Detailed Analysis of the Scope and Claims of United States Patent 6,150,366: Ziprasidone Formulations
Introduction
United States Patent 6,150,366, titled "Ziprasidone formulations," is a pharmaceutical patent that describes specific formulations of ziprasidone, a medication used to treat schizophrenia and bipolar disorder. This analysis will delve into the scope and claims of the patent, as well as the broader patent landscape surrounding ziprasidone formulations.
Patent Overview
Publication Number and Authority
The patent, numbered US6150366A, was issued by the United States Patent and Trademark Office (USPTO) and is now expired[4].
Prior Art and Background
The patent builds on prior art related to pharmaceutical formulations, particularly those involving ziprasidone. It addresses the need for stable and effective formulations of this drug.
Claims
The patent includes several claims that define the scope of the invention. Key claims involve:
- Composition of Matter: The patent claims a composition of matter that includes crystalline ziprasidone particles with specific characteristics, such as particle size and distribution[4].
- Methods of Preparation: Claims also cover methods for preparing these formulations, including processes like reflux, stirring, and heat treatment[4].
- Dosage Forms: The patent specifies various dosage forms, such as powders, granulates, and solid products obtained through processes like spray drying or emulsion solvent evaporation[4].
Scope of the Invention
Active Ingredients and Excipients
The invention focuses on the formulation of ziprasidone with various excipients to enhance stability, bioavailability, and patient compliance. The patent details the use of substances like sodium laurylsulphate, NaH2PO4, and other solvents and buffers to achieve these goals[4].
Physical Form
The patent describes the physical form of the formulations, including particulate forms like powders, granulates, and microbeadlets. These forms are designed to improve the drug's performance and ease of administration[4].
Patent Landscape Analysis
Technological Domain
Patent landscape analysis for ziprasidone formulations involves understanding the broader technological domain of pharmaceutical formulations, particularly those related to antipsychotic medications.
Competitor Analysis
- Market Players: Other pharmaceutical companies have developed similar formulations of ziprasidone or other antipsychotic drugs. Analyzing their patents helps in identifying market trends and competitor strategies[5].
- Patent Trends: Trends in patent filings can indicate areas of innovation, such as new delivery systems or improved formulations. This analysis can reveal whether there is a shift towards more patient-friendly or cost-effective formulations[5].
Legal Status and Expiry Dates
- Expired Status: Since US6150366A has expired, it no longer provides patent protection. This opens up opportunities for generic formulations and new innovations in the field[4].
- Expected Expiry Dates of Related Patents: Analyzing the expiry dates of related patents can help in planning future product launches or research initiatives[5].
Claim Coverage and Gaps
Claim Coverage Matrix
Using a Claim Coverage Matrix, as described in patent analytics, can help in understanding which claims of the patent are actively protecting the intellectual property and where gaps or opportunities exist. This involves categorizing claims by scope concepts and reviewing them with technical experts to determine their applicability to target products or methods[3].
Interactive Claim Charts
Interactive claim charts generated by software like ClaimScape® can facilitate the review of patent coverage with engineers, scientists, and management. These charts help in identifying areas where claim coverage is lacking and highlight future design opportunities[3].
International Patent Landscape
Global Patent Databases
To understand the global landscape, one must search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), World Intellectual Property Organization (WIPO), and other national intellectual property offices. This helps in identifying similar or related patents filed in different countries[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by participating IP offices, enabling a comprehensive view of the global patent landscape for ziprasidone formulations[1].
Business and Technical Insights
Market Developments
Patent landscape studies reveal market developments such as mergers and acquisitions, in/out-licensing, and litigation activities. These insights are crucial for strategic decision-making and minimizing business risks[5].
Technical Innovations
The analysis highlights technical innovations in the field, such as new formulation techniques, delivery systems, or excipients used. This information can guide research and development efforts to stay competitive in the market[5].
Key Takeaways
- Expired Patent: US6150366A is no longer in force, allowing for generic formulations and new innovations.
- Claim Coverage: Analyzing claim coverage using matrices and interactive charts helps in identifying gaps and opportunities.
- Global Landscape: Searching international patent databases and using tools like CCD provides a comprehensive view of the global patent landscape.
- Market and Technical Insights: Patent landscape analysis offers valuable insights into market trends, competitor strategies, and technical innovations.
FAQs
What is the current legal status of US6150366A?
The patent US6150366A has expired, meaning it no longer provides patent protection.
What are the key claims of US6150366A?
The key claims include the composition of matter involving crystalline ziprasidone particles and methods for preparing these formulations.
How can patent landscape analysis help in understanding ziprasidone formulations?
Patent landscape analysis helps in understanding the technological domain, identifying competitor strategies, and revealing market trends and technical innovations.
What tools are available for searching global patent databases?
Tools like the Common Citation Document (CCD), European Patent Office's esp@cenet, and World Intellectual Property Organization's PATENTSCOPE® Search Service are available for searching global patent databases.
Why is claim coverage analysis important?
Claim coverage analysis is important for identifying which patents and claims are actively protecting intellectual property and where gaps or opportunities exist, helping in strategic decision-making and future design opportunities.
