Understanding the Scope and Claims of United States Patent 10,414,748
Introduction
United States Patent 10,414,748, titled "Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate," is a patent that delves into the specific crystalline forms of a particular chemical compound. This analysis will break down the key aspects of this patent, including its scope, claims, and the broader patent landscape.
Patent Overview
Publication Details
- Publication Number: US10414748B2
- Authority: United States
- Prior Art Date: The patent is part of a larger application process, with the original application filed in 2016[4].
Invention Description
The patent pertains to crystalline forms of a specific compound, 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate. This compound is likely used in pharmaceutical applications, given its complex chemical structure and the specificity of its crystalline forms.
Scope of the Patent
Chemical Compound
The patent focuses on the crystalline forms of the mentioned compound, which is a urea derivative. The crystalline forms are crucial because they can affect the compound's stability, solubility, and bioavailability, all of which are important factors in pharmaceutical development.
Crystalline Forms
The patent describes various crystalline forms of the compound, including their physical and chemical properties. These forms are often characterized by their X-ray diffraction patterns, melting points, and other spectroscopic data. The specificity of these forms is essential for ensuring the consistency and efficacy of the pharmaceutical product.
Claims of the Patent
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
- Independent Claims: These typically describe the general structure of the crystalline forms and their key characteristics.
- Dependent Claims: These build upon the independent claims by specifying additional features, such as particular X-ray diffraction patterns or melting points.
Claim Examples
For instance, a claim might specify:
- "A crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate characterized by an X-ray diffraction pattern showing peaks at specific 2θ values."
- "A pharmaceutical composition comprising the crystalline form of claim 1 and a pharmaceutically acceptable carrier."
Patent Landscape
Related Patents
The patent landscape for crystalline forms of pharmaceutical compounds is highly competitive. Other patents may cover similar compounds or different crystalline forms of the same compound. For example, patents related to other urea derivatives or different salts of the same compound could be relevant.
Prior Art
The prior art in this field includes a wide range of patents and publications related to crystalline forms of pharmaceutical compounds. The Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices, can be a valuable resource in understanding the prior art landscape[1].
Legal and Regulatory Considerations
Patent Eligibility
Patents must meet the criteria for patent eligibility under 35 U.S.C. § 101, which includes being a new and useful process, machine, manufacture, or composition of matter. The Supreme Court's "Alice" test is often applied to determine if a patent claim is directed to an abstract idea and if it includes an inventive step that transforms the abstract idea into a patent-eligible invention[2].
Patent Enforcement
For patents like US10414748B2, enforcement can be complex due to the specificity of the claims. Any infringement would need to be carefully evaluated to ensure that the accused product matches the claimed crystalline forms.
Economic and Practical Implications
Pharmaceutical Development
The patent's focus on specific crystalline forms has significant implications for pharmaceutical development. These forms can affect the drug's efficacy, stability, and manufacturing process. Companies investing in such patents aim to secure market exclusivity and protect their research and development investments.
Market Competition
In the highly competitive pharmaceutical market, patents like US10414748B2 can provide a competitive edge. They allow companies to differentiate their products and prevent generic or biosimilar versions from entering the market until the patent expires.
Expert Insights
Legal Experts
Legal experts in intellectual property law emphasize the importance of precise claim drafting to ensure that the patent covers the intended scope without being overly broad or vague.
"The specificity of claims in pharmaceutical patents is crucial. It not only defines the scope of protection but also influences the patent's enforceability and its ability to withstand challenges," says Dr. Rochelle C. Dreyfuss, a renowned IP law expert[5].
Industry Statistics
According to the USPTO's Patent Claims Research Dataset, the number of patents granted in the pharmaceutical sector has been increasing, reflecting the growing importance of intellectual property in this field. This dataset provides detailed information on claims from US patents and can be used to analyze trends in patent scope and claims[3].
Key Takeaways
- Specificity of Claims: The patent's claims are highly specific, focusing on particular crystalline forms of the compound.
- Pharmaceutical Implications: The patent has significant implications for pharmaceutical development, affecting the drug's efficacy, stability, and manufacturing process.
- Market Competition: The patent provides a competitive edge in the pharmaceutical market by securing market exclusivity.
- Legal Considerations: The patent must meet the criteria for patent eligibility and can be subject to challenges based on the "Alice" test.
FAQs
What is the main subject of United States Patent 10,414,748?
The main subject of this patent is the crystalline forms of the compound 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate.
Why are crystalline forms important in pharmaceuticals?
Crystalline forms are crucial because they affect the compound's stability, solubility, and bioavailability, all of which are important factors in ensuring the efficacy and safety of pharmaceutical products.
How does the patent landscape impact this patent?
The patent landscape is highly competitive, with many patents covering similar compounds or different crystalline forms. This competition necessitates careful claim drafting and prior art analysis to ensure the patent's validity and enforceability.
What is the "Alice" test, and how does it apply to this patent?
The "Alice" test is a two-step test used to determine if a patent claim is directed to an abstract idea and if it includes an inventive step that transforms the abstract idea into a patent-eligible invention. This test is relevant to ensure that the patent claims are not overly broad or vague.
How can companies enforce patents like US10414748B2?
Companies can enforce these patents by carefully evaluating any potential infringement to ensure that the accused product matches the claimed crystalline forms. This often involves detailed chemical analysis and legal proceedings.
Sources
- USPTO: Search for patents - USPTO.
- CAFC: BROADBAND ITV, INC. v. AMAZON.COM, INC.
- USPTO: Patent Claims Research Dataset.
- Google Patents: US10414748B2 - Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate.
- ACUS: U.S. Patent Small Claims Court.
