Detailed Analysis of the Scope and Claims of United States Patent 5,919,485
Introduction
United States Patent 5,919,485, titled "Oral 2-methyl-thieno-benzodiazepine formulation," is a patent that describes a specific pharmaceutical formulation and its manufacturing process. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, issued on July 6, 1999, pertains to a pharmaceutically acceptable solid oral formulation of olanzapine, a medication used primarily in the treatment of schizophrenia and bipolar disorder. The invention includes the formulation itself and the process for its manufacture[2][5].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected.
Claims
The patent includes multiple claims that cover various aspects of the formulation and its production process. Here are some key claims:
- Claim 1: This claim describes the solid oral formulation of olanzapine, specifying the composition and the form in which it is presented (e.g., tablets, capsules).
- Claims 2-5: These claims detail the process for making the formulation, including the steps involved in preparing the active ingredient and combining it with excipients.
- Claims 6-10: These claims cover specific embodiments of the formulation, such as the dosage forms and the stability of the formulation.
Claim Analysis
To understand the protection offered by this patent, it is crucial to analyze each claim in detail.
Claim Coverage Matrix
A Claim Coverage Matrix, as described in patent analytics, can help in understanding which claims are actively protecting the intellectual property and where gaps or opportunities exist. For US Patent 5,919,485, this matrix would categorize claims by their scope concepts, such as the composition of the formulation, the manufacturing process, and the dosage forms[3].
Scope Concepts
The claims can be categorized into several scope concepts:
- Composition: Claims related to the specific ingredients and their proportions in the formulation.
- Manufacturing Process: Claims detailing the steps and methods used to prepare the formulation.
- Dosage Forms: Claims covering the different forms in which the formulation can be presented (e.g., tablets, capsules).
Patent Landscape
Understanding the broader patent landscape is essential for assessing the significance and potential impact of this patent.
Related Patents
The patent landscape for olanzapine formulations includes other patents that may cover similar or related inventions. For instance, other patents might cover different formulations, delivery methods, or manufacturing processes for olanzapine. Using tools like the USPTO's Patent Public Search or international databases such as the European Patent Office's esp@cenet can help identify these related patents[1].
Global Dossier
The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices. This can be useful in identifying other patents within the same patent family and understanding how they relate to US Patent 5,919,485[1].
Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This can provide insights into how US Patent 5,919,485 has been cited and how it fits into the broader landscape of related inventions[1].
Market Impact
The market impact of this patent can be significant, especially in the pharmaceutical industry.
Competitive Advantage
The exclusive rights granted by this patent can provide a competitive advantage to the patent holder by preventing others from manufacturing or selling the same formulation. This can be particularly important in a market where generic versions of medications are common.
Licensing and Collaboration
The patent holder may also use this patent as a basis for licensing agreements or collaborations with other pharmaceutical companies. This can expand the reach of the formulation and generate revenue through royalties.
Legal and Regulatory Considerations
Understanding the legal and regulatory environment is crucial for navigating the patent landscape.
Patent Term
The patent term for US Patent 5,919,485 has expired, as it was issued in 1999 and patents generally have a term of 20 years from the filing date. This means that the formulation and process described in the patent are now in the public domain.
Generic Competition
With the patent term expired, generic versions of the olanzapine formulation can now be manufactured and sold by other companies, potentially increasing competition in the market.
Conclusion
United States Patent 5,919,485 provides a detailed description of a specific oral formulation of olanzapine and its manufacturing process. The claims of the patent define the scope of protection, and analyzing these claims using tools like a Claim Coverage Matrix can help in understanding the patent's impact. The broader patent landscape, including related patents and citation data, is also important for assessing the significance of this invention.
Key Takeaways
- Patent Scope: The patent covers a specific oral formulation of olanzapine and its manufacturing process.
- Claims Analysis: Claims are categorized into scope concepts such as composition, manufacturing process, and dosage forms.
- Patent Landscape: Understanding related patents and citation data is crucial for assessing the patent's impact.
- Market Impact: The patent provided a competitive advantage during its term but is now in the public domain.
- Legal Considerations: The patent term has expired, allowing for generic competition.
FAQs
Q: What is the main subject of United States Patent 5,919,485?
A: The main subject is a pharmaceutically acceptable solid oral formulation of olanzapine and its manufacturing process.
Q: How can one analyze the claims of this patent?
A: Using a Claim Coverage Matrix to categorize claims by scope concepts such as composition, manufacturing process, and dosage forms.
Q: Is the patent still in force?
A: No, the patent term has expired, as it was issued in 1999 and patents generally have a term of 20 years from the filing date.
Q: What is the impact of the patent's expiration on the market?
A: The expiration allows for generic versions of the olanzapine formulation to be manufactured and sold, increasing competition in the market.
Q: How can one find related patents in the same field?
A: Using tools like the USPTO's Patent Public Search, Global Dossier, and international databases such as the European Patent Office's esp@cenet.
Sources
- USPTO: "Search for patents - USPTO"
- Unified Patents Portal: "US-5919485-A - Unified Patents Portal"
- Schwegman: "Patent Analytics | Intellectual Property Law"
- U.S. Department of Commerce: "U.S. Patent and Trademark Office | U.S. Department of Commerce"
- Justia Patents: "US Patent for Oral 2-methyl-thieno-benzodiazepine formulation ..."
