DCT

1:25-cv-00857

Janssen Pharma Inc v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00857, D. Del., 07/10/2025
  • Venue Allegations: Plaintiff alleges venue is proper in Delaware because Defendant Sun Inc. is a Delaware corporation and Defendant Sun Ltd. has purposefully availed itself of the district through continuous business contacts and has previously consented to or not contested venue in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the antipsychotic drug Invega Sustenna® infringes a patent covering a specific dosing regimen for the drug.
  • Technical Context: The lawsuit concerns a long-acting injectable drug formulation and its associated dosing protocol for the treatment of schizophrenia, a market where ensuring patient compliance through optimized, long-term dosing is a significant clinical objective.
  • Key Procedural History: This is a Hatch-Waxman action initiated after Plaintiff received a Notice Letter on or after May 28, 2025, in which Defendant stated it had filed ANDA No. 217818 with a Paragraph IV certification, asserting that the patent-in-suit is invalid, unenforceable, and/or not infringed by its proposed generic product. The complaint notes that Defendant has not provided a detailed statement of non-infringement or a copy of its ANDA.

Case Timeline

Date Event
2007-12-19 '906 Patent Priority Date
2016-09-13 '906 Patent Issue Date
2025-05-28 Date of Sun's Notice Letter to Plaintiffs
2025-07-10 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.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of achieving a stable and therapeutically effective plasma concentration for long-acting injectable paliperidone palmitate, an antipsychotic drug. The inventors discovered that the drug's absorption into the bloodstream was unexpectedly complex and highly dependent on the injection site (e.g., deltoid vs. gluteal muscle), making it difficult to establish an optimal dosing protocol for patients. (’906 Patent, col. 2:1-9).
  • The Patented Solution: The patent discloses a specific dosing regimen designed to rapidly achieve and then maintain therapeutic plasma levels. The solution involves administering two initial, higher-dose "loading" injections into the deltoid muscle, which results in faster initial drug absorption. These are followed by lower, monthly "maintenance" doses that can be administered in either the deltoid or gluteal muscle. (’906 Patent, col. 2:11-26; col. 5:1-15).
  • Technical Importance: This regimen was designed to improve clinical outcomes by providing sustained plasma concentrations, which may enhance compliance for psychiatric patients who have difficulty adhering to daily oral medication schedules. (’906 Patent, col. 2:50-60).

Key Claims at a Glance

  • The complaint asserts claims 1-21, which include independent claims 1, 4, 8, and 11. (Compl. ¶47).
  • Independent Claim 1 recites a dosing regimen for a psychiatric patient comprising the following essential elements:
    • Administering a first loading dose of about 150 mg-eq. of paliperidone palmitate intramuscularly into the deltoid muscle on the first day of treatment.
    • Administering a second loading dose of about 100 mg-eq. of paliperidone palmitate intramuscularly into the deltoid muscle between the 6th and 10th day of treatment.
    • Administering a first maintenance dose of about 25 mg-eq. to 150 mg-eq. of paliperidone palmitate intramuscularly into the deltoid or gluteal muscle a month (±7 days) after the second loading dose.
  • The complaint reserves the right to pursue infringement of all asserted claims, including dependent claims. (Compl. ¶47).

III. The Accused Instrumentality

Product Identification

  • "Sun's Proposed Generic Products," which are the proposed generic versions of Janssen's Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) for which Sun Ltd. has submitted ANDA No. 217818 to the FDA. (Compl. ¶2).

Functionality and Market Context

  • The complaint alleges that Sun’s generic product is a pharmaceutical formulation intended for use in treating schizophrenia. (Compl. ¶¶ 2, 39). Its relevant functionality is its administration to patients according to a prescribed dosing schedule. The complaint alleges on information and belief that the proposed generic product will be sold with instructions for use that are "substantially identical" to the FDA-approved labeling for the brand-name Invega Sustenna® product. (Compl. ¶45). The product seeks to compete with the established brand product by offering a generic alternative prior to the expiration of the ’906 Patent. (Compl. ¶2).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide specific details of the accused product's proposed label beyond alleging it will be substantially identical to the Invega Sustenna® label. (Compl. ¶¶ 44-45, 52). The following chart summarizes the infringement theory as articulated in the 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... Sun's proposed generic product is indicated for the treatment of schizophrenia and will be prescribed to such patients. The instructions for use will allegedly constitute the claimed regimen. ¶¶ 39, 45, 57 col. 2:11-12
(1) 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 product label will, on information and belief, instruct physicians and patients to administer a first loading dose of 150 mg-eq. into the deltoid muscle on day one of treatment. ¶¶ 45, 57 col. 2:13-18
(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; The proposed product label will, on information and belief, instruct the administration of a second loading dose of 100 mg-eq. into the deltoid muscle approximately one week after the first dose. ¶¶ 45, 57 col. 2:18-22
(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 label will, on information and belief, instruct the administration of subsequent monthly maintenance doses in the specified range and locations. ¶¶ 45, 57 col. 2:22-26

