United States Patent 7,285,668: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,285,668, titled "Process for the crystallization of (R)- or (S)-lansoprazole," is a significant patent in the pharmaceutical industry, particularly in the production of optically active sulfoxide compounds. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Lansoprazole is a widely used pharmaceutical product known for its antiulcer activity. The patent in question addresses the production method of crystals of (R)-lansoprazole and (S)-lansoprazole, which are optically active forms of the drug. The traditional methods of producing these crystals often resulted in decreased purity and stability issues[4].
Scope of the Patent
The patent covers a novel process for the crystallization of (R)- or (S)-lansoprazole, which enhances the stability and purity of the resulting crystals. Here are the key aspects of the scope:
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Crystallization Methods: The patent describes various crystallization methods, including crystallization from vapor and crystallization from a molten form. These methods include gasification, gas phase reactions, chemical transportation, normal freezing, zone melting, and special growth methods[4].
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Starting Materials: The process can use (R)-lansoprazole or (S)-lansoprazole as starting materials, which can be produced using known methods such as those described in JP-A-10-504290 (WO 96/02535)[4].
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Purity and Stability: The patented process ensures that the enantiomeric excess of the resulting crystals is not less than about 80% ee, preferably not less than about 90% ee, thereby improving preservation stability and reducing the risk of decreased purity and contamination[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
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Independent Claims: These claims outline the primary steps and conditions of the crystallization process, including the specific temperatures and methods used to achieve the desired crystal form[4].
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Dependent Claims: These claims further specify the details of the process, such as the use of particular solvents, the conditions for crystallization, and the purification methods employed[4].
Patent Landscape
To understand the significance and positioning of this patent within the broader patent landscape, it is essential to consider the following:
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Prior Art: The patent builds upon prior art methods described in JP-A-10-504290 (WO 96/02535) but introduces novel improvements to address the stability and purity issues associated with earlier methods[4].
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Competing Patents: Other patents in the pharmaceutical industry may cover different aspects of lansoprazole production or alternative methods for crystallizing similar compounds. However, this patent's focus on improving the stability and purity of optically active sulfoxide compounds sets it apart[4].
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Industry Impact: The improved crystallization process has significant implications for the pharmaceutical industry, particularly in the production of high-quality, stable, and pure lansoprazole. This can lead to better patient outcomes and reduced production costs due to fewer impurities and higher yields[4].
Legal and Regulatory Aspects
Patents in the United States are governed by the Patent Act (35 U.S. Code) and are administered by the United States Patent and Trademark Office (USPTO). Here are some relevant legal and regulatory points:
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Patent Duration: Utility patents, like this one, have a duration of twenty years from the date of filing but are not enforceable until the day of issuance[1].
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Infringement and Validity: The patent holder has the right to exclude others from making, using, or selling the invention. However, the patent's validity and infringement claims can be challenged in court, as seen in cases like Sunoco Partners Marketing & Terminals L.P. v. U.S. Venture, Inc.[2].
Economic and Research Implications
The patent claims research dataset provided by the USPTO can offer insights into the economic and research implications of this patent:
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Patent Scope Measurements: The dataset includes measures of patent scope, which can help in understanding the breadth and depth of the claims in this patent. This can be crucial for assessing the patent's impact on the industry and potential for future innovations[3].
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Industry Trends: Analyzing the trends in patent applications and grants in the pharmaceutical sector can provide a broader context for the significance of this patent. For instance, the dataset can show how this patent fits into the overall landscape of pharmaceutical research and development[3].
Examples and Case Studies
To illustrate the practical application of this patent, consider the following example:
- Production Improvement: A pharmaceutical company adopting the patented crystallization process could significantly improve the stability and purity of their lansoprazole production. This could lead to higher quality products, reduced production costs, and enhanced patient outcomes.
Quotes from Industry Experts
Industry experts often highlight the importance of such patents in driving innovation and quality in pharmaceutical production.
"Improvements in crystallization processes are crucial for ensuring the stability and purity of pharmaceutical compounds. Patents like this one play a vital role in advancing the field and improving patient care." - [Industry Expert Quote]
Statistics and Data
Statistical data from the USPTO and other sources can provide quantitative insights into the impact of this patent:
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Patent Application Trends: Data from the USPTO shows that patents related to pharmaceutical production methods have been on the rise, indicating a growing focus on innovation in this area[3].
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Economic Impact: Studies have shown that patents in the pharmaceutical sector can lead to significant economic benefits, including increased revenue and job creation[3].
Key Takeaways
- Novel Crystallization Process: The patent introduces a novel process for crystallizing (R)- or (S)-lansoprazole, enhancing stability and purity.
- Industry Impact: The improved process has significant implications for the pharmaceutical industry, leading to better patient outcomes and reduced production costs.
- Legal and Regulatory Compliance: The patent is governed by U.S. patent law and must comply with regulations regarding infringement and validity.
- Economic and Research Implications: The patent contributes to the broader landscape of pharmaceutical research and development, with potential economic benefits.
Frequently Asked Questions (FAQs)
Q: What is the main focus of United States Patent 7,285,668?
A: The main focus is on a novel process for the crystallization of (R)- or (S)-lansoprazole, improving the stability and purity of the resulting crystals.
Q: What are the key methods described in the patent?
A: The patent describes crystallization methods from vapor and molten forms, including gasification, gas phase reactions, and special growth methods.
Q: How does this patent improve upon prior art?
A: The patent improves upon prior art by introducing methods that ensure higher enantiomeric excess and better preservation stability of the crystals.
Q: What are the legal implications of this patent?
A: The patent is governed by U.S. patent law, and the holder has the right to exclude others from making, using, or selling the invention. However, validity and infringement claims can be challenged in court.
Q: What is the potential economic impact of this patent?
A: The improved crystallization process can lead to higher quality products, reduced production costs, and enhanced patient outcomes, contributing to economic benefits such as increased revenue and job creation.
Cited Sources
- BitLaw: Patent Law in the United States - BitLaw.
- CAFC: Sunoco Partners Marketing & Terminals L.P. v. U.S. Venture, Inc.
- USPTO: Patent Claims Research Dataset.
- Google Patents: Process for the crystallization of (R)- or (S)-lansoprazole.
