DCT

2:18-cv-13478

Sumitomo Dainippon Pharma Co Ltd v. Piramal Healthcare Uk Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-13478, D.N.J., 10/24/2018
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the defendant committed an act of patent infringement in the district by submitting its Abbreviated New Drug Application (ANDA) and because its affiliates maintain a regular and established place of business in the state.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an ANDA to market generic lurasidone hydrochloride tablets constitutes infringement of a patent covering methods of treating schizophrenia or manic depressive psychosis without causing clinically significant weight gain.
  • Technical Context: The technology concerns a method of administering an antipsychotic drug, lurasidone (marketed as Latuda®), in a specific dosage regimen that achieves therapeutic effects while avoiding the common side effect of patient weight gain.
  • Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 212091 with a Paragraph IV certification, challenging Plaintiffs' patent rights. Plaintiffs allege that Defendant’s proposed label for its generic product will induce infringement of the patent-in-suit, which is listed in the FDA's Orange Book for Latuda®. The complaint notes that Plaintiffs have not yet been provided a copy of the ANDA.

Case Timeline

Date Event
2002-08-22 U.S. Patent No. 9,815,827 Priority Date
2017-11-14 U.S. Patent No. 9,815,827 Issue Date
2018-07-19 Date of Piramal's Paragraph IV Notice Letter
2018-07-20 Plaintiffs' Receipt of Piramal's Notice Letter
2018-10-24 Amended Complaint Filing Date

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

U.S. Patent No. 9,815,827 - "Agent for Treatment of Schizophrenia"

  • Patent Identification: U.S. Patent No. 9,815,827, "Agent for Treatment of Schizophrenia," issued November 14, 2017.

The Invention Explained

  • Problem Addressed: The patent’s background section states that conventional antipsychotic drugs for treating disorders like schizophrenia were known to cause serious side effects, including unwanted weight gain (Compl. ¶20-21; ’827 Patent, col. 1:57-63). There was a recognized need for effective antipsychotic treatments that did not produce such undesirable effects (Compl. ¶24).
  • The Patented Solution: The invention is a method of treatment that involves orally administering a specific daily dose of lurasidone or its salt (20 mg to 120 mg) to treat schizophrenia or manic depressive psychosis. The patent asserts that this specific dosing regimen allows patients to receive therapeutic benefits "without being accompanied by extrapyramidal symptoms" or other side effects, thereby improving the safety profile of the treatment (’827 Patent, col. 7:27-41, Abstract). A key outcome of this method is that the patient does not experience clinically significant weight gain (Compl. ¶31).
  • Technical Importance: This patented method purports to offer a significant therapeutic advance by uncoupling the antipsychotic effect of lurasidone from the common and problematic side effect of weight gain, potentially improving patient adherence and outcomes (Compl. ¶39).

Key Claims at a Glance

  • The complaint identifies independent claim 40 and dependent claim 43 as illustrative of the patent's scope (Compl. ¶31).
  • Independent Claim 40 recites:
    • A method of treating a patient with an antipsychotic without a clinically significant weight gain, comprising:
    • orally administering once daily to the patient a pharmaceutical composition comprising 20 to 120 mg of (1R, 2S, 3R, 4S)-N-[(1R, 2R)-2-[4-(1,2-benzoisothiazol-3-ly)-1-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1]heptanedicarboximide [lurasidone] or a pharmaceutically acceptable salt thereof as the sole active ingredient
    • such that the patient does not experience a clinically significant weight gain.
  • The complaint does not explicitly reserve the right to assert other claims but states that the commercial product is covered by "at least one claim of the ’827 patent" (Compl. ¶30).

III. The Accused Instrumentality

Product Identification

  • Piramal’s Proposed ANDA Product, identified as generic lurasidone hydrochloride tablets in 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg strengths (Compl. ¶40).

Functionality and Market Context

  • As this is an ANDA case, the accused instrumentality is a generic version of Plaintiffs’ commercially successful product, Latuda® (Compl. ¶1, ¶10). The infringement allegation is based on the future, intended use of the generic product as will be described in its FDA-approved labeling.
  • The complaint alleges, on information and belief, that Piramal’s proposed label will instruct for the oral administration of its lurasidone tablets to treat schizophrenia and depressive episodes associated with bipolar disorder (Compl. ¶45).
  • Crucially, the complaint alleges the proposed label will include clinical data demonstrating that patients taking the drug do not experience clinically significant weight gain, thereby encouraging the practice of the patented method (Compl. ¶46). The complaint provides an example of such data from the Latuda® label, which the proposed generic label is expected to mirror (Compl. ¶38). This includes "Table 11: Mean Change in Weight (kg) from Baseline in the Adult Monotherapy Bipolar Depression Study," which presents data showing minimal weight gain for patients treated with lurasidone in the claimed dose range (Compl. p. 10, ¶38).

