DCT

1:21-cv-01784

Janssen Pharma Inc v. Tolmar Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01784, D. Del., 12/21/2021
  • Venue Allegations: Venue is alleged to be proper as all Defendant entities are incorporated under the laws of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the long-acting injectable antipsychotic Invega Sustenna® constitutes an act of infringement of a patent covering a specific dosing regimen for the drug.
  • Technical Context: The case involves a long-acting injectable formulation of paliperidone palmitate, a drug used to treat schizophrenia, where maintaining patient adherence and achieving stable therapeutic drug levels is a significant clinical challenge.
  • Key Procedural History: The complaint notes this is the fourth Hatch-Waxman litigation involving the patent-in-suit. In a prior case, a district court rejected another generic manufacturer's invalidity challenges after a full bench trial, a fact that may inform the strategic landscape of this litigation.

Case Timeline

Date Event
2007-12-19 U.S. Patent No. 9,439,906 Priority Date
2016-09-13 U.S. Patent No. 9,439,906 Issue Date
2021-11-12 Defendant sent notice letter regarding ANDA submission
2021-11-15 Plaintiff received notice letter
2021-12-21 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 rapidly achieving and maintaining an effective therapeutic plasma concentration for long-acting injectable paliperidone palmitate. The inventors discovered that the drug’s absorption into the bloodstream was unexpectedly complex and highly dependent on the site of injection (i.e., deltoid vs. gluteal muscle), making it difficult to establish a reliable dosing protocol (’906 Patent, col. 1:63-col. 2:9).
  • The Patented Solution: The patent discloses a specific multi-step dosing regimen, rather than the drug compound itself. The solution involves administering two initial, high-dose "loading" injections into the deltoid muscle—which allows for faster initial drug absorption—to quickly bring the patient’s plasma concentration to a therapeutic level. This is followed by subsequent, lower "maintenance" doses that can be administered in either the deltoid or gluteal muscle to maintain that level over time (’906 Patent, col. 5:1-16).
  • Technical Importance: This dosing method provides clinicians with a predictable way to initiate treatment and overcome the initial lag in therapeutic effect common with long-acting injectables, which is critical for managing acute symptoms and improving patient compliance in conditions like schizophrenia (’906 Patent, col. 1:50-59).

Key Claims at a Glance

  • The complaint asserts claims 1-21 of the ’906 Patent (Compl. ¶29). The key independent claims appear to be method claims 1 and 4.
  • Independent Claim 1 recites a dosing regimen with three essential steps:
    • Administering a first loading dose of about 150 mg-eq. of paliperidone palmitate in the deltoid on the first day of treatment.
    • Administering a second loading dose of about 100 mg-eq. in 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. in the deltoid or gluteal muscle approximately one month (±7 days) after the second loading dose.
  • Independent Claim 4 recites a nearly identical regimen, but narrows the timing of the second loading dose specifically to the "eighth day of treatment."
  • The complaint does not specify which dependent claims will be asserted.

III. The Accused Instrumentality

Product Identification

The act of submitting Abbreviated New Drug Application (ANDA) No. 211995 to the U.S. Food and Drug Administration (FDA) for a generic version of Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) (Compl. ¶2, ¶30).

Functionality and Market Context

The infringement alleged is statutory under the Hatch-Waxman Act, where the submission of an ANDA seeking approval to market a generic drug prior to the expiration of a listed patent is an act of infringement (Compl. ¶37). The complaint alleges that Tolmar’s proposed product is a generic version of Janssen’s Invega Sustenna® and seeks approval for various dosages, including 234 mg, which corresponds to the 150 mg-equivalent (mg-eq.) dose of paliperidone (Compl. ¶30; ’906 Patent, col. 14:19-22). As a generic, the proposed product’s labeling is expected to copy the instructions for use from the brand-name product’s FDA-approved label (Compl. ¶39). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed infringement analysis, noting that Defendant's Paragraph IV notice letter "did not include a detailed statement of allegations of non-infringement" (Compl. ¶34). The infringement theory is based on the allegation that Defendant’s ANDA seeks approval for a product whose label will instruct administration in a manner that practices the patented method.

