DCT

1:25-cv-00458

Veloxis Pharma Inc v. Glenmark Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00458, D. Del., 04/14/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is incorporated in Delaware and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) for generic extended-release tacrolimus tablets constitutes an act of infringement of eight U.S. patents covering Plaintiff's branded drug, ENVARSUS XR®.
  • Technical Context: The dispute centers on formulations of tacrolimus, a critical immunosuppressant drug used to prevent organ rejection in transplant patients, particularly in extended-release dosage forms that allow for once-daily administration.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendant’s submission of ANDA No. 217905 and its accompanying Paragraph IV certifications. Defendant asserts in a March 3, 2025 notice letter that the asserted patents are either not infringed and/or are invalid.

Case Timeline

Date Event
2007-05-30 Earliest Priority Date ('998, '199, '081, '331, '103 Patents)
2010-02-17 Earliest Priority Date ('918, '190, '823 Patents)
2014-04-01 U.S. Patent No. 8,685,998 Issues
2017-01-24 U.S. Patent No. 9,549,918 Issues
2019-01-01 U.S. Patent No. 10,166,190 Issues
2020-12-15 U.S. Patent No. 10,864,199 Issues
2021-09-07 U.S. Patent No. 11,110,081 Issues
2021-09-21 U.S. Patent No. 11,123,331 Issues
2022-08-23 U.S. Patent No. 11,419,823 Issues
2024-09-10 U.S. Patent No. 12,083,103 Issues
2025-03-03 Date of Defendant's ANDA Notice Letter
2025-04-14 Complaint Filing Date

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

Full analysis is provided for the third and fourth patents listed in the complaint, U.S. Patent Nos. 10,166,190 and 10,864,199, as representative of the two distinct technology groups asserted.

U.S. Patent No. 10,166,190: "Stabilized Tacrolimus Composition" (Issued Jan. 1, 2019)

The Invention Explained

  • Problem Addressed: The patent's background section describes that tacrolimus, a poorly soluble drug, is often formulated as a solid dispersion to improve bioavailability. However, this formulation format increases the molecular motility of the drug, which in turn increases the risk of chemical degradation and the formation of undesirable impurities over the product's shelf-life ('190 Patent, col. 3:49-65).
  • The Patented Solution: The invention claims to solve this problem with a pharmaceutical composition that includes a "stabilizing agent" within the solid dispersion ('190 Patent, Abstract). This agent, preferably an organic acid like tartaric acid, is capable of providing a pH below 7 when the composition is re-dispersed in water, which prevents or reduces the formation of major degradation products, particularly an isomer known as 8-epitacrolimus ('190 Patent, col. 4:16-39, col. 8:5-12).
  • Technical Importance: This technology allows for the creation of oral tacrolimus formulations that combine the bioavailability advantages of a solid dispersion with improved chemical stability, a critical factor for ensuring consistent potency and safety in pharmaceutical products (Compl. ¶2).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶56).
  • The complaint does not provide sufficient detail to break down the asserted claim into its essential elements.

U.S. Patent No. 10,864,199: "Tacrolimus for Improved Treatment of Transplant Patients" (Issued Dec. 15, 2020)

The Invention Explained

  • Problem Addressed: The patent addresses the clinical challenges of conventional immediate-release tacrolimus formulations, which exhibit highly variable absorption and metabolism. This variability necessitates frequent, often twice-daily, dosing and careful blood monitoring to keep the drug within its narrow therapeutic window and avoid significant side effects associated with high peak plasma concentrations ('199 Patent, col. 2:37-52).
  • The Patented Solution: The invention is an extended-release oral dosage form that releases tacrolimus over a "very extended period of time" ('199 Patent, Abstract). This formulation is designed to provide an improved pharmacokinetic profile characterized by a lower peak concentration (Cmax), an extended time to reach that peak (Tmax), and a higher minimum concentration (Cmin) over a 24-hour period, enabling effective once-daily dosing ('199 Patent, col. 4:35-54). The patent's Figure 1 graphically depicts such a dissolution profile ('199 Patent, Fig. 1).
  • Technical Importance: This extended-release profile allows for once-daily administration, which may improve patient compliance, while also providing a more stable and predictable drug concentration in the blood, potentially reducing the risk of both organ rejection (from low troughs) and toxicity (from high peaks) (Compl. ¶2).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 14 (Compl. ¶67).
  • The complaint does not provide sufficient detail to break down the asserted claim into its essential elements.

