DCT
2:22-cv-07529
Vanda Pharma Inc v. Apotex Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vanda Pharmaceuticals Inc. (Washington, D.C.)
- Defendant: Apotex Inc. (Canada) and Apotex Corp. (Florida)
- Plaintiff’s Counsel: Robinson Miller LLC
- Case Identification: 2:22-cv-07529, D.N.J., 12/27/2022
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendants conduct business in the district and have previously consented to venue and jurisdiction in other legal actions in the district.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of HETLIOZ® (tasimelteon) constitutes an act of infringement of a patent covering a method of administering the drug that accounts for its interaction with beta-blockers.
- Technical Context: The technology concerns pharmaceutical treatments for Non-24-Hour Sleep-Wake Disorder, a circadian rhythm disorder primarily affecting totally blind individuals, which disrupts the normal sleep-wake cycle.
- Key Procedural History: The complaint notes prior patent litigation between the parties over HETLIOZ® in the District of Delaware. The patent-in-suit in this action, U.S. Patent No. 11,285,129, issued on March 29, 2022, during the trial of the prior case, and thus could not have been asserted in that action.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-26 | '129 Patent Priority Date |
| 2014-01-31 | Vanda's HETLIOZ® New Drug Application (NDA) approved by FDA |
| 2018-01-31 | Apotex files ANDA No. 211607 for generic tasimelteon |
| 2020-02-02 | FDA tentatively approves Apotex's ANDA |
| 2022-03-29 | '129 Patent Issue Date |
| 2022-06-15 | Vanda receives Apotex's Paragraph IV Certification Notice Letter |
| 2022-12-27 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 11,285,129, "Treatment of Circadian Rhythm Disorders", issued March 29, 2022.
The Invention Explained
- Problem Addressed: The patent addresses Non-24-Hour Sleep-Wake Disorder (Non-24), a condition where individuals, primarily those who are totally blind and lack light perception, are unable to synchronize their internal "master body clock" to the 24-hour day. This leads to a "free running" clock, causing a cyclical pattern of sleep-wake disruption, daytime sleepiness, and impaired social and occupational functioning ('129 Patent, col. 1:49 - 2:11).
- The Patented Solution: The invention is a method for administering tasimelteon, a melatonin agonist used to treat Non-24, that specifically addresses a negative drug-drug interaction. The method requires first determining if a patient is also taking a beta-adrenergic receptor antagonist (a "beta-blocker"). Depending on the outcome, the method involves either administering tasimelteon directly (if no beta-blocker is used) or instructing the patient to cease the beta-blocker before administering tasimelteon ('129 Patent, Abstract; Claim 1).
- Technical Importance: The complaint asserts that the discovery of this negative interaction was significant because prior art allegedly "taught away" from the invention by suggesting that beta-blockers could be useful in treating circadian rhythm disorders (Compl. ¶19).
Key Claims at a Glance
- The complaint asserts infringement of at least one claim, which must include independent claim 1 ('129 Patent, Claim 1).
- The essential elements of independent claim 1 are:
- A method of administering tasimelteon to a patient.
- First, determining whether the patient is being treated with a beta-adrenergic receptor antagonist.
- If the patient is not being treated with a beta-blocker, administering 20 mg of tasimelteon daily.
- If the patient is being treated with a beta-blocker, instructing the patient to cease treatment with the beta-blocker, and then administering 20 mg of tasimelteon daily.
- The complaint reserves the right to assert infringement of other claims of the '129 patent (Compl. ¶52).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Apotex's Abbreviated New Drug Application (ANDA) No. 211607 and the generic tasimelteon 20mg oral capsule product described therein (Compl. ¶ p.1). The act of infringement alleged under the Hatch-Waxman Act is the submission of the ANDA to the FDA to seek approval for commercial sale prior to the '129 patent's expiration (Compl. ¶52).
Functionality and Market Context
- The technical functionality at issue is not in the drug itself, but in its proposed labeling. The complaint alleges, on information and belief, that the proposed prescribing information for Apotex's product will be "identical to that in Section 7.3 of the currently approved HETLIOZ® prescribing information" (Compl. ¶39). This section of the label allegedly states that beta-blockers "may reduce the efficacy of HETLIOZ®" (Compl. ¶31).
