Details for Patent: 4,328,213

Summary for Patent: 4,328,213

Title:	Stable injectable labetalol formulation
Abstract:	An injectable formulation for the pharmaceutically acceptable acid addition salts of labetalol, its isomers and mixtures thereof is provided which has enhanced stability properties.
Inventor(s):	Ecker; Varda (New York, NY), Shah; Yogendra M. (Piscataway, NJ), Chaudry; Imtiaz A. (Denville, NJ)
Assignee:	Schering Corporation (Kenilworth, NJ)
Application Number:	06/098,166
Patent Claim Types: see list of patent claims	Formulation;

Analyzing the Scope and Claims of United States Patent 4,328,213: A Comprehensive Guide

Introduction

Understanding the scope and claims of a patent is crucial for determining its validity, enforceability, and the protection it offers. This article will delve into the details of United States Patent 4,328,213, issued on May 4, 1982, to V. Ecker et al., and provide a comprehensive analysis of its scope and claims.

Background of the Patent

United States Patent 4,328,213 pertains to "Stable injectable antiemetic compositions" and was granted to V. Ecker et al. This patent is significant in the pharmaceutical field, particularly in the development of antiemetic drugs used to prevent nausea and vomiting.

Understanding Patent Claims

What are Patent Claims?

Patent claims are the most critical part of a patent application, as they define the scope of the invention and what is protected by the patent. Claims must be clear, concise, and supported by the patent's specification[4].

Claims in Patent 4,328,213

The claims in Patent 4,328,213 would typically include various aspects of the stable injectable antiemetic compositions, such as the formulation, the active ingredients, and the method of preparation. Here is a hypothetical breakdown of what these claims might include:

• Independent Claims: These would define the broadest scope of the invention, such as the composition itself and its primary use.
• Dependent Claims: These would narrow down the scope by adding specific details, such as the concentration of active ingredients or the method of administration.

Claim Analysis

To analyze the claims of Patent 4,328,213, one would need to identify the key elements that define the invention. This involves:

• Identifying the Subject Matter: Determine what the patent claims cover, such as the specific antiemetic composition and its components.
• Scope of Protection: Understand the breadth of protection offered by each claim. For example, does the patent protect only a specific formulation or a broader class of antiemetic compositions?
• Dependency Relationships: Analyze how dependent claims relate to independent claims, as this can affect the overall scope of protection[3].

Patent Scope and Coverage

Scope Concepts

The scope of a patent can be categorized using scope concepts, which are overarching themes that link claims on similar patents. For Patent 4,328,213, these might include:

• Formulation: The specific combination and concentration of active and inactive ingredients.
• Method of Preparation: The steps involved in preparing the injectable composition.
• Therapeutic Use: The specific use of the antiemetic composition, such as in preventing nausea and vomiting associated with chemotherapy or surgery[5].

Claim Coverage Matrix

A Claim Coverage Matrix can be used to visualize which patents and claims are actively protecting the intellectual property related to Patent 4,328,213. This matrix helps in identifying gaps or opportunities in the patent landscape. For instance:

• Existing Coverage: Identify which claims in the patent cover the current technology and products.
• Gaps in Coverage: Determine if there are areas where the patent does not provide adequate protection, indicating potential future development opportunities[5].

Patent Landscape Analysis

Global Patent Family

To understand the full scope of protection, it is essential to analyze the global patent family associated with Patent 4,328,213. This involves:

• Global Dossier: Use services like the Global Dossier to access file histories of related applications from participating IP Offices, which can provide insights into the international scope of the patent[1].
• International Patent Offices: Search databases from other international intellectual property offices to see if similar patents have been granted abroad[1].

Prior Art and Citation Data

Analyzing prior art and citation data is crucial for understanding the novelty and non-obviousness of the invention. Tools like the Common Citation Document (CCD) can consolidate prior art cited by multiple offices, providing a comprehensive view of the prior art landscape[1].

Inventorship and Ownership

Determining Inventorship

Proper inventorship is critical for the validity of a patent. For Patent 4,328,213, the inventors listed would be those who conceived the idea of the stable injectable antiemetic compositions. This involves identifying individuals who contributed to the conception of the invention, not just those who reduced it to practice[4].

Patent Assignment and Ownership

Changes in ownership or assignments of the patent can affect its enforceability. The Patent Assignment Search website can be used to track any changes in ownership or assignments related to Patent 4,328,213[1].

Practical Applications and Future Directions

Claim Charts and Technical Review

Using tools like ClaimScape® software, interactive claim charts can be generated to help technical experts review the patent coverage. This can aid in determining whether a particular scope concept is applicable to a target product or method, highlighting future design opportunities[5].

Updating and Maintaining Patent Coverage

As new patents are filed or as development avenues are explored, the claim charts and coverage matrix should be updated. This ensures that the patent landscape remains accurately reflected and that any gaps in coverage are identified and addressed[5].

Key Takeaways

• Clear Claims: The claims in Patent 4,328,213 must be clear and supported by the specification to ensure broad and enforceable protection.
• Scope Analysis: Understanding the scope concepts and coverage matrix is essential for identifying gaps and opportunities in the patent landscape.
• Global Perspective: Analyzing the global patent family and prior art is crucial for a comprehensive understanding of the patent's scope.
• Inventorship: Correct determination of inventorship is vital for the patent's validity and enforceability.
• Continuous Monitoring: Regularly updating claim charts and coverage matrices ensures that the patent remains relevant and protective of the intellectual property.

FAQs

Q: What is the significance of patent claims in a patent application?

A: Patent claims define the scope of the invention and what is protected by the patent, making them the most critical part of a patent application.

Q: How can I determine the scope of protection offered by a patent?

A: Analyze the independent and dependent claims, and use tools like a Claim Coverage Matrix to understand the breadth of protection.

Q: What is the importance of global patent family analysis?

A: It helps in understanding the international scope of the patent and identifying related applications filed in other countries.

Q: Why is correct inventorship determination crucial?

A: Correct inventorship ensures the patent's validity and enforceability, as errors can lead to the patent being unenforceable.

Q: How can I keep my patent coverage up-to-date?

A: Use tools like ClaimScape® software to generate interactive claim charts and regularly update the coverage matrix as new patents are filed or development avenues are explored.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. European Patent Office - Stable injectable antiemetic compositions: https://data.epo.org/publication-server/rest/v1.0/publication-dates/19871021/patents/EP0241837NWA2/document.pdf
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Oregon State University - Determining Inventorship for US Patent Applications: https://agsci.oregonstate.edu/sites/agsci/files/main/research/vrc_release_inventorship-gattari.pdf
5. Schwegman Lundberg & Woessner - Patent Analytics: https://www.slwip.com/services/patent-analytics/

Drugs Protected by US Patent 4,328,213

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate