DCT
1:18-cv-00651
Vanda Pharma Inc v. Teva Pharma USA Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Vanda Pharmaceuticals Inc. (Delaware)
- Defendant: MSN Pharmaceuticals Inc. (Delaware) and MSN Laboratories Private Limited (India)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Paul, Weiss, Rifkind, Wharton & Garrison LLP
- Case Identification: 1:18-cv-00651, D. Del., 05/05/2021
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant MSN Pharmaceuticals Inc. is incorporated in Delaware, and Defendant MSN Laboratories Private Limited is an Indian corporation subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendants’ proposed generic tasimelteon product, by virtue of its Abbreviated New Drug Application (ANDA) filing and proposed product label, will induce infringement of patents related to specific methods of using tasimelteon to treat circadian rhythm disorders.
- Technical Context: The dispute centers on tasimelteon (marketed by Plaintiff as Hetlioz®), a melatonin agonist used to treat Non-24-Hour Sleep-Wake Disorder, a condition primarily affecting totally blind individuals whose internal body clocks are not synchronized to a 24-hour day.
- Key Procedural History: This First Amended Complaint was filed in a consolidated action. The act of infringement is statutory under the Hatch-Waxman Act, based on Defendants’ filing of ANDA No. 211654 with a Paragraph IV Certification asserting that Plaintiff's patents are invalid, unenforceable, or will not be infringed by the proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-26 | U.S. Patent No. 10,610,510 Priority Date |
| 2013-11-12 | U.S. Patent No. 10,610,511 Priority Date |
| 2014-01-31 | FDA approves Vanda's Hetlioz® (tasimelteon) |
| 2020-04-07 | U.S. Patent No. 10,610,510 Issues |
| 2020-04-07 | U.S. Patent No. 10,610,511 Issues |
| 2021-03-24 | Vanda receives Notice Letter regarding MSN's ANDA |
| 2021-05-05 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,610,510 - "Treatment Of Circadian Rhythm Disorders"
Issued April 7, 2020.
The Invention Explained
- Problem Addressed: The patent identifies that smoking increases the metabolic clearance of the drug tasimelteon, which can reduce a patient's exposure to the drug and potentially diminish its therapeutic efficacy in treating circadian rhythm disorders (’510 Patent, col. 33:57-61; Compl. ¶36).
- The Patented Solution: The invention provides methods for treating circadian rhythm disorders by administering tasimelteon to patients based on their status as a smoker. The methods include administering tasimelteon to a patient who is a smoker, sometimes coupled with an instruction for the patient to reduce or eliminate smoking, thereby managing the pharmacokinetic interaction (’510 Patent, Abstract; Compl. ¶36).
- Technical Importance: This approach represents a step toward personalized medicine, allowing clinicians to account for a patient's lifestyle factor (smoking) that directly impacts drug metabolism and efficacy.
Key Claims at a Glance
- The complaint asserts claims 1-13, which include independent claims 1, 6, and 9 (Compl. ¶54).
- Essential elements of independent claim 1 include:
- A method of treating a patient for a circadian rhythm disorder in whom treatment with tasimelteon was ineffective.
- The improvement comprising determining whether the patient is a smoker.
- And in the case that the patient is determined to be a smoker: administering to the patient a dose of tasimelteon that is greater than 20 mg once daily before bedtime; or instructing the patient to cease or reduce smoking; and administering to the patient 20 mg of tasimelteon once daily before bedtime.
- The complaint alleges infringement of one or more claims of the ’510 Patent (Compl. ¶58).
U.S. Patent No. 10,610,511 - "Method of Treatment"
Issued April 7, 2020.
The Invention Explained
- Problem Addressed: The patent describes a clinical study showing that administering tasimelteon with a high-fat meal decreases the drug's maximum concentration (Cmax) and lengthens the time to reach that concentration (Tmax), which can negatively affect the drug's absorption profile and intended therapeutic effect (’511 Patent, col. 4:45-58).
- The Patented Solution: The invention provides a method for administering tasimelteon under "fasted conditions" to optimize its pharmacokinetic profile. This method, by avoiding co-administration with food, results in a more rapid and higher peak absorption of the drug, which is desirable for a sleep-inducing agent (’511 Patent, col. 4:25-34; Compl. ¶40-41).
- Technical Importance: The invention provides critical dosing instructions that ensure patients achieve a consistent and therapeutically effective absorption profile, maximizing the drug's potential benefit for sleep disorders.
Key Claims at a Glance
- The complaint asserts claims 1-2 and 4-19, which include independent claims 1, 4, 12, and 18 (Compl. ¶75).
- Essential elements of independent claim 1 include:
- A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder.
- The method comprises instructing the patient that tasimelteon should be taken without food.
- And orally administering to the patient an effective dose of tasimelteon without food.
- The complaint alleges infringement of one or more claims of the ’511 Patent (Compl. ¶79).
III. The Accused Instrumentality
Product Identification
Defendants' proposed generic tasimelteon oral capsules in a 20 mg strength, for the treatment of Non-24-Hour Sleep-Wake Disorder, as described in ANDA No. 211654 (“MSN’s ANDA Product”) (Compl. ¶11, ¶51).
