Analyzing the Scope and Claims of United States Patent 10,266,523
Introduction
United States Patent 10,266,523, titled "Crystalline Forms of Monophosphate," is a patent that delves into the preparation and characteristics of specific crystalline forms of a monophosphate compound. This analysis will explore the patent's scope, claims, and the broader patent landscape in which it resides.
Patent Overview
The patent, filed under the application number US15/579,881, pertains to medicinal preparations containing organic active ingredients, specifically focusing on crystalline forms of a monophosphate compound. The patent is categorized under various international patent classifications, including A61K31/00, A61K31/33, and A61K31/395, indicating its relevance to medicinal preparations and heterocyclic compounds[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they outline what the patent holder can legally enforce as their exclusive right.
-
Claim 1: This claim describes the crystalline Form A of the monophosphate compound, characterized by specific X-ray powder diffraction peaks. For example, the X-ray powder diffraction pattern shows characteristic peaks at 2theta values of 17.5° ± 0.2°, 5.1° ± 0.2°, and 13.0° ± 0.2°[4].
-
Claim 2: This claim details another crystalline form, Form B, with different X-ray powder diffraction peaks, such as 17.2° ± 0.2°, 15.4° ± 0.2°, and 25.0° ± 0.2°[4].
Dependent Claims
Dependent claims further specify the invention by adding additional limitations to the independent claims. These claims often describe specific processes, compositions, or uses of the crystalline forms.
- Dependent Claims: These include claims related to the process of preparation of the crystalline forms, coating layers for the crystalline forms (e.g., shellac isolation coating, sugar coating), and the use of excipients such as water, oils, and glycols[4].
Scope of the Patent
The scope of the patent is defined by the claims and the detailed description provided in the patent document.
Crystalline Forms
The patent focuses on two primary crystalline forms, Form A and Form B, each with distinct X-ray powder diffraction patterns. These forms are significant due to their stability and low hygroscopicity, making them suitable for storage and use in pharmaceutical applications[4].
Stability and Hygroscopicity
The crystalline forms described in the patent have good stability and low hygroscopicity, which are critical properties for pharmaceutical compounds. This ensures that the compounds do not undergo unwanted crystal transformations, which could affect their efficacy and shelf life[4].
Coating and Excipients
The patent also covers various coating layers and excipients that can be used with the crystalline forms. This includes polymer coatings, anti-sticking agents, and other additives that enhance the formulation's stability and usability[4].
Broader Patent Landscape
Trends in Pharmaceutical Patents
The pharmaceutical sector has seen significant patent activity in recent years, with a focus on novel crystalline forms and formulations. This trend is driven by the need for stable and effective pharmaceutical compounds. The USPTO's Patent Claims Research Dataset provides insights into such trends, showing an increase in patents related to medicinal preparations and their formulations[5].
Patent Scope and Claims Analysis
Research on patent scope and claims, such as the work by Marco, Alan C., and Sarnoff, Joshua D., highlights the importance of measuring patent scope through metrics like independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims, which are crucial for determining the patent's validity and enforceability[3][5].
Economic and Legal Implications
Market Impact
Patents like US 10,266,523 can have a significant impact on the pharmaceutical market. By securing exclusive rights to specific crystalline forms, the patent holder can control the production and distribution of these compounds, potentially influencing market prices and availability.
Litigation and Licensing
The patent's scope and claims can also affect litigation and licensing strategies. Clear and narrow claims, as validated by research, are more likely to withstand legal challenges and facilitate smoother licensing agreements[3].
Key Takeaways
- Crystalline Forms: The patent focuses on two distinct crystalline forms of a monophosphate compound, each with specific X-ray powder diffraction patterns.
- Stability and Hygroscopicity: The crystalline forms are characterized by good stability and low hygroscopicity, making them suitable for pharmaceutical use.
- Coating and Excipients: The patent covers various coating layers and excipients that enhance the formulation's stability and usability.
- Broader Trends: The patent is part of a broader trend in pharmaceutical patents, emphasizing novel crystalline forms and formulations.
- Economic and Legal Implications: The patent's scope and claims have significant implications for market control, litigation, and licensing.
FAQs
-
What is the main subject of United States Patent 10,266,523?
- The main subject is the crystalline forms of a monophosphate compound, specifically their preparation and characteristics.
-
What are the key characteristics of the crystalline forms described in the patent?
- The crystalline forms are characterized by specific X-ray powder diffraction peaks and have good stability and low hygroscopicity.
-
How do coating layers and excipients relate to the patent?
- The patent covers various coating layers and excipients that can be used with the crystalline forms to enhance their stability and usability.
-
What is the significance of the patent in the broader pharmaceutical sector?
- The patent is part of a trend focusing on novel crystalline forms and formulations, which is crucial for developing stable and effective pharmaceutical compounds.
-
How can the scope and claims of the patent impact litigation and licensing?
- Clear and narrow claims can help the patent withstand legal challenges and facilitate smoother licensing agreements.
Sources
-
Google Patents - US10266523B2
- This source provides the detailed patent document for US 10,266,523, including claims and descriptions.
-
Patent Claims Research Dataset - USPTO
- This dataset offers insights into trends and metrics related to patent claims and scope.
-
Patent Claims and Patent Scope - SSRN
- This paper discusses metrics for measuring patent scope and their implications.
-
Recent Trends in Article of Manufacture of Design Claims - Quarles
- Although not directly related, this article provides context on broader patent trends and the importance of specific claim types.
-
Data Download Tables - PatentsView
- This resource offers access to patent data sets, which can be used to analyze broader patent trends and landscapes.
