Understanding the Scope and Claims of United States Patent RE42461
Introduction
The United States Patent RE42461, titled "Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents," is a reissue patent that focuses on specific chemical compounds designed to lower cholesterol levels and inhibit the formation of cholesterol-containing lesions. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background of the Patent
The patent RE42461E1 involves hydroxy-substituted azetidinone compounds, which are chemically defined and have been identified as useful in reducing cholesterol levels. These compounds are part of a broader class of pharmaceuticals aimed at managing cardiovascular health by targeting cholesterol production and absorption[1].
Patent Scope
The scope of a patent is defined by its claims, which are the legally binding descriptions of the invention. Here are some key aspects of the scope of RE42461:
Claims
The patent includes multiple claims that specifically describe the hydroxy-substituted azetidinone compounds, their structures, and their uses. These claims are crucial as they define the boundaries of what is protected under the patent. For instance, the claims might specify the particular chemical structures, the methods of synthesizing these compounds, and their therapeutic applications[1].
Independent and Dependent Claims
The patent likely includes both independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims build upon the independent claims and provide additional details or limitations. The number and length of these claims can influence the patent's scope and its enforceability[3].
Claim Language and Patent Scope
The language used in the claims is critical in determining the patent's scope. Metrics such as independent claim length and count can provide insights into the breadth and clarity of the patent. Generally, narrower claims with clear language are associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for RE42461 would have involved a thorough review by the United States Patent and Trademark Office (USPTO) to ensure that the claims are clear, distinct, and supported by the specification. The process may have included revisions to narrow the scope of the claims to ensure they are not overly broad and to enhance their validity[3].
Therapeutic Applications
The patent's scope extends to the therapeutic applications of the hydroxy-substituted azetidinone compounds. These compounds are intended to act as hypocholesterolemic agents, meaning they are designed to lower cholesterol levels and prevent the formation of cholesterol-containing lesions. This makes them valuable in the treatment and prevention of cardiovascular diseases[1].
Chemical Structure and Synthesis
The patent details the specific chemical structures of the hydroxy-substituted azetidinone compounds and possibly the methods for their synthesis. This information is essential for understanding how these compounds can be produced and used in pharmaceutical applications[1].
Prior Art and Disclosure
The patent application would have included a discussion of prior art to distinguish the invention from existing knowledge. The specification must describe the invention completely, including any improvements over prior art, and explain the best mode of carrying out the invention[2].
Legal and Regulatory Aspects
Patents like RE42461 are subject to various legal and regulatory requirements. For instance, the patent holder must comply with regulations related to the disclosure of prior art and the listing of patents in databases such as the Orange Book, which is crucial for pharmaceutical patents[5].
Valuation and Market Impact
The value of a patent like RE42461 can be significant, especially in the pharmaceutical industry where patents can provide exclusive rights to market life-saving drugs. The valuation can be determined using methods such as the cost approach, income approach, or market approach. For example, the sale of patents can be a major factor in corporate transactions, as seen in deals like the Google-Motorola acquisition, where patents were a key asset[4].
Case Studies and Litigation
The patent landscape is often shaped by litigation and anticompetitive practices. For instance, the case involving Merck and its patents for Zetia highlights how patent strategies can impact market competition and lead to legal challenges. Similar issues could arise with RE42461 if its claims are contested or if there are allegations of anticompetitive conduct[5].
Key Takeaways
- Patent Scope: Defined by the claims, which specify the chemical structures, synthesis methods, and therapeutic applications.
- Claim Language: Critical in determining the breadth and clarity of the patent.
- Examination Process: Involves a thorough review by the USPTO to ensure clear and distinct claims.
- Therapeutic Applications: The compounds are designed to lower cholesterol levels and prevent cholesterol-containing lesions.
- Legal and Regulatory Aspects: Compliance with regulations such as prior art disclosure and Orange Book listing.
- Valuation and Market Impact: Significant value in the pharmaceutical industry, determined by cost, income, or market approaches.
FAQs
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What are hydroxy-substituted azetidinone compounds?
Hydroxy-substituted azetidinone compounds are chemical entities designed to lower cholesterol levels and inhibit the formation of cholesterol-containing lesions.
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How is the scope of a patent defined?
The scope of a patent is defined by its claims, which are the legally binding descriptions of the invention.
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What is the significance of claim language in a patent?
Claim language is critical in determining the breadth and clarity of the patent, influencing its enforceability and validity.
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How does the USPTO examine patent claims?
The USPTO examines patent claims to ensure they are clear, distinct, and supported by the specification, often requiring revisions to narrow the scope.
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Why are patents valuable in the pharmaceutical industry?
Patents in the pharmaceutical industry are valuable because they provide exclusive rights to market life-saving drugs, impacting market competition and corporate transactions.
Sources
- USRE42461E1 - Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents - Google Patents
- Applying for Patents - USPTO
- Patent Claims and Patent Scope - SSRN
- The value of a patent - Perpetual Motion Patents
- Humana v Merck complaint - CROWELL & MORING LLP
