DCT

1:17-cv-00392

Otsuka Pharmaceutical Co Ltd v. Mylan NV

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00392, D.N.J., 01/19/2017
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants conduct business in the District of New Jersey, including manufacturing, marketing, and selling generic drugs, and have previously submitted to the Court's jurisdiction.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for generic aripiprazole tablets constitutes an act of infringement of a patent covering combination therapies for treating mood disorders.
  • Technical Context: The technology relates to pharmaceutical treatments for mood disorders, specifically combining a carbostyril derivative, which acts as a dopamine-serotonin system stabilizer, with a serotonin reuptake inhibitor (SRI).
  • Key Procedural History: This action was triggered by Mylan Pharmaceuticals' submission of ANDA No. 206-240 to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of aripiprazole tablets. Plaintiff Otsuka lists the patent-in-suit in the FDA's "Orange Book" for its branded aripiprazole product, Abilify®. Otsuka received a formal notice letter from Mylan dated December 8, 2016, certifying its ANDA filing concerning the patent-in-suit.

Case Timeline

Date Event
2002-11-15 Otsuka’s New Drug Application (NDA) for aripiprazole tablets approved
2002-12-27 ’182 Patent Priority Date
2016-07-12 U.S. Patent No. 9,387,182 (’182 Patent) Issued
2016-12-08 Otsuka receives Mylan's ANDA Notice of Certification letter
2017-01-19 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,387,182 - "Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders"

  • Patent Identification: U.S. Patent No. 9,387,182, "Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued July 12, 2016.

The Invention Explained

  • Problem Addressed: The patent's background section notes that while serotonin reuptake inhibitors (SRIs) are common antidepressants, a significant portion of patients (about 30%) do not respond to them ('182 Patent, col. 2:10-14). Furthermore, while combining antidepressants with atypical antipsychotic drugs was a known strategy, existing antipsychotics carried risks of significant side effects, including weight gain, increased risk of diabetes, and cardiac issues ('182 Patent, col. 2:35-56).
  • The Patented Solution: The invention proposes a pharmaceutical composition or method of treatment that combines a carbostyril derivative, specifically one that acts as a "dopamine-serotonin system stabilizer" like aripiprazole, with an SRI ('182 Patent, Abstract; col. 3:1-9). This combination is asserted to be an effective therapy for mood disorders, such as major depressive disorder, while avoiding the deleterious side effects associated with prior art combination treatments ('182 Patent, col. 2:57-65).
  • Technical Importance: The invention purports to provide a safer and more effective treatment option for patients with mood disorders, particularly those who are refractory to conventional monotherapies.

Key Claims at a Glance

  • The complaint alleges infringement of "at least one claim" without specifying which ones (Compl. ¶24). Independent method claim 17 is representative of the asserted technology.
  • The essential elements of independent claim 17 are:
    • A method of treating a mood disorder selected from a specified group (including depression of major depressive disorder, dementia with depressive symptoms, etc.).
    • The method comprises administering to the patient an effective amount of a pharmaceutical composition.
    • The composition comprises (a) a compound selected from aripiprazole or a specified metabolite thereof.
    • The composition is administered in combination with (b) at least one serotonin reuptake inhibitor selected from a specified group (including fluoxetine, citalopram, sertraline, etc.).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Mylan Pharmaceuticals' proposed generic "aripiprazole oral tablets" that are the subject of ANDA No. 206-240 (Compl. ¶5, ¶23).

Functionality and Market Context

  • The product is a generic version of Otsuka’s branded drug Abilify® (Compl. ¶19). Under the Hatch-Waxman Act, the filing of an ANDA seeking approval to market a generic drug before the expiration of a relevant patent is a statutory act of infringement (Compl. ¶25). Mylan’s product is intended to be a bioequivalent substitute for the branded drug, and the infringement allegation centers on the proposed use of this generic product, which Otsuka claims will align with the methods protected by the ’182 Patent (Compl. ¶28).

