DCT
1:20-cv-01334
Vanda Pharma Inc v. MSN Pharma Inc
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: 1:20-cv-01334, D. Del., 10/01/2020
- Venue Allegations: Venue is asserted based on Defendant MSN Pharmaceuticals Inc. being a Delaware corporation and Defendant MSN Laboratories Private Limited being an Indian company subject to personal jurisdiction in the district.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's drug Hetlioz® (tasimelteon) constitutes an act of infringement of two patents covering methods of using the drug.
- Technical Context: The technology involves pharmaceutical methods for treating Non-24-Hour Sleep-Wake Disorder (Non-24), a circadian rhythm disorder particularly prevalent in totally blind individuals.
- Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' filing of ANDA No. 211654 seeking FDA approval to market generic tasimelteon. The patents-in-suit are listed in the FDA's "Orange Book" for Vanda's approved New Drug Application for Hetlioz®. The complaint notes a prior, related lawsuit was filed by Vanda against MSN on March 3, 2020.
Case Timeline
| Date | Event |
|---|---|
| 2012-01-26 | ’510 Patent Priority Date |
| 2013-11-12 | ’511 Patent Priority Date |
| 2014-01-31 | FDA approves Vanda’s New Drug Application for Hetlioz® |
| 2020-03-03 | Vanda files prior patent infringement suit against MSN |
| 2020-04-07 | ’510 Patent, “Treatment Of Circadian Rhythm Disorders,” is issued |
| 2020-04-07 | ’511 Patent, “Method of Treatment,” is issued |
| 2020-10-01 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,610,510 - Treatment Of Circadian Rhythm Disorders
- Patent Identification: U.S. Patent No. 10,610,510, titled “Treatment Of Circadian Rhythm Disorders,” issued on April 7, 2020 (Compl. ¶34).
The Invention Explained
- Problem Addressed: The treatment of circadian rhythm disorders like Non-24 can be complicated by patient-specific factors that alter a drug's pharmacokinetics (Compl. ¶33). The patent specification explains that smoking can increase the clearance of tasimelteon from the body, thereby reducing a patient's exposure to the drug and potentially diminishing its therapeutic effect (’510 Patent, col. 30:6-14).
- The Patented Solution: The patent describes methods for treating patients with tasimelteon that account for the patient's smoking status. The methods involve steps such as determining if a patient is a smoker and, if so, providing specific instructions, such as ceasing or reducing smoking, or adjusting the dose to counteract the reduced drug exposure (’510 Patent, Claim 6; Compl. ¶33).
- Technical Importance: This approach seeks to personalize treatment by accounting for a known factor (smoking) that influences drug metabolism, with the goal of achieving more consistent and effective outcomes for patients with circadian rhythm disorders (Compl. ¶33).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-13 (Compl. ¶50-52).
- Independent Claim 1 is directed to an improvement in a method of treating a patient for whom tasimelteon was ineffective, comprising either: (i) administering a dose greater than 20 mg, or (ii) determining if the patient is a smoker (’510 Patent, Claim 1).
- Independent Claim 6 recites a method of treating a patient comprising:
- determining whether the patient is a smoker; and
- if the patient is a smoker, performing one of the following: administering a dose greater than 20 mg, instructing the patient to reduce or cease smoking, or administering 20 mg (’510 Patent, Claim 6).
- The complaint asserts both direct and indirect infringement of these method claims, reserving the right to assert the dependent claims (Compl. ¶51, ¶54).
U.S. Patent No. 10,610,511 - Method of Treatment
- Patent Identification: U.S. Patent No. 10,610,511, titled “Method of Treatment,” issued on April 7, 2020 (Compl. ¶39).
The Invention Explained
- Problem Addressed: The absorption of an orally administered drug can be affected by the presence of food in the gastrointestinal tract. A clinical study described in the patent found that administering tasimelteon with a high-fat meal resulted in a lower peak concentration (Cmax) and a delayed time to peak concentration (Tmax) compared to administration under fasted conditions (’511 Patent, col. 2:45-58).
