DCT

2:24-cv-07094

Janssen Pharma Inc v. Qilu Pharmaceutical Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07094, D.N.J., 06/18/2024
  • Venue Allegations: Venue is asserted based on Defendants' alleged systematic and continuous business contacts within New Jersey, including the sale of pharmaceutical products. The complaint also cites prior litigation in the district where Defendants allegedly consented to or did not contest venue.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the antipsychotic drug Invega Sustenna® constitutes an act of infringement of a patent covering a specific dosing regimen.
  • Technical Context: The technology concerns long-acting injectable formulations of paliperidone palmitate for treating schizophrenia, where specific dosing regimens are critical for rapidly achieving and maintaining therapeutic plasma concentrations, thereby improving patient compliance and treatment efficacy.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiff, via a letter dated May 8, 2024, of their ANDA filing containing a Paragraph IV certification of non-infringement, invalidity, or unenforceability of the patent-in-suit. The complaint notes previous cases in the District of New Jersey where Defendants have consented to jurisdiction and venue.

Case Timeline

Date Event
2007-12-19 U.S. Patent No. 9,439,906 Earliest Priority Date
2016-09-13 U.S. Patent No. 9,439,906 Issue Date
2024-05-08 Date of Defendants' Notice Letter regarding ANDA filing
2024-06-18 Complaint Filing Date

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

U.S. Patent No. 9,439,906 - "Dosing Regimen Associated With Long Acting Injectable Paliperidone Esters"

  • Patent Identification: U.S. Patent No. 9,439,906, "Dosing Regimen Associated With Long Acting Injectable Paliperidone Esters," issued September 13, 2016. (Compl. ¶36).

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of administering long-acting injectable paliperidone palmitate to achieve a therapeutic plasma concentration quickly and maintain it. The patent’s background section notes that the absorption of the drug from injections was discovered to be "far more complex than was originally anticipated" and dependent on the injection site, making it difficult to establish an optimal dosing regimen. (’906 Patent, col. 2:1-6).
  • The Patented Solution: The invention provides a specific dosing regimen to overcome this problem. It consists of initial, higher "loading doses" administered into the deltoid (shoulder) muscle, which results in a faster initial rise in drug concentration, followed by subsequent, lower "maintenance doses" administered monthly. (’906 Patent, Abstract; col. 5:1-15). This front-loading approach is designed to rapidly bring the patient to a therapeutic level, which is then sustained by the monthly injections.
  • Technical Importance: For chronic illnesses like schizophrenia, adherence to daily oral medication is a significant challenge. This patented regimen for a long-acting injectable offers a method to enhance compliance and ensure sustained therapeutic effect, which is a critical factor in managing the disease and preventing relapse. (’906 Patent, col. 2:49-59).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-21. (Compl. ¶40).
  • Independent Claim 1, a method claim, recites the core elements of the dosing regimen:
    • Administering a first loading dose of "about 150 mg-eq." of paliperidone palmitate in the deltoid muscle on the first day of treatment.
    • Administering a second loading dose of "about 100 mg-eq." in the deltoid muscle on the "6th to about 10th day of treatment."
    • Administering a first maintenance dose of "about 25 mg-eq. to about 150 mg-eq." in the deltoid or gluteal muscle "a month (±7 days) after the second loading dose."
  • Independent Claims 4, 8, and 11 recite similar dosing regimens with variations in timing and dosage amounts, including specific regimens for renally impaired patients.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "Qilu's Proposed Generic Products," which are the subject of ANDA No. 217889. These products are generic versions of Plaintiff's Invega Sustenna® brand paliperidone palmitate extended-release injectable suspension products. (Compl. ¶2, 41).

Functionality and Market Context

  • The accused products are injectable suspensions of paliperidone palmitate intended for the treatment of schizophrenia. (Compl. ¶2; ’906 Patent, col. 2:11-16). The complaint alleges the act of infringement is the submission of the ANDA itself, which seeks FDA approval to market generic versions in 117 mg, 156 mg, and 234 mg doses. (Compl. ¶41, 48). A central allegation is that, pursuant to FDA regulations, the labeling for Qilu's proposed generic products must be the same as the FDA-approved labeling for Invega Sustenna®, which allegedly instructs users to practice the patented dosing method. (Compl. ¶50).

IV. Analysis of Infringement Allegations

The complaint does not contain an explicit claim chart. The infringement theory is predicated on the submission of ANDA No. 217889 under 35 U.S.C. § 271(e)(2) and the allegation that the proposed product label will instruct for an infringing use. (Compl. ¶48, 50). The following chart summarizes the apparent infringement theory for the lead independent claim.

No probative visual evidence provided in complaint.

