Janssen Pharma Inc v. Pharmascience Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Janssen Pharmaceuticals, Inc. (Pennsylvania) and Janssen Pharmaceutica NV (Belgium)
  • Defendant: Pharmascience Inc. (Canada), Mallinckrodt plc (Ireland), and SpecGx LLC (Delaware)
  • Plaintiff’s Counsel: Ashby & Geddes
• Case Identification: 1:19-cv-02313, D. Del., 12/20/2019
• Venue Allegations: Venue is alleged based on Defendants' business activities in Delaware, including the distribution and sale of pharmaceutical products, and SpecGx’s incorporation in Delaware.
• Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Invega Sustenna® product constitutes an act of infringement of a patent covering a specific dosing regimen.
• Technical Context: The technology concerns a long-acting injectable formulation of paliperidone palmitate, an antipsychotic drug used for treating schizophrenia, and a method for administering it to rapidly achieve and maintain therapeutic plasma concentrations.
• Key Procedural History: This is a Hatch-Waxman action initiated in response to a Paragraph IV certification letter sent by Defendant Pharmascience on November 7, 2019, asserting that U.S. Patent No. 9,439,906 is invalid, unenforceable, and/or will not be infringed by the proposed generic product. The complaint was filed within the 45-day statutory window, triggering a 30-month stay of FDA approval for the defendants' generic product.

Case Timeline

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, issued September 13, 2016.

The Invention Explained

• Problem Addressed: The patent describes challenges in treating schizophrenia, noting that up to 75% of patients have difficulty adhering to daily oral medication regimens (’906 Patent, col. 1:51-54). While long-acting injectables can improve compliance, the patent explains that achieving a therapeutically effective plasma concentration of paliperidone was discovered to be "far more complex than was originally anticipated" and dependent on the site of injection (’906 Patent, col. 2:1-6).
• The Patented Solution: The patent discloses a specific dosing regimen designed to rapidly achieve and maintain therapeutic drug levels. The method involves administering two initial "loading doses" into the deltoid muscle—which the patent identifies as enabling a faster rise in plasma concentration—followed by subsequent monthly "maintenance doses" that can be administered in either the deltoid or gluteal muscle (’906 Patent, Abstract; col. 5:1-15). This front-loading approach aims to quickly stabilize the patient while transitioning them to a less frequent, long-term maintenance schedule.
• Technical Importance: This dosing strategy provides a method to overcome the complex pharmacokinetics of the drug, allowing clinicians to quickly bring a patient's drug plasma levels into the therapeutic window and then maintain them with once-monthly injections, thereby improving patient compliance (’906 Patent, col. 1:56-60).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 (’906 Patent, Compl. ¶45).
• Independent Claim 1 requires:
  • A dosing regimen for administering paliperidone palmitate to a psychiatric patient for schizophrenia or related disorders.
  • Administering a first loading dose of about 150 mg-eq. in the deltoid muscle 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 after the second loading dose.
• The complaint does not specify assertion of any dependent claims but makes general allegations of infringement of "at least one claim" (Compl. ¶45).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the proposed generic versions of JPI's Invega Sustenna® brand products described in ANDA No. 210397, submitted by Defendant Pharmascience (Compl. ¶¶2, 46).

Functionality and Market Context

• The accused products are generic paliperidone palmitate extended-release injectable suspensions for which Defendants seek FDA approval in various dose strengths, including 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg (Compl. ¶46).
• The core of the infringement allegation is that the act of seeking FDA approval for this product constitutes infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶53). The complaint alleges that upon approval, Defendants will market the generic product with a label that is a copy of the FDA-approved Invega Sustenna® labeling, and that use of the product according to this label will directly infringe the ’906 Patent (Compl. ¶¶54-55).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement theory is based on the allegation that the instructions for use on the proposed label for Defendants' ANDA product will direct physicians and patients to perform the steps of the patented method.

