DCT

1:24-cv-00417

Urogen Pharma Ltd v. Teva Pharma Inc

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00417, D. Del., 05/19/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendants are incorporated in Delaware, maintain agents for service in the district, and have previously consented to jurisdiction in the district through participation in other litigation.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's JELMYTO® product infringes three patents related to thermoreversible hydrogel drug delivery compositions and methods of their use.
  • Technical Context: The technology involves a polymer-based hydrogel that is liquid at cooler temperatures for administration into a body cavity but becomes a viscous gel at body temperature, allowing for sustained, localized delivery of a therapeutic agent like the chemotherapy drug mitomycin.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s February 20, 2024 notice letter, which certified pursuant to Paragraph IV that the asserted patents are invalid, unenforceable, and/or will not be infringed by its proposed generic product. The patents-in-suit are listed in the FDA's Orange Book for JELMYTO®.

Case Timeline

Date Event
2010-01-20 Earliest Patent Priority Date for ’074, ’069, and ’745 Patents
2015-05-26 U.S. Patent No. 9,040,074 Issued
2018-04-24 U.S. Patent No. 9,950,069 Issued
2020-04-15 FDA Approved New Drug Application for JELMYTO®
2024-02-20 Defendant sent Paragraph IV Notice Letter to Plaintiff
2025-04-08 U.S. Patent No. 12,268,745 Issued
2025-05-19 Complaint Filed

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

U.S. Patent No. 9,040,074 - *Material and Method for Treating Internal Cavities*

The Invention Explained

  • Problem Addressed: The patent describes the difficulty of topically treating diseases in internal body cavities, such as bladder cancer, because conventional liquid drug instillations are quickly expelled, leading to short exposure times and reduced efficacy (’074 Patent, col. 7:1-14). Adhering a treatment material to wet, flexible, non-adherent mucosal tissue like the bladder wall is described as a significant challenge (’074 Patent, col. 7:15-39).
  • The Patented Solution: The invention is a "thermoreversible hydrogel" composition that is liquid at room temperature, allowing it to be easily injected into a body cavity, but which transitions to a viscous, adhesive gel at body temperature (’074 Patent, col. 10:3-10). This property, known as reverse thermal gelation, allows the material to conform to and coat the internal surfaces of an organ, providing a stable reservoir for the sustained release of a therapeutic agent directly to the target tissue (’074 Patent, col. 9:46-54).
  • Technical Importance: This approach provides a method for prolonging the contact time between a topical drug and its target tissue within a body cavity, potentially enhancing treatment efficacy while minimizing systemic exposure (’074 Patent, col. 9:55-63).

Key Claims at a Glance

  • The complaint alleges infringement of "at least one claim" (Compl. ¶34). Based on the infringement allegations, independent claim 1 appears to be a representative asserted claim.
  • Claim 1 (Composition):
    • A thermoreversible hydrogel, comprising:
    • between 23% and 27% (w/w) of an ethylene oxide/propylene oxide triblock copolymer having a general formula E101 P56 E101;
    • between 0.1% and 0.2% hydroxypropylmethylcellulose (HPMC);
    • between 0.5% and 1% polyethylene glycol 400 (PEG-400); and
    • the balance water.

U.S. Patent No. 9,950,069 - *Material and Method for Treating Internal Cavities*

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’074 Patent: the difficulty of achieving sustained topical drug delivery within internal body cavities due to fluid flow and the non-adherent nature of mucosal tissues (’069 Patent, col. 7:1-14, 7:15-39).
  • The Patented Solution: The ’069 Patent discloses a substantially similar thermoreversible hydrogel composition designed to be liquid at lower temperatures for administration and to become a viscous gel at body temperature, thereby adhering to organ walls for sustained drug release (’069 Patent, col. 9:46-54, 10:3-10). The specific formulation is intended to provide a stable platform for delivering therapeutic agents over a prolonged period.
  • Technical Importance: The technology aims to improve outcomes for localized diseases like bladder cancer by maintaining a higher drug concentration at the treatment site for a longer duration compared to standard liquid instillations (’069 Patent, col. 5:49-54).

Key Claims at a Glance

  • The complaint alleges infringement of "at least one claim" (Compl. ¶57). Based on the infringement allegations, independent claim 1 appears to be a representative asserted claim.
  • Claim 1 (Composition):
    • A thermoreversible hydrogel, comprising:
    • between 23% and 27% (w/w) of an ethylene oxide/propylene oxide triblock copolymer having a general formula E101 P56 E101;
    • between 0.1% and 0.2% hydroxypropylmethylcellulose (HPMC);
    • between 0.5% and 1% polyethylene glycol 400 (PEG-400); and
    • the balance water.

