DCT

2:20-cv-13103

Janssen Pharma Inc v. Mylan Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:20-cv-13103, D.N.J., 09/23/2020
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey based on Defendants’ business operations, sales of pharmaceutical products within the state, and the act of filing an Abbreviated New Drug Application (ANDA) that will foreseeably cause harm to Plaintiffs in New Jersey. The complaint also notes that Defendant Mylan Labs has agreed not to contest venue and jurisdiction for this action.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an ANDA to market a generic version of the long-acting injectable antipsychotic Invega Trinza® constitutes an act of infringement of a patent covering a specific dosing regimen for patients who have missed a scheduled dose.
  • Technical Context: The technology concerns a method for managing patients treated with a long-acting (3-month) injectable antipsychotic who miss a dose, a significant issue for maintaining therapeutic efficacy and preventing relapse in the treatment of chronic psychiatric conditions.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants’ submission of ANDA No. 212290 with a Paragraph IV certification, asserting that U.S. Patent No. 10,143,693 is invalid, unenforceable, or will not be infringed by their proposed generic product. The patent-in-suit is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for Invega Trinza®.

Case Timeline

Date Event
2015-04-07 ’693 Patent Priority Date
2018-12-04 ’693 Patent Issued
2020-08-14 Defendants send Paragraph IV Notice Letter
2020-09-23 Complaint Filed

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

U.S. Patent No. 10,143,693 - "Dosing Regimen For Missed Doses For Long-Acting Injectable Paliperidone Esters," issued December 4, 2018

The Invention Explained

  • Problem Addressed: The patent addresses a clinical challenge in psychiatric treatment: how to safely and effectively re-initiate treatment for a patient who is on a 3-month long-acting injectable antipsychotic (paliperidone palmitate) but misses a scheduled dose by a significant period of time ('693 Patent, col. 2:20-29). Simply resuming the 3-month dose could result in sub-therapeutic drug concentrations, increasing the risk of relapse ('693 Patent, col. 2:15-20).
  • The Patented Solution: The invention provides specific, multi-step "re-initiation regimens" tailored to the length of time a dose has been missed. For example, for a patient who misses a dose by more than nine months, the patented method involves administering a series of lower-dose, monthly formulation injections to re-establish a stable plasma concentration before resuming the standard 3-month injections ('693 Patent, col. 2:33-52; col. 4:8-52). This structured "re-loading" process is designed to bridge the therapeutic gap created by the missed dose.
  • Technical Importance: The invention provides a standardized, data-supported protocol to manage patient non-adherence, a critical factor in the long-term management of chronic mental illnesses like schizophrenia where maintaining stable drug levels is paramount for symptom control ('693 Patent, col. 1:52-59).

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 (Compl. ¶50, 57-61).
  • Independent Claim 1 recites a six-step dosing regimen for a patient who has missed a 3-month paliperidone palmitate injection by more than nine months, comprising:
    • Administering a first reinitiation loading dose of 150 mg eq. of a monthly formulation (PP1M)
    • Administering a second reinitiation loading dose of 100 mg eq. of PP1M between 4 and 12 days later
    • Administering a first reinitiation maintenance dose of 50-150 mg eq. of PP1M between 23 and 37 days after the second dose
    • Administering a second reinitiation maintenance dose of 50-150 mg eq. of PP1M between 23 and 37 days after the first maintenance dose
    • Administering a third reinitiation maintenance dose of 50-150 mg eq. of PP1M between 23 and 37 days after the second maintenance dose
    • Administering a 175-525 mg eq. dose of the 3-month formulation (PP3M) between 23 and 37 days after the last maintenance dose
  • The complaint's broad assertion of infringement of "one or more claims" suggests the right to assert dependent claims may be preserved (Compl. ¶B).

III. The Accused Instrumentality

Product Identification

  • Defendants' proposed generic versions of Janssen's Invega Trinza® brand products, which are described as generic paliperidone palmitate extended-release injectable suspensions and are the subject of ANDA No. 212290 (Compl. ¶¶ 51, 58).

Functionality and Market Context

  • As a generic product submitted via an ANDA, the functionality of the accused product is defined by its proposed labeling. The complaint alleges that Defendants are required by regulation to copy the FDA-approved labeling for the brand-name drug, Invega Trinza® (Compl. ¶60). The infringement theory is therefore premised on the allegation that the instructions for use on the label of Defendants' proposed generic product will direct medical professionals and patients to perform the patented dosing regimen (Compl. ¶60). The product is intended to compete as a lower-cost alternative to the brand-name drug for the treatment of psychiatric disorders (Compl. ¶2).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not include a claim chart. The infringement theory is based on induced infringement, where the proposed product label for Defendants' generic drug is alleged to instruct users to perform the patented method.

