DCT
1:23-cv-00152
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: 1:23-cv-00152, D. Del., 05/12/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva is a Delaware corporation and thus resides in the judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s generic version of the drug HETLIOZ® (tasimelteon) infringes a patent covering a method of administering the drug based on a patient's concurrent use of beta-blockers.
- Technical Context: The case involves tasimelteon, a melatonin agonist used to treat Non-24-Hour Sleep-Wake Disorder, a circadian rhythm disorder common in totally blind individuals.
- Key Procedural History: The complaint notes prior litigation between the parties where different patents related to HETLIOZ® were adjudicated, with some claims being found obvious. The patent-in-suit in this action, U.S. Patent No. 11,285,129, issued during the bench trial of that prior case and could not have been asserted therein.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-26 | '129 Patent Priority Date |
| 2018-01-31 | Teva files ANDA No. 211601 for generic tasimelteon |
| 2021-09-27 | FDA issues tentative approval for Teva's ANDA |
| 2022-03-29 | U.S. Patent No. 11,285,129 issues |
| 2022-04-15 | Vanda lists the '129 Patent in the FDA Orange Book |
| 2022-09-12 | Vanda receives Teva's Paragraph IV Notice Letter for the '129 Patent |
| 2022-12-12 | FDA issues final approval for Teva's ANDA |
| 2023-05-12 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,285,129 - "Treatment of Circadian Rhythm Disorders"
The Invention Explained
- Problem Addressed: The patent addresses Non-24-Hour Sleep-Wake Disorder (Non-24), a condition where an individual's internal biological clock is not synchronized to the 24-hour day, leading to significant disruptions in sleep patterns and daytime functioning ('129 Patent, col. 1:49-2:11). The patent background notes this is particularly common in totally blind individuals who cannot perceive light, the primary environmental cue for synchronizing the body clock ('129 Patent, col. 1:55-60).
- The Patented Solution: The invention is a method for administering tasimelteon, a melatonin agonist, that accounts for a known drug-drug interaction. The patent claims a two-path treatment regimen: first, a healthcare provider determines if a patient is taking a beta-adrenergic receptor antagonist (a "beta-blocker"). If not, the patient is administered 20 mg of tasimelteon. If the patient is taking a beta-blocker—which can reduce natural melatonin production and thus drug efficacy—the provider is to instruct the patient to cease beta-blocker treatment before administering the tasimelteon ('129 Patent, col. 9:1-9; col. 37:46-38:1).
- Technical Importance: The method provides a personalized treatment protocol that aims to maximize the therapeutic effect of tasimelteon by actively managing a known negative drug-drug interaction.
Key Claims at a Glance
- The complaint asserts infringement of at least one claim, referencing independent Claim 1 and dependent Claims 2 and 3 (Compl. ¶¶64, 77).
- Independent Claim 1 requires:
- Determining whether the patient is being treated with a beta-adrenergic receptor antagonist;
- Either (if the patient is not on a beta-blocker) administering 20 mg of tasimelteon once daily before bedtime;
- Or (if the patient is on a beta-blocker) instructing the patient to cease treatment with the beta-blocker and then administering 20 mg of tasimelteon once daily before bedtime.
- The complaint reserves the right to assert other claims (Compl. ¶78).
III. The Accused Instrumentality
Product Identification
Teva's generic tasimelteon 20mg oral capsules, sold under Abbreviated New Drug Application (ANDA) No. 211601 (Compl. ¶30).
Functionality and Market Context
- Teva's product is a generic version of Vanda's HETLIOZ® and is indicated for the treatment of Non-24 (Compl. ¶¶30, 38). The infringement allegation centers on the product's prescribing information (the "Teva Label").
- The complaint alleges the Teva Label is the primary method of communicating drug information to healthcare professionals and is identical to the HETLIOZ® label in its warning about beta-blockers (Compl. ¶¶40, 42).
- The label states, in Section 7.3, that "Nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of tasimelteon" (Compl. ¶42). This warning is the basis for Vanda's inducement of infringement theory. The complaint includes a screenshot of this section from the DailyMed website. This screenshot shows the warning regarding "Beta-Adrenergic Receptor Antagonists" (Compl. ¶47).
