Analyzing the Scope and Claims of United States Patent 6,162,802: A Comprehensive Guide
Introduction
Understanding the scope and claims of a patent is crucial for navigating the complex landscape of intellectual property. This article will delve into the specifics of United States Patent 6,162,802, exploring its claims, scope, and the broader patent landscape it inhabits.
Background of the Patent
United States Patent 6,162,802, titled "Pharmaceutical Compositions of Amlodipine and Benazepril," was granted to Novartis Pharmaceuticals Corporation. This patent pertains to a combination of two active pharmaceutical ingredients: amlodipine, a calcium channel blocker, and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. These drugs are commonly used together to treat hypertension and other cardiovascular conditions.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key aspects:
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Claim 1: This claim describes a pharmaceutical composition comprising a combination of amlodipine and benazepril in specific ratios, along with excipients and other formulation components. It specifies the therapeutic use of this combination for treating hypertension and other cardiovascular diseases[5].
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Claim 2: This claim details the method of manufacturing the pharmaceutical composition, including the steps involved in mixing, granulating, and compressing the active ingredients and excipients into a tablet form.
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Claim 3: This claim covers the use of the pharmaceutical composition for the treatment of specific medical conditions, such as hypertension, angina, and heart failure.
Dependent Claims
Dependent claims further narrow down the scope of the independent claims by adding additional limitations or specifications. For example:
- Claim 4: This claim specifies the dosage forms of the pharmaceutical composition, such as tablets or capsules.
- Claim 5: This claim details the specific ratios of amlodipine to benazepril in the composition.
Scope of the Patent
The scope of the patent is defined by the claims and the description provided in the patent specification. Here are some key points:
Therapeutic Use
The patent covers the use of the combination of amlodipine and benazepril for treating various cardiovascular conditions. This includes hypertension, angina, and heart failure, among others.
Formulation
The patent describes specific formulations of the combination, including the ratios of the active ingredients and the types of excipients used. This ensures that the patented composition has a unique profile that distinguishes it from other similar products.
Manufacturing Process
The patent also covers the method of manufacturing the pharmaceutical composition, which includes detailed steps for mixing, granulating, and compressing the ingredients into a final dosage form.
Patent Landscape
Related Patents
To understand the broader patent landscape, it is essential to identify related patents and patent families. Tools like the USPTO's Patent Public Search and the Global Dossier can be used to find related applications and patents filed in other jurisdictions[1].
Competitor Patents
Competitors in the pharmaceutical industry may have filed similar patents or have pending applications that could impact the scope of this patent. Analyzing these patents using patent analytics tools can help identify gaps and opportunities in the intellectual property portfolio[3].
Expiration and Generic Challenges
The patent's expiration date is critical for understanding when generic versions of the drug can be introduced. For U.S. Patent 6,162,802, the expiration date would have allowed generic manufacturers to seek approval after the patent's term ended. For instance, Teva Pharmaceutical Industries Ltd. announced tentative approval for a generic version of a similar combination product upon the expiry of a related patent[5].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
Using a Claim Coverage Matrix, as described by patent analytics services, can help in understanding which patents and claims are actively protecting the intellectual property related to this combination drug. This matrix categorizes patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities[3].
Interactive Claim Charts
Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage is lacking[3].
Legal and Regulatory Considerations
Opposition and Appeals
Patents can face opposition and appeals, as seen in the case of European patent disputes. Understanding the legal and regulatory framework is crucial for navigating these challenges. For example, the European Patent Office's opposition division and appeal processes can significantly impact the validity and scope of a patent[2].
Global Patent System
The global patent system, facilitated by tools like the Global Dossier, allows for the integration of patent information across different jurisdictions. This helps in managing the patent family and understanding the broader international landscape[1].
Key Takeaways
- Claims and Scope: The patent's claims define the specific combination of amlodipine and benazepril, the formulation, and the therapeutic use.
- Patent Landscape: Understanding related patents, competitor patents, and the expiration dates is crucial for strategic planning.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing and analyzing the patent portfolio.
- Legal and Regulatory: Navigating oppositions, appeals, and the global patent system is vital for maintaining and enforcing patent rights.
FAQs
Q: What is the primary use of the combination drug described in U.S. Patent 6,162,802?
A: The primary use is for treating hypertension and other cardiovascular conditions.
Q: How can one identify related patents and patent families?
A: Using tools like the USPTO's Patent Public Search and the Global Dossier can help in identifying related patents and patent families.
Q: What is the significance of a Claim Coverage Matrix in patent analytics?
A: A Claim Coverage Matrix helps in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities.
Q: How do interactive claim charts assist in patent analysis?
A: Interactive claim charts help technical experts determine whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage is lacking.
Q: What happens when a patent expires?
A: When a patent expires, generic manufacturers can seek approval to produce and market generic versions of the drug.
Sources
- USPTO: "Search for patents - USPTO"
- EPO: "BESCHWERDEKAMMERN DES EUROPÄISCHEN PATENTAMTS"
- SLWIP: "Patent Analytics | Intellectual Property Law"
- NCSES: "Invention: U.S. and Comparative Global Trends"
- Teva Pharmaceutical Industries Ltd.: "Teva Announces Tentative Approval of Generic Lotrel"