’693 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A dosing regimen for... a patient... treated with a 3-month injectable paliperidone palmitate depot (PP3M), wherein said patient had been last administered a PP3M injection more than 9 months ago... The proposed product label for Defendants' generic drug will allegedly instruct its use for re-initiating treatment in patients who have missed a dose of the 3-month formulation by more than nine months. ¶60 col. 6:52-61
(1) administering intramuscularly in the deltoid muscle... a first reinitiation loading dose of 150 mg eq. of monthly injectable paliperidone palmitate depot (PP1M); The proposed label will allegedly instruct the administration of a first 150 mg eq. dose of a monthly formulation as the initial step in the re-initiation regimen. ¶60 col. 4:8-13
(2) administering... a second reinitiation loading dose of 100 mg eq. of PP1M on about the 4th day to about the 12th day after administering said first reinitiation loading dose; The proposed label will allegedly instruct the administration of a second 100 mg eq. monthly formulation dose within the specified time window. ¶60 col. 4:19-24
(3)-(5) administering... a first, second, and third reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M... at specified intervals... The proposed label will allegedly instruct the administration of three subsequent monthly maintenance doses within the claimed dosage range and timing. ¶60 col. 4:25-42
(6) administering... from about 175 mg eq. to about 525 mg eq. of the 3-month formulation of paliperidone palmitate (PP3M)... after administering of the last reinitiation maintenance dose... The proposed label will allegedly instruct the resumption of the 3-month formulation at the claimed dosage and timing, completing the re-initiation regimen. ¶60 col. 4:43-52
  • Identified Points of Contention:
    • Scope Questions: A primary issue will be whether the specific instructions in Defendants' proposed product label will map precisely onto every step of the claimed method. A potential defense strategy could involve arguing that the label recommends an alternative, non-infringing regimen, or that it omits instruction for one or more of the six required steps, thereby breaking the chain of literal infringement. The case may raise the question of whether Defendants can "carve out" the patented method of use from their label to avoid inducement.
    • Technical Questions: The dispute may focus on whether the clinical guidance provided in the proposed generic label constitutes an instruction to perform the specific sequence of "loading" and "maintenance" doses as defined in the patent. For instance, what evidence does the complaint provide that the proposed label will require the specific dose amounts (150 mg eq. then 100 mg eq.) for the first two "loading" doses, as distinguished from the subsequent "maintenance" doses?

V. Key Claim Terms for Construction

  • The Term: "about" (e.g., "on about the 4th day to about the 12th day")

  • Context and Importance: This term appears in the timing limitations for several steps of the claimed method. Its construction is critical because it defines the window of permissible deviation from the specified dates. Practitioners may focus on this term because a narrow interpretation could allow Defendants to design a label with slightly different timing recommendations that fall outside the literal scope of the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides explicit numerical ranges that correspond to the "about" language, such as "on about the 8th day±4 (e.g. 4th day to about the 12th day)" ('693 Patent, col. 2:50-52). This language may support an interpretation that "about" encompasses a defined, multi-day window of flexibility.
    • Evidence for a Narrower Interpretation: Defendants may argue that the explicit examples provided (e.g., "4th day to about the 12th day") define the full extent of "about" and that the term does not grant broader, unspecified flexibility beyond those stated ranges.

  • The Term: "reinitiation loading dose" / "reinitiation maintenance dose"

  • Context and Importance: Claim 1 distinguishes between the first two doses ("loading doses" of 150 mg eq. and 100 mg eq.) and the next three doses ("maintenance doses" of 50-150 mg eq.). This distinction is central to the claimed method. A key question for infringement will be whether Defendants' proposed label instructs a regimen that reflects this specific two-tiered dosing structure.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent's "Summary of the Invention" and detailed description frame the regimen as a structured sequence designed to first rapidly increase and then sustain plasma levels, implicitly defining the terms by their function within the overall method ('693 Patent, col. 2:33-65).
    • Evidence for a Narrower Interpretation: A party could argue that these terms have a specific clinical definition and that a labeled regimen using, for example, a flat dose for all initial injections would not meet the claim's requirement for distinct "loading" and "maintenance" doses.

VI. Other Allegations

  • Indirect Infringement: The complaint's central theory is indirect infringement.
    • Inducement: Plaintiffs allege that Defendants will induce infringement by physicians and patients because their proposed product label will instruct users to perform the patented method (Compl. ¶60). The complaint alleges the requisite knowledge and intent are demonstrated by Defendants’ ANDA filing, their knowledge of the patent, and the regulatory requirement to copy the brand-name drug's label (Compl. ¶¶ 56, 60).
    • Contributory Infringement: Plaintiffs also allege contributory infringement, stating that Defendants' proposed product is a material part of the invention, is not a staple article of commerce suitable for substantial non-infringing use, and is specifically designed for use in an infringing manner (Compl. ¶61).
  • Willful Infringement: The complaint pleads that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶64). While not using the word "willful," the factual basis for such a claim rests on alleged pre-suit knowledge of the '693 Patent, as evidenced by Defendants’ Paragraph IV certification letter (Compl. ¶¶ 51, 56).

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

  • A core issue will be one of induced infringement and label-to-claim mapping: Will the instructions for use on Defendants’ final, FDA-approved product label direct a user to perform every step of the specific six-part re-initiation regimen recited in Claim 1? A material deviation in any element—dose, timing, or formulation—could provide a basis for a non-infringement defense.
  • A second key question will involve the viability of a "skinny label" defense: Can Defendants successfully "carve out" the patented method of use from their product's label? The case may turn on whether the patented regimen is severable from the product's primary indications or if any commercially significant use of the generic product would inevitably require practicing the claimed method.
  • A final dispositive issue may be one of claim construction: How broadly will the court interpret terms like "about" when applied to the timing of doses? The court's definition of this term will set the literal boundaries of the claims and could determine whether the instructions on Defendants' proposed label fall inside or outside that scope.