DCT

1:24-cv-00815

Vanda Pharma Inc v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00815, D. Del., 07/12/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant MSN Pharmaceuticals is a Delaware corporation and both Defendants have previously consented to venue in the district through conduct in prior litigation.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Hetlioz LQ® (tasimelteon) oral suspension constitutes an act of infringement of seven U.S. patents covering methods of treatment.
  • Technical Context: The technology involves methods of using tasimelteon, a melatonin-receptor agonist, to treat sleep disturbances, particularly those associated with the rare genetic disorder Smith-Magenis Syndrome (SMS) and in specific patient populations.
  • Key Procedural History: This lawsuit was triggered by Defendants' submission of ANDA No. 219541 to the FDA and subsequent sending of a notice letter with a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, and/or not infringed. The patents are listed in the FDA's Orange Book as covering the Hetlioz LQ® product.

Case Timeline

Date Event
2012-01-26 Priority Date for '129, '229, '510, and '770 Patents
2014-09-02 Priority Date for '119 and '622 Patents
2019-01-15 U.S. Patent No. 10,179,119 Issues
2019-12-13 Priority Date for '446 Patent
2020-04-07 U.S. Patent No. 10,610,510 Issues
2020-12-01 FDA approves Vanda's Hetlioz LQ® oral suspension
2021-04-20 U.S. Patent No. 10,980,770 Issues
2022-03-08 U.S. Patent No. 11,266,622 Issues
2022-03-29 U.S. Patent No. 11,285,129 Issues
2023-09-19 U.S. Patent No. 11,759,446 Issues
2023-12-26 U.S. Patent No. 11,850,229 Issues
2024-06-03 Plaintiff receives Defendants' ANDA notice letter
2024-07-12 Complaint Filed

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

U.S. Patent No. 10,179,119 - "Method of Treatment"

  • Issued: January 15, 2019

The Invention Explained

  • Problem Addressed: The patent describes the lack of an effective treatment for severe, chronic sleep disturbances in patients with Smith-Magenis Syndrome (SMS), a rare genetic disorder. These disturbances are linked to an "inverse" circadian pattern of melatonin, where melatonin is high during the day and low at night, opposite the normal pattern. (’119 Patent, col. 1:26-54, col. 2:1-4).
  • The Patented Solution: The invention provides a method for treating these sleep disturbances by administering an effective amount of tasimelteon, a melatonin agonist, once daily before bedtime. This pharmacological intervention is intended to correct or mitigate the effects of the disrupted melatonin cycle. (’119 Patent, col. 2:7-11).
  • Technical Importance: The invention provided a targeted pharmacological approach for treating a debilitating symptom of a rare disease that previously had no effective treatment options. (Compl. ¶13; ’119 Patent, col. 2:1-4).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶80).
  • Essential elements of Claim 1:
    • A method for the treatment of sleep disturbances in a patient with Smith-Magenis Syndrome
    • that comprises internally administering to the patient an effective amount of tasimelteon
    • once daily before bedtime.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes general allegations of infringement of "at least one claim." (Compl. ¶81).

U.S. Patent No. 11,266,622 - "Method of Treatment"

  • Issued: March 8, 2022

The Invention Explained

  • Problem Addressed: As a continuation of the same patent family, the ’622 Patent addresses the same problem of treating sleep disturbances in SMS patients. (Compl. ¶33; ’622 Patent, col. 1:26-54).
  • The Patented Solution: This patent claims a more specific method of treatment than the ’119 Patent, reciting the administration of a precise 20 mg dose of tasimelteon once daily before bedtime. (’622 Patent, col. 8:1-4).
  • Technical Importance: This patent provides a specific, clinically determined dosage regimen for administering tasimelteon to SMS patients. (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶90).
  • Essential elements of Claim 1:
    • A method of treating a patient suffering from Smith-Magenis Syndrome (SMS)
    • the method comprising: administering to the patient 20 mg of tasimelteon
    • once daily before bedtime.
  • The complaint does not explicitly reserve the right to assert dependent claims but makes general allegations of infringement. (Compl. ¶91).

