DCT
2:25-cv-13061
Janssen Pharma Inc v. Sun Pharmaceutical Industries Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Janssen Pharmaceuticals, Inc. (Pennsylvania) and Janssen Pharmaceutica NV (Belgium)
- Defendant: Sun Pharmaceutical Industries Ltd. (India) and Sun Pharmaceutical Industries, Inc. (Delaware)
- Plaintiff’s Counsel: ROBINSON MILLER LLC
- Case Identification: 2:25-cv-13061, D.N.J., 07/09/2025
- Venue Allegations: Venue is alleged based on Defendant Sun Inc. having a regular and established place of business in New Jersey and having committed acts of infringement in the district. For Sun Ltd., an Indian corporation, venue is alleged to be proper in any judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s proposed generic version of the long-acting injectable antipsychotic Invega Sustenna®, for which Defendant has filed an Abbreviated New Drug Application (ANDA) with the FDA, will infringe a patent covering a specific method-of-use dosing regimen.
- Technical Context: The technology concerns dosing protocols for long-acting injectable antipsychotic drugs used to treat schizophrenia, which are designed to improve patient compliance and therapeutic outcomes compared to daily oral medications.
- Key Procedural History: This action was triggered by a "Notice Letter" dated May 28, 2025, in which Sun notified Janssen of its ANDA filing and its Paragraph IV certification that the patent-in-suit is invalid, unenforceable, or not infringed. The complaint notes a subsequent dispute between the parties regarding the terms of confidential access to the ANDA materials.
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 |
| 2025-05-28 | Sun Ltd. sends Notice Letter regarding ANDA No. 217818 to Plaintiff |
| 2025-07-09 | 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," Issued September 13, 2016
The Invention Explained
- Problem Addressed: The patent addresses the challenge of patient non-adherence to daily oral antipsychotic medication regimens for treating schizophrenia ('906 Patent, col. 1:50-58). For long-acting injectable alternatives, the patent identifies a further problem: the absorption of the drug and attainment of a therapeutic plasma level is complex and was discovered to be highly dependent on the injection site ('906 Patent, col. 2:1-6).
- The Patented Solution: The invention provides a specific dosing regimen designed to quickly achieve and maintain a therapeutic plasma concentration of paliperidone. The solution is not the drug itself, but a method of administration involving a sequence of two initial "loading doses" injected into the deltoid muscle, followed by subsequent "maintenance doses" injected into either the deltoid or gluteal muscles ('906 Patent, Abstract; col. 2:11-29). This specific protocol of site, timing, and dosage is intended to overcome the slow and variable initial absorption profile.
- Technical Importance: This dosing regimen enables a rapid attainment of therapeutic drug concentrations, which is critical for managing acute psychotic symptoms, while providing sustained release for long-term maintenance, thereby enhancing patient compliance ('906 Patent, col. 5:1-9).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-21 (Compl. ¶51). Independent claim 1 is representative.
- The essential elements of independent claim 1 are:
- A dosing regimen for administering paliperidone palmitate to a psychiatric patient for treatment of schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising:
- (1) administering intramuscularly in the deltoid of a patient a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate on the first day of treatment;
- (2) 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; and
- (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 as paliperidone palmitate a month (±7 days) after the second loading dose.
- The complaint’s assertion of claims 1-21 reserves the right to assert all dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are "Sun's Proposed Generic Products," which are generic versions of Janssen's Invega Sustenna® brand products, submitted for FDA approval via ANDA No. 217818 (Compl. ¶2).
Functionality and Market Context
- The proposed products are generic extended-release injectable suspensions of paliperidone palmitate (Compl. ¶2, ¶43). The complaint alleges that infringement will occur because the instructions for use (i.e., the product label) for Sun's generic products will be "substantially identical" to the FDA-approved labeling for Invega Sustenna®, which is covered by the '906 Patent (Compl. ¶49, ¶61). This allegation of a "copycat" label is central to the infringement theory in this ANDA litigation.
IV. Analysis of Infringement Allegations
'906 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment; | The complaint alleges on information and belief that the proposed labeling for Sun's generic product will instruct healthcare providers to administer an initial 150 mg-eq. loading dose in the deltoid muscle on the first day of treatment, mirroring the patented regimen. | ¶¶ 49, 61 | col. 8:11-18 |
| (2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and | The complaint asserts that Sun's product label will instruct a second loading dose of 100 mg-eq. in the deltoid muscle on or around day 8, which falls within the claimed timeframe and dosage, thereby inducing infringement. | ¶¶ 49, 61 | col. 8:18-22 |
| (3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a first maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation a month (±7 days) after the second loading dose. | The complaint asserts that Sun's proposed label will instruct a subsequent maintenance dose in the claimed dosage range and administration site, to be given approximately one month after the second loading dose, thus completing the infringing regimen. | ¶¶ 49, 61 | col. 8:22-29 |
- Identified Points of Contention:
- Scope Questions: The primary dispute will likely center on the content of Sun's proposed product label. A key question for the court will be whether Sun's instructions for use, as detailed in its ANDA, directs a method that falls completely within the scope of the asserted claims. Sun may attempt to "carve out" the patented method from its label to avoid infringement, and the effectiveness of such a carve-out will be a central issue.