Functionality and Market Context
The accused instrumentality is a generic drug product that has not yet been commercially launched. The basis for the infringement action is the filing of the ANDA seeking FDA approval. The complaint alleges that the proposed product label for MSN's ANDA Product will be substantially a copy of the label for Vanda's approved Hetlioz® drug product, as required by FDA regulations (Compl. ¶54, ¶75). The complaint alleges that this proposed label will instruct, recommend, or encourage physicians and patients to use the generic product in a manner that directly infringes the patents-in-suit (Compl. ¶54-55, ¶75-76).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'510 Patent Infringement Allegations
| Claim Element (from Independent Claim 6) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a patient for a circadian rhythm disorder, the method comprising: determining whether the patient is a smoker; | The proposed label allegedly instructs prescribers to consider a patient's smoking status because it states that tasimelteon exposure is lower and efficacy may be reduced in smokers. | ¶50, ¶54 | col. 33:57-61 |
| and in the case that the patient is determined to be a smoker: administering to the patient a dose of tasimelteon that is greater than 20 mg once daily before bedtime; or instructing the patient to cease or reduce smoking; and administering to the patient 20 mg of tasimelteon once daily before bedtime. | The proposed label for the 20 mg product, by warning of reduced efficacy in smokers, allegedly instructs, recommends, and/or suggests that prescribers should administer the drug to smokers for the treatment of Non-24, thereby infringing the claimed method. | ¶50, ¶54-55 | col. 38:6-14 |
'511 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder, the method comprising: | MSN's ANDA seeks approval to market generic tasimelteon for the treatment of Non-24, a circadian rhythm sleep disorder. | ¶66-67, ¶69 | col. 4:3-5 |
| instructing the patient that tasimelteon should be taken without food; | The proposed label, by copying the Hetlioz® label, allegedly instructs prescribers and patients that the drug "should be taken without food." | ¶71, ¶75 | col. 3:1-12 |
| and orally administering to the patient an effective dose of tasimelteon without food. | By seeking approval for a product with a label that instructs administration without food, MSN allegedly will induce patients and prescribers to administer the drug in an infringing manner upon FDA approval. | ¶72, ¶75-76 | col. 4:65-67 |
Identified Points of Contention
- Scope Questions: For the ’510 Patent, a central question may be whether a label that warns of reduced drug exposure in smokers (Compl. ¶50) constitutes an affirmative instruction or encouragement to "treat" a patient who is a smoker, as required by the claims. For the ’511 Patent, a question may arise as to whether the label's instruction to take the drug "without food" (Compl. ¶71) is coextensive with the claim term "under fasted conditions."
- Technical Questions: The infringement analysis will likely focus on legal questions of claim construction and inducement rather than technical disputes over the product's operation, as the case is based on the contents of a proposed product label rather than the physical composition or operation of an existing product.
V. Key Claim Terms for Construction
The Term: "instructing the patient to ... eliminate smoking" (’510 Patent, Claim 6)
Context and Importance
This case is one of induced infringement, where liability turns on whether MSN's product label encourages or instructs infringement. The specific language used on the label will be compared against the claim language. Practitioners may focus on whether the label's alleged warning about smoking's effect on efficacy (Compl. ¶50) constitutes an "instruction" to change smoking behavior.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent specification describes the invention as relating to the effects of smoking on tasimelteon exposure and includes treating a patient with a method that comprises "instructing the patient to reduce or eliminate smoking" (’510 Patent, col. 34:33-36). This may support an argument that any language on the label that informs the patient of the negative effects of smoking could be seen as an implicit instruction.
- Evidence for a Narrower Interpretation: Defendants may argue that a mere warning about a drug interaction does not constitute an affirmative "instruction" to take a specific action as required by the claim. The claim requires an active step of "instructing," which may imply a direct command rather than a cautionary statement.
The Term: "under fasted conditions" (’511 Patent, Claim 1)
Context and Importance
Infringement of the ’511 Patent hinges on whether the proposed label's instruction to take the drug "without food" (Compl. ¶71) meets this limitation. The construction of this term will be critical to determining if the label induces an infringing use.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: A party could argue that in common parlance and for practical purposes, taking a drug "without food" is synonymous with taking it in a "fasted condition." The patent abstract describes the method as administering tasimelteon "without food or under fasted conditions" (Compl. ¶40), potentially suggesting the terms are interchangeable.
- Evidence for a Narrower Interpretation: The detailed description of the clinical study in the patent specification defines "fasted conditions" with specificity as "after at least a 10-hour fast" (’511 Patent, col. 4:27-29). A party may argue that this provides a specific definition that limits the claim scope, and that a general instruction to take a drug "without food" does not necessarily require a 10-hour fast.
VI. Other Allegations
Indirect Infringement
The complaint's core theory is inducement of infringement under 35 U.S.C. § 271(b). It alleges that by filing an ANDA with a proposed label that essentially copies the Hetlioz® label, Defendants intend for prescribers and patients to use the generic product in accordance with that label upon approval (Compl. ¶54-55, ¶75-76). This intended use, according to the complaint, will directly infringe the asserted method claims of the ’510 and ’511 patents.
Willful Infringement
The complaint does not contain an explicit count for willful infringement. However, it alleges that Defendants have "actual knowledge" of the patents-in-suit, citing the receipt of Vanda’s Notice Letter on March 24, 2021 (Compl. ¶13, ¶47, ¶68). These allegations may form a basis for a future claim of willful infringement, particularly for any infringing conduct that occurs after this date.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of induced infringement: Does MSN’s proposed product label, which allegedly warns about smoking’s effect on tasimelteon efficacy, rise to the level of actively encouraging or instructing physicians to perform the patented method of "treating a patient...wherein the patient is a smoker" as required by the '510 Patent, or is it merely a non-infringing warning?
- A key question of claim construction will determine the scope of the '511 Patent: Can the term "under fasted conditions," which is described in the specification with reference to a specific 10-hour fast, be construed to cover the proposed label's more general instruction to take the drug "without food"?
- A central legal question will be label interpretation: How will the court interpret the language of the proposed product label in the context of established Federal Circuit precedent on induced infringement in ANDA litigation, where the analysis turns on whether the label encourages, recommends, or promotes an infringing use?