Multi-Patent Capsule: U.S. Patent Nos. 11,285,129 and 11,850,229 (Beta Blocker Interaction Patents)

  • Patent Identification: U.S. Patent No. 11,285,129, issued March 29, 2022, and U.S. Patent No. 11,850,229, issued December 26, 2023; both titled “Treatment of Circadian Rhythm Disorders.”
  • Technology Synopsis: These patents relate to methods of administering tasimelteon while accounting for its interaction with beta-adrenergic receptor antagonists ("beta blockers"). The patents are based on studies showing that patients receiving beta blockers were less likely to respond to tasimelteon therapy. (Compl. ¶45-46).
  • Asserted Claims: At least claim 1 of each patent is asserted. (Compl. ¶100, ¶110).
  • Accused Features: The complaint alleges that Section 7.3 of the proposed product label for MSN’s ANDA Product, which warns about the reduced efficacy of tasimelteon when taken with beta blockers, will instruct prescribers to determine if a patient is taking a beta blocker and to either administer the product (if the patient is not) or have the patient cease beta blocker use before administration. (Compl. ¶49-51).

Multi-Patent Capsule: U.S. Patent Nos. 10,610,510 and 10,980,770 (Smoker Method of Treatment Patents)

  • Patent Identification: U.S. Patent No. 10,610,510, issued April 7, 2020, and U.S. Patent No. 10,980,770, issued April 20, 2021; both titled “Treatment of Circadian Rhythm Disorders.”
  • Technology Synopsis: These patents cover methods of administering tasimelteon that avoid the negative impact of smoking on the drug's metabolism. The ’770 patent is also directed to methods avoiding harmful effects from co-administration with a CYP1A2 inhibitor. (Compl. ¶58).
  • Asserted Claims: At least claim 1 of each patent is asserted. (Compl. ¶120, ¶130).
  • Accused Features: The complaint alleges that Sections 8.7 and 7.1 of the proposed product label will instruct prescribers to determine if a patient is a smoker or taking a CYP1A2 inhibitor and to counsel the patient to cease or reduce such activity before using the product. (Compl. ¶63-65).

Multi-Patent Capsule: U.S. Patent No. 11,759,446 (Suspension SMS Method of Treatment Patent)

  • Patent Identification: U.S. Patent No. 11,759,446, “Liquid Tasimelteon Formulations and Methods of Use Thereof,” issued September 19, 2023.
  • Technology Synopsis: This patent relates to methods of treating SMS using tasimelteon in a liquid dosage form, with specific dosage amounts that depend on a patient's weight. (Compl. ¶71).
  • Asserted Claims: At least claim 1 is asserted. (Compl. ¶140).
  • Accused Features: The complaint alleges that the Dosing and Administration Section and Section 2.4 of the proposed product label will instruct prescribers to administer the tasimelteon liquid suspension based on patient weight and to shake the formulation before administering, as claimed in the patent. (Compl. ¶76).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "MSN's ANDA Product," identified as a generic version of Vanda's Hetlioz LQ® tasimelteon (4mg/mL) oral suspension, for which Defendants have sought FDA approval via ANDA No. 219541. (Compl. ¶1, ¶16).

Functionality and Market Context

  • The accused product is a liquid oral suspension of tasimelteon intended for the treatment of nighttime sleep disturbances caused by SMS in children from 3 to 15 years of age. (Compl. ¶26). The complaint alleges that the product is bioequivalent to Hetlioz LQ® and that its proposed prescribing information (label) will be substantially identical to the FDA-approved label for Hetlioz LQ®. (Compl. ¶27, ¶36, ¶84). The core of the infringement allegation is that this proposed label will instruct prescribers and patients to use the generic drug in a manner that practices the methods claimed in the patents-in-suit. (Compl. ¶37, ¶50, ¶64, ¶76). A visual from the currently approved label, included in the complaint, specifies dosing based on patient age and weight, distinguishing between capsules for older patients and oral suspension for pediatric patients. (Compl. ¶18).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,179,119 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the treatment of sleep disturbances in a patient with Smith-Magenis Syndrome The proposed label for MSN's ANDA Product will indicate its use for the treatment of nighttime sleep disturbances caused by SMS. ¶26 col. 6:55-58
that comprises internally administering to the patient an effective amount of tasimelteon The proposed label will instruct prescribers to administer MSN's ANDA Product, which contains tasimelteon, in an amount effective to treat sleep disturbances. ¶37, ¶80 col. 2:9-11
once daily before bedtime. The proposed label will instruct patients to take the product orally once daily before bedtime. ¶37 col. 6:58-61

U.S. Patent No. 11,266,622 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a patient suffering from Smith-Magenis Syndrome (SMS) The proposed label for MSN's ANDA Product will indicate its use for treating nighttime sleep disturbances associated with SMS. ¶26 col. 8:1-2
the method comprising: administering to the patient 20 mg of tasimelteon The proposed label, mirroring the Hetlioz LQ® label, will instruct that pediatric patients weighing more than 28 kg should be administered a 20 mg dose. ¶18, ¶35, ¶90 col. 7:7-8
once daily before bedtime. The proposed label will instruct patients to take the product once per day, one hour prior to bedtime. ¶18, ¶35, ¶90 col. 8:3-4

