Detailed Analysis of the Scope and Claims of United States Patent 10,584,112
Introduction
United States Patent 10,584,112, issued to KemPharm, Inc., is a significant development in the field of pharmaceuticals, particularly concerning methylphenidate-prodrugs. This patent delves into the compositions, processes, and uses of these prodrugs, which are crucial for treating conditions such as Attention Deficit Hyperactivity Disorder (ADHD).
Overview of the Patent
The patent, titled "Methylphenidate-prodrugs, processes of making and using the same," focuses on specific stereoisomer compounds of methylphenidate and their various compositions[1][2].
Scope of the Patent
Compositions
The patent covers compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. These compositions include various prodrugs designed to enhance the delivery and efficacy of methylphenidate. The prodrugs are engineered to improve the pharmacokinetic profile, stability, and bioavailability of the active ingredient[1].
Stereoisomers
A key aspect of the patent is the specific stereoisomer compound of serdexmethylphenidate (SDX), which is a prodrug of d-threo-methylphenidate. This stereoisomer is critical for the therapeutic efficacy and safety of the drug[2].
Pharmaceutical Formulations
The patent describes various pharmaceutical formulations, including tablets, capsules, and other dosage forms. These formulations can include a range of excipients, such as fillers, disintegrants, and coating agents, to enhance the drug's performance[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the specific chemical structures of the prodrugs, methods of synthesizing these compounds, and the pharmaceutical compositions containing them. For instance, the claims specify the use of nicotinoyl and other conjugates to form the prodrugs[1].
Dependent Claims
Dependent claims further detail the specific aspects of the independent claims, such as the types of excipients used, the methods of coating, and the dosages of the active ingredients. These claims provide a comprehensive outline of the various embodiments of the invention[1].
Patent Landscape
Related Patents
KemPharm, Inc. has been granted several patents related to serdexmethylphenidate (SDX), including U.S. Patent No. 10,584,113, which also covers compositions of matter. These patents collectively form a robust intellectual property portfolio for KemPharm, protecting their innovations in the field of methylphenidate-prodrugs[2][5].
Expiration Dates
The patents, including U.S. Patent No. 10,584,112, are slated to expire on December 9, 2037. This provides KemPharm with exclusive rights to manufacture and market these prodrugs for nearly two decades, allowing them to recoup their investment in research and development[5].
Orange Book Listing
The listing of these patents in the Orange Book by the FDA further solidifies KemPharm's position in the market. The Orange Book is a critical resource for pharmaceutical companies, as it lists approved drugs and their corresponding patents, helping to prevent generic competition during the patent term[5].
Impact on Innovation and Competition
Patent Scope and Quality
The scope of the patent claims is a crucial factor in determining the patent's quality and its impact on innovation. Narrower claims, as seen in this patent, are generally associated with higher patent quality and a shorter examination process. This can encourage innovation by providing clear boundaries and reducing litigation costs[3].
Licensing and Litigation
The issuance of these patents can influence licensing agreements and litigation strategies within the pharmaceutical industry. Companies seeking to develop similar prodrugs must navigate these patents carefully to avoid infringement, which can drive innovation through the development of new and distinct technologies[3].
Practical Applications
Therapeutic Benefits
The prodrugs covered by this patent offer several therapeutic benefits, including improved bioavailability and a more stable pharmacokinetic profile. This can lead to better patient outcomes and compliance, especially for conditions like ADHD where consistent drug levels are crucial[1].
Manufacturing Process
The patent details specific methods for synthesizing these prodrugs, which can be adopted by manufacturers to ensure consistent and high-quality production. This includes the use of specific reagents and conditions to form the desired conjugates[1].
Regulatory Considerations
FDA Approval
The approval and listing of these patents in the Orange Book indicate that the FDA has reviewed and approved the safety and efficacy of these prodrugs. This regulatory approval is a significant milestone for KemPharm, validating their research and development efforts[5].
International Protection
While this patent is specific to the United States, KemPharm may also seek international protection through various global patent offices. This would extend their intellectual property rights beyond the U.S., further protecting their innovations worldwide[4].
Key Takeaways
- Compositions and Prodrugs: The patent covers specific compositions of d-threo-methylphenidate conjugates and unconjugated methylphenidate.
- Stereospecificity: The patent emphasizes the importance of specific stereoisomer compounds, such as serdexmethylphenidate (SDX).
- Pharmaceutical Formulations: Various formulations are described, including tablets and capsules, with detailed excipients and manufacturing processes.
- Patent Claims: Independent and dependent claims define the scope of the invention, including chemical structures, synthesis methods, and pharmaceutical compositions.
- Patent Landscape: The patent is part of a broader intellectual property portfolio for KemPharm, with related patents and an Orange Book listing.
- Impact on Innovation: The patent's scope and quality can influence innovation and competition within the pharmaceutical industry.
- Practical Applications: The prodrugs offer improved therapeutic benefits and manufacturing processes.
FAQs
Q: What is the main focus of United States Patent 10,584,112?
A: The main focus is on compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate, including specific stereoisomer compounds like serdexmethylphenidate (SDX).
Q: Who is the assignee of this patent?
A: The assignee is KemPharm, Inc.
Q: What is the significance of the Orange Book listing for this patent?
A: The Orange Book listing by the FDA indicates that the patent has been approved and listed, providing KemPharm with exclusive rights to market the drug during the patent term.
Q: How long are the patents related to this invention slated to expire?
A: The patents, including U.S. Patent No. 10,584,112, are set to expire on December 9, 2037.
Q: What are the potential impacts of this patent on the pharmaceutical industry?
A: The patent can influence innovation by setting clear boundaries, reducing litigation costs, and driving the development of new technologies to avoid infringement.
Sources
- US10584112B2 - Methylphenidate-prodrugs, processes of making and using the same - Google Patents
- KemPharm Announces Issuance of Two Additional U.S. Patents Governing KP415 and KP484 - BioSpace
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- KemPharm, Inc. Announces Orange Book Listing for Six Patents Covering Serdexmethylphenidate (SDX) - BioFlorida
