Detailed Analysis of the Scope and Claims of United States Patent 6,127,425
Introduction
United States Patent 6,127,425, titled "Oral liquid medicine solution," is a patent that describes a pharmaceutical preparation of Tamoxifen Citrate. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Dates
The patent was published on October 3, 2000, with the publication number US6127425A. The application was filed on June 26, 1998, and it has since expired due to the end of its lifetime[4].
Inventors and Assignees
While the specific inventors and assignees are not detailed in the provided sources, the patent is associated with a series of applications and family members across various countries, indicating a global interest in the invention.
Claims
Independent and Dependent Claims
The patent includes several claims that define the scope of the invention. Here are some key points:
- Claim 1: This claim describes a pharmaceutical preparation that provides a dosage form of Tamoxifen, where the dosage form comprises at least 1.5 mg/ml of Tamoxifen Citrate.
- Dependent Claims: These claims further specify the composition, including the presence of solvents such as ethanol, water, and glycol, which are used to enhance the solubility and stability of Tamoxifen Citrate[4].
Scope of the Invention
Pharmaceutical Preparation
The patent focuses on an oral liquid medicine solution of Tamoxifen Citrate, which is a significant improvement over traditional solid dosage forms. This liquid formulation enhances patient compliance, especially for those who have difficulty swallowing tablets or capsules.
Composition
The solution includes Tamoxifen Citrate as the active ingredient, along with various solvents and excipients. The specific composition is designed to ensure the stability and bioavailability of Tamoxifen Citrate, making it an effective treatment option.
Classification and Prior Art
International Classification
The patent is classified under the International Patent Classification (IPC) system, specifically under A61K, which pertains to preparations for medical, dental, or toilet purposes. More precisely, it falls under A61K47/00 and A61K47/06, which deal with medicinal preparations characterized by non-active ingredients and organic compounds, respectively[4].
Prior Art
The patent cites several prior art documents related to pharmaceutical preparations and the use of Tamoxifen. These citations indicate that the invention builds upon existing knowledge but introduces a novel and non-obvious improvement in the form of an oral liquid solution.
Patent Family and Global Landscape
Family Applications
The patent is part of a larger family of applications filed in various countries, including the United States, Europe, Japan, and others. This global filing strategy suggests that the inventors and assignees sought broad protection for their invention across different jurisdictions[4].
Country Status
The status of the patent varies by country, with some patents having expired or been withdrawn, while others remain active. For example, the US patent has expired, but the European and Japanese counterparts may still be in force or have different legal statuses[4].
Economic and Practical Implications
Market Impact
The development of an oral liquid medicine solution of Tamoxifen Citrate has significant market implications. It provides a more convenient and potentially more effective treatment option for patients, which can lead to increased market share and patient satisfaction.
Cost and Accessibility
Liquid formulations can sometimes be more expensive to produce than solid dosage forms, but they offer better bioavailability and patient compliance. This balance between cost and efficacy is crucial in the pharmaceutical industry.
Legal and Regulatory Considerations
Patent Expiration
The expiration of the US patent means that the invention is now in the public domain, allowing other companies to manufacture and market similar products without infringing on the original patent. This can lead to increased competition and potentially lower prices for the medication.
Global Patent System
The global patent system, facilitated by tools like the Global Dossier and Common Citation Document (CCD), helps in harmonizing patent searches and examinations across different countries. This ensures that similar inventions are treated consistently worldwide, reducing the complexity of international patent management[1].
Expert Insights and Statistics
Pharmaceutical Industry Trends
Experts in the pharmaceutical industry often highlight the importance of innovative formulations like the one described in this patent. For instance, a study by the USPTO on patent claims and scope notes that novel formulations can significantly expand the scope of patent protection and enhance the commercial viability of a drug[3].
Market Statistics
The market for Tamoxifen and similar medications is substantial. According to industry reports, the global market for breast cancer treatments, where Tamoxifen is commonly used, is projected to grow significantly due to increasing incidence rates and advancements in treatment options.
Key Takeaways
- Innovative Formulation: The patent describes an innovative oral liquid medicine solution of Tamoxifen Citrate, enhancing patient compliance and bioavailability.
- Global Protection: The invention is part of a global patent family, with filings in multiple countries.
- Economic Impact: The patent's expiration opens the market to generic versions, potentially increasing competition and reducing prices.
- Regulatory Harmonization: Tools like the Global Dossier and CCD facilitate international patent management and harmonization.
FAQs
What is the main claim of US Patent 6,127,425?
The main claim describes a pharmaceutical preparation providing a dosage form of Tamoxifen, where the dosage form comprises at least 1.5 mg/ml of Tamoxifen Citrate.
Why is the oral liquid formulation important?
The oral liquid formulation is important because it enhances patient compliance, especially for those who have difficulty swallowing tablets or capsules, and it may offer better bioavailability compared to solid dosage forms.
What is the current status of the US patent?
The US patent has expired due to the end of its lifetime.
How does the global patent family impact the invention?
The global patent family ensures broad protection for the invention across different jurisdictions, allowing the inventors and assignees to safeguard their intellectual property rights internationally.
What tools facilitate international patent management?
Tools like the Global Dossier and Common Citation Document (CCD) facilitate international patent management by providing a single point of access to prior art and citation data, helping to harmonize patent searches and examinations globally.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) | USAGov: https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US6127425A - Oral liquid medicine solution - Google Patents: https://patents.google.com/patent/US6127425A/en
- U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