IV. Analysis of Infringement Allegations
'129 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| In a method of administering tasimelteon to a patient, the improvement comprising: determining whether the patient is being treated with a beta-adrenergic receptor antagonist; | A physician performs this determination as a necessary step before prescribing therapy, particularly when the drug label highlights a potential drug-drug interaction. | ¶49, ¶51 | col. 9:7-9 |
| and in the case that it is determined that the patient is not being treated with a beta-adrenergic receptor antagonist, administering to the patient 20 mg of tasimelteon once daily... | Teva's product is a 20 mg capsule of tasimelteon, and its label instructs this dosage for treating Non-24, which would apply to patients not taking beta-blockers. | ¶27, ¶38 | col. 21:52-53 |
| or in the case that it is determined that the patient is being treated with a beta-adrenergic receptor antagonist: instructing the patient to cease treatment with the beta-adrenergic receptor antagonist; and then administering to the patient 20 mg of tasimelteon... | The complaint alleges that Teva's label, by warning that beta-blockers "may reduce the efficacy of tasimelteon," encourages and instructs physicians to have patients cease beta-blocker use to ensure the effectiveness of Teva's product. | ¶48, ¶55, ¶59 | col. 37:58-38:1 |
- Identified Points of Contention:
- Scope Questions: A central dispute will likely be whether the Teva Label's cautionary language that beta-blockers "may reduce the efficacy of tasimelteon" (Compl. ¶42) rises to the level of an affirmative "instructing the patient to cease treatment" as required by the claim. The defense may argue this is a non-infringing warning, not an instruction.
- Technical Questions: The complaint's theory of infringement is inducement, which requires evidence of an underlying direct infringement by a third party (e.g., a physician). A key evidentiary question will be whether Vanda can prove that physicians, relying on Teva's label, actually perform the complete, multi-step method of Claim 1, including the "instructing to cease" step.
V. Key Claim Terms for Construction
- The Term: "instructing the patient to cease treatment"
- Context and Importance: This term is the lynchpin of the infringement allegation for patients taking beta-blockers. The outcome of the case may depend on whether Teva's product label, which warns of reduced efficacy, is found to constitute an "instruction to cease." Practitioners may focus on this term because the infringement allegation is one of inducement, and the strength of the "instruction" on the label is central to proving Teva's intent to cause infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party arguing for a broader view may contend that, in the context of medical practice, a label warning that a concomitant drug "may reduce the efficacy" of a therapy is understood by a physician as a clear signal to avoid or cease the interfering drug to achieve the desired therapeutic outcome, thus functioning as an instruction.
- Evidence for a Narrower Interpretation: A party arguing for a narrower view may point to the plain meaning of "instructing" and "cease," arguing they require a direct command that is absent from the label. The patent itself uses this specific, active language in the claim ('129 Patent, col. 37:58-61), suggesting that a mere warning or cautionary statement falls short of the claimed step.
VI. Other Allegations
- Indirect Infringement: The complaint's primary theory is induced infringement under 35 U.S.C. § 271(b). It alleges Teva encourages infringement by distributing its product with a label that, when read by a physician, will lead the physician to perform the patented method (Compl. ¶¶89-92). The alleged encouraging act is the marketing and sale of the generic drug with the specific label language regarding beta-blockers (Compl. ¶60).
- Willful Infringement: Willfulness is alleged based on Teva's knowledge of the '129 patent, which the complaint claims existed at least as of the launch of its ANDA product or the receipt of Vanda's Notice Letter (Compl. ¶90). The complaint also pleads willful blindness, alleging Teva deliberately avoided confirming the infringing nature of its product's use (Compl. ¶91).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of inducement and instruction: Can the warning on Teva’s product label—that beta-blockers "may reduce the efficacy of tasimelteon"—be proven to constitute an affirmative "instruction" for physicians "to cease treatment" with beta-blockers, as required to establish inducement of the patented method?
- A key evidentiary question will be one of direct infringement: Can Vanda produce sufficient evidence to demonstrate that physicians, acting upon the language in Teva's label, are in fact performing the complete set of steps recited in Claim 1, thereby directly infringing the patent and providing the necessary predicate for Vanda's inducement claim against Teva?