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Evidentiary Question: The central dispute will likely focus on the specific instructions contained in the proposed labeling for Sun's ANDA product. As the complaint was filed without access to the ANDA, a primary question is whether Sun’s proposed label will actually direct, teach, or encourage physicians to administer the product according to the specific sequence of doses, injection sites, and timings recited in the asserted claims.
    • Scope Questions: Should the ANDA label differ from the patented regimen, the case may turn on claim construction. For instance, if Sun’s label specifies a slightly different dosage, a key question for the court will be whether that dosage falls within the scope of "about 150 mg-eq." as used in the patent. Similarly, a dispute could arise over the meaning of "a month (±7 days)" if an alternative dosing interval is proposed.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a full analysis of claim construction disputes. However, based on the claim language and the nature of ANDA litigation, the following terms may become central to the case.

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

  • Context and Importance: This term modifies all key dosages in the claimed regimen. Its interpretation is critical because it defines the permissible range of deviation from the recited numerical values. Practitioners may focus on this term because its scope could determine whether a proposed generic with a slightly different, but bioequivalent, dosage literally infringes the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification repeatedly uses ranges for doses (e.g., "about 25 to about 150 mg-eq.") and describes dosing as "approximately monthly," which may suggest the inventors intended the term "about" to afford significant flexibility rather than being tied to a precise number. (’906 Patent, col. 2:23-24; col. 3:7-9).
    • Evidence for a Narrower Interpretation: The patent claims recite specific loading dose values ("150 mg-eq." and "100 mg-eq.") derived from clinical trials described in the specification. A party could argue that these specific examples and the supporting clinical data should limit the scope of "about" to a narrow range of instrumental or manufacturing tolerance. (’906 Patent, Example 8, col. 23-28).

  • The Term: "a month (±7 days)"

  • Context and Importance: This term defines the timing for the first and subsequent maintenance doses. Its construction is important for determining whether a dosing schedule that falls outside this explicit window would avoid literal infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification also uses the less precise phrase "approximately monthly," which could be used to argue that the "±7 days" language is illustrative, not strictly limiting. (’906 Patent, col. 3:7-9).
    • Evidence for a Narrower Interpretation: The claim language itself provides a specific, bounded definition ("±7 days"). A party may argue this demonstrates a clear intent by the patentee to define "a month" with this precise numerical boundary, which should not be expanded. (’906 Patent, col. 32:32-34).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegation is based on the assertion that Sun, with knowledge of the ’906 Patent, will sell its product with a label that instructs and encourages physicians and patients to perform the patented dosing regimen. (Compl. ¶57). The contributory infringement allegation posits that the generic product is specifically designed for this infringing use and is not a staple article of commerce suitable for substantial non-infringing use. (Compl. ¶58).
  • Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it alleges that Sun has "actual knowledge" of the ’906 Patent, citing the Paragraph IV notice letter. (Compl. ¶53). This allegation of pre-suit knowledge, combined with the prayer for relief requesting that the case be declared "exceptional" under 35 U.S.C. § 285, lays the foundation for a potential future claim for enhanced damages. (Compl. p. 14, ¶F).

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

  • A core issue will be one of infringement by labeling: will the final, FDA-approved label for Sun’s generic product instruct physicians to follow the specific, multi-step dosing protocol—defined by dose amounts, injection sites, and timing—that is recited in the independent claims of the ’906 Patent? The case will likely depend heavily on a comparison of the accused label to the claim language.
  • The case may also hinge on definitional scope: can the term "about", as applied to the 150 mg-eq. and 100 mg-eq. loading doses, be construed to encompass the dosages in Sun's proposed regimen if they are not identical? The court's interpretation of this term could be dispositive on the question of literal infringement.