- Technical Questions: A key evidentiary question will be whether Sun's proposed product, including its various dosage forms, is intended and labeled for use in the specific sequence and combination defined by the claims. The complaint does not contain details of Sun's product, stating that Sun has not provided a copy of its ANDA (Compl. ¶48). The analysis of infringement is therefore based entirely on the allegation that Sun's label will be "substantially identical" to Janssen's (Compl. ¶49).
No probative visual evidence provided in complaint.
V. Key Claim Terms for Construction
- The Term: "about" (e.g., "about 150 mg-eq.", "about 100 mg-eq.")
- Context and Importance: The scope of "about" is critical for determining the literal scope of the claimed dosage amounts. Sun could argue that its proposed dosages, if not identical to 150 mg or 100 mg, are not "about" those amounts and thus do not infringe. Practitioners may focus on this term because the precision of numerical ranges is a frequent point of contention in patent litigation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent uses ranges elsewhere (e.g., "6th to about 10th day" and "about 25 mg-eq. to about 150 mg-eq." in claim 1), which suggests the inventors contemplated a degree of variability and not strict numerical limits. The specification also uses the term "approximately" when describing dosing schedules, further supporting a flexible interpretation ('906 Patent, col. 5:27-29).
- Evidence for a Narrower Interpretation: The patent provides specific dosages used in clinical trials (e.g., the 25, 100, and 150 mg eq. doses in Example 8) ('906 Patent, col. 23:30-43). A party could argue that "about" should be interpreted narrowly in light of these specific examples, cabining its meaning to functionally equivalent doses demonstrated in the patent.
- The Term: "a month (±7 days)"
- Context and Importance: This term defines the timing for all maintenance doses following the initial loading doses. Its construction is key to determining whether Sun's proposed maintenance schedule infringes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The inclusion of "(±7 days)" explicitly provides a two-week window for administration, indicating that the inventors intended flexibility to accommodate real-world clinical practice. The specification reinforces this by referring generally to "monthly" injections ('906 Patent, col. 5:27-29).
- Evidence for a Narrower Interpretation: A defendant could argue that the phrase should be strictly construed to mean the interval must begin after the second loading dose and recur at intervals of one month, plus or minus seven days. Any alternative schedule (e.g., every 5 weeks) might be argued to fall outside the claim's scope. The claim's language itself sets the boundaries, which a party could argue should not be expanded further.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement theory is based on the allegation that Sun's product labeling will actively instruct and encourage physicians and patients to use the proposed generic drug in accordance with the patented method (Compl. ¶61). The contributory infringement theory alleges that Sun's product is not a staple article of commerce suitable for non-infringing use and is specifically designed for use in a manner that infringes the patent (Compl. ¶62).
- Willful Infringement: The complaint alleges that Sun has "actual knowledge of the 906 Patent" based on its Notice Letter (Compl. ¶57). While the complaint does not contain a formal count for "willful infringement," it requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which could entitle Plaintiffs to an award of attorneys' fees (Compl. ¶65, Prayer for Relief ¶F). This allegation of pre-suit knowledge is a required predicate for any future argument for enhanced damages.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of infringement by labeling: will the product label included in Sun's ANDA instruct a dosing regimen that meets every limitation of an asserted claim? Because infringement is predicated on the content of future instructions, the case will depend on whether Sun's proposed label directs users to perform the patented method, or if it successfully "carves out" such instructions.
- A second key issue will be one of claim construction: how will the court define the scope of numerical terms like "about" and timing elements like "a month (±7 days)"? The resolution of these terms will be dispositive if there are minor differences between the patented regimen and the instructions on Sun's proposed label.
- Finally, a central question for the defense will be patent validity: although not detailed in the complaint, Sun's Paragraph IV certification asserts that the '906 Patent is invalid (Compl. ¶54). The case will therefore likely involve a significant dispute over whether the claimed dosing regimen was obvious or anticipated in light of prior art knowledge regarding paliperidone and other long-acting antipsychotic treatments.