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Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 9,254,328
Introduction
United States Patent 9,254,328 is a significant patent in the pharmaceutical industry, particularly related to the drug tigecycline, which is used to treat various bacterial infections. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
- The patent number is 9,254,328, and it is associated with tigecycline formulations.
Assignee and Inventors
- The patent is assigned to Pfizer Inc., a major pharmaceutical company. The inventors and specific details about their contributions are typically listed in the patent document, but for this analysis, we focus on the patent's content and implications.
Scope of the Patent
Drug and Formulation
- The patent pertains to a specific formulation of tigecycline, an antibiotic used to treat infections caused by certain bacteria. The formulation includes maltose instead of lactose, which is present in the original listed drug, Tygacil[1].
Therapeutic Use
- Tigecycline is a broad-spectrum antibiotic effective against a wide range of bacteria, including those resistant to other antibiotics. The patent's scope includes the method of preparation, composition, and use of this formulation.
Claims of the Patent
Independent and Dependent Claims
- The patent includes both independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
- For example, an independent claim might cover the composition of the tigecycline formulation, while a dependent claim might specify the exact ratio of maltose to tigecycline.
Claim Types
- The claims can be categorized into different types such as composition claims, method claims, and use claims. Composition claims would cover the specific formulation of tigecycline and maltose, method claims would cover the process of preparing the formulation, and use claims would cover the therapeutic uses of the formulation[3].
Patent Landscape
Related Patents and Expiry Dates
- The patent 9,254,328 is part of a larger patent portfolio related to tigecycline. Other patents in this portfolio include US Patent No. 7,879,828, US Patent No. 8,372,995, and US Patent No. 8,975,242, among others. These patents have different expiry dates, with some expiring as early as 2026 and others in 2028 and 2030[1].
Paragraph IV Certifications
- The applicant for the generic version of tigecycline submitted Paragraph IV certifications for several patents, including 9,254,328. This certification asserts that the generic version does not infringe the listed patents or that the patents are invalid. This led to litigation, which was eventually settled[1].
Litigation and Settlements
Patent Disputes
- The patent holder, Pfizer Inc., sued the generic manufacturers, Accord Healthcare Inc. and Intas Pharmaceuticals Ltd., for patent infringement. However, a settlement agreement was reached, and the lawsuit was dismissed[1].
Regulatory Considerations
FDA Approval
- The FDA's approval process for generic drugs involves assessing the bioequivalence and safety of the generic formulation. For this patent, the FDA reviewed and approved the NDA (New Drug Application) after ensuring that the manufacturing facilities and the formulation met the required standards[1].
Economic and Strategic Implications
Market Impact
- The approval of generic versions of tigecycline can significantly impact the market by increasing competition and potentially reducing prices. This can make the drug more accessible to patients while also affecting the revenue of the original patent holder.
Research and Development
- The patent landscape around tigecycline encourages continuous research and development in antibiotic formulations. Companies invest in developing new formulations to extend patent protection and maintain market share.
Tools for Patent Analysis
USPTO Resources
- The USPTO provides several tools for analyzing patents, including the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS). These tools help in understanding the patent's scope, claims, and the broader patent landscape[4].
Conclusion
United States Patent 9,254,328 is a critical component of the intellectual property strategy surrounding tigecycline. Understanding its scope, claims, and the associated patent landscape is essential for pharmaceutical companies, researchers, and regulatory bodies.
Key Takeaways
- Patent Scope: The patent covers a specific formulation of tigecycline with maltose.
- Claims: Include composition, method, and use claims.
- Patent Landscape: Part of a larger portfolio with various expiry dates.
- Litigation: Settlement agreements resolved patent disputes.
- Regulatory Considerations: FDA approval ensured bioequivalence and safety.
- Economic Implications: Generic versions impact market competition and prices.
FAQs
Q: What is the main difference between the patented tigecycline formulation and the original Tygacil?
A: The patented formulation uses maltose instead of lactose.
Q: What is the significance of Paragraph IV certifications in this context?
A: These certifications assert that the generic version does not infringe the listed patents or that the patents are invalid.
Q: How does the FDA ensure the safety and efficacy of generic drug formulations?
A: The FDA reviews the NDA, assesses bioequivalence, and inspects manufacturing facilities.
Q: What tools are available for analyzing patents like 9,254,328?
A: The USPTO provides tools such as the Patent Public Search tool, Global Dossier, and PEDS.
Q: How does the patent landscape around tigecycline impact market competition?
A: The approval of generic versions increases competition, potentially reducing prices and making the drug more accessible.
Sources
- FDA NDA Summary: "208744Orig1s000 SumR" - accessdata.fda.gov
- USPTO Overview: "U.S. Patent and Trademark Office (USPTO)" - usa.gov
- Patent Claims Research Dataset: "Patent Claims Research Dataset" - uspto.gov
- Patent Search Resources: "Search for patents" - uspto.gov
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