United States Patent 6,727,283: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,727,283, titled "Sertraline oral concentrate," is a significant patent in the pharmaceutical industry, particularly in the field of psychiatric medications. This patent, issued to Pfizer, Inc., describes an essentially nonaqueous, liquid pharmaceutical concentrate composition for oral administration containing sertraline or its pharmaceutically acceptable salts.
Background of Sertraline
Sertraline, known by its chemical name (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine, is a widely used selective serotonin reuptake inhibitor (SSRI). It is primarily prescribed for treating various mental health conditions, including depression, anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder[1].
Scope of the Patent
The patent covers several key aspects:
Composition
The patent describes an oral concentrate composition that is essentially nonaqueous, containing sertraline or its pharmaceutically acceptable salts, along with one or more pharmaceutically acceptable excipients. The preferred excipients include ethanol and glycerin, which enhance the stability and palatability of the concentrate[1].
Preparation Method
The patent outlines a method for preparing the sertraline concentrate. This involves dissolving sertraline in a solvent system that includes ethanol and glycerin, ensuring the solution remains stable and homogeneous. The hydrochloride salt of sertraline is preferred due to its stability and ease of preparation[1].
Use and Administration
The concentrate is designed to be convenient for measuring different doses, which is crucial for various indications. It can be easily mixed with water or another aqueous solution to create a palatable and stable oral dosage form. This flexibility in dosing and administration makes the concentrate highly practical for clinical use[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Composition
The first claim describes the nonaqueous liquid pharmaceutical concentrate composition containing sertraline or its pharmaceutically acceptable salts and one or more excipients like ethanol and glycerin[1].
Claim 2: Method of Preparation
This claim covers the method of preparing the concentrate by dissolving sertraline in a solvent system and ensuring its stability and homogeneity[1].
Claim 3: Use of the Concentrate
The patent claims the use of this concentrate composition to prepare an aqueous solution of sertraline for oral administration. It also covers the treatment or prevention of various diseases or conditions using this concentrate[1].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights associated with this invention.
Related Patents
Other patents related to sertraline, such as U.S. Pat. No. 5,597,826, describe novel compositions containing SSRIs and their use in treating various mood and anxiety disorders. These patents highlight the broader therapeutic applications of sertraline and its formulations[1].
Global Patent System
The patent landscape extends beyond the U.S., with similar patents and applications filed in other countries. Tools like the Global Dossier and Common Citation Document (CCD) provided by the USPTO and other international intellectual property offices help in tracking and analyzing the global patent family for sertraline-related inventions[4].
Patent Analytics
Patent analytics tools, such as those offered by Schwegman, help in categorizing patents by claims and scope concepts. This allows for a comprehensive analysis of the patent landscape, identifying gaps and opportunities in the coverage of intellectual property related to sertraline formulations[3].
Advantages and Benefits
The sertraline oral concentrate offers several advantages:
Convenience and Dosing Flexibility
The concentrate provides convenience in measuring different doses, which is essential for various clinical indications. This flexibility ensures that patients receive the precise dosage required for their condition[1].
Stability and Palatability
The composition ensures good physical and chemical stability throughout the product's shelf-life and use interval. Additionally, the use of ethanol and glycerin improves the taste upon administration, making it more acceptable to patients[1].
Manufacturing Ease
The solution form of the concentrate is preferred over suspensions due to ease of manufacture and optimal control of dosing homogeneity. This simplifies the production process and ensures consistent quality[1].
Legal and Regulatory Considerations
Patents, including U.S. Patent 6,727,283, are subject to legal and regulatory scrutiny.
Claim Construction and Validity
The construction of claim terms is a critical legal issue. Courts often engage in detailed analyses to determine the validity and scope of patent claims, ensuring they are not indefinite or mutually exclusive[2].
International Harmonization
The global patent system is moving towards greater harmonization, with tools like the Global Dossier and CCD facilitating the integration of patent data across different jurisdictions. This harmonization helps in managing the complex landscape of international patent rights[4].
Key Takeaways
- Composition and Preparation: The patent describes a nonaqueous liquid pharmaceutical concentrate containing sertraline and excipients like ethanol and glycerin.
- Convenience and Stability: The concentrate offers flexibility in dosing and ensures good stability and palatability.
- Patent Landscape: The patent is part of a broader landscape of sertraline-related inventions, with global implications.
- Legal Considerations: Claim construction and validity are crucial for maintaining the patent's integrity.
- Regulatory Harmonization: International tools facilitate the management of global patent rights.
FAQs
Q: What is the main active ingredient in the sertraline oral concentrate?
A: The main active ingredient is sertraline, which may be present as its free base or as its pharmaceutically acceptable salts, such as the hydrochloride salt[1].
Q: What are the advantages of the sertraline oral concentrate over other formulations?
A: The concentrate offers convenience in measuring different doses, good physical and chemical stability, and improved taste upon administration[1].
Q: How is the sertraline oral concentrate prepared?
A: The concentrate is prepared by dissolving sertraline in a solvent system that includes ethanol and glycerin, ensuring the solution remains stable and homogeneous[1].
Q: What are the therapeutic applications of the sertraline oral concentrate?
A: The concentrate is used to treat or prevent various diseases or conditions, including mood disorders, anxiety disorders, and other psychiatric conditions[1].
Q: How does the global patent system impact the management of sertraline-related patents?
A: Tools like the Global Dossier and CCD help in tracking and analyzing the global patent family, facilitating greater integration of the global patent system[4].
Cited Sources
- US6727283B2 - Sertraline oral concentrate - Google Patents
- VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC. - CAFC
- Patent Analytics - Schwegman
- Search for patents - USPTO
