Understanding the Scope and Claims of United States Patent 8,951,504: A Comprehensive Analysis
Introduction
Patent US 8,951,504, titled "Excipient selection for solid-state phase transformation in formulation during wet granulation," is a significant patent in the pharmaceutical industry. This article will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Abstract
The patent, US 8,951,504, focuses on the selection of excipients to influence solid-state phase transformations during the wet granulation process in pharmaceutical formulations. This is crucial because the physical state of the active pharmaceutical ingredient (API) can significantly affect the stability, bioavailability, and overall efficacy of the drug product[5].
Scope of the Patent
Background and Context
The scope of the patent is rooted in the need to control and predict the physical state of APIs during the formulation process. Solid-state phase transformations can occur due to various factors, including the choice of excipients, processing conditions, and storage environments. The patent aims to provide a method to select excipients that minimize undesirable phase transformations, thereby ensuring the stability and performance of the final drug product.
Technical Field
The technical field of this patent is pharmaceutical formulation, specifically the area of solid-state chemistry and wet granulation. It involves understanding the interactions between APIs and excipients and how these interactions affect the physical state of the API during and after the formulation process.
Claims of the Patent
Independent Claims
The independent claims of the patent define the core inventions and are critical for understanding the scope of protection. These claims typically include:
- The method of selecting excipients based on their ability to influence solid-state phase transformations.
- The specific excipients identified and their roles in maintaining the desired physical state of the API.
- The process conditions under which the wet granulation is performed to achieve the desired outcomes[5].
Dependent Claims
Dependent claims further specify the independent claims by adding additional limitations or details. These might include:
- Specific ratios of API to excipient.
- Particular processing conditions such as temperature, humidity, and mixing times.
- Additional steps or components that enhance the stability of the formulation.
Patent Claims Analysis
Claim Length and Count
Research has shown that the length and count of independent claims can be indicative of patent scope. Narrower claims with fewer words and fewer independent claims often result in a more focused and potentially stronger patent. In contrast, broader claims with more words and more independent claims may indicate a wider scope but also increase the risk of challenges during the examination process[3].
Examination Process Impact
The examination process can significantly narrow the scope of patent claims. Studies have indicated that the duration of the examination process can influence the final claim scope, with longer examinations often resulting in narrower claims. This is crucial for understanding the final enforceable scope of the patent[3].
Patent Landscape
Global Dossier and International Search
To understand the broader patent landscape, tools like the Global Dossier and international patent databases are essential. These resources allow users to see the patent family for a specific application, including related applications filed at participating IP Offices, and access citation data and office actions. This helps in identifying similar inventions and potential prior art[1].
Public Search Facilities and PTRCs
Utilizing resources such as the USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) can provide access to a wide range of patent and trademark information. These facilities offer trained staff to assist in searching and understanding the patent landscape[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) consolidates prior art cited by multiple IP offices for the same patent application, providing a single point of access to citation data. This tool is invaluable for assessing the novelty and non-obviousness of the invention claimed in US 8,951,504[1].
Industry Impact and Relevance
Pharmaceutical Formulation
The patent's focus on excipient selection and solid-state phase transformations is highly relevant in the pharmaceutical industry. Ensuring the stability and bioavailability of APIs is critical for drug efficacy and safety. This patent provides valuable insights and methods that can be applied in the development of various pharmaceutical products.
Regulatory Compliance
Compliance with regulatory standards is a key aspect of pharmaceutical development. Patents like US 8,951,504 help in meeting these standards by providing scientifically validated methods for formulating drugs. This not only aids in regulatory approvals but also in maintaining the quality and consistency of the final product.
Examples and Case Studies
Real-World Applications
In practice, the methods described in US 8,951,504 can be applied in various pharmaceutical formulations. For instance, in the development of solid oral dosage forms, the selection of excipients based on their ability to influence solid-state phase transformations can significantly impact the product's stability and shelf life.
Industry Expert Insights
Industry experts often emphasize the importance of controlling physical state transformations in pharmaceutical formulations. For example, a pharmaceutical formulation expert might say, "The choice of excipients is not just about bulking up the formulation; it's about ensuring that the API remains in a stable and bioavailable form throughout the product's lifecycle."
Statistics and Data
Patent Maintenance and Forward Citations
Studies have shown that patents with narrower claims at publication tend to have a higher probability of grant and shorter examination processes. Additionally, these patents often receive more forward citations, indicating their impact and relevance in the field. For US 8,951,504, analyzing the forward citations and patent maintenance data can provide insights into its influence and the value it adds to the pharmaceutical industry[3].
Key Takeaways
- Patent Scope and Claims: The scope of US 8,951,504 is defined by its claims, which focus on the selection of excipients to control solid-state phase transformations during wet granulation.
- Patent Landscape: Understanding the broader patent landscape using tools like Global Dossier and CCD is crucial for assessing the novelty and non-obviousness of the invention.
- Industry Impact: The patent is highly relevant in the pharmaceutical industry, aiding in the development of stable and bioavailable drug products.
- Regulatory Compliance: The methods described in the patent help in meeting regulatory standards, ensuring the quality and consistency of pharmaceutical products.
FAQs
What is the main focus of US Patent 8,951,504?
The main focus of US Patent 8,951,504 is on the selection of excipients to influence solid-state phase transformations during the wet granulation process in pharmaceutical formulations.
How does the patent impact pharmaceutical formulation?
The patent provides methods to ensure the stability and bioavailability of APIs by controlling solid-state phase transformations, which is critical for drug efficacy and safety.
What tools can be used to understand the broader patent landscape?
Tools such as the Global Dossier, Common Citation Document (CCD), and resources from the USPTO Public Search Facility and PTRCs can be used to understand the broader patent landscape.
Why is the length and count of independent claims important?
The length and count of independent claims can indicate the scope and strength of the patent. Narrower claims often result in a more focused and potentially stronger patent.
How does the examination process affect patent claims?
The examination process can significantly narrow the scope of patent claims, with longer examinations often resulting in narrower claims to ensure the patent's enforceability.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) | USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims and Patent Scope - Search eLibrary :: SSRN. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Rigel Pharmaceuticals, Inc. - 10-Q. Retrieved from https://www.rigel.com/investors/sec-filings/all-sec-filings/content/0001558370-24-014862/0001558370-24-014862.pdf
- Unified Patents Portal - US-20090123539-A1. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-20090123539-A1
