United States Patent 10,512,612: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,512,612, titled "Methods and compositions particularly for treatment of attention deficit disorder," is a significant patent in the pharmaceutical field, particularly in the treatment of attention deficit hyperactivity disorder (ADHD). This patent, granted to innovators in the field of pharmaceuticals, outlines novel methods and compositions for delivering central nervous system stimulants.
Background
Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity. The treatment often involves the use of central nervous system stimulants, such as methylphenidate. The patent in question addresses the need for improved delivery systems for these medications.
Scope of the Patent
The patent covers a range of innovations related to the formulation and delivery of central nervous system stimulants, particularly for the treatment of ADHD.
Coated Beads
The patent describes a coated bead composition that includes:
- First Plurality of Coated Beads: Each bead consists of a granule coated with a first layer containing the active pharmaceutical ingredient (API), which is a central nervous system stimulant. These beads are designed to provide substantially immediate release of the API[1].
- Second Plurality of Coated Beads: Each bead includes a granule coated with a first layer containing the API and a second layer that delays the release of the API until the bead reaches the distal intestine. This delayed release mechanism ensures that the medication is absorbed at the intended site[1].
- Third Plurality of Coated Beads: Similar to the second plurality, these beads have a granule coated with a first layer containing the API and a second layer that delays the release until the bead reaches the distal intestine[1].
Claims
The patent includes several claims that define the scope of the invention:
Claim 1
This claim describes the coated bead composition, including the granule, the first layer with the API, and the optional second layer for delayed release[1].
Claim 7
This claim specifies the process for preparing the coated beads, including the steps of granulating, coating, and optionally adding a second layer to delay release[1].
Claim 10
This claim covers the oral solid pharmaceutical composition comprising the coated beads, emphasizing the combination of immediate and delayed release formulations[1].
Patent Landscape
The patent landscape surrounding US 10,512,612 is complex and involves several key aspects:
Prior Art
The patent builds upon existing knowledge in the field of pharmaceutical formulations, particularly those related to ADHD treatments. Prior art includes various formulations of central nervous system stimulants, but the unique aspect of this patent lies in its multi-layered release system[1].
Competing Patents
Other patents in the field may cover similar formulations or delivery mechanisms, but the specific combination of immediate and delayed release in a single composition is a distinguishing feature of this patent. For example, patents related to eluxadoline tablets, as seen in the Allergan case, involve different therapeutic areas and do not directly compete with the ADHD treatment focus of US 10,512,612[2].
Regulatory Environment
The FDA approval process for new drug applications (NDAs) is stringent, and any patent in this space must comply with FDA regulations. The patent's claims and scope must be supported by clinical data and manufacturing processes that meet FDA standards[2].
Economic and Market Impact
The economic and market impact of this patent can be significant:
Market Demand
The demand for effective ADHD treatments is high, and a formulation that offers both immediate and delayed release can provide a competitive edge in the market. This can lead to increased market share and revenue for the patent holder.
Innovation
The multi-layered release system described in the patent can drive innovation in pharmaceutical formulations, encouraging further research and development in controlled release technologies.
Legal Considerations
The legal landscape surrounding this patent involves several considerations:
Validity and Infringement
The validity of the patent claims can be challenged based on obviousness, written description, or other grounds. The Allergan case highlights the complexities of patent validity and the importance of distinct claims[2].
Terminal Disclaimers
In cases where multiple patents are filed with overlapping claims, terminal disclaimers may be necessary to avoid obviousness-type double patenting issues[2].
Technological Advancements
The technological advancements described in this patent are crucial for improving the efficacy and patient compliance of ADHD treatments:
Controlled Release
The controlled release mechanism ensures that the medication is delivered at the right time and in the right amount, enhancing the therapeutic effect and reducing side effects.
Manufacturing Process
The process of preparing the coated beads involves advanced techniques such as granulation and multi-layer coating, which require specialized equipment and expertise[1].
Clinical Implications
The clinical implications of this patent are substantial:
Improved Efficacy
The combination of immediate and delayed release formulations can provide sustained therapeutic effects throughout the day, improving the management of ADHD symptoms.
Patient Compliance
The convenience of a single dosage form that offers both immediate and delayed release can enhance patient compliance, as it simplifies the treatment regimen.
Future Directions
The future directions for this technology include further research into other therapeutic areas where controlled release formulations could be beneficial:
Expansion to Other Disorders
The multi-layered release system could be adapted for treating other conditions that require controlled drug delivery, such as chronic pain or gastrointestinal disorders.
Combination Therapies
Combining different APIs in a single formulation could offer synergistic effects and improve treatment outcomes for complex conditions.
Key Takeaways
- Innovative Formulation: The patent introduces a novel multi-layered release system for central nervous system stimulants.
- Clinical Benefits: The formulation offers improved efficacy and patient compliance in ADHD treatment.
- Market Impact: The patent has significant economic and market implications due to high demand for effective ADHD treatments.
- Legal Considerations: The patent's validity and infringement potential are critical, with considerations for terminal disclaimers and distinct claims.
- Future Directions: The technology has potential applications in other therapeutic areas and combination therapies.
FAQs
What is the main innovation of US Patent 10,512,612?
The main innovation is the multi-layered release system for central nervous system stimulants, providing both immediate and delayed release in a single formulation.
How does the coated bead composition work?
The coated beads consist of a granule with a first layer containing the API and an optional second layer that delays the release of the API until it reaches the distal intestine.
What are the clinical benefits of this formulation?
The formulation offers sustained therapeutic effects throughout the day, improving the management of ADHD symptoms and enhancing patient compliance.
How does this patent impact the market?
The patent can lead to increased market share and revenue due to its innovative formulation that meets high demand for effective ADHD treatments.
What are the potential future directions for this technology?
The technology could be adapted for treating other conditions requiring controlled drug delivery, such as chronic pain or gastrointestinal disorders, and could also be used in combination therapies.
Citations
- US10512612B2 - Methods and compositions particularly for treatment of attention deficit disorder - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Tablets and granulates containing mesna as active substance - PubChem
