DCT
1:20-cv-01333
Vanda Pharma Inc v. Apotex Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vanda Pharmaceuticals Inc. (Delaware)
- Defendant: Apotex Inc. (Canada) and Apotex Corp. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:20-cv-01333, D. Del., 10/01/2020
- Venue Allegations: Venue is asserted based on Defendant Apotex Corp.'s incorporation in Delaware and Defendant Apotex Inc.'s amenability to suit in any district where it is subject to personal jurisdiction.
- Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug tasimelteon constitutes an act of infringement of two patents covering methods of using the drug.
- Technical Context: The case involves methods of treatment for Non-24-Hour Sleep-Wake Disorder ("Non-24"), a rare circadian rhythm disorder, using the melatonin agonist tasimelteon, marketed by Plaintiff as Hetlioz®.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' Paragraph IV certification for their generic tasimelteon ANDA. The complaint notes the patents-in-suit are listed in the FDA's "Orange Book" and references a prior, separate patent infringement action between the same parties.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-26 | '510 Patent Priority Date |
| 2013-11-12 | '511 Patent Priority Date |
| 2014-01-31 | FDA approval of Hetlioz® (tasimelteon) |
| 2020-04-07 | '510 Patent Issue Date |
| 2020-04-07 | '511 Patent Issue Date |
| 2020-10-01 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
U.S. Patent No. 10,610,510 - Treatment Of Circadian Rhythm Disorders
- Patent Identification: U.S. Patent No. 10,610,510, "Treatment Of Circadian Rhythm Disorders," issued April 7, 2020.
The Invention Explained
- Problem Addressed: The patent and complaint explain that smoking increases the metabolic clearance of the drug tasimelteon, which reduces a patient's exposure to the drug and may decrease its therapeutic efficacy (Compl. ¶25; ’510 Patent, col. 6:35-40, FIGS. 12-17).
- The Patented Solution: The invention provides specific methods for treating patients with circadian rhythm disorders who are smokers. The claimed methods aim to compensate for the reduced drug exposure either by administering a higher dose (>20 mg) or by instructing the patient to reduce or stop smoking while maintaining a 20 mg dose, thereby standardizing the therapeutic effect for this patient sub-population (’510 Patent, cl. 1).
- Technical Importance: The invention provides a tailored dosing strategy to address pharmacokinetic variability within a specific patient group (smokers), potentially improving treatment outcomes (Compl. ¶25).
Key Claims at a Glance
- The complaint asserts claims 1–13 of the '510 patent (Compl. ¶42).
- Independent claim 1 claims a method of improving ineffective tasimelteon treatment by either:
- administering a dose greater than 20 mg; OR
- determining if the patient is a smoker, instructing the patient to cease or reduce smoking, and administering a 20 mg dose.
- The complaint does not explicitly reserve the right to assert dependent claims but references claims 1-13 generally.
U.S. Patent No. 10,610,511 - Method of Treatment
- Patent Identification: U.S. Patent No. 10,610,511, "Method of Treatment," issued April 7, 2020.
The Invention Explained
- Problem Addressed: Administering tasimelteon with food, particularly a high-fat meal, delays the drug's absorption and the time it takes to reach peak concentration in the blood (Tmax) (’511 Patent, col. 2:45-58). This pharmacokinetic variability could result in a delayed or less predictable therapeutic effect for a drug meant to regulate sleep cycles.
- The Patented Solution: The invention describes administering tasimelteon under "fasted conditions," or "without food." This method results in a faster rate of absorption and a shorter Tmax, leading to a more rapid and predictable onset of action without changing the total drug exposure (AUC) (’511 Patent, col. 2:58-62).
- Technical Importance: This method of administration standardizes the drug's pharmacokinetic profile, which is critical for ensuring a consistent therapeutic effect for a sleep-regulating medication (Compl. ¶29).
Key Claims at a Glance
- The complaint asserts claims 1–2 and 4–19 of the '511 patent (Compl. ¶62).
- Independent claim 1 claims a method of treatment comprising:
- instructing the patient that tasimelteon should be taken without food; and
- orally administering an effective dose of tasimelteon without food.
- The complaint does not explicitly reserve the right to assert dependent claims but references claims 1-2 and 4-19 generally.
III. The Accused Instrumentality
Product Identification
- Defendants' proposed generic tasimelteon 20 mg oral capsules, for which they seek FDA approval via Abbreviated New Drug Application (ANDA) No. 211607 (Compl. ¶¶5, 40, 60).
Functionality and Market Context
- The accused product is a generic equivalent of Vanda's Hetlioz®, intended for treating Non-24 (Compl. ¶¶37, 40). The central feature for infringement purposes is the proposed product label. The complaint alleges that this label will "essentially copy" the FDA-approved label for Hetlioz® and will therefore instruct, encourage, or recommend that prescribers and patients perform the methods claimed in the patents-in-suit (Compl. ¶¶42, 62).
- Defendants are generic pharmaceutical manufacturers seeking to market their product prior to the expiration of the patents-in-suit (Compl. ¶¶6, 10, 34).