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The central infringement allegation is statutory under 35 U.S.C. § 271(e)(2)(A), where the act of infringement is the submission of the ANDA itself (Compl. ¶25). The complaint further alleges that upon approval, the use of Mylan's product as directed would induce infringement of the patented methods (Compl. ¶28). The following table summarizes the likely infringement theory for representative method claim 17.

No probative visual evidence provided in complaint.

U.S. Patent No. 9,387,182 Infringement Allegations

Claim Element (from Independent Claim 17) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a mood disorder selected from the group consisting of depression of major depressive disorder... Mylan's proposed product label will allegedly instruct or encourage the use of its generic aripiprazole tablets for treating the claimed mood disorders. ¶28 col. 29:19-27
administering to the patient an effective amount of a pharmaceutical composition which comprise(s) (a) a compound selected from aripiprazole or metabolite of aripiprazole... Patients, following physician instructions allegedly encouraged by Mylan's label, will take Mylan's generic aripiprazole oral tablets. ¶23, ¶27 col. 29:28-32
in combination with (b) at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine... Mylan's product will be prescribed and used by patients concurrently with a separate SRI, an act the complaint alleges Mylan will encourage. ¶28 col. 29:33-38
  • Identified Points of Contention:
    • Scope Questions: A central issue may be whether Mylan's actions and proposed product labeling will rise to the level of actively inducing infringement. The dispute will question what constitutes "encouragement" for physicians to prescribe Mylan's single-agent product "in combination with" a separate SRI for the patented method.
    • Technical Questions: Does the clinical use described in Mylan's proposed product labeling for its generic aripiprazole overlap with the specific methods of treatment claimed in the ’182 Patent? The complaint does not provide the proposed label, which would be a key piece of evidence.

V. Key Claim Terms for Construction

  • The Term: "administering... in combination with"
  • Context and Importance: This term is critical because the accused product is a single-ingredient aripiprazole tablet, while the asserted claim is for a combination therapy method. The infringement theory relies on inducement, where Mylan allegedly encourages the combined use. The construction of this term will define what actions constitute the infringing method—for example, whether it requires simultaneous administration, administration within a specific timeframe, or merely concurrent treatment regimens.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not appear to strictly limit the method of combination. The specification discusses "combined therapies using an atypical antipsychotic drug... together with an antidepressant drug" without specifying the mode or timing of administration, which may support a broader reading that includes concurrent prescriptions. ('182 Patent, col. 2:28-34).
    • Evidence for a Narrower Interpretation: The patent also claims "pharmaceutical composition[s]" comprising both agents (e.g., claim 1), which could be used to argue that "in combination with" in the method claims should be construed in a similarly close therapeutic relationship, potentially excluding non-contemporaneous administrations.

VI. Other Allegations

  • Indirect Infringement: The complaint explicitly alleges both direct infringement by future users (physicians and patients) and induced infringement by Mylan (Compl. ¶27-28). The inducement allegation is based on the assertion that Mylan "will take active steps to encourage the sale and use" of its generic product in a manner that infringes the patent's method claims, with knowledge and intent for that outcome (Compl. ¶28).
  • Willful Infringement: The complaint does not use the term "willful," but it pleads facts that may support such a claim later. It alleges that Mylan has "actual knowledge of the ’182 patent" based on a notice letter it sent to Otsuka on December 8, 2016 (Compl. ¶21-22). The prayer for relief requests a declaration that the case is "exceptional" under 35 U.S.C. § 285, which allows for an award of attorney fees (Compl. p. 8).

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

  • A core issue will be one of inducement and intent: What evidence does the complaint, and subsequent discovery, provide that Mylan’s proposed drug label and marketing materials will specifically encourage physicians to co-prescribe its generic aripiprazole with a separate SRI to treat the mood disorders claimed in the patent, thereby meeting the legal standard for inducing infringement?
  • A key legal question will be one of validity: As is common in ANDA litigation, a central defense will likely involve challenging the validity of the ’182 Patent. The case may turn on whether the claimed combination of aripiprazole and an SRI would have been considered obvious to a person of ordinary skill in the art at the time of the invention, given the pre-existing knowledge of other combination therapies for mood disorders.