DCT

2:18-cv-02620

Sumitomo Dainippon Pharma Co Ltd v. Aurobindo Pharma Ltd

Log In

I. Executive Summary and Procedural Information

Case Timeline

Date Event
2002-08-22 Earliest Priority Date for ’827 Patent
2005-05-26 Earliest Priority Date for ’794 Patent
2017-11-14 ’827 Patent Issue Date
2018-01-25 Aurobindo sends Paragraph IV notice letter for ’827 Patent
2018-03-06 ’794 Patent Issue Date
2018-04-04 Sun Pharma sends Paragraph IV notice letter for ’794 Patent
2018-04-27 Dr. Reddy's sends Paragraph IV notice letter for ’794 Patent
2018-05-04 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 (Compl. ¶167).

The Invention Explained

  • Problem Addressed: The patent and complaint describe that conventional antipsychotic drugs used to treat disorders like schizophrenia are known to cause serious side effects, including undesired metabolic changes and significant weight gain (Compl. ¶¶162-163; ’827 Patent, col. 1:57-63). This creates a need for effective antipsychotics that do not cause such undesirable side effects (Compl. ¶166).
  • The Patented Solution: The invention is a method for treating patients with an antipsychotic, specifically lurasidone, while avoiding the side effect of "clinically significant weight gain." This is achieved by administering a specific oral daily dose of 20 mg to 120 mg of lurasidone or a pharmaceutically acceptable salt thereof (Compl. ¶173; ’827 Patent, Abstract). The patent suggests this specific dosing regimen allows for effective treatment without the common weight gain side effect observed with other drugs in its class (’827 Patent, col. 7:1-11).
  • Technical Importance: The claimed method offers a therapeutic approach that may improve patient outcomes and adherence to treatment by mitigating a common and burdensome side effect associated with antipsychotic medication (Compl. ¶166).

Key Claims at a Glance

  • The complaint asserts infringement of the ’827 Patent generally and identifies Claim 40 as illustrative (Compl. ¶173; Count I).
  • Independent Claim 40 requires:
    • 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's infringement counts are directed broadly to the patent, which may suggest an intent to assert other claims, including dependent claims, during litigation.

U.S. Patent No. 9,907,794 - Pharmaceutical Composition

  • Patent Identification: U.S. Patent No. 9,907,794, "Pharmaceutical Composition," issued March 6, 2018 (Compl. ¶182).

The Invention Explained

  • Problem Addressed: The patent addresses the technical challenge of creating oral drug tablets with different dosage strengths that still exhibit an "equivalent dissolution profile." This is necessary to ensure bioequivalence, but can be difficult to achieve for slightly water-soluble active ingredients like lurasidone, especially when increasing the dose within the tablet (’794 Patent, col. 1:40-51, col. 2:15-24).
  • The Patented Solution: The patent discloses a specific tablet formulation that solves this problem. The formulation comprises lurasidone, a "pregelatinized starch," a water-soluble excipient, a water-soluble polymer binder, and a lubricant (’794 Patent, col. 3:1-12). This combination is purported to provide a rapid and consistent dissolution rate across a wide range of tablet strengths, from 20 mg to 120 mg, thereby maintaining bioequivalence (’794 Patent, col. 4:45-54).
  • Technical Importance: This formulation technology allows for the creation of a commercially viable product line with multiple, interchangeable dosage strengths that provide predictable therapeutic effects (Compl. ¶186).

Key Claims at a Glance

  • The complaint asserts infringement of the ’794 Patent and identifies Claim 1 as illustrative (Compl. ¶187; Count III).
  • Independent Claim 1 requires:
    • A tablet for oral administration, comprising: from 20 mg to 120 mg of lurasidone hydrochloride; a pregelatinized starch; a water-soluble excipient; a water-soluble polymer binder; and a lubricant.
    • The tablet must have lurasidone at a content ratio of 20 to 45% (wt/wt).
    • The tablet must have a dissolution rate of 80% or more at 30 minutes under specified test conditions.
    • The tablet must have a "similar dissolution profile to a second tablet" with a different lurasidone content, where similarity is defined by a similarity factor "f2 value of 50 or more."
    • The first and second tablets must be prepared by the same method and have the same ratio of ingredients.
  • The complaint also identifies independent claim 15 as illustrative, which is directed to a similar composition where the active ingredient and excipients are first formed into granules (Compl. ¶187).