- The Patented Solution: To ensure a more consistent and predictable pharmacokinetic profile, the patent discloses methods of treatment that involve administering tasimelteon "without food" or under "fasted conditions" (Compl. ¶37-38). The invention includes instructing patients that the drug should be taken without food to achieve the intended absorption characteristics (’511 Patent, col. 4:1-5).
- Technical Importance: For a drug intended to regulate the body's internal clock, consistent timing and rate of absorption are important for efficacy; standardizing administration relative to food intake helps achieve this consistency (’511 Patent, col. 2:59-62).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-2 and 4-19 (Compl. ¶69-71).
- Independent Claim 1 recites a method of treating a patient comprising the steps of: (i) instructing the patient that tasimelteon should be taken without food; and (ii) orally administering an effective dose of tasimelteon without food (’511 Patent, Claim 1).
- Independent Claim 12 is directed to an improvement in a method of treatment comprising instructing the patient to take tasimelteon without food, where the patient has had no food for at least 1/2 hour prior to administration (’511 Patent, Claim 12).
- Independent Claim 18 recites a method of treatment comprising instructing the patient to take tasimelteon without food before orally administering it (’511 Patent, Claim 18).
- The complaint reserves the right to assert the specified dependent claims (Compl. ¶69).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendants' proposed generic tasimelteon oral capsules in a 20 mg strength, for which Defendants seek FDA approval via Abbreviated New Drug Application (ANDA) No. 211654 ("MSN's ANDA Product") (Compl. ¶11, ¶47).
Functionality and Market Context
The product is a generic equivalent of Vanda's branded drug, Hetlioz®, intended for the same therapeutic indication: the treatment of Non-24 (Compl. ¶11). The act of infringement alleged is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2) (Compl. ¶13). The infringement theory is based on the contents of the proposed product label that will accompany the generic drug. The complaint alleges that this label will necessarily instruct physicians and patients to use the drug in a manner that infringes the asserted method claims of the ’510 and ’511 patents, as FDA regulations require a generic label to essentially copy the label of the branded reference drug (Compl. ¶50, ¶69). The complaint alleges MSN intends for its product to displace sales of Hetlioz® (Compl. ¶25).
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 |
|---|---|---|---|
| determining whether the patient is a smoker | The proposed product label, by allegedly copying the Hetlioz® label, provides information about the reduced efficacy and lower drug exposure in smokers, which would cause a prescriber to determine the patient's smoking status before treatment. | ¶46, ¶50 | col. 33:1-4 |
| in the case that the patient is determined to be a smoker: ... instructing the patient to cease or reduce smoking; and administering to the patient 20 mg of tasimelteon once daily before bedtime | The proposed label allegedly recommends, encourages, or suggests that prescribers instruct smoking patients to reduce or cease smoking to improve the efficacy of the 20 mg dose, based on the label's warning that smoking reduces drug exposure. | ¶46, ¶50, ¶51 | col. 33:5-8 |
'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 | The proposed product label for MSN's ANDA Product allegedly copies the Hetlioz® label, which explicitly instructs that "HETLIOZ should be taken without food." | ¶65, ¶69 | col. 3:1-5 |
| orally administering to the patient an effective dose of tasimelteon without food | Patients and prescribers, following the instructions on the proposed label, will administer the 20 mg oral capsule without food. | ¶66, ¶70 | col. 1:26-30 |
Identified Points of Contention
- Scope Questions: A central question for the '510 patent is whether providing pharmacokinetic data about smokers on a drug label, as alleged in the complaint (Compl. ¶46), legally constitutes "instructing the patient to cease or reduce smoking" as required by the claim. This raises a question of the scope of "instructing" in the context of induced infringement. For the '511 patent, a question may arise as to whether the term "without food" requires a specific fasting period, or if it has a broader ordinary meaning.