’906 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising: The proposed product is a generic version of Invega Sustenna®, an antipsychotic for treating schizophrenia, and its labeling is alleged to instruct a dosing regimen for this patient population. ¶2, 50 col. 1:12-16
(1) administering intramuscularly in the deltoid...a first loading dose of about 150 mg-eq. of paliperidone...on the first day of treatment; The proposed product labeling will allegedly instruct the administration of a 150 mg-eq. dose (equivalent to the 234 mg dosage form in the ANDA) in the deltoid on day 1. ¶41, 50 col. 2:63-67
(2) administering intramuscularly in the deltoid muscle...a second loading dose of about 100 mg-eq. of paliperidone...on the 6th to about 10th day of treatment; and The proposed product labeling will allegedly instruct the administration of a 100 mg-eq. dose (equivalent to the 156 mg dosage form in the ANDA) in the deltoid approximately one week after the first dose. ¶41, 50 col. 3:1-4
(3) administering intramuscularly in the deltoid or gluteal muscle...a first maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone...a month (±7 days) after the second loading dose. The proposed product labeling will allegedly instruct monthly administration of maintenance doses within the claimed range (covered by the 117 mg, 156 mg, and 234 mg dosage forms) in either the deltoid or gluteal muscle. ¶41, 50 col. 5:37-40
  • Identified Points of Contention:
    • Scope Questions: A likely point of dispute will be the interpretation of the term "about" as it applies to the dosage amounts. The parties may contest the degree of numerical precision required by the claims. The timing elements, such as "on the 6th to about 10th day" and "a month (±7 days)," may also be subject to construction arguments regarding their precise scope and flexibility.
    • Technical Questions: The primary question is one of infringement. As an ANDA filer, Qilu has certified non-infringement. (Compl. ¶42). This raises the question of whether Qilu’s proposed labeling will contain a "carve-out" of the patented method of use. The complaint does not contain the proposed label, so the exact nature of the non-infringement defense is not yet detailed. A defense of invalidity, likely based on obviousness over prior art paliperidone formulations and known pharmacokinetic principles, is also anticipated.

V. Key Claim Terms for Construction

  • The Term: "about [X] mg-eq." (e.g., "about 150 mg-eq.")

  • Context and Importance: This term appears in the dosing limitations of all asserted independent claims. Its construction is critical because it defines the scope of the claimed dosages. The court’s interpretation will determine whether the specific dosage strengths for which Qilu seeks approval fall within the literal scope of the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The repeated use of "about" throughout the patent specification in the context of doses may suggest the inventors intended a degree of variability and not strict numerical limits. (e.g., ’906 Patent, col. 2:15, 19, 24).
    • Evidence for a Narrower Interpretation: The patent discloses specific clinical trial data and pharmacokinetic models based on precise doses (e.g., 150 mg, 100 mg). (e.g., ’906 Patent, Figs. 1-3; Example 8). A party could argue that these specific values are what distinguishes the invention and that "about" should therefore be construed narrowly to encompass only minor variations.

  • The Term: "a month (±7 days)"

  • Context and Importance: This term in Claim 1 defines the timing for administering the first and subsequent maintenance doses. Practitioners may focus on this term because the regularity and timing of injections are central to maintaining the therapeutic effect that the patent claims to provide.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent explicitly provides a window of "±7 days," indicating flexibility was contemplated. The specification also refers to dosing "approximately monthly," which could support an interpretation that strict adherence to a 30-day cycle is not required. (’906 Patent, col. 3:8, col. 5:25-26).
    • Evidence for a Narrower Interpretation: The patent’s focus on achieving and maintaining a steady-state plasma concentration could be used to argue that the timing window is a critical part of the calibrated regimen and should not be expanded beyond its explicit terms. (’906 Patent, col. 2:3, col. 5:11-15).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement theory is based on the allegation that Qilu knows its product, if approved, will be used in an infringing manner because its label will be required to copy the innovator's label, which instructs the patented method. (Compl. ¶50). The contributory infringement allegation posits that Qilu’s product is specifically designed for this infringing use and is not a staple article of commerce with substantial non-infringing uses. (Compl. ¶51).
  • Willful Infringement: The complaint alleges that Qilu has actual knowledge of the ’906 Patent, evidenced by the notice letter sent to Janssen. (Compl. ¶46). This forms the basis for a claim that any post-approval infringement would be willful, potentially entitling Plaintiffs to enhanced damages. The complaint also seeks a finding that the case is exceptional, which could lead to an award of attorneys' fees. (Compl. ¶54).

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

  • A key legal and factual question will be one of infringement by labeling: will Qilu’s proposed generic label necessarily instruct the performance of the patented dosing regimen, or can Qilu successfully "carve out" the patented method of use to avoid inducement, and if so, can its product still be considered a generic equivalent to Invega Sustenna®?
  • The case will likely turn on a question of invalidity: was the claimed dosing regimen—specifically the use of deltoid-injected loading doses to achieve a rapid therapeutic effect—an obvious-to-try approach for a person of ordinary skill in pharmacokinetics, given prior knowledge of paliperidone and the generally understood differences in absorption rates between deltoid and gluteal injection sites?
  • A core issue will also be one of definitional scope: how will the court construe the term "about" in the context of the claimed dosages? The outcome of this claim construction will be pivotal in determining whether the specific doses in Qilu's ANDA literally infringe the patent.