III. The Accused Instrumentality

Product Identification

The Defendants’ proposed generic lurasidone hydrochloride tablets, for which each Defendant has submitted an ANDA to the FDA seeking approval for commercial manufacture and sale. The proposed products are in strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg (e.g., Compl. ¶¶188, 204).

Functionality and Market Context

The accused products are intended to be generic equivalents of Plaintiffs’ branded antipsychotic drug, Latuda® (Compl. ¶¶170, 193). The proposed labels for the generic products will indicate their use for the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (e.g., Compl. ¶193). The filing of an ANDA under 35 U.S.C. § 271(e)(2) is the statutory act of infringement alleged in the complaint, preceding any actual commercial sale (e.g., Compl. ¶361).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,815,827 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: Defendants' proposed labels will instruct physicians and healthcare providers to administer the generic product to treat schizophrenia and manic depressive psychosis without the patient experiencing clinically significant weight gain. ¶195 col. 7:4-11
orally administering once daily...a pharmaceutical composition comprising 20 to 120 mg of [lurasidone] or a pharmaceutically acceptable salt thereof Defendants' proposed products are oral tablets containing 20, 40, 60, 80, and 120 mg of lurasidone hydrochloride, and their proposed labels will instruct administration for the indicated conditions. ¶188, ¶193 col. 7:12-19
as the sole active ingredient The proposed products are generic versions of Latuda®, which contains lurasidone hydrochloride as its sole active ingredient. ¶173, ¶188 col. 7:18-19
such that the patient does not experience a clinically significant weight gain. The complaint alleges that Defendants' proposed labels will include clinical data demonstrating that patients receiving the product do not experience clinically significant weight gain. This is supported by reference to clinical data from the Latuda® Prescribing Information, such as Table 11, which shows minimal mean weight changes after six weeks of treatment (Compl. p. 42). ¶180, ¶194 col. 7:20-22
  • Identified Points of Contention:
    • Scope Questions: A primary issue for claim construction may be the phrase "clinically significant weight gain." The complaint relies on clinical trial data showing low average weight gain to support infringement allegations (Compl. ¶180). A dispute may arise over whether this limitation requires a guaranteed outcome for an individual patient or refers to the statistical profile of a patient population. The construction of "sole active ingredient" may also be contested if Defendants' formulations contain other compounds with therapeutic effects.
    • Legal Questions: Infringement of this method claim is alleged on a theory of inducement. The central question will be whether the Defendants' proposed labels, by describing the clinical outcomes and indications for use, actively "encourage" or "instruct" physicians to perform the patented method with the requisite intent under 35 U.S.C. § 271(b) (Compl. ¶195).

U.S. Patent No. 9,907,794 Infringement Allegations

The complaint does not provide sufficient detail for analysis of the specific composition or dissolution characteristics of the Defendants' proposed products against the claim limitations of the ’794 patent. The narrative infringement theory is that by seeking approval for a generic drug that is bioequivalent to Latuda®, the Defendants' products will necessarily infringe the claims of the ’794 patent, which covers the formulation of the branded product (e.g., Compl. ¶200).

  • Identified Points of Contention:
    • Evidentiary Questions: The dispute will likely focus on factual evidence from the Defendants' ANDA submissions. Key questions will include: Does the accused generic formulation contain a "pregelatinized starch" as construed by the court? Do the accused tablets meet the specific dissolution rate of "80% or more at 30 minutes"?
    • Technical Questions: A significant technical question will be whether the accused products, across their different dosage strengths, demonstrate a "similar dissolution profile" as defined by the "similarity factor f2 value of 50 or more" limitation in Claim 1. Proving infringement will require comparative dissolution testing of the Defendants' various tablet strengths.