'906 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A central question will be whether Defendants' proposed product label will induce infringement. This may turn on whether the label requires administration according to the claimed regimen or if non-infringing uses are also taught. The defendants' Paragraph IV notice letter asserts non-infringement, which could be based on a "carve-out" of the patented method from their proposed label (Compl. ¶47).
  • Technical Questions: The claim uses the term "about" to qualify dose amounts (e.g., "about 150 mg-eq."). The dispute may focus on whether the specific dosages in Defendants' ANDA (e.g., 234 mg and 156 mg) fall within the scope of "about 150 mg-eq." and "about 100 mg-eq.", respectively, as those terms are understood in light of the patent's specification. The patent notes that 156 mg of the ester corresponds to 100 mg of paliperidone (’906 Patent, col. 14:21-23), suggesting a direct correspondence between the claimed "mg-eq." values and the dosages in the ANDA product.

V. Key Claim Terms for Construction

• The Term: "about"

  • Context and Importance: This term appears in the limitations defining the first and second loading doses ("about 150 mg-eq." and "about 100 mg-eq."). Its construction is critical because it will determine whether the specific commercial dosages for which Defendants seek approval (e.g., 234 mg and 156 mg) literally meet the claimed dosage limitations. Practitioners may focus on this term because its breadth is a primary determinant of the infringement analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification uses ranges, such as a first loading dose "from about 100 mg-eq. to about 150 mg-eq." (’906 Patent, col. 2:15-16), which may suggest the patentee did not intend the values to be exact and that "about" imparts significant flexibility.
    • Evidence for a Narrower Interpretation: The patent provides specific clinical trial data and examples using precise dosages (’906 Patent, Example 8, col. 23-24). A party could argue that "about" should be construed narrowly in light of these specific embodiments and the established conversion between the ester form and the active drug equivalent (e.g., 156 mg of the ester for 100 mg-eq of paliperidone).

• The Term: "dosing regimen...comprising"

  • Context and Importance: The claim is directed to a multi-step method. The infringement case hinges on whether the proposed product label induces performance of this entire sequence of steps. The use of the open-ended term "comprising" followed by a specific sequence of administrations raises the question of what a user must be instructed to do to infringe.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: "Comprising" is generally interpreted to be open-ended, meaning the regimen can include other steps. A plaintiff may argue that any label that instructs the three core steps infringes, regardless of what other information or options are provided.
    • Evidence for a Narrower Interpretation: A defendant may argue that for inducement, the label must actively instruct or encourage the specific patented regimen as a whole, not just its individual components. If the label presents the claimed steps merely as one of several options, or fails to link them into the claimed sequence, it may not meet the standard for inducement. The patent's background emphasizes the novelty of the complete regimen as a solution to a specific problem (’906 Patent, col. 2:3-6), potentially supporting an interpretation that requires instruction of the entire sequence as a unit.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on the allegation that Defendants' product label, by law a copy of the Invega Sustenna® label, will instruct and encourage physicians and patients to use the generic product in a manner that infringes the ’906 Patent (Compl. ¶55). Contributory infringement is based on the allegation that the product is specifically designed for this infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶56).
• Willful Infringement: The complaint does not use the word "willful," but it alleges that Defendants have "actual knowledge of the '906 Patent" based on their Paragraph IV notice letter (Compl. ¶51) and requests a finding that the case is "exceptional" to support an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶59). This forms a basis for a potential claim for enhanced damages should infringement be found.

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

The resolution of this case will likely depend on the court's findings on two central issues:

• A core issue will be one of inducement: Does the proposed product label for the generic drug, as submitted in ANDA No. 210397, inevitably lead a significant number of physicians to administer the drug according to the complete, multi-step regimen of Claim 1, or does the label provide for substantial non-infringing uses that would defeat a claim of induced infringement?
• A key question of claim scope will also be dispositive: Can the term "about," as used in the dosage limitations of Claim 1, be construed to encompass the precise commercial dosage strengths of Defendants' proposed generic product, particularly in light of the specific dose-to-equivalent conversions disclosed in the patent's specification?