Janssen Pharma Inc v. Teva Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Janssen Pharmaceuticals, Inc. (Pennsylvania) and Janssen Pharmaceutica NV (Belgium)
  • Defendant: Teva Pharmaceuticals USA, Inc. (Delaware) and Teva Pharmaceuticals Industries, Ltd. (Israel)
  • Plaintiff’s Counsel: Robinson Miller LLC
• Case Identification: 2:18-cv-00734, D.N.J., 01/17/2018
• Venue Allegations: Venue is based on Defendant Teva Pharmaceuticals USA's consent to jurisdiction and venue in the District of New Jersey, as well as its alleged systematic and continuous business contacts within the state.
• Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the antipsychotic drug Invega Sustenna® 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 for treating schizophrenia, with the patent-in-suit directed to a method for achieving therapeutic plasma concentrations more rapidly at the start of treatment.
• Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Paragraph IV certification notice from Teva, which asserted that the patent-in-suit is invalid, unenforceable, or would not be infringed by Teva's proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" as covering Plaintiff's Invega Sustenna® product.

Case Timeline

Date	Event
2007-12-19	'906 Patent Priority Date
2016-09-13	'906 Patent Issue Date
2017-12-05	Teva sends Paragraph IV Notice Letter to Plaintiffs
2018-01-17	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 "’906 Patent"). (Compl. ¶29).

The Invention Explained

• Problem Addressed: The patent’s background section states that for long-acting injectable formulations of paliperidone, the absorption of the drug into the bloodstream was discovered to be "far more complex than was originally anticipated" and that attaining a "potential therapeutic plasma level" was "dependent on the site of injection." (’906 Patent, col. 1:63-col. 2:3). This created a challenge in quickly achieving an effective drug concentration in patients beginning treatment.
• The Patented Solution: The invention is a specific dosing regimen designed to solve this problem by rapidly achieving and maintaining therapeutic plasma levels. The method involves administering two initial high-dose "loading" injections into the deltoid (shoulder) muscle, followed by subsequent lower "maintenance" doses that can be injected into either the deltoid or gluteal muscle. (’906 Patent, col. 2:11-25). The specification explains that "deltoid injections result in a faster rise in initial plasma concentration," which facilitates the rapid attainment of therapeutic levels. (’906 Patent, col. 5:2-5).
• Technical Importance: This regimen addresses a significant clinical challenge by providing a method to quickly bring patients to a therapeutic drug level, which is critical for managing acute symptoms of schizophrenia and improving patient compliance at the onset of long-term injectable therapy. (’906 Patent, col. 2:1-9).

Key Claims at a Glance

• The complaint asserts infringement of at least Claim 1 of the ’906 Patent. (Compl. ¶34, ¶41).
• The essential elements of independent claim 1 are:
  • A dosing regimen for administering paliperidone palmitate to a psychiatric patient for treating schizophrenia, schizoaffective disorder, or schizophreniform disorder.
  • 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 on the 6th to 10th day of treatment.
  • Administering a first maintenance dose of "about 25 mg-eq. to about 150 mg-eq." of paliperidone palmitate intramuscularly into the deltoid or gluteal muscle "a month (±7 days) after the second loading dose."
• The complaint’s prayer for relief seeks a judgment of infringement of "one or more claims of the 906 Patent," a standard formulation that may implicitly reserve the right to assert additional claims. (Compl. p. 10, ¶B).

III. The Accused Instrumentality

Product Identification

• Teva's proposed generic versions of JPI's Invega Sustenna® brand paliperidone palmitate extended-release injectable suspension products, as identified in ANDA No. 211149. (Compl. ¶35).

Functionality and Market Context

• The complaint alleges that Teva's ANDA seeks approval to market generic paliperidone palmitate injectable suspensions in 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg doses. (Compl. ¶35). The product is intended for the treatment of schizophrenia and schizoaffective disorder. (Compl. ¶32).
• The infringement allegation is based on the functionality that will be described in the proposed product's labeling. The complaint alleges that federal regulations require Teva to copy the FDA-approved labeling for Invega Sustenna®, and that this labeling instructs administration of the product in a manner that directly infringes the ’906 Patent. (Compl. ¶43).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'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 complaint alleges that Teva's proposed product label will instruct physicians to use the product to treat these conditions according to the claimed regimen.	¶43	col. 31:51-56
(1) administering intramuscularly in the deltoid of a patient... a first loading dose of about 150 mg-eq. of paliperidone... on the first day of treatment;	The complaint alleges that Teva's proposed label will instruct the administration of a first loading dose consistent with this limitation.	¶43	col. 32:7-14
(2) 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; and	The complaint alleges that Teva's proposed label will instruct the administration of a second loading dose consistent with this limitation.	¶43	col. 32:15-22
(3) 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 complaint alleges that Teva's proposed label will instruct the administration of a maintenance dose consistent with this limitation.	¶43	col. 32:23-29

