United States Patent 5,912,226: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,912,226, hereafter referred to as the '226 patent, is a significant patent in the field of antibiotics, particularly focusing on the identification, isolation, and use of daptomycin. This patent, originally filed and later reissued as RE39,071, has been a cornerstone in the intellectual property portfolio of Cubist Pharmaceuticals, Inc. (now part of Merck & Co.).
Background and History
The '226 patent was initially granted and later reissued as RE39,071, which is a reissue of the original patent. This reissue process is often used to correct errors or to broaden the scope of the original claims. The patent's history involves several legal and technical challenges, including disputes over its validity and scope[1].
Scope and Claims
Identification and Isolation of Daptomycin
The '226 patent describes the identification and isolation of daptomycin, a naturally occurring antibiotic produced by the fermentation of Streptomyces roseosporus. The patent details the methods for isolating and purifying daptomycin, as well as its use in treating bacterial infections[2].
Antibiotic Compounds, Compositions, and Formulations
The patent encompasses a broad range of claims related to antibiotic compounds, compositions, and formulations. It includes descriptions of the chemical structure of daptomycin and its derivatives, as well as methods for preparing these compounds. The claims also cover various formulations of daptomycin, including those suitable for clinical use[1].
Methods of Treating Bacterial Infections
A key aspect of the '226 patent is its focus on methods for treating bacterial infections using daptomycin. The patent describes the efficacy of daptomycin against a variety of bacterial strains and provides guidance on dosage regimens and administration methods[1].
Patent Landscape
Related Patents
The '226 patent is part of a larger family of patents related to daptomycin. Other patents in this family include U.S. Patent Nos. 6,852,689 and 6,468,967, which focus on dosage regimens for administering daptomycin, and U.S. Patent Nos. 8,058,238 and 8,129,342, which deal with high-purity lipopeptides[1].
Legal Challenges and Validity
The '226 patent has faced several legal challenges, particularly regarding its validity. In the case of Cubist Pharmaceuticals, Inc. v. Hospira, Inc., the court upheld the validity of the '071 patent (the reissue of the '226 patent) against claims of invalidity due to lack of an adequate written description. The court determined that the specification provided sufficient identifying characteristics to distinguish daptomycin from other compounds, despite errors in the structural diagram[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by the '226 patent and its related patents, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Interactive Claim Charts
Using tools like ClaimScape® software, interactive claim charts can be generated to review patent coverage with technical experts. These charts help determine whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking and identifying future design opportunities[3].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several resources for searching and analyzing patents. The Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) are invaluable for conducting thorough patent searches and analyzing the patent landscape related to the '226 patent[4].
International Patent Offices
For a global perspective, databases from international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) can be used to see if similar patents have been filed or granted abroad[4].
Key Takeaways
- Broad Scope of Claims: The '226 patent covers a wide range of aspects related to daptomycin, including its identification, isolation, formulations, and methods of use.
- Legal Validity: The patent has been upheld in court against challenges related to its written description and validity.
- Related Patents: It is part of a larger family of patents that collectively protect various aspects of daptomycin.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for understanding and managing the patent landscape.
- Global Search: Utilizing international patent databases is crucial for a comprehensive analysis of the global patent landscape.
FAQs
What is the main subject of United States Patent 5,912,226?
The main subject of the '226 patent is the identification, isolation, and use of daptomycin, a naturally occurring antibiotic.
How has the validity of the '226 patent been challenged?
The validity of the '226 patent has been challenged on grounds of lack of an adequate written description, but it was upheld in court.
What other patents are related to the '226 patent?
Other related patents include U.S. Patent Nos. 6,852,689, 6,468,967, 8,058,238, and 8,129,342, which cover dosage regimens and high-purity lipopeptides.
What tools can be used to analyze the patent landscape of the '226 patent?
Tools such as Claim Coverage Matrix, interactive claim charts, and resources from the USPTO and international patent offices can be used.
Why is it important to conduct a global patent search for the '226 patent?
Conducting a global patent search helps in understanding if similar patents have been filed or granted in other countries, which is crucial for international intellectual property protection.
Sources
- United States Court of Appeals for the Federal Circuit - CUBIST PHARMACEUTICALS, INC. v. HOSPIRA, INC.[1]
- Google Patents - Methods for preparing ... WO2002059145A1[2]
- Schwegman, Lundberg & Woessner, P.A. - Patent Analytics[3]
- United States Patent and Trademark Office - Search for patents[4]
