DCT

2:19-cv-16484

Janssen Pharma Inc v. Mylan Laboratories Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-16484, D.N.J., 08/08/2019
  • Venue Allegations: Venue is asserted based on Defendants' alleged systematic and continuous business contacts within New Jersey, including the sale of pharmaceutical products, and because Plaintiff Janssen Pharmaceuticals, Inc. maintains its principal place of business in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of the antipsychotic drug Invega Sustenna® constitutes an act of infringement of a patent covering a specific dosing regimen for the drug.
  • Technical Context: The technology concerns a long-acting injectable formulation of an antipsychotic drug developed to improve patient compliance, a significant challenge in the treatment of chronic mental illnesses like schizophrenia.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following a notice letter dated June 28, 2019, in which Mylan notified Janssen of its ANDA filing and its certification that the patent-in-suit is invalid, unenforceable, and/or not infringed. The complaint also notes prior litigation in the same district involving the same patent asserted against a different defendant.

Case Timeline

Date Event
2007-12-19 '906' Patent - Earliest Priority Date
2016-09-13 '906 Patent - Issue Date
2019-06-28 Date of Mylan's Notice Letter to Plaintiffs
2019-07-02 Date Plaintiffs Received Mylan's Notice Letter
2019-08-08 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 9,439,906, "Dosing Regimen Associated with Long Acting Injectable Paliperidone Esters," issued September 13, 2016.

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of achieving and maintaining a therapeutic plasma concentration of the antipsychotic drug paliperidone when delivered as a long-acting injectable. While such injectables improve patient compliance over daily oral pills, the patent notes that the drug's absorption was discovered to be "far more complex than was originally anticipated," with outcomes dependent on the site of injection (Compl., Ex. A, '906 Patent, col. 1:60-col. 2:4).
  • The Patented Solution: The patent discloses a specific dosing regimen designed to solve this problem by rapidly achieving therapeutic levels. The method involves administering initial "loading doses" into the deltoid muscle, which was found to produce a "faster rise in initial plasma concentration" compared to other injection sites, followed by subsequent monthly maintenance doses that can be administered in either the deltoid or gluteal muscle ('906 Patent, col. 5:1-16).
  • Technical Importance: This regimen provided a method to make long-acting injectable paliperidone a more effective and reliable treatment option for schizophrenia by quickly establishing therapeutic drug levels, thereby addressing the critical clinical challenge of patient non-adherence to daily oral medication ('906 Patent, col. 1:49-54).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶49).
  • The essential elements of independent claim 1 are:
    • Administering intramuscularly in the deltoid muscle a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate on the first day of treatment.
    • Administering intramuscularly in the deltoid muscle a second loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate on the 6th to about 10th day of treatment.
    • Administering intramuscularly in the deltoid or gluteal muscle a first maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate a month (±7 days) after the second loading dose.
  • The complaint alleges infringement of at least one claim, which may include dependent claims or other independent claims not specifically enumerated in the initial pleading (Compl. ¶55).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants’ proposed generic paliperidone palmitate extended-release injectable suspension products, as described in ANDA No. 213124 (Compl. ¶¶2, 50).

Functionality and Market Context

  • The products are generic versions of Plaintiffs’ Invega Sustenna® brand product, which is indicated for the treatment of schizophrenia and schizoaffective disorder in adults (Compl. ¶47). The complaint alleges that Defendants seek approval to market their generic products in various doses, including 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg, prior to the expiration of the ’906 Patent (Compl. ¶50). The infringement allegation is based on the use of these products according to a proposed label that Plaintiffs allege will instruct for an infringing dosing regimen (Compl. ¶58).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not include a claim chart. The infringement theory is one of inducement, based on the allegation that the instructions for use on the label of Defendants' proposed generic product will direct medical professionals to administer the drug in a manner that directly infringes the method claimed in the ’906 Patent.

