ¶2).

Functionality and Market Context

  • LYRICA® CR is a once-daily prescription therapy for managing certain types of neuropathic pain (Compl. ¶15). The complaint alleges that the product’s formulation contains pregabalin as the active ingredient, along with several excipients, including polyethylene oxide and carbomer (Compl. ¶21). The complaint asserts these specific excipients are "swellable polymers" as contemplated by the ’205 Patent (Compl. ¶20). The complaint cites the product’s FDA-approved Prescribing Information as the source for its list of ingredients (Compl. ¶21).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'205 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A gastroretentive tablet The complaint alleges that the LYRICA® CR tablet infringes Claim 1, which is for a "gastroretentive tablet," by containing the components of such a tablet (Compl. ¶19). ¶19 col. 2:1-5
comprising pregabalin, The Prescribing Information for LYRICA® CR states that the tablet contains pregabalin (Compl. ¶21). ¶21 col. 2:10-12
at least one swellable polymer, The LYRICA® CR tablet contains polyethylene oxide and carbomer (Compl. ¶21). The complaint alleges these are swellable polymers, and the patent specification identifies "polyethylene oxide" and "carbomer" as examples of such polymers (’205 Patent, col. 2:55-67; Compl. ¶20). ¶20, ¶21 col. 2:55-67
and other pharmaceutically acceptable excipients. The LYRICA® CR tablet contains inactive ingredients such as Kollidon SR, crospovidone, magnesium stearate, and others (Compl. ¶21). The patent describes the use of such excipients, including binders, lubricants, and diluents (’205 Patent, col. 3:41-43). ¶21 col. 3:41-43
  • Identified Points of Contention:
    • Scope Questions: A primary question will be whether the preamble term "gastroretentive tablet" is a limiting element of the claim. If it is, the analysis will turn on whether the LYRICA® CR product meets the functional requirements of being "gastroretentive," as described in the patent.
    • Technical Questions: What evidence does the complaint provide that the accused LYRICA® CR tablet actually performs the function of being "gastroretentive" (i.e., swelling in the stomach to a size sufficient to be retained)? The complaint identifies the presence of ingredients that can cause this effect but does not explicitly allege that the accused product is designed to or actually does function in this manner.

V. Key Claim Terms for Construction

  • The Term: "gastroretentive tablet"
  • Context and Importance: This term appears in the preamble of independent claim 1 and describes the overall nature of the invention. Its construction will be critical. If the court determines the preamble is limiting, Plaintiff must prove that LYRICA® CR is not just an extended-release tablet containing the listed ingredients, but one that achieves its effect through the specific mechanism of gastric retention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue the term is met by any tablet containing the claimed components (pregabalin and a swellable polymer) that results in a longer gastric residence time than a conventional immediate-release tablet. The specification provides a broad list of "swellable polymers" that could achieve this effect through various means, including simple swelling (’205 Patent, col. 2:55-67).
    • Evidence for a Narrower Interpretation: A party could argue the term requires a specific functional outcome. The patent describes the problem as pregabalin’s limited "absorption window" of about six hours and proposes the invention as a solution (’205 Patent, col. 1:44-49). This suggests "gastroretentive" implies a tablet that swells to a sufficient size to be retained in the stomach for a period of time that meaningfully extends beyond that of a conventional dosage form to solve the stated problem (’205 Patent, col. 2:47-54).

VI. Other Allegations

  • Indirect Infringement: The complaint makes a conclusory allegation of inducement and/or contribution to infringement but does not plead specific facts explaining how Defendants allegedly induced others (e.g., by providing specific instructions to patients or doctors to use the product in an infringing manner) (Compl. ¶24).
  • Willful Infringement: The complaint alleges that infringement has been and continues to be willful, basing this allegation on Defendants' alleged knowledge of the ’205 Patent since at least February 7, 2019, following a notice letter sent by Plaintiff (Compl. ¶26, ¶28).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of claim construction and function: Is the preamble term "gastroretentive tablet" a positive limitation of Claim 1? If so, what degree of swelling and gastric retention time is required to meet this limitation, and does the accused product exhibit that specific functionality?
  • A key evidentiary question will be one of infringement: Can Plaintiff prove, as a matter of fact, that the LYRICA® CR tablet—which contains ingredients that can be used for gastroretention—is actually designed to and does function as a "gastroretentive tablet" as defined by the patent, or does it achieve its extended-release properties through an alternative, non-infringing mechanism?