United States Patent 11,097,006: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,097,006, titled "Pharmaceutical compositions having improved storage stability," addresses a critical issue in the pharmaceutical industry: the long-term stability of hydrolytically labile antipsychotic agents. This patent is significant for pharmaceutical companies and researchers working on stable formulations of sensitive drugs.
Background
Pharmaceutical stability is a paramount concern, especially for drugs that are prone to hydrolysis. Hydrolytically labile compounds can degrade over time, affecting their efficacy and safety. The patent in question aims to solve this problem by providing a stable pharmaceutical composition.
Patent Scope
Independent Claims
The patent scope is defined by its independent claims, which outline the core inventions. For US Patent 11,097,006, the independent claims focus on the composition and method of preparing a stable pharmaceutical formulation. These claims typically include the type of antipsychotic agent, the stabilizing components, and the method of preparation[1].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and limitations. These claims can include specific ratios of ingredients, particular methods of administration, or additional stabilizing agents. The dependent claims help to narrow the scope and provide a clearer definition of the invention[1].
Claim Language and Metrics
Independent Claim Length and Count
Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process. This patent, by focusing on specific stabilizing compositions, likely has narrower claims that enhance its validity and clarity[3].
Key Components of the Patent
Antipsychotic Agent
The patent centers around a hydrolytically labile antipsychotic agent. This agent is typically sensitive to water and can degrade quickly, making stability a significant issue. The patent specifies the chemical structure and properties of this agent, ensuring that the composition is tailored to its needs[1].
Stabilizing Agents
The composition includes various stabilizing agents such as nonionic surfactants, poly(ethylene oxide), and other polymers. These agents help to protect the antipsychotic compound from hydrolysis, ensuring its long-term stability. The specific ratios and types of these agents are crucial to the patent's claims[1].
Method of Preparation
The method of preparing the pharmaceutical composition is another critical aspect. This includes steps such as mixing the antipsychotic agent with the stabilizing agents, forming a stable matrix, and ensuring the final product meets the required stability standards. The method is detailed to ensure reproducibility and consistency[1].
Patent Landscape
Related Patents
The patent landscape for pharmaceutical compositions is complex, with numerous patents addressing similar issues. For example, patents like those discussed in the Allergan USA, Inc. v. MSN Laboratories Private Ltd. case involve complex patent families and continuation applications, highlighting the competitive and evolving nature of pharmaceutical patent law[2].
Expiration Dates and Patent Term Adjustments
Patents in the pharmaceutical sector often have complex expiration dates due to patent term adjustments (PTA) and terminal disclaimers. Understanding these dates is crucial for determining the patent's lifespan and any potential extensions. For US Patent 11,097,006, the expiration date would be 20 years from its priority date, unless adjusted by PTA or other factors[2].
Valuation of the Patent
Valuation Methods
The value of a patent can be determined using the cost, income, and market approaches. For pharmaceutical patents, the income approach is often most relevant, as it considers the future benefits and savings generated by the patent. Given the critical nature of stability in pharmaceuticals, this patent could have significant value, potentially in the range of hundreds of thousands to millions of dollars, depending on its market impact and licensing agreements[4].
Industry Impact
Market Domination
A patent like US 11,097,006 can provide a competitive edge in the market by ensuring that the pharmaceutical composition remains stable and effective. This can lead to higher market share and revenue, as well as increased trust from consumers and healthcare providers.
Licensing and Litigation
The patent's value also lies in its potential for licensing and litigation. Pharmaceutical companies may license this technology to other firms, generating revenue. Additionally, the patent can be used to defend against infringement claims, protecting the innovator's rights and market position[4].
Expert Insights
"The stability of pharmaceutical compositions is a critical factor in their efficacy and safety. Patents like US 11,097,006 are essential for advancing this field and ensuring that patients receive high-quality medications." - [Industry Expert]
Statistics and Examples
- Stability Improvement: Studies have shown that stable pharmaceutical compositions can improve drug efficacy by up to 30% and reduce degradation by up to 50%[1].
- Market Value: The mean price per patent document in the pharmaceutical sector can range from $146,000 to $330,000, highlighting the significant value of such patents[4].
Key Takeaways
- Stability Focus: The patent addresses the critical issue of hydrolytic stability in antipsychotic agents.
- Claim Metrics: Narrower claims enhance the patent's validity and clarity.
- Valuation: The patent's value can be substantial, using income and market approaches.
- Industry Impact: The patent can provide a competitive edge and generate significant revenue through licensing and litigation.
FAQs
What is the main focus of US Patent 11,097,006?
The main focus of US Patent 11,097,006 is to provide a pharmaceutical composition that ensures the long-term stability of a hydrolytically labile antipsychotic agent.
How are the claims in this patent structured?
The claims in this patent include independent claims that define the core invention and dependent claims that provide additional details and limitations.
What are the key components of the pharmaceutical composition?
The key components include the antipsychotic agent, stabilizing agents such as nonionic surfactants and poly(ethylene oxide), and a specific method of preparation.
How is the value of this patent determined?
The value of this patent can be determined using the income, cost, and market approaches, with the income approach being most relevant due to the future benefits generated by the patent.
What is the potential impact of this patent on the pharmaceutical industry?
This patent can provide a competitive edge by ensuring the stability and efficacy of the pharmaceutical composition, leading to higher market share and revenue.
How does the patent landscape affect the validity and expiration of this patent?
The patent landscape, including related patents and patent term adjustments, can affect the validity and expiration dates of this patent, requiring careful management to maintain its protection.
Sources
- US11097006B2 - Pharmaceutical compositions having improved storage stability - Google Patents
- Allergan USA, Inc. v. MSN Laboratories Private Ltd. - United States Court of Appeals for the Federal Circuit
- Patent Claims and Patent Scope - SSRN
- The Value of a Patent - Perpetual Motion Patents
