Analyzing the Scope and Claims of United States Patent 4,515,805: A Comprehensive Guide
Introduction
United States Patent 4,515,805, titled "Soluble sodium cromoglycate compositions," is a pharmaceutical patent that has significant implications for the treatment of asthma. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US4515805A
- Authority: United States
- Prior Art Date: October 28, 1981
- Legal Status: Expired - Lifetime[4].
Invention Description
The patent describes a new pharmaceutical formulation of soluble sodium cromoglycate, a drug well-known for its efficacy in treating asthma when administered by inhalation. The formulation involves a dry powder mixture consisting of fine particles of sodium cromoglycate and coarser particles of lactose. The objective is to create a composition where the drug particles adhere to the lactose but can be easily shaken off in the airstream during inhalation[4].
Claims Analysis
Independent and Dependent Claims
The patent includes several claims that define the scope of the invention. Here are the key claims:
- Independent Claim: The patent claims a pharmaceutical composition comprising a dry powder mixture of sodium cromoglycate and lactose, where the lactose particles are in the range of 30-80 microns and the sodium cromoglycate particles are in a specific weight ratio to the lactose.
- Dependent Claims: These claims further specify the particle size of the lactose and sodium cromoglycate, as well as the weight ratio between them. For example, one dependent claim specifies that the particle size of the lactose can be from 80 to 150 microns, and another specifies that the particle size of the sodium cromoglycate can be from 2 to 4 microns[4].
Claim Scope
The claims are designed to protect the specific formulation and method of preparing the dry powder mixture. They ensure that any similar formulations must differ significantly in terms of particle size and weight ratio to avoid infringement.
Prior Art and Related Patents
British Patent Specifications
The patent is a continuation of earlier work described in British Patent Specifications No. 1,242,211, No. 1,381,872, and No. 1,410,588. These specifications detail earlier modifications and formulations of the sodium cromoglycate and lactose mixture[4].
International Patent Landscape
To understand the global patent landscape, one must refer to international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO). These databases can reveal similar patents or applications filed in other countries, which could impact the global market for this formulation[1].
Search and Analysis Tools
USPTO Resources
For a comprehensive analysis, one can use the USPTO's Patent Public Search tool, which provides enhanced access to prior art and allows for a detailed search of patent documents. The Global Dossier service is also useful for viewing the patent family and related applications from participating IP offices[1].
Common Citation Document (CCD)
The CCD application consolidates citation data from multiple IP offices, enabling a single-point access to prior art cited by different offices. This is particularly useful for understanding the global context of the patent and identifying potential overlaps or conflicts[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can provide insights into the scope and trends of patent claims over time. This dataset, which includes claims from U.S. patents granted between 1976 and 2014, can help in understanding the broader trends in pharmaceutical patenting and the specific metrics related to patent scope[3].
Practical Applications and Impact
Treatment of Asthma
The formulation described in the patent has a direct impact on the treatment of asthma. By ensuring that the sodium cromoglycate particles are effectively delivered to the lungs, this formulation enhances the efficacy of the treatment and improves patient outcomes.
Market and Competitive Landscape
Understanding the patent landscape is crucial for companies developing similar pharmaceutical formulations. The expiration of this patent means that other companies can now develop and market similar products, potentially increasing competition in the asthma treatment market.
Legal Considerations
Patent Expiration
The patent has expired, which means that the specific formulation described is no longer protected by patent law. This opens up opportunities for generic or similar formulations to enter the market.
Reporting and Compliance
For companies involved in patent filings or litigation, it is essential to report patent and trademark filings accurately. Forms such as the AO 120 provided by the U.S. Courts can be used for this purpose[5].
Key Takeaways
- Patent Scope: The patent protects a specific dry powder mixture of sodium cromoglycate and lactose with defined particle sizes and weight ratios.
- Prior Art: The invention builds on earlier British Patent Specifications and is part of a broader international patent landscape.
- Search Tools: Utilize USPTO resources like Patent Public Search and Global Dossier for comprehensive analysis.
- Economic Implications: The Patent Claims Research Dataset provides valuable insights into patent trends and scope.
- Practical Impact: The formulation enhances asthma treatment efficacy and has significant market implications.
FAQs
Q: What is the main objective of the formulation described in US Patent 4,515,805?
A: The main objective is to create a dry powder mixture where sodium cromoglycate particles adhere to lactose particles but can be easily shaken off during inhalation.
Q: What are the key components of the patent claims?
A: The claims specify the particle size of lactose and sodium cromoglycate, as well as their weight ratio in the dry powder mixture.
Q: How can one search for similar patents internationally?
A: Use databases provided by the EPO, JPO, WIPO, and other international IP offices to search for similar patents.
Q: What is the significance of the Common Citation Document (CCD)?
A: The CCD consolidates citation data from multiple IP offices, providing a single-point access to prior art cited by different offices.
Q: Why is the Patent Claims Research Dataset important?
A: It provides detailed information on claims from U.S. patents and helps in understanding trends and metrics related to patent scope.
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 Research Dataset - USPTO. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US4515805A - Soluble sodium cromoglycate compositions - Google Patents. Retrieved from https://patents.google.com/patent/US4515805A/en
- Report on Filing Patent/Trademark | United States Courts. Retrieved from https://www.uscourts.gov/forms-rules/forms/report-filing-patent-trademark
