United States Patent 4,844,902: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,844,902, titled "Topically applicable formulations of gyrase inhibitors," is a significant patent in the field of pharmaceuticals, particularly in the treatment and prophylaxis of infections. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted on July 4, 1989, pertains to the development of topically applicable formulations of gyrase inhibitors. Gyrase inhibitors are a class of antibiotics that target bacterial DNA gyrase, an enzyme essential for bacterial DNA replication. The invention focuses on the treatment or prophylaxis of deep-lying or systemic infections through topical application of these inhibitors[2].
Scope of the Patent
The scope of the patent encompasses the formulation, composition, and method of use of gyrase inhibitors in a topical context. Here are the key aspects:
Formulation
The patent describes formulations that include gyrase inhibitors, typically in concentrations ranging from about 0.01 to 30% by weight. These formulations can be creams, ointments, gels, or other topical preparations designed to deliver the active ingredient effectively to the site of infection[2].
Composition
The compositions may include additional ingredients such as solvents, emollients, and preservatives to enhance stability and efficacy. The patent specifies the importance of selecting ingredients that do not interfere with the antimicrobial activity of the gyrase inhibitors[2].
Method of Use
The method of use involves applying the formulation topically to the affected area. This approach is particularly useful for treating infections that are accessible through the skin or mucous membranes, offering a targeted and potentially less invasive treatment option compared to systemic antibiotics[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: A topically applicable formulation comprising a gyrase inhibitor in a concentration effective to treat or prevent bacterial infections.
- Claim 2: The formulation of claim 1, wherein the gyrase inhibitor is selected from a group of specified compounds.
- Claim 3: The formulation of claim 1, further comprising a solvent and an emollient[2].
Dependent Claims
- Dependent claims elaborate on the specific concentrations of the gyrase inhibitors, the types of solvents and emollients used, and the methods of application.
Patent Landscape
Related Patents
The patent landscape around U.S. Patent 4,844,902 includes several related patents and applications:
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U.S. Patent Nos. 6,284,804 and 6,359,016: These patents also cover aspects of the composition, formulation, and method of use of gyrase inhibitors, often citing the original patent as prior art[4].
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International Patents: Similar formulations and methods are described in international patents, such as the Japanese patent JP2006518769A, which also claims stable ophthalmic compositions using gyrase inhibitors[5].
Global Dossier
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This service helps in understanding the global patent family and the status of related applications across different jurisdictions[1].
Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for visualizing the citation data related to U.S. Patent 4,844,902 and its international counterparts[1].
Impact on the Pharmaceutical Industry
The invention described in U.S. Patent 4,844,902 has had a significant impact on the pharmaceutical industry:
- Targeted Treatments: The development of topical formulations of gyrase inhibitors has provided healthcare professionals with targeted treatment options for bacterial infections, reducing the risk of systemic side effects.
- Innovation in Formulations: The patent has inspired further research and development in pharmaceutical formulations, leading to more effective and patient-friendly treatments.
- Compliance and Regulation: The patent and its related applications have contributed to the regulatory framework surrounding the use of gyrase inhibitors, ensuring that products meet stringent safety and efficacy standards.
Challenges and Limitations
While the patent has been influential, there are challenges and limitations to consider:
- Resistance Development: The use of antibiotics, including gyrase inhibitors, can lead to the development of antibiotic-resistant bacteria, a growing global health concern.
- Formulation Stability: Ensuring the stability and shelf life of topical formulations can be challenging, requiring careful selection of ingredients and manufacturing processes.
- Regulatory Hurdles: Navigating the regulatory landscape for new pharmaceutical formulations can be complex and time-consuming, involving extensive clinical trials and approval processes.
Future Directions
The future of gyrase inhibitors and their topical formulations looks promising:
- Advanced Delivery Systems: Research into advanced delivery systems, such as nanotechnology and microencapsulation, could enhance the efficacy and stability of these formulations.
- Combination Therapies: Investigating combination therapies that include gyrase inhibitors with other antimicrobial agents could offer broader spectrum activity and reduced resistance.
- Global Access: Efforts to make these formulations more accessible in developing countries could significantly impact public health outcomes.
Key Takeaways
- Innovative Formulations: U.S. Patent 4,844,902 introduced innovative topical formulations of gyrase inhibitors.
- Broad Scope: The patent covers various aspects of formulation, composition, and method of use.
- Global Impact: The invention has influenced the pharmaceutical industry globally, with related patents and applications in multiple jurisdictions.
- Challenges and Future Directions: Despite challenges, ongoing research aims to improve these formulations and expand their use.
FAQs
What is the main focus of U.S. Patent 4,844,902?
The main focus of U.S. Patent 4,844,902 is the development of topically applicable formulations of gyrase inhibitors for the treatment or prophylaxis of bacterial infections.
What are gyrase inhibitors?
Gyrase inhibitors are a class of antibiotics that target bacterial DNA gyrase, an enzyme essential for bacterial DNA replication.
How do the formulations described in the patent work?
The formulations work by delivering the gyrase inhibitors topically to the affected area, providing a targeted treatment option for bacterial infections.
Are there any related international patents?
Yes, there are related international patents, such as the Japanese patent JP2006518769A, which also describe stable ophthalmic compositions using gyrase inhibitors.
What are the potential challenges with using gyrase inhibitors?
Potential challenges include the development of antibiotic-resistant bacteria and ensuring the stability and shelf life of the topical formulations.
How can I access more information about related patent applications?
You can use the Global Dossier service provided by the USPTO to access the file histories of related applications from participating IP Offices[1].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Justia - US Patent for Topically applicable formulations of gyrase inhibitors: https://patents.justia.com/patent/4844902
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- FDA - CiproDex Otie NDA 21-537: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021537_Ciprodex_admincorres.PDF
- Google Patents - Stable ophthalmic composition: https://patents.google.com/patent/JP2006518769A/en