Multi-Patent Capsules

  • U.S. Patent No. 8,685,998: "Tacrolimus for Improved Treatment of Transplant Patients" (Issued Apr. 1, 2014)

    • Technology Synopsis: This patent, like the ’199 Patent, relates to extended-release oral dosage forms of tacrolimus designed to provide an improved pharmacokinetic profile for once-daily dosing in transplant patients (Compl. ¶10).
    • Asserted Claims: At least claim 1 (Compl. ¶34).
    • Accused Features: Defendant's ANDA Products and their proposed method of use (Compl. ¶34).

  • U.S. Patent No. 9,549,918: "Stabilized Tacrolimus Composition" (Issued Jan. 24, 2017)

    • Technology Synopsis: This patent, like the ’190 Patent, is directed to stabilizing tacrolimus compositions, particularly solid dispersions, against chemical degradation through the use of specific excipients (Compl. ¶11).
    • Asserted Claims: At least claim 1 (Compl. ¶45).
    • Accused Features: The composition of Defendant's ANDA Products (Compl. ¶45).

  • U.S. Patent No. 11,110,081: "Tacrolimus for Improved Treatment of Transplant Patients" (Issued Sep. 7, 2021)

    • Technology Synopsis: This patent relates to extended-release oral dosage forms of tacrolimus designed to provide an improved pharmacokinetic profile for once-daily dosing in transplant patients (Compl. ¶14).
    • Asserted Claims: At least claim 1 (Compl. ¶77).
    • Accused Features: Defendant's ANDA Products and their proposed method of use (Compl. ¶77).

  • U.S. Patent No. 11,123,331: "Tacrolimus for Improved Treatment of Transplant Patients" (Issued Sep. 21, 2021)

    • Technology Synopsis: This patent relates to extended-release oral dosage forms of tacrolimus designed to provide an improved pharmacokinetic profile for once-daily dosing in transplant patients (Compl. ¶15).
    • Asserted Claims: At least claim 1 (Compl. ¶87).
    • Accused Features: Defendant's ANDA Products and their proposed method of use (Compl. ¶87).

  • U.S. Patent No. 11,419,823: "Stabilized Tacrolimus Composition" (Issued Aug. 23, 2022)

    • Technology Synopsis: This patent is directed to stabilizing tacrolimus compositions, particularly solid dispersions, against chemical degradation through the use of specific excipients (Compl. ¶16).
    • Asserted Claims: At least claim 1 (Compl. ¶97).
    • Accused Features: The composition of Defendant's ANDA Products (Compl. ¶97).

  • U.S. Patent No. 12,083,103: "Tacrolimus for Improved Treatment of Transplant Patients" (Issued Sep. 10, 2024)

    • Technology Synopsis: This patent relates to extended-release oral dosage forms of tacrolimus designed to provide an improved pharmacokinetic profile for once-daily dosing in transplant patients (Compl. ¶17).
    • Asserted Claims: At least claim 1 (Compl. ¶108).
    • Accused Features: Defendant's ANDA Products and their proposed method of use (Compl. ¶108).

III. The Accused Instrumentality

  • Product Identification: Defendant’s proposed 0.75 mg, 1 mg, and 4 mg extended-release tablets containing tacrolimus, for which Defendant submitted ANDA No. 217905 to the FDA (Compl. ¶1).
  • Functionality and Market Context: The accused products are generic versions of Plaintiff’s ENVARSUS XR® product (Compl. ¶2). By filing the ANDA, Defendant represents that its products contain the same active ingredient, are administered by the same route, and have the same dosage form and strengths as ENVARSUS XR® (Compl. ¶23). The products are immunosuppressants intended for the prophylaxis of organ rejection in kidney transplant patients (Compl. ¶19, ¶23). Defendant seeks FDA approval to market these generic products prior to the expiration of the Patents-in-Suit (Compl. ¶1, ¶22).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for analysis of infringement on a claim-element-by-claim-element basis. The pleading makes conclusory allegations that the Defendant's ANDA Products and/or their use in accordance with the product label will satisfy each element of the asserted claims (e.g., Compl. ¶34, ¶45, ¶56, ¶67, ¶77, ¶87, ¶97, ¶108). No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Compositional Questions: For the patents directed to "Stabilized Tacrolimus Compositions" (e.g., the '190 Patent), a central question will be factual and evidentiary: does the specific formulation of Defendant's ANDA product contain a "stabilizing agent" that provides a "pH below 7" as those terms are defined in the patents? The dispute may focus on whether the excipients in the generic product perform the claimed stabilizing function.
    • Functional/Performance Questions: For the patents directed to "Improved Treatment" (e.g., the '199 Patent), a key issue will be whether Defendant's product meets the specific pharmacokinetic or in-vitro dissolution profiles recited in the claims. The fact that Defendant's product is represented as bioequivalent does not automatically mean it infringes claims directed to a particular method of achieving that result (Compl. ¶23).