- Technical Questions: The infringement theories are contingent on the specific language contained within MSN's proposed generic drug label. A key factual question will be whether the final proposed label in ANDA No. 211654 contains the exact instructional language that Vanda alleges. The complaint makes these allegations "on information and belief" based on the regulatory requirement for label copying (Compl. ¶50, ¶69).
V. Key Claim Terms for Construction
"instructing the patient" ('510 Patent, Claim 6 and '511 Patent, Claim 1)
- Context and Importance: This term is critical to the indirect infringement allegations for both patents. The dispute will likely center on whether the informational statements allegedly on MSN's proposed label rise to the level of an affirmative "instruction" that encourages or recommends the infringing method.
- Evidence for a Broader Interpretation: A party may argue that in the context of a drug label, providing a prescriber with information that a certain behavior (smoking) reduces efficacy or that administration should be done a certain way (without food) is functionally equivalent to an instruction to act on that information to ensure patient safety and therapeutic benefit. The patent specification repeatedly uses the term "instructing" in the context of the method claims (e.g., ’510 Patent, col. 33:6-8; ’511 Patent, col. 4:1-2).
- Evidence for a Narrower Interpretation: A party could contend that "instructing" requires a direct command (e.g., "Patients must stop smoking" or "Do not take with food"), and that merely providing clinical data or a recommendation (e.g., "efficacy may be reduced in smokers" or "should be taken without food") does not meet this standard, leaving the ultimate decision to the prescriber's judgment. The claims do not explicitly define the term.
"without food" ('511 Patent, Claim 1)
- Context and Importance: The scope of this term defines the prohibited act of administration. Its construction will determine whether any administration not taken with a meal infringes, or if a more specific condition is required. Practitioners may focus on this term because the patent provides both general and specific descriptions of fasted conditions.
- Evidence for a Broader Interpretation: The plain language of Claim 1 does not specify a duration of fasting. A party could argue it carries its plain meaning of not being taken concurrently with a meal. The fact that dependent claims add specific time limitations (e.g., "at least ½ hour prior to administration" in Claim 2) may suggest, by the doctrine of claim differentiation, that the independent claim is not so limited.
- Evidence for a Narrower Interpretation: The specification describes the clinical study underpinning the invention, in which "fasted conditions" involved "at least a 10-hour fast" before administration and no food for "at least 4 hours postdose" (’511 Patent, col. 2:27-31). A party might argue that this context limits the term "without food" to a clinically meaningful fasting period, not just the absence of a concurrent meal.
VI. Other Allegations
Indirect Infringement
The core of the complaint rests on allegations of indirect infringement. Vanda alleges that by seeking approval for its ANDA with a product label that will copy the Hetlioz® label, MSN knowingly encourages and aids prescribers and patients to use the generic drug in ways that directly infringe the asserted method claims (Compl. ¶50-51, ¶69-70). The complaint further alleges that MSN's product is not a staple article of commerce and has no substantial non-infringing uses (Compl. ¶52, ¶71).
Willful Infringement
The complaint does not contain an explicit count for willful infringement. However, it alleges that MSN has "actual knowledge" of both the '510 and '511 patents, citing an FDA communication accessible to Defendants (Compl. ¶43, ¶62). Furthermore, Vanda alleges that the case is "exceptional" and seeks attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶58, ¶77), a remedy often associated with findings of willfulness or other litigation misconduct.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of inducement and claim scope: Can statements on a drug label that describe pharmacokinetic interactions (e.g., the effect of smoking) or provide administration guidance (e.g., "should be taken without food") be legally construed as an affirmative "instruction" sufficient to establish induced infringement under 35 U.S.C. § 271(b)?
- A key evidentiary question will be one of proof: What is the exact language of the proposed product label submitted with MSN’s ANDA? The infringement analysis is entirely dependent on this evidence, which the complaint alleges "on information and belief" will mirror the language of the branded drug's label.