United States Patent 7,612,208: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 7,612,208, titled "Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same," is a significant patent in the pharmaceutical sector. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a crystalline form of a specific salt of a carboxamide compound, which is particularly useful as an angiogenesis inhibitor or c-Kit kinase inhibitor. The crystalline form and its solvate exhibit excellent physical properties, such as dissolution rate, and pharmacokinetics, including bioavailability[4][5].
Publication and Legal Status
The patent was published on October 27, 2009, and is currently active, with an expiration date based on the patent term from its filing date. The legal status indicates it is active, but this is subject to change based on maintenance fees and other legal considerations[4].
Claims Analysis
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 specific limitations.
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Independent Claims: These claims define the crystalline form of the salt and its solvate, as well as the process for preparing these forms. For example, Claim 1 might describe the crystalline form of the salt, while Claim 2 describes the solvate of the salt[4].
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Dependent Claims: These claims build upon the independent claims by adding specific details such as the physical properties (e.g., dissolution rate) and pharmacokinetic characteristics (e.g., bioavailability)[4].
Claim Scope and Breadth
The scope of the claims is crucial in determining the patent's breadth and its impact on the market. Narrower claims, as validated by research, are often associated with a higher probability of grant and a shorter examination process. In this case, the claims are specific to the crystalline form and its solvate, indicating a focused scope that avoids overly broad claims[3].
Patent Scope Metrics
Independent Claim Length and Count
Studies have shown that metrics such as independent claim length and count can be used to measure patent scope. For US 7,612,208, the independent claims are detailed but not excessively broad, suggesting a balanced scope that is neither too narrow nor too wide. This balance is important for maintaining the incentives for innovation while avoiding unnecessary litigation costs[3].
Patent Examination Process
Narrowing of Claims
During the patent examination process, the scope of patent claims often narrows. This is evident in the final granted claims of US 7,612,208, which are specific and well-defined. The examination process ensures that the claims are clear, valid, and not overly broad, which is crucial for maintaining patent quality[3].
Patent Landscape
Competitive Environment
The patent landscape for pharmaceuticals, particularly in the area of kinase inhibitors and angiogenesis inhibitors, is highly competitive. Patents like US 7,612,208 play a significant role in this landscape by protecting specific compounds and their formulations. This protection allows the patent holder to maintain market exclusivity and recoup investment in research and development.
Litigation and Settlements
In the pharmaceutical industry, patent litigation and settlements are common. For example, cases like those involving ANDA (Abbreviated New Drug Application) litigation often result in settlements that allow generic manufacturers to enter the market under specific conditions. While US 7,612,208 is not directly mentioned in recent ANDA litigation settlements, its protection could influence future generic entries into the market[2].
Maintenance and Expiration
Maintenance Fees
To keep the patent active, the patent holder must pay maintenance fees at 3.5, 7.5, and 11.5 years after the grant date. Failure to pay these fees can result in the patent expiring, as seen in other cases where patents have lapsed due to non-payment of maintenance fees[1].
Expiration Date
The patent will expire based on the patent term from its filing date, typically 20 years from the earliest filing date of the application. This expiration date is crucial for planning future market strategies, including the potential entry of generic competitors.
Key Takeaways
- Specific Claims: The patent has specific claims that define the crystalline form and its solvate, ensuring a balanced scope.
- Pharmaceutical Significance: The invention is significant in the pharmaceutical sector, particularly for angiogenesis and c-Kit kinase inhibition.
- Patent Landscape: The patent is part of a competitive landscape where patent protection is crucial for market exclusivity.
- Maintenance and Expiration: Regular maintenance fees are necessary to keep the patent active, and the expiration date will impact future market dynamics.
Frequently Asked Questions (FAQs)
1. What is the main subject of United States Patent 7,612,208?
The main subject is the crystalline form of a specific salt of a carboxamide compound and its solvate, useful as an angiogenesis inhibitor or c-Kit kinase inhibitor.
2. How are the claims structured in this patent?
The claims include independent claims that broadly define the invention and dependent claims that add specific limitations, such as physical properties and pharmacokinetic characteristics.
3. What metrics can be used to measure the scope of patent claims?
Metrics such as independent claim length and count can be used to measure patent scope, indicating the breadth and clarity of the claims.
4. Why is the patent examination process important for patent scope?
The examination process ensures that the claims are narrowed to be clear, valid, and not overly broad, maintaining patent quality and avoiding unnecessary litigation.
5. What happens if the maintenance fees for this patent are not paid?
If the maintenance fees are not paid, the patent will expire at the end of the 4th, 8th, or 12th anniversary of the grant date, depending on the first maintenance fee that was not paid.
Cited Sources:
- USPTO, Patent and Trademark Office Notices, USPTO
- Robins Kaplan LLP, ANDA Litigation Settlements, Robins Kaplan LLP
- SSRN, Patent Claims and Patent Scope, SSRN
- Google Patents, US7612208B2, Google Patents
- PubChem, Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt, PubChem