- Plaintiff alleges that its branded version, HETLIOZ®, is one of only two of its approved products and accounted for nearly 65% of its revenue in 2021, underscoring the commercial importance of the dispute (Compl. ¶47).
IV. Analysis of Infringement Allegations
The infringement theory is one of induced infringement under 35 U.S.C. § 271(b), based on the allegation that Apotex's proposed drug label will instruct medical professionals and patients to perform the steps of the patented method.
No probative visual evidence provided in complaint.
U.S. Patent No. 11,285,129 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; | The complaint alleges that Apotex's proposed label, by warning of a negative interaction with beta-blockers, will necessarily cause physicians to determine whether a patient is taking such a drug before prescribing Apotex's product. | ¶40 | col. 38:6-8 |
| 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... | The proposed label will instruct the administration of generic tasimelteon for its approved indication (Non-24) to patients, including those not on beta-blockers. | ¶34, ¶37 | col. 38:9-13 |
| 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 the label's warning of reduced efficacy from co-administration with beta-blockers would be understood by a reader "to instruct the reader to avoid the use of beta blockers," including counseling patients to cease their use to realize the benefit of tasimelteon. | ¶31, ¶40, ¶41 | col. 38:14-21 |
Identified Points of Contention
- Scope Questions: A primary point of contention will be whether the language in the proposed label, which allegedly warns that beta-blockers "may reduce the efficacy" of tasimelteon (Compl. ¶31), can satisfy the claim limitation of "instructing the patient to cease treatment." The court will have to determine if a warning of reduced efficacy constitutes an affirmative instruction to stop taking an interacting medication.
- Technical Questions: A key factual question is what Apotex’s final, FDA-approved label will state. The complaint's allegations regarding the label's contents are made "on information and belief" (Compl. ¶39), and any deviation from the HETLIOZ® label's language could impact the infringement analysis.
V. Key Claim Terms for Construction
- The Term: "instructing the patient to cease treatment"
- Context and Importance: The construction of this term is central to Plaintiff's inducement theory. The case may turn on whether the warning contained in the proposed product label constitutes an "instruction to cease." Practitioners may focus on this term because it is the active step that allegedly links the label's content to the infringing performance of the patented method by end-users.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party may argue that in the context of pharmaceutical labeling and medical practice, a direct warning that a co-administered drug "may reduce the efficacy" of the primary therapeutic is functionally equivalent to an instruction to avoid or cease its use to achieve the intended medical benefit. The patent does not appear to provide an explicit definition, potentially leaving the term open to its plain and ordinary meaning in the relevant art.
- Evidence for a Narrower Interpretation: A party may argue that the claim requires an explicit, affirmative command to "cease treatment," which is distinct from a more passive warning about potentially reduced efficacy. The patent uses the active word "instructing," which could be construed to require more than merely providing information from which a user might infer a course of action.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The theory is that Apotex’s proposed product label, by describing the negative drug-drug interaction, will encourage and instruct physicians to perform the patented method, including determining a patient's beta-blocker status and counseling patients to cease beta-blocker use before administering Apotex's product (Compl. ¶40-41, 53).
- Willful Infringement: The complaint alleges that Apotex has actual knowledge of the '129 patent, at least as of its receipt of Vanda's notice letter on June 15, 2022 (Compl. ¶36, 54). The prayer for relief seeks enhanced damages for willful infringement (Compl. p.14).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this case will likely depend on the answers to two central questions:
- A core issue will be one of definitional scope and inducement: Can a warning in a drug's prescribing information stating that a second drug "may reduce the efficacy" of the first be legally construed as "instructing the patient to cease treatment" with the second drug, as required to prove induced infringement of claim 1?
- A key evidentiary question will be one of factual proof: Assuming the court finds a warning can constitute an instruction, what will the final, FDA-approved label for Apotex's generic product state, and will its specific language be sufficient to meet the elements of Vanda's infringement theory?