’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 submission of ANDA No. 211995 seeks approval to market a generic version of Invega Sustenna®, which is indicated for the treatment of schizophrenia and schizoaffective disorder. ¶2, ¶26, ¶37 col. 32:11-14
(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 ANDA seeks approval to market doses including a 234 mg dose (corresponding to 150 mg-eq.), and the proposed label is expected to instruct an initial deltoid injection on day one, mirroring the patented regimen. ¶30, ¶39 col. 32:15-19
(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 label is expected to instruct a second deltoid injection of about 100 mg-eq. (corresponding to a 156 mg dose) within the claimed timeframe. ¶30, ¶39 col. 32:20-25
(3) administering intramuscularly in the deltoid or gluteal muscle...a first maintenance dose of about 25 mg-eq. to about 150 mg-eq...a month (±7 days) after the second loading dose. The proposed label is expected to instruct subsequent monthly maintenance doses in the claimed range, consistent with the final step of the patented method. ¶30, ¶39 col. 32:26-32

Identified Points of Contention

  • Scope Questions: Since infringement of method claims in a Hatch-Waxman case is based on the proposed product label, a central question is whether Defendant will argue its label "carves out" or omits instructions for the patented dosing regimen. The complaint proceeds as if no such carve-out is planned.
  • Technical Questions: A potential dispute could arise over the formulation of the generic drug. While not detailed in the complaint, if the defendant's formulation differs significantly from that described in the patent's composition claims (e.g., claim 17), it might raise non-infringement arguments for those claims.

V. Key Claim Terms for Construction

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

  • Context and Importance: The definition of "about" is critical for determining the literal scope of the dosage limitations. Defendant may argue that its specific dosages fall outside the claimed range, while Plaintiff will likely argue the term encompasses standard manufacturing and clinical variability. Practitioners may focus on this term because even slight differences in marketed dosages could form the basis of a non-infringement argument.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification frequently uses ranges for dosages, such as for the maintenance dose ("about 25 mg-eq. to 150 mg-eq.") (’906 Patent, col. 5:38-40), suggesting the inventors intended flexibility rather than rigid numerical precision.
    • Evidence for a Narrower Interpretation: The claims recite specific numerical values (150, 100). The patent also provides pharmacokinetic simulation figures (FIGS. 1-3) based on these specific doses, which a party could argue anchors the term "about" to values very close to those explicitly tested and disclosed.

The Term: "a month (±7 days)"

  • Context and Importance: This term defines the timing for the first and subsequent maintenance doses. Its construction is key to determining whether alternative dosing schedules fall outside the claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the rationale for this window is to "avoid a missed dose" and refers to the schedule as "approximately once a month," suggesting a practical, clinical meaning rather than a strict mathematical one (’906 Patent, col. 6:17-24).
    • Evidence for a Narrower Interpretation: The claim language itself provides an explicit numerical boundary ("±7 days"). A party could argue this constitutes a clear definition that the patentee chose to adopt, defining the outer limits of the invention.

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement under 35 U.S.C. § 271(b), stating that Defendant intends for its generic product to be used according to its proposed labeling, which must copy the FDA-approved label for Invega Sustenna® and will therefore instruct physicians and patients to perform the patented method (Compl. ¶39).

Willful Infringement

The complaint does not use the term "willful," but it does request that the case be declared "exceptional" under 35 U.S.C. § 285, seeking attorneys' fees (Compl. ¶43, ¶F). The complaint alleges that Defendant has "actual knowledge of the '906 Patent" based on its submission of the Paragraph IV notice letter (Compl. ¶35).

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

  • A primary issue will be one of patent validity: In light of a prior federal court ruling that upheld the validity of the ’906 Patent against another challenger, what novel legal arguments or prior art will the Defendant present to argue the patent is invalid or unenforceable?
  • A key question for infringement will be one of label interpretation: Will the Defendant’s proposed generic label inevitably direct clinicians to perform the patented dosing regimen, or will the Defendant pursue a "skinny label" strategy to carve out the patented method, and is such a carve-out commercially and regulatorily viable?
  • The case may also involve a question of definitional scope: Will the term "about," as applied to drug dosages, be construed broadly to cover minor variations, or will it be interpreted narrowly, potentially allowing the Defendant to design around the claim by using a dosage that is numerically close but arguably not "about" the claimed amount?