V. Key Claim Terms for Construction

  • Term 1 (from '190 Patent family): "stabilizing agent"

    • Context and Importance: The infringement analysis for the composition patents hinges on whether Defendant's formulation contains this claimed element. Its construction will determine what types of excipients fall within the claim scope. Practitioners may focus on this term because Defendant will likely argue that its formulation achieves stability via a different, non-infringing mechanism or using excipients that do not meet the patent's definition of a "stabilizing agent."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a functional definition, stating the agent is one "capable of providing a pH below 7 in the composition, as measured after re-dispersing the composition in water" ('190 Patent, col. 4:25-28). It also provides a broad list of potential agents, including "inorganic acids, inorganic bases, inorganic salts, organic acids, organic bases, and pharmaceutically acceptable salts thereof" ('190 Patent, col. 4:30-35).
      • Evidence for a Narrower Interpretation: The preferred embodiments and examples consistently focus on organic acids with metal-chelating properties, such as tartaric acid, citric acid, and oxalic acid ('190 Patent, col. 4:37-39; col. 8:5-12). A defendant may argue that the term should be limited to substances that provide both pH regulation and chelation, which the patent identifies as a key mechanism for stability.

  • Term 2 (from '199 Patent family): "releases the active substance over an very extended period of time"

    • Context and Importance: This term is central to the point of novelty for the extended-release patents. Its construction will define the required dissolution performance for infringement. Defendant will likely argue its product, while being an "extended-release" tablet in the FDA's view, does not release over a "very extended period" as construed from the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The abstract and summary describe the invention in general terms, contrasting it with conventional immediate-release formulations without being strictly limited to a single numerical profile ('199 Patent, Abstract).
      • Evidence for a Narrower Interpretation: The specification provides highly specific, quantitative definitions of the release profile, such as releasing "at the most 63.5% of the content of the active substance at the 12 hours time point" when tested under specific USP dissolution conditions ('199 Patent, col. 10:35-42). A defendant may argue these quantitative descriptions define and limit the scope of the term.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is based on the allegation that Defendant's product labeling will instruct physicians and patients to administer the ANDA products in a manner that infringes the asserted method claims (e.g., Compl. ¶37, ¶69). Contributory infringement is based on the allegation that the ANDA products are especially made or adapted for an infringing use and have no substantial non-infringing use (e.g., Compl. ¶38, ¶70).
  • Willful Infringement: Willfulness is alleged based on Defendant’s alleged knowledge of the patents prior to filing its ANDA (e.g., Compl. ¶41, ¶52, ¶63). The complaint asserts this makes the case "exceptional" and entitles Plaintiff to enhanced damages and attorneys' fees (e.g., Compl. ¶42, ¶53, ¶64).

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

  • A central issue will be one of compositional identity: Does the precise formulation of Defendant's generic product, as disclosed in its confidential ANDA, contain a "stabilizing agent" that functions in the manner claimed by the '190 patent family, or does it achieve stability through alternative, non-infringing means?
  • A key evidentiary question will be one of functional performance: Will testing of Defendant's ANDA product demonstrate that it meets the specific, quantitative in-vitro dissolution profiles required by the claims of the '199 patent family, or does it achieve bioequivalence through a release mechanism that falls outside the claimed parameters?
  • A third question, common in Hatch-Waxman litigation, will be the validity of the asserted claims. Defendant has asserted in its Paragraph IV notice letter that the claims are invalid, and this will likely be a primary defense, focusing on issues such as obviousness over prior art tacrolimus formulations (Compl. ¶24-31).