’906 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone... on the first day of treatment; The proposed labeling for Defendants' generic product allegedly instructs physicians to administer a first loading dose in the deltoid muscle, as required by the claim. ¶¶58-59 col. 5:1-9
administering intramuscularly in the deltoid muscle of the patient... a second loading dose of about 100 mg-eq. of paliperidone... on the 6th to about 10th day of treatment; The proposed labeling for Defendants' generic product allegedly instructs physicians to administer a second loading dose in the deltoid muscle within the claimed time frame. ¶¶58-59 col. 5:10-16
administering intramuscularly in the deltoid or gluteal muscle of the patient... 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 labeling for Defendants' generic product allegedly instructs physicians to administer a subsequent maintenance dose in either the deltoid or gluteal muscle within the claimed time frame and dosage range. ¶¶58-59 col. 5:10-29
  • Identified Points of Contention:
    • Scope Questions: A potential issue for the court is whether the term "about" as used in the claims (e.g., "about 150 mg-eq.") can be interpreted to read on the specific dosages that will be instructed on Defendants' proposed label. The resolution of this question may be central to the literal infringement analysis.
    • Technical Questions: A key evidentiary question is what instructions the final, FDA-approved label for Mylan's generic product will contain. The infringement case hinges on whether those instructions will direct users to perform every step of the claimed dosing regimen. The complaint's assertion that Mylan is required to copy the brand-name label for Invega Sustenna® is the foundation of its infringement theory (Compl. ¶58).

V. Key Claim Terms for Construction

  • The Term: "about [X] mg-eq." (e.g., "about 150 mg-eq.", "about 100 mg-eq.")

  • Context and Importance: The construction of "about" is critical because infringement will depend on whether the dosages instructed on the accused product's label fall within the claimed numerical ranges. Practitioners may focus on this term because its breadth will directly impact the comparison between the claimed method and the method instructed by the accused label.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification repeatedly uses the term "about" when describing dosages, suggesting the patentee intended the term to convey numerical flexibility and not be limited to the exact values stated (e.g., '906 Patent, col. 2:15, 2:18, 2:23).
    • Evidence for a Narrower Interpretation: The patent describes clinical studies and provides figures based on specific, precise dosages (e.g., 150 mg eq., 100 mg eq.). A party could argue that these concrete examples should limit the scope of "about" to prevent the term from encompassing a wide range of clinically distinct doses ('906 Patent, FIG. 1-3; Example 8).

  • The Term: "a month (±7 days) after the second loading dose"

  • Context and Importance: This term defines the timing for the first maintenance dose. Its interpretation is important for determining whether the schedule instructed on the accused label meets this temporal limitation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification uses less precise, more general phrasing like "approximately monthly" when describing the maintenance dose schedule, which could support a reading that is not strictly confined to the explicit window ('906 Patent, col. 3:7-9).
    • Evidence for a Narrower Interpretation: The claim itself provides an explicit and precise window—"a month (±7 days)". A party may argue that this specific language, chosen by the patentee for the claim, should control over more general descriptions in the specification and defines the absolute boundary of the limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Defendants' product labeling will actively encourage and instruct physicians and patients to use the generic drug in a manner that directly infringes Claim 1 (Compl. ¶58). Contributory infringement is based on the allegation that the accused product is a material part of the invention and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶59).
  • Willful Infringement: The complaint alleges that Defendants have "actual knowledge of the '906 Patent" as evidenced by their notice letter (Compl. ¶54). While not using the word "willful," it pleads that the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285, which is predicated on such knowledge and conduct (Compl. ¶62).

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

  • A core issue will be one of claim construction: how broadly will the court interpret the term "about" in the context of specific pharmaceutical dosages? The outcome of this determination will significantly influence whether the instructions on Mylan's proposed label fall within the scope of the asserted claims.
  • A key evidentiary question will be one of induced infringement: will the final, FDA-approved label for Mylan’s generic product contain instructions that direct a user to perform every step of the patented dosing method? The case will likely turn on a detailed comparison of the accused product's label against the limitations of the asserted claims.