IV. Analysis of Infringement Allegations
'510 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| determining whether the patient is a smoker; | The proposed label allegedly copies the Hetlioz® label, which warns that smoking reduces tasimelteon exposure, thereby causing a prescriber to determine the patient's smoking status. | ¶39, ¶42 | col. 37:61-62 |
| instructing the patient to cease or reduce smoking; and | The label's warning that efficacy may be reduced in smokers is alleged to instruct, encourage, and/or suggest that prescribers will instruct patients to reduce or cease smoking to achieve the desired therapeutic effect. | ¶39, ¶42 | col. 38:1-2 |
| administering to the patient 20 mg of tasimelteon once daily before bedtime. | Defendants' ANDA seeks approval for a 20 mg oral capsule, and the proposed label is alleged to recommend a 20 mg daily dosage. | ¶38, ¶40 | col. 38:3-5 |
- Identified Points of Contention:
- Scope Questions: A primary issue for the '510 Patent is whether a product label that warns of reduced drug efficacy in smokers, as the complaint alleges, satisfies the affirmative claim requirement of "instructing the patient to cease or reduce smoking." The dispute may center on whether a warning or suggestion is sufficient to meet the "instructing" limitation.
- Technical Questions: The infringement theory relies on the actions of third-party prescribers. A key evidentiary question will be what proof is sufficient to show that the language on the proposed label will necessarily lead a prescriber to perform both the "determining" and "instructing" steps as claimed.
'511 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| instructing the patient that tasimelteon should be taken without food; and | The proposed label is alleged to copy the Hetlioz® label, which the complaint quotes as explicitly stating that "HETLIOZ should be taken without food." | ¶59, ¶62 | col. 3:42-45 |
| orally administering to the patient an effective dose of tasimelteon without food. | Defendants' ANDA product is an oral capsule, and the alleged label instructions will cause patients to take it without food. | ¶60, ¶63 | col. 4:51-54 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis for the '511 Patent appears more direct, as it is based on an alleged explicit instruction on the product label. The primary question will be whether Defendants' proposed label does, in fact, contain this instruction.
- Technical Questions: If the label contains the "without food" instruction, the dispute may shift to the proper construction of that term. The parties may contest whether the patent's description of a clinical trial with a "10-hour fast" (’511 Patent, col. 2:28-29) limits the claim's scope to a specific duration of fasting.
V. Key Claim Terms for Construction
Term from the '510 Patent:
- The Term: "instructing the patient to cease or reduce smoking"
- Context and Importance: This term is the lynchpin of the induced infringement allegation for the '510 patent. Its construction will determine whether a label that warns about a drug interaction with smoking, rather than issuing an explicit command, falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party may argue that in the context of the invention, which aims to overcome the effects of smoking on drug efficacy (’510 Patent, Abstract), any label language that would cause a reasonable physician to advise a patient to stop smoking for the treatment to be effective should be considered "instructing."
- Evidence for a Narrower Interpretation: A party may argue that the plain meaning of "instructing" requires a direct command. The use of an active verb suggests an affirmative step that is more than a warning or disclosure of information.
Term from the '511 Patent:
- The Term: "without food" / "under fasted conditions"
- Context and Importance: This phrase defines the central condition of the claimed method. Its definition is critical because if the term is construed narrowly, it could create a non-infringement argument even if the accused label contains a general "take without food" instruction.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent uses the phrase "HETLIOZ should be taken without food" when discussing label language, suggesting the term's scope aligns with its common, plain-language meaning of not taking the drug concurrently with a meal (’511 Patent, col. 3:42-45).
- Evidence for a Narrower Interpretation: A party may point to the detailed description of the clinical study, where "fasted conditions" are defined as "after at least a 10-hour fast" (’511 Patent, col. 2:28-29), to argue that the claims require a specific, extended period of fasting that may not be performed by a typical patient following the general instruction.
VI. Other Allegations
Indirect Infringement
- The complaint's theory is entirely based on induced infringement. It alleges that Defendants' act of seeking approval for their ANDA product with its proposed label will induce infringement by prescribers and patients, who will follow the label's instructions to perform the patented methods (Compl. ¶¶42-43, 62-63). The complaint further alleges the product has no substantial non-infringing uses (Compl. ¶¶44, 64).
Willful Infringement
- The complaint alleges the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶51, 71). It asserts that Defendants have "actual knowledge" of the patents, citing their listing in the FDA's Orange Book and a related FDA letter (Compl. ¶¶36, 56). These allegations may form the basis for a claim of willful infringement based on post-suit conduct.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of inducement and claim scope: For the '510 patent, does a drug label that warns of reduced efficacy in smokers, as alleged, meet the affirmative claim requirement of "instructing the patient to cease or reduce smoking," or is an explicit command required?
- A key evidentiary question will be the content of the accused label: The infringement allegations for both patents depend entirely on the language of Defendants' proposed product label. The case will likely turn on whether that language, once produced in discovery, is sufficient to prove that Defendants will induce physicians and patients to perform every step of the claimed methods.
- Finally, a potential dispute will concern claim construction: Can the term "without food" in the '511 patent, which is described in the specification with reference to a 10-hour clinical trial fast, be construed to cover the more general practice of not taking a drug with a meal, as may be instructed on the accused label?