Vanda Pharma Inc v. Teva Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Vanda Pharmaceuticals Inc. (Washington, D.C.)
  • Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
  • Plaintiff’s Counsel: McCarter & English, LLP; McDermott Will & Emery LLP
• Case Identification: 1:24-cv-01345, D. Del., 12/09/2024
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva is incorporated in Delaware and has previously litigated in the district without challenging venue.
• Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's HETLIOZ® (tasimelteon) product infringes a patent covering a method of administering the drug to patients who are also being treated with beta-blockers.
• Technical Context: The technology relates to managing drug-drug interactions in the treatment of circadian rhythm disorders, which affect the body's natural sleep-wake cycle.
• Key Procedural History: The complaint notes that the parties are currently engaged in separate, ongoing litigation involving the same accused product but a different patent (U.S. Patent No. 11,285,129). The patent-in-suit in this case was not asserted previously because it had not yet issued at the time the prior lawsuit was filed.

Case Timeline

Date	Event
2012-01-26	'556 Patent Priority Date
2014-01-31	Vanda's HETLIOZ® NDA Approval Date
2018-01-31	Teva's ANDA Filing Date (no later than)
2021-09-27	FDA Tentative Approval of Teva's ANDA
2022-09-12	Vanda Receives Teva's Notice Letter (approx.)
2022-12-12	FDA Final Approval of Teva's ANDA
2022-12-27	Vanda Files Prior Suit Against Teva on '129 Patent
2022-12-29	Teva's Commercial Launch of ANDA Product (approx.)
2024-03-05	'556 Patent Issue Date
2024-12-09	Complaint Filing Date

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

U.S. Patent No. 11,918,556 - "Treatment of Circadian Rhythm Disorders"

• Patent Identification: U.S. Patent No. 11,918,556, "Treatment of Circadian Rhythm Disorders", issued March 5, 2024.

The Invention Explained

• Problem Addressed: The co-administration of certain drugs can lead to negative interactions. Specifically, beta-adrenergic receptor antagonists ("beta-blockers"), a common class of cardiovascular drugs, are known to reduce the body's production of melatonin, which can in turn reduce the effectiveness of melatonin agonist drugs like tasimelteon ('556 Patent, col. 9:1-14; Compl. ¶25).
• The Patented Solution: The patent claims a specific method to overcome this problem. The method involves first discontinuing a patient's treatment with a beta-blocker and then administering tasimelteon. This sequential administration is intended to avoid the drug-drug interaction and preserve the therapeutic efficacy of tasimelteon ('556 Patent, col. 38:35-50).
• Technical Importance: This claimed method provides a therapeutic regimen for patients who may require treatment for both a cardiovascular condition (with a beta-blocker) and a circadian rhythm disorder, allowing them to receive the intended benefit of tasimelteon.

Key Claims at a Glance

• The complaint asserts infringement of at least one claim of the '556 patent, with its infringement theory mapping to independent claim 1 (Compl. ¶49-51).
• Independent Claim 1 requires:
  • A method of treating a patient for a circadian rhythm or sleep disorder, where the patient is currently being treated with a beta-adrenergic receptor antagonist.
  • Discontinuing treatment with the beta-adrenergic receptor antagonist.
  • Then administering 20 mg of tasimelteon once daily about one-half to one-and-one-half hours before the target bedtime.
  • Thereby avoiding the decreased efficacy of tasimelteon that would result from co-administration with the beta-blocker.
• The complaint does not explicitly reserve the right to assert dependent claims, but makes a general allegation of infringement of "one or more claims" (Compl. ¶17).

III. The Accused Instrumentality

Product Identification

• Product Identification: Teva’s ANDA Product, which is a generic version of Vanda's HETLIOZ® (tasimelteon) 20 mg oral capsules (Compl. ¶ Intro).