Identified Points of Contention

  • Scope Questions: A primary question for the court will be whether the act of submitting an ANDA with a proposed label that mirrors the innovator's label demonstrates the specific intent required to induce infringement of method-of-use patents. The analysis may explore whether the label actively encourages an infringing use or merely communicates FDA-approved information.
  • Technical Questions: For the ’622 Patent, which claims a specific 20 mg dose, a key question will be whether a label that also instructs a different, non-infringing dose (0.7 mg/kg for patients ≤28 kg) can give rise to infringement. This raises the question of whether the availability of substantial non-infringing uses, as taught by the same label, negates a finding of inducement for the patient population that would receive the claimed 20 mg dose.

V. Key Claim Terms for Construction

The Term: "effective amount" (from ’119 Patent, Claim 1)

  • Context and Importance: This term's construction is central to defining the scope of infringement for the ’119 Patent. The dispute will likely focus on what dosage levels are captured by this term. Practitioners may focus on this term because its breadth or narrowness could determine whether various dosing instructions on the accused label fall within the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification does not appear to explicitly define "effective amount," which may support giving the term its plain and ordinary meaning: an amount sufficient to produce the desired therapeutic response for sleep disturbances in an SMS patient. (’119 Patent, col. 2:10).
    • Evidence for a Narrower Interpretation: The patent's dependent claims recite a specific dose of "about 20 mg/d." (’119 Patent, col. 8:7-9). A defendant may argue that the specification's examples and the dependent claims limit the scope of "effective amount" to this specific dosage.

The Term: "administering to the patient 20 mg of tasimelteon" (from ’622 Patent, Claim 1)

  • Context and Importance: While seemingly straightforward, the construction of this entire phrase in the context of induced infringement is critical. The dispute will not be over the meaning of "20 mg," but whether the accused label instructs this specific act for the patient population defined in the claim's preamble ("a patient suffering from SMS").
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A plaintiff may argue that because the label explicitly directs a 20 mg dose for a subset of SMS patients (those >28 kg), it directly instructs the administration claimed by the patent. (Compl. ¶18, ¶35). The method is practiced whenever a patient in that subgroup follows the label.
    • Evidence for a Narrower Interpretation: A defendant may argue that the claim preamble covers all patients with SMS, but the label provides a different, non-infringing instruction (0.7 mg/kg dose) for another subset of SMS patients (those ≤28 kg). This could support an argument that the label as a whole does not universally instruct the claimed method and has substantial non-infringing uses.

VI. Other Allegations

Indirect Infringement

  • The complaint's core theory is indirect infringement. For each asserted patent, it alleges induced infringement under 35 U.S.C. § 271(b), stating that MSN's proposed label will instruct and encourage prescribers and patients to perform the patented methods. (Compl. ¶85-86, ¶95-96, ¶105-106, ¶115-116, ¶125-126, ¶135-136, ¶145-146). It also alleges contributory infringement under 35 U.S.C. § 271(c), asserting that the tasimelteon oral suspension is a material part of the claimed invention and not a staple article of commerce suitable for substantial non-infringing use. (Compl. ¶87, ¶97, ¶107, ¶117, ¶127, ¶137, ¶147).

Willful Infringement

  • The complaint does not explicitly allege willful infringement. It requests a declaration that the case is "exceptional" under 35 U.S.C. § 285 in the prayer for relief, but it does not plead facts to support a claim of willfulness based on pre- or post-suit knowledge. (Compl. ¶j, p. 33).

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

  • A core issue will be one of induced infringement: Does MSN's proposed product label, by being a "substantive copy" of the innovator label as required by FDA regulations, demonstrate the specific intent required to encourage infringement of the asserted method claims, or does it merely convey information without such intent?
  • A key evidentiary question will be one of substantial non-infringing use: For the patents claiming specific dosages or patient management steps (e.g., the '622 patent's 20 mg dose), can infringement be found when the same accused label also explicitly instructs different, non-infringing methods for other patient subpopulations (e.g., weight-based dosing for smaller children)?
  • An underlying issue, arising from the defendant's Paragraph IV certification, will be the validity of the asserted claims: Can the patents, which claim specific methods of using a known compound, withstand obviousness challenges, particularly regarding the claimed dosage amounts and patient-specific treatment protocols?