U.S. Patent No. 12,268,745 - *Material and Method for Treating Internal Cavities*

The Invention Explained

  • Technology Synopsis: The ’745 patent is directed to a specific method of using a thermoreversible hydrogel composition for treating renal pelvis cancer. The method involves preparing a composition containing mitomycin C and an excipient (mannitol) in a specific hydrogel formulation and administering it to the renal pelvis of a patient (’745 Patent, Abstract; col. 1:1-21).
  • Accused Features: The accused features are the anticipated use of Teva's Proposed ANDA Product by healthcare professionals, following instructions on its proposed label, to reconstitute mitomycin C (which contains mannitol) with the provided hydrogel and administer it to treat low-grade Upper Tract Urothelial Cancer, which includes renal pelvis cancer (Compl. ¶¶ 83-90).

Key Claims at a Glance

  • Asserted Claims: Claim 1 (independent method claim) (Compl. ¶¶ 79-80).

III. The Accused Instrumentality

Product Identification

  • Defendant's Proposed ANDA Product, a generic version of JELMYTO® (mitomycin) for pyelocalyceal solution, 40 mg/vial (Compl. ¶9).

Functionality and Market Context

  • The complaint alleges the accused product is a kit that will contain a powder with 40 mg of mitomycin and a separate vial of a sterile thermoreversible hydrogel for reconstitution (Compl. ¶¶ 34, 57, 82). The complaint states, on information and belief, that this hydrogel will comprise specific weight-by-weight percentages of poloxamer, hydroxypropylmethylcellulose (HPMC), and polyethylene glycol (PEG-400) (Compl. ¶¶ 34, 57, 87).
  • The proposed labeling for the product is alleged to be substantially identical to the JELMYTO® label, instructing healthcare professionals to reconstitute the mitomycin powder with the hydrogel and instill it into a patient's pyelocalyceal system to treat low-grade Upper Tract Urothelial Cancer (LG-UTUC) (Compl. ¶¶ 35-36, 83-84). The complaint references the JELMYTO® label (Exhibit D), which describes how the product will "fill and conform to the cavity and become a gel" for prolonged exposure to mitomycin (Compl. ¶36).

IV. Analysis of Infringement Allegations

’074 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A thermoreversible hydrogel, comprising: Teva's Proposed ANDA Product will be sold with a sterile thermoreversible hydrogel composition for reconstitution. ¶34 col. 10:3-6
between 23% and 27% (w/w) of an ethylene oxide/propylene oxide triblock copolymer having a general formula E101 P56 E101; The complaint alleges, on information and belief, that the accused hydrogel comprises between 23% and 27% (w/w) poloxamer. The patent identifies Poloxamer 407 (PF-127) as a suitable copolymer. ¶34, ¶45 col. 33:63-34:20
between 0.1% and 0.2% hydroxypropylmethylcellulose (HPMC); The complaint alleges, on information and belief, that the accused hydrogel comprises between 0.1% and 0.2% HPMC. ¶34, ¶45 col. 35:3-13
between 0.5% and 1% polyethylene glycol 400 (PEG-400); and The complaint alleges, on information and belief, that the accused hydrogel comprises between 0.5% and 1% PEG-400. ¶34, ¶45 col. 31:18-30
the balance water. The complaint does not explicitly allege the presence of water, but it is an inherent component of an aqueous hydrogel formulation as described. ¶34, ¶45 col. 11:24-30

’069 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A thermoreversible hydrogel, comprising: Teva's Proposed ANDA Product will be sold with a sterile thermoreversible hydrogel composition for reconstitution. ¶57 col. 10:3-6
between 23% and 27% (w/w) of an ethylene oxide/propylene oxide triblock copolymer having a general formula E101 P56 E101; The complaint alleges, on information and belief, that the accused hydrogel comprises between 23% and 27% (w/w) poloxamer. The patent identifies Poloxamer 407 (PF-127) as a suitable copolymer. ¶57, ¶68 col. 33:63-34:20
between 0.1% and 0.2% hydroxypropylmethylcellulose (HPMC); The complaint alleges, on information and belief, that the accused hydrogel comprises between 0.1% and 0.2% HPMC. ¶57, ¶68 col. 35:3-13
between 0.5% and 1% polyethylene glycol 400 (PEG-400); and The complaint alleges, on information and belief, that the accused hydrogel comprises between 0.5% and 1% PEG-400. ¶57, ¶68 col. 31:18-30
the balance water. The complaint does not explicitly allege the presence of water, but it is an inherent component of an aqueous hydrogel formulation as described. ¶57, ¶68 col. 11:24-30