Functionality and Market Context

• The accused product is a generic equivalent to HETLIOZ®, intended for treating Non-24-Hour Sleep-Wake Disorder (Non-24), a type of circadian rhythm disorder (Compl. ¶19, ¶39).
• The infringement allegation is not based on the product's chemical composition but on the instructions for its use provided in its package insert, or "Label" (Compl. ¶35). The complaint alleges Teva's Label contemplates that patients taking its product may also be on beta-blockers for other conditions (Compl. ¶40). The Label allegedly warns that "nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of tasimelteon," and instructs a dosage of "20 mg one hour before bedtime" (Compl. ¶42-43).
• The complaint alleges that Teva commercially launched its ANDA product on or around December 29, 2022 (Compl. ¶34).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

11,918,556 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating a patient for a circadian rhythm disorder or a sleep disorder wherein the patient is being treated with a beta-adrenergic receptor antagonist,	Teva's Label instructs prescribers to use the ANDA Product to treat Non-24 (a circadian rhythm disorder) and contemplates that the patient population may be taking beta-blockers for other conditions.	¶39-40	col. 38:35-38
the method comprising: discontinuing treatment with the beta-adrenergic receptor antagonist;	The complaint alleges that Teva's Label, by warning that beta-blockers "may reduce the efficacy of tasimelteon," encourages and induces prescribers to have patients discontinue beta-blocker treatment before prescribing or continuing therapy with Teva's product.	¶42-44	col. 38:39-40
and then administering to the patient with 20 mg tasimelteon once daily about one-half hour to about one-and-one-half hours before the target bedtime;	Teva's Label instructs administering a 20 mg dose of tasimelteon "one hour before bedtime," which is within the claimed time range.	¶43	col. 38:41-45
thereby avoiding decreased efficacy of tasimelteon treatment due to co-administration with the beta-adrenergic receptor antagonist.	This is alleged to be the direct and intended result of a prescriber following the instructions and heeding the warnings on Teva's Label.	¶44	col. 38:46-50

• Identified Points of Contention:
  • Scope Questions: A central dispute may concern whether Teva's Label, which provides a warning about a potential drug interaction, can be considered to instruct or induce the affirmative step of "discontinuing treatment" as required by the claim. The defense may argue that a warning is not an instruction.
  • Technical Questions: What evidence does the complaint provide that a physician would necessarily follow the specific sequence of steps outlined in Claim 1 based solely on Teva's Label? The analysis will likely focus on whether the Label's language is sufficient to establish Teva's specific intent to encourage infringement.

V. Key Claim Terms for Construction

• The Term: "discontinuing treatment with the beta-adrenergic receptor antagonist"
• Context and Importance: This term is the lynchpin of the inducement allegation. The case may turn on whether Teva's Label is found to encourage this specific, affirmative act. Practitioners may focus on this term because proving that a warning constitutes inducement to perform an action is a high evidentiary bar.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that the plain and ordinary meaning simply requires stopping the beta-blocker, an action a physician would reasonably take upon being warned of a negative interaction, without requiring proof of the physician's specific motive.
  • Evidence for a Narrower Interpretation: The claim's purpose clause, "thereby avoiding decreased efficacy" ('556 Patent, col. 38:46-47), suggests that "discontinuing" is not just any cessation, but one performed for the specific purpose of avoiding the interaction. A party could argue the claim requires this causal link, which a mere warning might not establish.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced infringement and contributory infringement.
  • Inducement (35 U.S.C. § 271(b)): The primary theory is that Teva's product Label actively encourages and instructs physicians and patients to use the generic drug in a manner that directly infringes the '556 Patent's method claim (Compl. ¶50, ¶59).
  • Contributory (35 U.S.C. § 271(c)): The complaint alleges that Teva's ANDA Product is a material part of the invention and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶51, ¶60).
• Willful Infringement: The complaint alleges that Teva had knowledge of the '556 patent on or around its issue date of March 5, 2024, or at the latest upon the filing of this complaint. It alleges that Teva's continued infringement is therefore willful, deliberate, and/or shows willful blindness (Compl. ¶53, ¶57-58, ¶61).

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

• A central issue will be one of inducement: does Teva's product label, which contains a warning about a drug-drug interaction, legally constitute active encouragement for a physician to perform the affirmative step of "discontinuing" a beta-blocker before administering tasimelteon, as required to prove induced infringement of Claim 1?
• A key question for claim construction will be the scope of the phrase "discontinuing treatment." The court will need to determine if this requires only the act of cessation, or if it also requires proof that the cessation was performed with the specific intent to "avoid[] decreased efficacy" of tasimelteon, a distinction that could prove dispositive for the inducement analysis.