Understanding the Scope and Claims of United States Patent 9,173,851 B1
Introduction
United States Patent 9,173,851 B1, titled "Methods for Storing Cysteamine Formulations and Related Methods of Treatment," is a significant patent in the field of pharmaceuticals, particularly for the treatment of cystinosis. This patent, assigned to Horizon Orphan LLC, involves innovative methods for storing and administering cysteamine formulations. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background of the Patent
The patent was granted on October 27, 2015, and is part of a series of patents related to cysteamine formulations. Cysteamine bitartrate, the active ingredient, was first approved in 1997 for the treatment of cystinosis, a rare genetic disorder that leads to the accumulation of cystine within cells[1][4].
Patent Scope
The scope of a patent is crucial as it defines the boundaries of what is protected by the patent. For US Patent 9,173,851 B1, the scope is centered around methods for storing cysteamine formulations to maintain their stability and efficacy.
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. In this patent, the independent claims focus on specific methods of storing cysteamine formulations, including:
- Methods for storing cysteamine formulations in a sealed container to prevent degradation.
- Methods for maintaining the stability of cysteamine formulations through controlled storage conditions[1][4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims may include specific storage conditions, such as temperature and humidity controls, and the use of particular packaging materials to ensure the stability of the cysteamine formulations.
Claim Language and Patent Scope Metrics
The language used in patent claims is a critical factor in determining the patent's scope. Metrics such as independent claim length and independent claim count can be used to measure patent scope. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Examination Process and Scope Narrowing
The examination process at the USPTO often results in the narrowing of patent claims. This patent, like others, would have undergone a rigorous examination process where the claims were scrutinized for clarity, breadth, and validity. The changes during the examination process can significantly impact the final scope of the patent, making it more specific and less broad[3].
Related Patents and Continuations
US Patent 9,173,851 B1 is part of a larger family of patents related to cysteamine formulations. It is a continuation of earlier applications, such as US Patent Application No. 16/195,481, which indicates a series of improvements and refinements in the methods for storing and treating cysteamine formulations[1][4].
Economic and Legal Implications
The economic implications of this patent are significant, particularly in the context of orphan drugs. The stability and efficacy of cysteamine formulations directly impact the treatment outcomes for patients with cystinosis. From a legal perspective, the patent's scope and claims influence licensing and litigation strategies, as broader or overly broad claims can lead to increased costs and disputes[3].
Impact on Innovation
The patent landscape around cysteamine formulations encourages innovation by providing incentives for further research and development. However, the balance between patent breadth and innovation is delicate. Narrower, more specific claims can foster innovation by reducing litigation costs and encouraging other researchers to build upon the existing knowledge[3].
Public and Stakeholder Input
In the broader context of patent law, public and stakeholder input play a crucial role. For instance, the Administrative Conference of the United States (ACUS) has engaged in studies to understand the need for a small claims patent court, which could impact how patents like 9,173,851 B1 are litigated and enforced[5].
Key Statistics and Data
- Patent Maintenance Payments: Narrower claims, like those in this patent, are associated with higher maintenance payments, indicating their value and the likelihood of being maintained over time[3].
- Forward Citations: The number of forward citations for this patent can indicate its influence on subsequent research and innovation in the field.
- Breadth of Patent Classes: The patent's classification within the A61K 31/145 and A61K 9/50 classes highlights its specificity and relevance within the pharmaceutical sector[1].
Expert Insights
Industry experts emphasize the importance of clear and specific claims in patents. For example, Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO, has highlighted the need for balanced patent scope to promote innovation while avoiding overly broad claims that could stifle competition[5].
Highlight: Importance of Claim Language
"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."
- Source: Hoover Institution[3]
Conclusion
US Patent 9,173,851 B1 is a significant contribution to the field of pharmaceuticals, particularly in the treatment of cystinosis. The patent's scope and claims are carefully crafted to ensure the stability and efficacy of cysteamine formulations. Understanding the metrics and implications of patent scope is crucial for both innovators and policymakers.
Key Takeaways
- Specific Claims: The patent's claims are specific and focused on methods for storing cysteamine formulations.
- Examination Process: The examination process at the USPTO narrowed the claims to ensure clarity and validity.
- Economic Implications: The patent has significant economic implications, especially in the context of orphan drugs.
- Innovation: The patent encourages innovation by providing incentives for further research and development.
- Public Input: Public and stakeholder input are crucial in shaping patent law and its enforcement.
FAQs
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What is the main subject of US Patent 9,173,851 B1?
- The main subject is methods for storing cysteamine formulations to maintain their stability and efficacy.
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Why is the scope of a patent important?
- The scope defines the boundaries of what is protected by the patent, influencing licensing, litigation, and innovation.
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How does the examination process affect patent claims?
- The examination process often results in the narrowing of patent claims to ensure clarity, breadth, and validity.
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What are the economic implications of this patent?
- The patent has significant economic implications, particularly in the context of orphan drugs, affecting treatment outcomes and costs.
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How does this patent impact innovation in the pharmaceutical sector?
- The patent encourages innovation by providing incentives for further research and development, while balanced claims avoid stifling competition.
