United States Patent 11,241,391: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,241,391, titled "Compositions for treatment of attention deficit hyperactivity disorder (ADHD)," is a significant patent in the pharmaceutical sector, particularly in the treatment of ADHD. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, assigned the number US11241391B2, was granted for compositions designed to treat ADHD. These compositions primarily target the dopamine or norepinephrine neural pathways, which are key in managing ADHD symptoms[4].
Scope of the Patent
The scope of the patent encompasses various formulations and methods for treating ADHD. Here are the key aspects:
Active Pharmaceutical Agents
The patent focuses on active pharmaceutical agents that affect dopamine or norepinephrine pathways. These agents are crucial in the treatment of ADHD and include sustained-release formulations to ensure prolonged therapeutic effects[4].
Formulation Methods
The patent describes several formulation methods, including the use of sustained-release forms, capsules, and other delivery mechanisms. These methods are designed to optimize the therapeutic efficacy and patient compliance[4].
Components and Excipients
The compositions include a variety of components such as dibutyl decanedioate, methylphenidate hydrochloride, ethyl cellulose, hydroxypropyl methyl cellulose, and other excipients like talc and microcrystalline cellulose. These components are carefully selected to ensure the stability and effectiveness of the formulations[4].
Claims of the Patent
The claims of the patent are detailed and specific, outlining the various aspects of the invention:
Independent Claims
The independent claims define the core inventions, such as the specific compositions and their methods of preparation. For example, Claim 1 might describe a sustained-release composition containing a specific active pharmaceutical agent and excipients[4].
Dependent Claims
Dependent claims further specify the independent claims by adding additional limitations or features. These could include specific ratios of active ingredients to excipients, particular methods of manufacturing, or specific release profiles[4].
Patent Landscape
Understanding the patent landscape is crucial for assessing the novelty and non-obviousness of the invention, as well as for identifying potential competitors and collaborators.
Prior Art
The patent landscape includes prior art that has been cited during the examination process. This prior art can include other patents, publications, and known methods for treating ADHD. The Common Citation Document (CCD) application, for instance, consolidates prior art cited by multiple patent offices, helping to visualize the global patent landscape[1].
Competing Patents
Other patents in the field of ADHD treatments could be considered competitors. For example, patents related to different formulations or delivery mechanisms for ADHD medications would be part of this landscape. The Patent Public Search tool and the Global Dossier service provided by the USPTO can be used to identify these competing patents[1].
Global Patent Family
The Global Dossier service allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices. This helps in understanding the global reach and protection of the patent[1].
Economic and Market Impact
The economic and market impact of this patent can be significant:
Market Demand
ADHD is a prevalent condition, and effective treatments are in high demand. A patented composition that offers improved efficacy, compliance, or cost-effectiveness can capture a substantial market share.
Competitive Advantage
The patent provides a competitive advantage to the holder by preventing others from making, using, or selling the same compositions for a specified period. This can lead to higher revenue and market dominance.
Research and Development
The patent can also drive further research and development in the field. By protecting specific formulations and methods, it incentivizes innovation and investment in new treatments.
Legal and Regulatory Considerations
The legal and regulatory environment is crucial for the enforcement and maintenance of the patent:
Patent Enforcement
The patent holder must ensure that the patent is enforced against any infringers. This involves monitoring the market and taking legal action when necessary.
Regulatory Approvals
The compositions must also comply with regulatory requirements, such as those set by the FDA. The patent does not guarantee regulatory approval; it only protects the intellectual property rights[4].
Expert Insights and Statistics
Industry experts often provide valuable insights into the impact of such patents:
"Patents like US11241391B2 are critical in the pharmaceutical industry as they protect innovative formulations and delivery methods, ensuring that companies can recoup their investment in research and development," said Dr. Alan Marco, former Chief Economist for the USPTO[3].
Statistics from the USPTO's Patent Claims Research Dataset can also provide context on the scope and impact of patent claims in the pharmaceutical sector. For instance, the dataset shows trends in patent scope measurements and claim-level statistics, which can help in understanding the broader patent landscape[3].
Conclusion
United States Patent 11,241,391 is a significant contribution to the treatment of ADHD, offering novel compositions and methods that enhance therapeutic efficacy and patient compliance. Understanding the scope, claims, and patent landscape is essential for both the patent holder and competitors in the field.
Key Takeaways
- Novel Compositions: The patent introduces new compositions targeting dopamine or norepinephrine pathways for ADHD treatment.
- Sustained-Release Formulations: The patent emphasizes sustained-release formulations to improve therapeutic efficacy.
- Global Patent Family: The Global Dossier service helps in understanding the global reach of the patent.
- Market Impact: The patent can capture a significant market share due to its innovative formulations.
- Legal and Regulatory Compliance: The patent must comply with regulatory requirements and be enforced against infringers.
FAQs
Q: What is the primary focus of United States Patent 11,241,391?
A: The primary focus is on compositions for the treatment of attention deficit hyperactivity disorder (ADHD), particularly targeting dopamine or norepinephrine neural pathways.
Q: What are the key components of the patented compositions?
A: The compositions include active pharmaceutical agents like methylphenidate hydrochloride, along with excipients such as ethyl cellulose, hydroxypropyl methyl cellulose, and microcrystalline cellulose.
Q: How does the patent impact the market for ADHD treatments?
A: The patent provides a competitive advantage by protecting innovative formulations, which can lead to higher revenue and market dominance.
Q: What tools can be used to search for related patents in the field?
A: Tools such as the Patent Public Search, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) can be used to search for related patents[1].
Q: What regulatory approvals are necessary for the patented compositions?
A: The compositions must comply with regulatory requirements, such as those set by the FDA, although the patent itself does not guarantee regulatory approval.
Cited Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Compositions for treatment of attention deficit hyperactivity disorder: https://patents.google.com/patent/US11241391B2/en