Identified Points of Contention

  • Factual Questions: A primary factual dispute will concern whether Teva's Proposed ANDA Product actually contains the components within the specific weight-by-weight percentage ranges required by the independent claims of the ’074 and ’069 Patents. The complaint makes these allegations "on information and belief," suggesting discovery will be required to confirm the precise formulation.
  • Scope Questions: For the ’745 Patent, a key issue may be whether the indication on the accused product's label, "low-grade Upper Tract Urothelial Cancer (LG-UTUC)" (Compl. ¶84), falls within the scope of the claim term "treating renal pelvis cancer" (Compl. ¶80). The parties may dispute whether LG-UTUC is synonymous with, inclusive of, or distinct from "renal pelvis cancer" as understood in the context of the patent.

V. Key Claim Terms for Construction

For the ’074 and ’069 Patents

  • The Term: "thermoreversible hydrogel"
  • Context and Importance: This term defines the fundamental nature of the claimed composition. Its construction is critical because it underpins the invention's core mechanism of being liquid at a cool administration temperature and gelling at body temperature. Practitioners may focus on this term because the scope could depend on the specific temperature transitions and viscosity changes required to qualify as "thermoreversible."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the concept broadly as compositions whose "viscosity increases with increasing temperature" (’074 Patent, col. 34:5-9). This could support an interpretation covering any hydrogel exhibiting this general property.
    • Evidence for a Narrower Interpretation: The specification also provides specific viscosity targets, such as "a viscosity of less than 200 Pa·s over a temperature range of 4° C.-12° C.; a viscosity of greater than 10³ Pas at 37° C." (’074 Patent, col. 9:17-20). This language could support a narrower construction requiring the hydrogel to meet these specific performance metrics.

For the ’745 Patent

  • The Term: "treating renal pelvis cancer"
  • Context and Importance: This term in method claim 1 of the ’745 Patent defines the specific disease to be treated. Its construction will be central to the infringement analysis, as infringement depends on whether the instructions on Teva's proposed label induce the performance of this claimed method. The complaint alleges the label will be for "low-grade Upper Tract Urothelial Cancer (LG-UTUC)" (Compl. ¶84), raising the question of whether this condition is equivalent to "renal pelvis cancer" for infringement purposes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not appear to provide an explicit definition of "renal pelvis cancer." A party might argue for its plain and ordinary meaning, which could encompass various cancers originating in that anatomical location, potentially including subtypes that fall under the broader LG-UTUC umbrella.
    • Evidence for a Narrower Interpretation: A party might argue that the term should be limited to the specific context of the invention and its disclosed embodiments. The patent's focus on "Transitional Cell Carcinoma (TCC) in the upper urinary tract" (’745 Patent, col. 8:62-65) could be cited to argue that "renal pelvis cancer" should be construed more narrowly than the full scope of what might be considered LG-UTUC.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement for all three patents. The basis for this allegation is that Teva's proposed product labeling, which is expected to be substantially identical to the JELMYTO® label, will instruct and encourage healthcare professionals to reconstitute and administer the product in a manner that practices the claimed methods and uses the claimed compositions (Compl. ¶¶ 37, 60, 92).
  • Willful Infringement: The complaint does not use the term "willful" but makes allegations that may support such a claim later. It alleges Teva has actual knowledge of the ’074 and ’069 patents from their listing in the Orange Book and from Teva's own notice letter (Compl. ¶¶ 37, 60). For the ’745 patent, knowledge is alleged as of the filing of the Amended Complaint (Compl. ¶91). The complaint further alleges that Teva's non-infringement and invalidity positions lack an objective good faith basis, asserting the case is "exceptional" (Compl. ¶¶ 40, 63, 95).

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

  • A central factual question will be one of compositional identity: will discovery confirm that Defendant’s proposed hydrogel formulation contains poloxamer, HPMC, and PEG-400 within the exact weight-by-weight percentage ranges recited in the asserted composition claims of the ’074 and ’069 patents?
  • A key issue of claim construction will be one of definitional scope: can the method claim term "treating renal pelvis cancer" in the ’745 patent be construed to cover the treatment of "low-grade Upper Tract Urothelial Cancer," the indication that Plaintiff alleges will appear on the accused product's label?
  • An evidentiary question for inducement will be one of instructional clarity: does the language of the accused product’s label, as described in the complaint by reference to the JELMYTO® label (Compl., Ex. D), actively instruct or encourage healthcare professionals to perform all steps of the asserted method claim, particularly the administration to a "renal pelvis" for treating "renal pelvis cancer"?