United States Patent 5,114,976: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,114,976, titled "Method for treating psychiatric disorders," is a significant patent in the field of psychiatry and pharmaceuticals. This patent, assigned to Eli Lilly and Company, pertains to the use of fluoxetine, a selective serotonin reuptake inhibitor (SSRI), for treating various psychiatric disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent was filed by Dr. Michael Norden and licensed to Eli Lilly and Company. Fluoxetine, the active ingredient in Prozac, is well-known for its application in treating depression and other mood-related disorders. The patent specifically addresses the use of fluoxetine for conditions such as premenstrual dysphoric disorder (PMDD) and other psychiatric disorders[2].
Scope of the Patent
The scope of U.S. Patent 5,114,976 is defined by its claims, which outline the specific methods and uses of fluoxetine for treating psychiatric disorders. Here are the key aspects:
- Method of Treatment: The patent describes a method for treating psychiatric disorders, including PMDD, using fluoxetine. This method involves administering a therapeutically effective amount of fluoxetine to patients suffering from these conditions[5].
- Dosage and Administration: The patent specifies the dosage and administration protocols for fluoxetine, ensuring that the treatment is both effective and safe.
- Psychiatric Disorders: The patent covers a range of psychiatric disorders, including but not limited to PMDD, borderline personality disorders, and other mood-related conditions.
Claims Analysis
The claims of a patent are crucial as they define the legal boundaries of the invention. Here is a breakdown of the claims in U.S. Patent 5,114,976:
- Independent Claims: These claims stand alone and define the core invention. For example, Claim 1 might describe the method of treating PMDD using fluoxetine.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, a dependent claim might specify the dosage range or the frequency of administration[5].
Patent Landscape
Understanding the patent landscape is essential for assessing the impact and validity of a patent.
Related Patents
- U.S. Patent 4,971,998: This patent, also related to fluoxetine, was involved in a patent infringement suit between Eli Lilly and Company and Teva Pharmaceuticals. The court's decision on claim construction in this case provides insight into how similar patents are interpreted[2].
- Other Patents by Dr. Michael Norden: Dr. Norden has filed several patents related to the use of fluoxetine, which are part of the broader patent family. These patents collectively contribute to the comprehensive coverage of fluoxetine's therapeutic applications.
Global Dossier and International Filings
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including all related applications filed at participating IP Offices. This service is useful for understanding the international scope and filings related to U.S. Patent 5,114,976[1].
Public Search and Documentation
Tools like the Patent Public Search and the Publication Site for Issued and Published Sequences (PSIPS) provide access to detailed information about the patent, including sequence listings and other mega items. These resources are invaluable for conducting thorough patent searches and analyses[1].
Patent Quality and Examination
The quality of a patent is crucial for its validity and enforceability. The USPTO has taken several steps to improve patent quality, including the Enhanced Patent Quality Initiative. This initiative focuses on ensuring that patents meet statutory requirements for novelty, clarity, and other criteria[4].
Claim Clarity and Examination Time
The GAO report highlights the importance of claim clarity and the need for sufficient examination time. While the USPTO has considered requiring additional clarity tools, such as glossaries of terms or claim charts, it has decided against such requirements due to stakeholder feedback. Instead, the USPTO has increased examination time for certain technology areas to ensure thorough reviews[4].
Legal and Regulatory Aspects
Patent infringement suits, such as the one between Eli Lilly and Teva Pharmaceuticals, often involve complex legal interpretations. The court's decision in such cases can significantly impact the scope and validity of the patent. For U.S. Patent 5,114,976, any legal challenges would need to carefully consider the intrinsic evidence, including the patent's specification, claims, and prosecution history[2].
Economic Impact
The economic impact of U.S. Patent 5,114,976 is substantial, given the widespread use of fluoxetine in treating psychiatric disorders. The patent has contributed significantly to Eli Lilly's revenue and has played a crucial role in the development of psychiatric treatments.
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to U.S. Patent 5,114,976. This dataset helps in analyzing patent scope and trends, which can be useful for understanding the economic and technological impact of the patent[3].
Key Takeaways
- Scope and Claims: U.S. Patent 5,114,976 covers the use of fluoxetine for treating various psychiatric disorders, with specific claims defining the method of treatment and dosage protocols.
- Patent Landscape: The patent is part of a broader family of patents related to fluoxetine, with international filings and related patents contributing to its comprehensive coverage.
- Patent Quality: The USPTO's initiatives to improve patent quality, such as the Enhanced Patent Quality Initiative, are crucial for ensuring the validity and enforceability of the patent.
- Legal and Regulatory Aspects: Legal interpretations and infringement suits can significantly impact the patent's scope and validity.
- Economic Impact: The patent has a substantial economic impact due to the widespread use of fluoxetine in psychiatric treatments.
FAQs
What is the main subject of U.S. Patent 5,114,976?
The main subject of U.S. Patent 5,114,976 is the method for treating psychiatric disorders, including PMDD, using fluoxetine.
Who are the inventors and assignees of the patent?
The patent was filed by Dr. Michael Norden and assigned to Eli Lilly and Company.
How does the patent fit into the broader patent landscape?
The patent is part of a family of patents related to fluoxetine, with international filings and related patents contributing to its comprehensive coverage.
What are the key claims of the patent?
The key claims define the method of treating psychiatric disorders using fluoxetine, including dosage and administration protocols.
What initiatives has the USPTO taken to improve patent quality?
The USPTO has initiated the Enhanced Patent Quality Initiative, which includes defining patent quality, reassessing examination time, and analyzing the effects of incentives on patent quality.
How can one access detailed information about the patent?
Detailed information about the patent can be accessed through tools like the Patent Public Search, Global Dossier, and the Publication Site for Issued and Published Sequences (PSIPS)[1][3].
