Detailed Analysis of the Scope and Claims of United States Patent 11,458,143
Introduction
United States Patent 11,458,143, titled "Method of treatment of attention deficit/hyperactivity disorder (ADHD)," is a significant patent held by Supernus Pharmaceuticals, Inc. This patent is crucial for understanding the treatment methods and pharmaceutical agents used for ADHD, particularly focusing on the drug Qelbree (viloxazine).
Overview of the Patent
The patent describes a method for treating ADHD and related disorders using a pharmaceutical agent that exhibits specific pharmacological activities. Here is a breakdown of the key aspects:
Pharmaceutical Agent and Mechanism
The patent identifies viloxazine as the primary pharmaceutical agent. Viloxazine is known for its activity in inhibiting either serotonin or noradrenergic reuptake transporters. The method involves selecting active agents that target multiple receptor types associated with ADHD, including nicotinic, dopaminergic, serotonergic, and gabaergic receptors[4].
Receptor Screening and Activity Determination
The process outlined in the patent includes several steps:
- Selecting active agents with known activity inhibiting serotonin or noradrenergic reuptake transporters.
- Conducting receptor screening assays to identify activity on ADHD-associated receptors.
- Determining whether the activity is agonistic or antagonistic.
- Selecting agents that target multiple types of ADHD-associated receptors.
- Optimizing the total dosage of the selected active agents[4].
Specific Pharmacological Activities
The patent specifies that the pharmaceutical agents should exhibit a combination of at least two of the following activities:
- 5HT1B antagonistic activity
- 5HT7 antagonistic activity
- α4/β2 antagonistic activity
- α7 antagonistic activity
These activities are crucial for the treatment of ADHD and related disorders[4].
SmartCubeTM Testing
An additional experimental platform, SmartCubeTM, is mentioned for testing the behavioral effects of the compounds. This platform uses robotics, computer video capture, and bioinformatics to analyze the behavioral signature of the compounds in animal models. This helps in identifying candidates predicted to have utility in treating ADHD[4].
Formulations and Administration
The patent also covers various formulations of viloxazine, including modified release formulations, which are designed to optimize the drug's delivery and efficacy. These formulations are disclosed in related patents, such as US9358204 and US9603853, which expire in February 2033[2][5].
Patent Claims and Scope
The patent claims are broad yet specific, covering the method of treatment, the identification process of pharmaceutical agents, and the formulations of viloxazine.
Method of Treatment
The patent claims a method for treating ADHD by administering a pharmaceutical agent with the specified pharmacological activities. This method is tailored to target multiple receptor types associated with ADHD, enhancing the efficacy of the treatment[4].
Identification Process
The claims include the process of identifying suitable pharmaceutical agents through receptor screening assays and optimizing their dosages. This ensures that the selected agents are effective and safe for treating ADHD[4].
Formulations
The patent also claims various formulations of viloxazine, including high-drug load formulations and modified release formulations. These formulations are designed to improve the drug's bioavailability and patient compliance[5].
Patent Expiration and Litigations
The patent US11458143B2 is set to expire on September 4, 2029. However, the landscape of patent expirations can be complex due to ongoing litigations and exclusivities granted by regulatory bodies.
Litigations
There have been legal proceedings challenging the validity of this patent, with the earliest litigation initiated in February 2021. These challenges could potentially affect the patent's expiration date if the patent is invalidated[2].
Exclusivities
The FDA has granted exclusivities to Qelbree, which prevent other companies from marketing generic or bioequivalent versions of the drug until these exclusivities expire. These exclusivities play a crucial role in delaying the generic launch of Qelbree[2].
Impact on the Pharmaceutical Industry
The patent landscape for ADHD treatments, particularly those involving viloxazine, is influenced by several factors:
Regulatory Uncertainty
Recent jurisprudence on 35 U.S.C. § 112 has introduced uncertainty in the biopharmaceutical industry, affecting the scope of patent claims. This has made it challenging for innovators to claim the full scope of their inventions without violating the enablement and written description requirements[3].
Competitive Landscape
The patent and exclusivity landscape for Qelbree ensures that Supernus Pharmaceuticals maintains a competitive edge in the market for ADHD treatments. However, this also means that generic versions of the drug are delayed, impacting patient access and affordability[2][5].
Key Takeaways
- Pharmaceutical Agent: Viloxazine is the primary agent used, targeting multiple receptor types associated with ADHD.
- Receptor Screening: The method involves detailed receptor screening to identify and optimize the pharmacological activities of the agents.
- Formulations: Various formulations of viloxazine are covered, including modified release formulations.
- Patent Expiration: The patent expires on September 4, 2029, but is subject to ongoing litigations and FDA-granted exclusivities.
- Regulatory Impact: The patent landscape is influenced by regulatory uncertainties and competitive dynamics.
FAQs
Q: What is the primary pharmaceutical agent covered by US Patent 11,458,143?
A: The primary pharmaceutical agent is viloxazine.
Q: What are the key pharmacological activities required for the treatment of ADHD according to the patent?
A: The activities include 5HT1B antagonistic, 5HT7 antagonistic, α4/β2 antagonistic, and α7 antagonistic activities.
Q: When is the patent set to expire?
A: The patent is set to expire on September 4, 2029.
Q: Are there any ongoing litigations that could affect the patent's expiration?
A: Yes, there have been legal proceedings challenging the validity of this patent.
Q: What role do FDA-granted exclusivities play in the availability of generic Qelbree?
A: FDA-granted exclusivities prevent other companies from marketing generic or bioequivalent versions of Qelbree until these exclusivities expire.
Sources
- Method of treatment of attention deficit/hyperactivity disorder (ADHD) - Google Patents
- Qelbree patent expiration - Pharsight
- Eviscerating Patent Scope - UIC Review of Intellectual Property Law
- Method of treatment of attention deficit/hyperactivity disorder (ADHD) - Google Patents
- Generic Qelbree Availability - Drugs.com
