United States Patent 5,910,319: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,910,319, titled "Fluoxetine enteric pellets and methods for their preparation and use," is a significant patent in the pharmaceutical industry, particularly in the field of antidepressant medications. This patent, granted to Eli Lilly and Company, pertains to the formulation, preparation, and use of fluoxetine, a widely used selective serotonin reuptake inhibitor (SSRI).
Background of Fluoxetine
Fluoxetine, commonly known by the brand name Prozac, is indicated for the treatment of depression, obsessive-compulsive disorder, and bulimia among other conditions. The development of enteric pellets of fluoxetine represents an advancement in drug delivery systems, aimed at improving the efficacy and patient compliance of this medication[1].
Scope of the Patent
The scope of US Patent 5,910,319 is broad and encompasses several key aspects:
Formulation
The patent describes the formulation of fluoxetine enteric pellets, which involves coating fluoxetine with an enteric material. This coating ensures that the drug is released in the intestinal tract rather than in the stomach, thereby reducing gastrointestinal side effects and improving bioavailability[1].
Preparation Methods
The patent details various methods for preparing these enteric pellets. These methods include layering the drug onto inert cores, applying a seal coating, and then adding an enteric coating. The enteric coating is designed to be acid-resistant, ensuring the drug is not released until it reaches the less acidic environment of the intestines[1].
Use
The patent specifies the use of these enteric pellets in treating various psychiatric and neurological disorders. The controlled release formulation is intended to provide a sustained action over a longer period, enhancing patient compliance and therapeutic efficacy[1].
Claims of the Patent
The claims of US Patent 5,910,319 are structured to protect the specific formulation and preparation methods described. Here are some key claims:
Independent Claims
- The patent includes claims for the enteric pellets themselves, comprising a core, a drug layer, and an enteric coating.
- Claims also cover the process of preparing these pellets, including the steps of layering, sealing, and applying the enteric coating[1].
Dependent Claims
- Dependent claims further specify the materials used in the formulation, such as the type of inert core, the composition of the drug layer, and the characteristics of the enteric coating.
- These claims also detail the optional subcoatings and outer finishing layers that can be included to enhance the stability and performance of the pellets[1].
Patent Landscape
The patent landscape surrounding US Patent 5,910,319 is complex and involves several related patents and technologies.
Related Patents
- Other patents, such as U.S. Pat. No. 4,847,092, also describe sustained release formulations of fluoxetine, highlighting the ongoing innovation in this area[1].
- Patents like U.S. Pat. No. 5,356,934 and U.S. Pat. No. 5,104,899 focus on controlled release and sustained release formulations of R-fluoxetine and S-fluoxetine, respectively, indicating a broader interest in optimizing fluoxetine delivery systems[1].
Industry Trends
- The development of enteric pellets and other controlled release formulations reflects industry trends towards improving drug delivery systems to enhance patient outcomes and compliance.
- The pharmaceutical industry continues to invest in research and development to create more effective and tolerable medications, with patents like US 5,910,319 playing a crucial role in protecting these innovations[1].
Valuation and Economic Impact
The economic impact of a patent like US 5,910,319 can be significant. Here are some considerations:
Patent Valuation
- The value of a patent can be determined using various methods, including cost, income, and market approaches. For pharmaceutical patents, the income approach often highlights the future benefits and savings generated by the patented technology[2].
- The sale prices of similar pharmaceutical patents can provide a benchmark. For instance, large-scale patent deals in the tech industry have seen prices per patent document ranging from $18,000 to $1 million, though pharmaceutical patents may have different valuation metrics[2].
Market Impact
- Patents like US 5,910,319 can significantly impact the market by providing exclusive rights to the patent holder, allowing them to dominate the market for the patented formulation.
- The exclusivity period of a patent (typically 20 years from the filing date) can be crucial for recouping investment in research and development and generating substantial revenue[2].
Patent Scope and Quality
The scope and quality of patents are critical factors in the patent landscape.
Metrics for Patent Scope
- Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Patent Quality Concerns
- The quality of patents, including their scope and clarity, has been a subject of debate. Broad or unclear claims can lead to increased licensing and litigation costs, potentially diminishing innovation incentives[3].
Conclusion
US Patent 5,910,319 represents a significant innovation in the formulation and delivery of fluoxetine, a widely used antidepressant. The patent's scope and claims are designed to protect the specific methods and formulations described, contributing to the broader landscape of pharmaceutical patents.
Key Takeaways
- Formulation and Preparation: The patent describes the formulation of fluoxetine enteric pellets and the methods for their preparation.
- Use and Efficacy: The controlled release formulation is intended to improve bioavailability and patient compliance.
- Patent Landscape: The patent is part of a larger landscape of related patents and technologies aimed at optimizing drug delivery systems.
- Economic Impact: The patent can have a significant economic impact through exclusive rights and market dominance.
- Patent Quality: The scope and clarity of the patent claims are crucial for maintaining patent quality and avoiding legal issues.
FAQs
What is the primary innovation of US Patent 5,910,319?
The primary innovation is the formulation of fluoxetine enteric pellets, which ensures the drug is released in the intestinal tract, reducing gastrointestinal side effects.
How do the enteric pellets improve patient compliance?
The controlled release formulation of the enteric pellets provides a sustained action over a longer period, enhancing patient compliance by reducing the frequency of dosing.
What are the key claims of the patent?
The key claims include the enteric pellets themselves, the process of preparing these pellets, and the specific materials used in the formulation.
How is the value of a pharmaceutical patent determined?
The value can be determined using cost, income, and market approaches, with the income approach often highlighting future benefits and savings generated by the patented technology.
Why is patent scope important?
Patent scope is important because narrower claims are associated with a higher probability of grant and a shorter examination process, while broader or unclear claims can lead to increased licensing and litigation costs.
Sources
- US5910319A - Fluoxetine enteric pellets and methods for their preparation and use - Google Patents
- The value of a patent - Perpetual Motion Patents
- Patent Claims and Patent Scope - Hoover Institution
