United States Patent RE42376: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent RE42376, titled "Substituted 3-cyanoquinolines," is a reissue patent that covers a class of compounds with specific structural features. This patent is crucial in the pharmaceutical industry, particularly for drugs like Bosutinib, which is used in the treatment of certain cancers. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent RE42376 is a reissue of an earlier patent, indicating that it has undergone revisions or expansions to its original claims. This type of patent is often used to correct errors or broaden the scope of protection for the invention[1].
Scope of the Patent
The patent RE42376 covers compounds of a specific structural formula, known as substituted 3-cyanoquinolines. These compounds are defined by various substituents and functional groups attached to the quinoline core. The scope includes a range of variations in these substituents, making the patent broadly applicable to a class of chemically related compounds.
Structural Formula
The patent specifies the structural formula for these compounds, including definitions for various groups such as G1, G2, R1, R4, Z, n, and X. These definitions are critical in determining the exact compounds that fall under the patent's protection[1].
Claims of the Patent
The claims of the patent are the most important part, as they define the legal boundaries of what is protected. Here are some key aspects of the claims:
Claim Types
- Composition of Matter Claims: These claims cover the specific chemical compounds and their variations.
- Method of Use Claims: These claims may cover specific methods of using the compounds, such as in the treatment of diseases.
- Process Claims: These claims cover the methods of preparing the compounds.
Claim Specificity
The claims are detailed and specific, ensuring that only compounds with the exact structural features are protected. This specificity is crucial for distinguishing the patented compounds from others in the same class[1].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding these compounds.
Related Patents
Other patents, such as US 7,417,148 and US 7,767,678, are related to the same class of compounds and are often involved in litigation and generic drug approvals. These patents also cover aspects of Bosutinib, a drug used in cancer treatment, and are subject to challenges from generic drug manufacturers[2].
Litigation and Challenges
The patent RE42376 and related patents have been involved in several legal battles, particularly with generic drug manufacturers seeking to market their own versions of Bosutinib before the patent expiration. These challenges often involve allegations of patent invalidity, unenforceability, or non-infringement[2].
Patent Analytics
To manage and analyze the complex patent landscape, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities. This is particularly useful for large portfolios where tracking individual patents and claims can be cumbersome[3].
Industrial Significance
The industrial significance of this patent lies in its protection of key pharmaceutical compounds.
Bosutinib Production
Bosutinib, a tyrosine kinase inhibitor, is a prime example of a drug protected under this patent. The production process of Bosutinib involves several intermediates and steps that are also covered by related patents. Improvements in the production process, such as those described in WO 2015/198249 A1, are crucial for maintaining industrial viability and environmental sustainability[4].
Generic Drug Approvals
Generic drug manufacturers often challenge these patents to gain approval for their own versions of the drug. The FDA's approval process for generic drugs involves a detailed analysis of the patent landscape to ensure that the generic version does not infringe on existing patents[2].
Strategic Implications
For companies involved in the development and manufacture of these compounds, understanding the scope and claims of this patent is vital.
Claim Coverage Matrix
Using a Claim Coverage Matrix can help companies identify which patents and claims are actively protecting their intellectual property. This tool categorizes patents by claims and scope concepts, making it easier to spot gaps in coverage and identify future design opportunities[3].
Collaborations and Licensing
Companies may need to collaborate or enter into licensing agreements to avoid infringement. This is particularly important in the pharmaceutical industry where the development of new drugs often builds upon existing patented compounds.
Key Takeaways
- Broad Scope: The patent RE42376 covers a wide range of substituted 3-cyanoquinolines, making it a significant player in the pharmaceutical patent landscape.
- Specific Claims: The claims are detailed and specific, ensuring strong protection for the patented compounds.
- Litigation and Challenges: The patent is often involved in legal battles with generic drug manufacturers.
- Industrial Significance: It protects key compounds like Bosutinib and influences the production processes and generic drug approvals.
- Strategic Importance: Understanding the patent's scope and claims is crucial for strategic decisions in research, development, and licensing.
FAQs
What is the main compound protected under the United States Patent RE42376?
The main compound protected is a class of substituted 3-cyanoquinolines, which includes variations defined by specific structural features.
How does this patent impact the production of Bosutinib?
This patent protects the production process and intermediates involved in making Bosutinib, ensuring that any generic versions must comply with these protections.
What tools are used to analyze the patent landscape for this patent?
Companies use patent analytics tools, such as Claim Coverage Matrix and Claim Charts, to analyze and manage the complex patent landscape.
Why is this patent often involved in litigation?
The patent is often challenged by generic drug manufacturers seeking to market their own versions of protected drugs before the patent expires.
How do companies ensure they do not infringe on this patent?
Companies use patent analytics, collaborate with other firms, or enter into licensing agreements to avoid infringement and ensure compliance with the patent's claims.
Sources
- USRE42376E1 - Substituted 3-cyanoquinolines - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXcorp
- Patent Analytics - SLWIP
- WO 2015/198249 A1 - Google APIs Storage