• Identified Points of Contention:
  • Scope Questions: The central infringement question in this ANDA case will be whether Teva's proposed product labeling, once finalized, will instruct users to perform all steps of the claimed method. The complaint alleges that it will, based on the legal requirement that a generic label mirror the brand-name label. (Compl. ¶43). The dispute will focus on the precise instructions contained in that label.
  • Technical Questions: A potential issue may arise regarding the practical administration of the regimen. The ’906 Patent specification discusses how factors like high Body Mass Index (BMI) can affect plasma concentrations and may require the use of longer needles to ensure a proper deep muscle injection into the deltoid. (’906 Patent, col. 6:44-59). This raises the question of whether the term "deltoid muscle" implies a functional requirement of achieving a specific pharmacokinetic profile, or simply refers to the anatomical location.

V. Key Claim Terms for Construction

• The Term: "deltoid muscle"

• Context and Importance: The location of the first two loading doses is a cornerstone of the invention, which is premised on the discovery that "deltoid injections result in a faster rise in initial plasma concentration." (’906 Patent, col. 5:2-5). The construction of this term is critical because if it is given a purely anatomical definition, any injection in that area meets the limitation. If it is construed to carry a functional requirement, infringement might be more difficult to prove.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The term is a standard anatomical term, and the claim language does not explicitly add a functional requirement. Parties arguing for a broader construction may assert that the plain and ordinary meaning should control.
  • Evidence for a Narrower Interpretation: The patent repeatedly links the use of the deltoid to the functional outcome of a "faster rise" in plasma concentration. (’906 Patent, col. 5:2-5). The specification also highlights that in patients with high BMI, a standard needle may result in injection into adipose tissue instead of "deep injection into muscle," potentially altering the drug's absorption profile. (’906 Patent, col. 6:44-54). A party could argue these passages support a narrower construction where "administering... in the deltoid muscle" requires an injection technique that achieves the functional purpose described in the patent.

• The Term: "a month (±7 days)"

• Context and Importance: This term defines the timing of the first maintenance dose, which is a required step of the claimed method. Its precision is important for determining whether a proposed label that allows for different or more flexible maintenance schedules would fall within the scope of the claim.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification uses less precise, more flexible language, such as "approximately once a month (e.g. monthly ±7 days or approximately once every four weeks)." (’906 Patent, col. 5:27-29). This language may support an argument that the claim term should be interpreted with some flexibility.
  • Evidence for a Narrower Interpretation: The claim language itself is specific. A party could argue that the explicit parenthetical "(±7 days)" provides a precise definition that should not be broadened by more general statements in the specification. The patent also describes an alternative embodiment as a "third dose between days 34 to 38 of treatment" (’906 Patent, col. 5:21-23), which represents a very specific 5-day window, suggesting the inventors were capable of claiming narrow time frames when intended.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis is the allegation that Teva intends for its generic product to be used in an infringing manner and will provide a product label that instructs physicians and patients to perform the steps of the claimed dosing regimen. (Compl. ¶43).
• Willful Infringement: The complaint does not explicitly use the word "willful." However, it alleges that Teva had "actual knowledge of the 906 Patent, as shown by the Notice Letter" it sent to Janssen, and it requests that the court declare the case "exceptional" under 35 U.S.C. § 285, which is a predicate for awarding attorneys' fees and can be related to conduct warranting enhanced damages. (Compl. ¶39, ¶47).

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

• A core issue will be one of label-driven inducement: Will Teva’s final, FDA-approved product label for its generic paliperidone palmitate instruct physicians and patients to follow the specific, multi-step dosing regimen recited in Claim 1 of the ’906 Patent? The outcome of the infringement analysis will likely depend entirely on the content of that label.
• A central question for the court will be one of patent validity: Does the claimed dosing regimen represent a non-obvious solution to the specific pharmacokinetic problems identified in the patent, or was it an obvious-to-try modification of known administrative techniques for similar long-acting injectable drugs? Teva’s Paragraph IV certification suggests this will be a primary defense.
• The dispute may also turn on a question of claim construction: Can the term "deltoid muscle," as used in the claims, be limited by the functional advantages described in the specification, or must it be given its plain anatomical meaning? The answer will define the evidentiary burden for proving infringement.