United States Patent 10,792,262: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,792,262, titled "Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives," is a patent that focuses on pharmaceutical compositions and their methods of manufacture. Here, we will delve into the key aspects of this patent, including its scope, claims, and the broader patent landscape.
Patent Scope
The patent scope defines the boundaries of what the patent protects. For US Patent 10,792,262, the scope is centered around stabilized formulations of specific chemical compounds, namely 4-amino-3-substituted butanoic acid derivatives.
Active Ingredients and Stabilizers
The patent emphasizes the use of active ingredients, such as baclofen, and various stabilizers to enhance the stability and efficacy of the pharmaceutical compositions. The stabilizers can include a range of substances like talc, crospovidone, hypromellose, and polyvinylpolypyrrolidone[1].
Methods of Manufacture
The scope also includes methods of manufacturing these stabilized formulations, which can involve processes such as mixing, dry granulation, milling, and slugging. These methods are crucial for ensuring the uniformity and stability of the final product[1].
Claims
The claims section of a patent is where the inventor specifies exactly what they are seeking to protect.
Independent Claims
The independent claims in this patent are broad and define the core inventions. For example, Claim 1 might describe a pharmaceutical composition comprising an active ingredient and a specific stabilizer, while Claim 2 might detail a method of manufacturing such a composition[1].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims might specify particular ratios of active ingredients to stabilizers, specific manufacturing steps, or the use of additional components like disintegrants or taste-masking agents[1].
Types of Claims
Drug Product Claims
These claims focus on the final pharmaceutical product, including its composition and physical form (e.g., tablets, capsules). For US Patent 10,792,262, drug product claims would cover the stabilized formulations of 4-amino-3-substituted butanoic acid derivatives in various forms[1].
Drug Substance Claims
These claims pertain to the active ingredients themselves and their purification or synthesis methods. Here, the claims would detail the specific derivatives of 4-amino-3-substituted butanoic acid and their stabilization[1].
Method of Use Claims
These claims describe how the pharmaceutical composition is to be used, including dosage regimens and administration methods. While not the primary focus of this patent, method of use claims could be included to protect specific therapeutic applications of the stabilized formulations[1].
Patent Landscape
The patent landscape surrounding US Patent 10,792,262 involves several key aspects:
Government Interest
While government-interest patent disclosures are relatively rare, they can be significant. For top-selling drugs, including those related to pharmaceutical compositions like the ones in this patent, government-interest disclosures are typically low, around 2.6% on average[2].
Patent Scope Metrics
Metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
International and National Patent Databases
The patent landscape is not limited to national databases. International databases like PATENTSCOPE and the Cooperative Patent Classification (CPC) system provide access to a global array of patent documents, allowing for comprehensive searches and analyses[4].
Legal and Regulatory Considerations
Enablement Requirement
The enablement requirement, as outlined in 35 U.S.C. ยง112(a), is crucial for patent validity. This requirement mandates that the patent specification must be detailed enough to enable a person skilled in the art to make and use the invention. This was a key issue in cases like Amgen Inc. v. Sanofi, where the court scrutinized whether the patent claims were overly broad and failed to meet this standard[5].
Key Components and Substances
Active Pharmaceutical Agents
The patent highlights the use of specific active pharmaceutical agents, such as baclofen, which is a derivative of 4-amino-3-substituted butanoic acid. These agents are stabilized using various excipients to enhance their efficacy and shelf life[1].
Excipients and Stabilizers
Excipients like talc, crospovidone, and hypromellose play a critical role in stabilizing the active ingredients. These substances help in maintaining the physical and chemical stability of the pharmaceutical compositions[1].
Manufacturing Processes
The patent details various manufacturing processes, including dry granulation, milling, and slugging. These processes are essential for producing uniform and stable pharmaceutical products[1].
Practical Applications
Therapeutic Uses
The stabilized formulations described in this patent have potential therapeutic applications, particularly in the treatment of conditions where the active ingredients are known to be effective. For example, baclofen is commonly used to treat muscle spasticity[1].
Market Impact
The development of stabilized formulations can significantly impact the pharmaceutical market by providing more reliable and effective treatments. This can lead to improved patient outcomes and increased market share for the patent holder.
Challenges and Limitations
Stability Issues
One of the primary challenges in pharmaceutical formulations is ensuring the stability of the active ingredients. The use of stabilizers and specific manufacturing processes addressed in this patent helps mitigate these issues[1].
Regulatory Compliance
Compliance with regulatory requirements, such as the enablement requirement, is crucial for the validity and enforceability of the patent. Failure to meet these requirements can lead to patent invalidation[5].
Key Takeaways
- Stabilized Formulations: The patent focuses on stabilized formulations of 4-amino-3-substituted butanoic acid derivatives, enhancing the stability and efficacy of pharmaceutical compositions.
- Manufacturing Methods: Detailed methods of manufacture, including dry granulation and milling, are provided to ensure uniformity and stability.
- Regulatory Compliance: The patent must comply with regulatory requirements, such as the enablement requirement, to ensure validity.
- Market Impact: The development of these formulations can significantly impact the pharmaceutical market by providing more reliable treatments.
- International Landscape: The patent landscape includes international databases and classification systems, facilitating comprehensive searches and analyses.
FAQs
What is the main focus of US Patent 10,792,262?
The main focus of US Patent 10,792,262 is on stabilized formulations of 4-amino-3-substituted butanoic acid derivatives, including their composition and methods of manufacture.
What are the key components of the stabilized formulations?
The key components include active pharmaceutical agents like baclofen and stabilizers such as talc, crospovidone, and hypromellose.
What manufacturing processes are detailed in the patent?
The patent details processes such as mixing, dry granulation, milling, and slugging to ensure the uniformity and stability of the pharmaceutical compositions.
What is the significance of the enablement requirement in patent law?
The enablement requirement mandates that the patent specification must be detailed enough to enable a person skilled in the art to make and use the invention, ensuring the patent's validity.
How does this patent impact the pharmaceutical market?
The development of stabilized formulations can lead to more reliable and effective treatments, improving patient outcomes and potentially increasing market share for the patent holder.
What international databases are relevant for patent searches related to this patent?
International databases such as PATENTSCOPE and the Cooperative Patent Classification (CPC) system are relevant for comprehensive patent searches and analyses.
Sources
- US10792262B1 - Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives - Google Patents
- Federal government-interest patent disclosures for recent top-selling small-molecule drugs - PubMed
- Patent Claims and Patent Scope - SSRN
- Research and Course Guides: Patent Searching, Advanced: Overview - Clemson University
- Amgen Inc. v. Sanofi - Supreme Court of the United States
