United States Patent 4,943,569: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,943,569, titled "B-lactam compounds," is a significant patent in the pharmaceutical industry, particularly in the development of antibacterial agents. This patent, issued to the inventors who conducted extensive research on carbapenem and penem derivatives, is crucial for understanding the synthesis, properties, and applications of these compounds.
Background and Inventors
The patent was granted to inventors who had conducted intensive investigations on the syntheses of carbapenem and penem derivatives. These compounds are part of the broader class of β-lactam antibiotics, which are vital in treating bacterial infections[1].
Scope of the Patent
Chemical Compounds
The patent covers a range of β-lactam compounds, specifically carbapenem and penem derivatives. These compounds are characterized by their unique chemical structures, which include various substituents such as alkyl, alkenyl, and hydroxy groups. The patent describes the synthesis methods and the chemical properties of these compounds in detail[1].
Synthesis Methods
The inventors outlined several methods for synthesizing these β-lactam compounds. These methods involve various chemical reactions and the use of protecting groups to ensure the stability and purity of the final products. The patent provides a comprehensive description of the synthesis procedures, including the reagents and conditions required[1].
Pharmaceutical Applications
The primary application of these β-lactam compounds is in the treatment of bacterial infections. The patent highlights the antibacterial properties of these compounds and their potential use in human drug products. One notable example is MERREM I.V., a carbapenem antibiotic that was developed based on this patent[2].
Claims of the Patent
Chemical Structure Claims
The patent includes claims that describe the specific chemical structures of the β-lactam compounds. These claims detail the types of substituents, the configuration of the β-lactam ring, and other structural features that define these compounds[1].
Synthesis Claims
The patent also claims the methods of synthesizing these compounds. These claims cover the various steps involved in the synthesis, including the use of specific reagents and reaction conditions[1].
Pharmaceutical Claims
Claims related to the pharmaceutical applications of these compounds are also included. These claims cover the use of these compounds as antibacterial agents and their formulation into drug products[1].
Patent Landscape
Regulatory Review and Approval
The patent underwent a significant regulatory review process before the approval of the drug product MERREM I.V. The FDA verified the dates of the investigational new drug application, the new drug application submission, and the approval date, which were crucial for determining the patent term extension[2].
Patent Term Extension
Due to the lengthy regulatory review period, the patent was eligible for a term extension. The FDA determined that the regulatory review period consisted of 2,608 days, with 1,640 days in the testing phase and 968 days in the approval phase. This led to a patent term extension application seeking 1,063 days[2].
Intellectual Property Protection
The patent is part of a broader intellectual property strategy that involves protecting the synthesis methods, chemical structures, and pharmaceutical applications of the β-lactam compounds. This protection is essential for maintaining the competitive edge of the inventors and the companies involved in developing these drugs[3].
Impact on the Pharmaceutical Industry
Development of Antibacterial Agents
The patent has significantly contributed to the development of new antibacterial agents. The carbapenem and penem derivatives covered by this patent have been used to create effective treatments for various bacterial infections, addressing a critical need in public health[1].
Research and Innovation
The detailed synthesis methods and chemical properties described in the patent have facilitated further research and innovation in the field of antibacterial drug development. This has led to the creation of new drugs and the improvement of existing ones[1].
Analyzing Patent Claims and Scope Concepts
Claim Coverage Matrix
To fully understand the scope of this patent, a Claim Coverage Matrix can be used. This tool categorizes the patents and claims by scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Interactive Claim Charts
Interactive claim charts generated by tools like ClaimScape® can be used to review the patent coverage with engineers, scientists, and management. 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 and identifying future design opportunities[3].
International Patent Landscape
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application. This service is useful for understanding the international patent landscape and identifying potential gaps or opportunities in global patent protection[4].
Searchable Databases
Searchable databases from international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can be used to determine if similar patents exist abroad. This is crucial for ensuring global protection of the intellectual property[4].
Key Takeaways
- Chemical Compounds: The patent covers carbapenem and penem derivatives with specific chemical structures and substituents.
- Synthesis Methods: Detailed methods for synthesizing these compounds are described, including the use of protecting groups.
- Pharmaceutical Applications: The compounds are used as antibacterial agents, with MERREM I.V. being a notable example.
- Regulatory Review: The patent underwent extensive regulatory review, leading to a patent term extension.
- Intellectual Property Protection: The patent is part of a broader strategy to protect synthesis methods, chemical structures, and pharmaceutical applications.
- Impact on Industry: The patent has significantly contributed to the development of new antibacterial agents and facilitated further research and innovation.
FAQs
What are the main chemical compounds covered by this patent?
The main chemical compounds covered by this patent are carbapenem and penem derivatives, which are types of β-lactam antibiotics.
How were these compounds synthesized?
The patent describes several synthesis methods involving various chemical reactions and the use of protecting groups to ensure the stability and purity of the final products.
What is the pharmaceutical application of these compounds?
These compounds are used as antibacterial agents, with MERREM I.V. being a notable example of a drug product developed based on this patent.
Why was the patent term extended?
The patent term was extended due to the lengthy regulatory review period, which included 2,608 days of testing and approval phases.
How can the scope of this patent be analyzed?
The scope of this patent can be analyzed using tools like a Claim Coverage Matrix and interactive claim charts to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist.
