Understanding the Scope and Claims of United States Patent 8,426,389
Introduction
United States Patent 8,426,389, titled "Crystalline form of (R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate," is a patent that covers a specific crystalline form of a pharmaceutical compound. This article will delve into the details of the patent's scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, granted on April 23, 2013, pertains to a crystalline form of a compound used in pharmaceutical applications. This compound is a dihydrogen phosphate salt of an oxazolidinone derivative, which is a class of antibiotics known for their effectiveness against resistant bacteria[1].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- The primary independent claim describes the crystalline form of the specified compound, including its chemical structure and physical properties.
- Other independent claims cover various aspects such as the process for preparing the crystalline form, pharmaceutical compositions containing the compound, and methods for treating bacterial infections using this compound[1].
Dependent Claims
- Dependent claims further specify the independent claims by detailing particular characteristics, such as the particle size of the crystalline form, the method of synthesis, and the use of specific excipients in pharmaceutical formulations[1].
Patent Scope
The scope of the patent is crucial in understanding what is protected and what is not.
Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth of a patent. For US Patent 8,426,389, the independent claims are relatively detailed, indicating a narrower scope focused on the specific crystalline form and its applications. This narrow scope can be beneficial in terms of clarity and validity, as broader claims might face challenges during the examination process[3].
Patent Maintenance and Forward Citations
The maintenance of the patent and the number of forward citations can also indicate its scope and impact. Patents with narrower claims at publication tend to have a higher probability of grant and shorter examination processes. Forward citations, which indicate how often the patent is cited by subsequent patents, can reflect the patent's influence and relevance in the field[3].
Patent Landscape
Understanding the broader patent landscape is essential for assessing the significance and competitive position of US Patent 8,426,389.
Related Patents and Applications
The patent is part of a larger family of patents related to oxazolidinone derivatives. Searching through databases like the USPTO's Patent Public Search or the Global Dossier can reveal related applications and patents, helping to map the intellectual property landscape in this field[4].
Competitors and Licensing
Identifying competitors and licensing agreements is crucial. For instance, if other companies have similar patents or are developing related compounds, it could impact the commercial viability of the patented compound. Licensing agreements can also affect how widely the technology is adopted[4].
Examination Process
The examination process for US Patent 8,426,389 would have involved a thorough review of the claims and prior art.
Narrowing of Claims
During the examination process, the scope of the patent claims may have been narrowed to ensure clarity and validity. This is a common practice, as broader claims are often subject to more scrutiny and may face rejection or require significant amendments[3].
Prior Art and Citations
The patent office would have considered prior art and citations to determine the novelty and non-obviousness of the invention. The Common Citation Document (CCD) application, which consolidates prior art cited by multiple offices, would be a useful tool in this process[4].
Practical Implications
For businesses and researchers, understanding the scope and claims of this patent is vital.
Manufacturing and Formulation
The patent provides detailed information on the crystalline form and its preparation, which is crucial for manufacturing and formulation processes. This ensures that any production adheres to the patented method, avoiding potential infringement issues[1].
Regulatory Compliance
Compliance with regulatory requirements is essential. The patent's focus on a specific crystalline form and its pharmaceutical applications means that any regulatory submissions must align with these specifications to ensure approval[1].
Key Takeaways
- Specific Crystalline Form: The patent protects a specific crystalline form of an oxazolidinone derivative.
- Narrow Scope: The claims are relatively narrow, focusing on the crystalline form, its preparation, and pharmaceutical applications.
- Examination Process: The patent likely underwent a rigorous examination process, with claims possibly narrowed to ensure clarity and validity.
- Regulatory Compliance: Adherence to the patented specifications is crucial for regulatory approval.
- Competitive Landscape: Understanding related patents and licensing agreements is vital for commercial strategy.
FAQs
Q: What is the main subject of US Patent 8,426,389?
A: The main subject is a crystalline form of the compound (R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate.
Q: How do independent claim length and count affect patent scope?
A: Independent claim length and count are metrics used to measure patent scope. Narrower claims (shorter length and fewer counts) tend to have a higher probability of grant and shorter examination processes.
Q: What tools can be used to search for related patents?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) application can be used to search for related patents and prior art.
Q: Why is regulatory compliance important for this patent?
A: Regulatory compliance is important because any pharmaceutical product must adhere to the specified crystalline form and preparation method to ensure regulatory approval.
Q: How does the patent landscape impact commercial strategy?
A: Understanding the patent landscape, including related patents and licensing agreements, is crucial for developing a commercial strategy that avoids infringement and maximizes market potential.
Sources
- US8426389B2 - Crystalline form of (R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate - Google Patents
- Patent Claims Research Dataset - USPTO
- Patent Claims and Patent Scope - Hoover Institution
- Search for patents - USPTO - USPTO
- BLUE GENTIAN, LLC v. TRISTAR PRODUCTS, INC - CAFC US Courts