V. Key Claim Terms for Construction

  • The Term: "clinically significant weight gain" (’827 Patent, Claim 40)

  • Context and Importance: The definition of this term is dispositive for the ’827 patent. Whether the accused labels induce infringement will depend on whether this term is construed to mean a low average weight gain across a population (as shown in clinical data) or the absence of a particular level of weight gain in each individual patient.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discusses the results of a clinical trial where patients were evaluated based on average changes in BPRS scores, suggesting a focus on population-level data (’827 Patent, col. 8:1-17). Plaintiffs may argue that "clinically significant" should be interpreted in this statistical context.
    • Evidence for a Narrower Interpretation: The claim language recites a method "such that the patient does not experience a clinically significant weight gain," which could suggest that the outcome must be achieved in the specific individual being treated (’827 Patent, col. 12:51-53). Defendants may argue this requires a more certain result than can be promised by a drug label that also warns of potential side effects.

  • The Term: "a similar dissolution profile to a second tablet" (’794 Patent, Claim 1)

  • Context and Importance: This functional language is a core limitation of the formulation patent. Infringement depends not only on the composition of a single tablet but on the comparative performance of tablets with different dosage strengths. Practitioners may focus on this term because non-infringement could be established by showing that the Defendants' family of products does not meet the required f2 value of 50 or more.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent itself defines the standard by which similarity is measured: "a similarity factor f2 value of 50 or more" (’794 Patent, col. 25:28-29). Plaintiffs may argue that any formulation meeting this explicit numerical threshold satisfies the claim, regardless of minor compositional differences.
    • Evidence for a Narrower Interpretation: Defendants might argue that the context provided by the patent's examples limits the scope of "similar." The specification includes figures showing dissolution profiles for the patented invention (e.g., FIG. 3) that demonstrate very high f2 values (88 and 97) (’794 Patent, col. 18:45-50). A defendant could argue that the term should be construed in light of these exemplary embodiments to require a higher degree of similarity than the bare minimum of f2=50.

VI. Other Allegations

  • Indirect Infringement: The allegations against the ’827 patent are primarily for indirect infringement. The complaint alleges that by submitting proposed labels that instruct physicians to use the generic products to treat schizophrenia without causing significant weight gain, Defendants will actively induce infringement under 35 U.S.C. § 271(b) (e.g., Compl. ¶¶195-196). It further alleges the products are not staple articles of commerce and are especially adapted for infringement, supporting contributory infringement under § 271(c) (e.g., Compl. ¶¶383-385).
  • Willful Infringement: While the complaint does not use the term "willful," it alleges that each Defendant became aware of the asserted patents no later than their issuance or listing in the Orange Book and continued to seek FDA approval for their infringing products (e.g., Compl. ¶¶363, 396). The prayer for relief explicitly requests a finding that the case is "exceptional" under 35 U.S.C. § 285, which provides a basis for seeking enhanced damages and attorneys' fees (Compl. p. 145).

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

  • A central issue will be one of definitional scope: can the term "clinically significant weight gain" in the ’827 patent be satisfied by evidence of low average weight gain in a patient population, as described on a drug label, or does it require a guaranteed outcome for each individual patient, which a label cannot ensure?
  • A key legal question will be one of intent to induce: does a generic drug manufacturer's proposed label, which replicates the clinical data and indications of the branded drug, constitute the affirmative intent required to induce infringement of a method-of-use patent, or is it merely a recitation of factual data mandated by FDA regulations?
  • A critical evidentiary question will be one of formulation equivalence: will discovery into the Defendants' confidential ANDA submissions reveal that their proposed generic products possess the specific combination of excipients and meet the functional dissolution profile limitations required by the ’794 patent, particularly the f2 similarity factor across different dosage strengths?