IV. Analysis of Infringement Allegations

'827 Patent Infringement Allegations

Claim Element (from Independent Claim 40) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a patient with an antipsychotic without a clinically significant weight gain, comprising: The Proposed Piramal Label will allegedly instruct physicians to administer the generic product to treat schizophrenia and manic depressive psychosis while avoiding clinically significant weight gain for the patient. ¶47 col. 10:50-52
orally administering once daily to the patient a pharmaceutical composition comprising 20 to 120 mg of ... lurasidone or a pharmaceutically acceptable salt thereof as the sole active ingredient Piramal’s Proposed ANDA Product consists of lurasidone hydrochloride tablets in 20, 40, 60, 80, and 120 mg strengths. The proposed label will allegedly instruct for once-daily oral administration for the specified conditions. ¶40, ¶45 col. 10:52-62
such that the patient does not experience a clinically significant weight gain. The complaint alleges that Piramal's proposed label will contain clinical data and statements that demonstrate and promote the fact that patients using the product do not experience clinically significant weight gain. ¶46 col. 10:63-65

Identified Points of Contention

  • Scope Questions: A primary dispute may concern the proper construction of the phrase "clinically significant weight gain." The patent itself does not provide a precise numerical definition. The question for the court will be whether this term should be defined by a common clinical standard (e.g., a ≥7% increase in baseline body weight, a metric mentioned in the Latuda® label text) or by the specific, smaller mean weight changes observed in the patent’s own clinical trial data tables.
  • Technical Questions: What will the final, FDA-approved label for Piramal's generic product actually state? The complaint bases its allegations on "information and belief," as Plaintiffs had not received the ANDA at the time of filing (Compl. ¶51, ¶53). The case will depend on whether discovery confirms that Piramal's label instructs, suggests, or encourages physicians to use the drug in a way that practices all steps of the claimed method, including the negative limitation of avoiding significant weight gain.

V. Key Claim Terms for Construction

  • The Term: "clinically significant weight gain"
  • Context and Importance: This term is the central negative limitation of the asserted claims and represents the core of the purported invention. The definition of this phrase is critical to the infringement analysis, as it sets the boundary for what the patented method achieves and what an accused infringer's product label must encourage to induce infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A defendant may argue that in the absence of an explicit definition in the patent, the term should be given its plain and ordinary meaning in the clinical context. This could involve referring to established clinical trial endpoints, such as a 7% or greater increase from baseline body weight, which is a specific threshold referenced in the background section of the Latuda® Prescribing Information cited in the complaint (Compl. p. 10, ¶38).
    • Evidence for a Narrower Interpretation: A plaintiff may argue that the term's meaning is informed by the patent's own data. The specification includes tables from clinical trials showing very small mean changes in weight for patients treated with lurasidone (e.g., +0.43 kg, +0.22 kg) compared to placebo (-0.02 kg) or other antipsychotics (e.g., +4.15 kg for olanzapine) (’827 Patent, col. 9, Table 5; Compl. p. 10, ¶38). Plaintiffs could argue that "clinically significant" should be construed as any weight gain that is statistically significant relative to placebo, which would set a much lower and more easily met threshold for infringement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Piramal’s filing of its ANDA will lead to induced and contributory infringement. The inducement theory is based on the allegation that Piramal's proposed product label will actively encourage and instruct physicians to prescribe the generic drug for the patented method (Compl. ¶47, ¶76). The contributory infringement allegation is based on the product having no substantial non-infringing uses and being especially made for an infringing purpose (Compl. ¶77-78).
  • Willful Infringement: Willfulness is alleged based on Piramal having actual knowledge of the ’827 patent, no later than its issuance and listing in the FDA Orange Book, and proceeding with its ANDA submission in alleged disregard of Plaintiffs' patent rights (Compl. ¶69, ¶86).

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

  • A core issue will be one of definitional scope: How will the court construe the claim term "clinically significant weight gain"? Will the definition be based on a high-threshold, standard clinical metric (e.g., ≥7% of body weight), or will it be a lower-threshold definition derived from the patent’s specific examples of minimal weight changes relative to a placebo?
  • A key evidentiary question will be one of label-based inducement: What will discovery of Piramal's ANDA and communications with the FDA reveal? The case will likely turn on whether the language and data in the final approved label for the generic product actively instruct or encourage physicians to use the drug with the expectation of avoiding "clinically significant weight gain," thereby meeting all limitations of the asserted claims.