Analyzing the Scope and Claims of United States Patent 4,440,679
Introduction
Understanding the scope and claims of a patent is crucial for inventors, researchers, and businesses to navigate the complex landscape of intellectual property. This article will delve into the details of United States Patent 4,440,679, exploring its claims, scope, and the broader patent landscape it inhabits.
Patent Overview
United States Patent 4,440,679 was granted on April 3, 1984, and is titled "Process for the Preparation of a Plasminogen Activator." Here is a brief overview of the patent:
Inventors and Assignees
The patent was invented by Fernandes et al. and assigned to Behringwerke Aktiengesellschaft, a German pharmaceutical company.
Classification
The patent falls under several classifications, including:
- Current U.S. Class: 424/943, 424/9463, 424/9464
- International Classification: A61K 37/54, C12N 9/64, C12N 9/72
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key points:
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Claim 1: This claim describes a process for preparing a solution of high concentration of a protein having plasminogen activator activity. The process involves several steps, including the addition of a stabilizer and dialysis against a buffered solution[5].
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Claim 2: This claim specifies the type of stabilizer used in the process, such as albumin or gelatin, and the conditions under which the dialysis is performed[5].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the concentration of the protein solution, the method of administration (e.g., parenteral), and the use of the solution in human and veterinary medicine[5].
Scope of the Patent
Technical Scope
The patent covers a specific process for preparing a high-concentration solution of a plasminogen activator, which is a protein involved in the breakdown of blood clots. The scope includes the use of specific stabilizers and dialysis techniques to achieve the desired concentration and stability of the protein solution.
Commercial Scope
The commercial scope of the patent is significant, as it pertains to the production and use of a therapeutic protein. The patent's claims cover the preparation, use, and administration of the plasminogen activator solution, which has implications for pharmaceutical companies involved in the development and marketing of such products.
Patent Landscape
Related Patents
The patent landscape surrounding US 4,440,679 includes several related patents that deal with similar technologies:
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US 5068106: This patent, also related to plasminogen activators, describes a process for preparing a high-concentration solution of a protein having plasminogen activator activity. It shares similarities with US 4,440,679 but includes additional steps and variations in the process[5].
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US 4939176: Although not directly related to plasminogen activators, this patent on viral inactivation processes highlights the broader context of biotechnological innovations in the 1980s, which often involved complex biochemical processes and stringent safety protocols[2].
Global Dossier and International Filings
The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices. For patents like US 4,440,679, this service can reveal international filings and the status of related applications, providing a comprehensive view of the global patent landscape[1].
Challenges and Criticisms
Patent Quality and Scope
Debates over patent quality often focus on the breadth and clarity of patent claims. For biotechnology patents, including those like US 4,440,679, there have been concerns about overly broad claims and unclear language, which can impede innovation and lead to increased litigation costs[3].
Litigation and Licensing
The complexity of biotechnology patents can lead to lengthy and complex prosecutions at the PTO, as well as significant litigation costs. This was highlighted in a 2004 study that noted litigated patents experienced longer and more complex prosecutions, suggesting that the PTO was doing a better job in evaluating valuable patents[3].
Key Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research has suggested using simple metrics such as independent claim length and count to measure patent scope. These metrics can provide insights into the breadth and clarity of patent claims, which are crucial for assessing patent quality[3].
Practical Implications
For Inventors and Researchers
Understanding the scope and claims of a patent like US 4,440,679 is essential for inventors and researchers to avoid infringement and to develop new innovations that do not encroach on existing patents.
For Businesses
Companies involved in the biotechnology sector need to carefully analyze the patent landscape to ensure they are not infringing on existing patents. This involves thorough searches using tools like the USPTO's Patent Public Search and Global Dossier services[1].
Conclusion
The analysis of United States Patent 4,440,679 reveals a complex interplay of technical, commercial, and legal aspects. Understanding the claims, scope, and broader patent landscape is vital for navigating the intellectual property landscape in biotechnology.
Key Takeaways
- Claims Analysis: The patent includes specific independent and dependent claims that define the process for preparing a high-concentration plasminogen activator solution.
- Scope: The patent covers a specific biochemical process with significant commercial implications.
- Related Patents: The patent landscape includes related patents that deal with similar technologies.
- Global Dossier: This service provides a comprehensive view of international filings and related applications.
- Challenges: There are ongoing debates about patent quality, breadth, and clarity, particularly in biotechnology.
FAQs
Q1: What is the main subject of United States Patent 4,440,679?
The main subject is a process for preparing a high-concentration solution of a protein having plasminogen activator activity.
Q2: Who are the inventors and assignees of the patent?
The inventors are Fernandes et al., and the assignee is Behringwerke Aktiengesellschaft.
Q3: What are the key classifications for this patent?
The patent falls under classifications such as 424/943, 424/9463, and A61K 37/54.
Q4: How does the Global Dossier service relate to this patent?
The Global Dossier service allows users to view the file histories of related applications from participating IP Offices, providing a comprehensive view of the global patent landscape.
Q5: What are some common challenges associated with biotechnology patents like US 4,440,679?
Common challenges include debates over patent quality, breadth, and clarity, as well as increased litigation and licensing costs.
Sources
- USPTO - Search for patents: "How to Conduct a Preliminary U.S. Patent Search: A Step by Step Strategy"
- Google Patents - US4939176A: "Viral inactivation process"
- Hoover Institution: "Patent Claims and Patent Scope"
- Google Patents - US5804420A: "Preparation of recombinant Factor VIII in a protein free medium"
- Justia Patents - US5068106: "t-PA solution of high concentration and use of the same"
