United States Patent 6,303,607: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 6,303,607, titled "Method for administering a sustained release ranolazine formulation," is a significant patent in the pharmaceutical field, particularly concerning the administration and formulation of ranolazine, a medication used to treat chronic angina. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Inventors and Assignees
The patent was granted to inventors associated with CV Therapeutics, Inc., now part of Gilead Sciences, Inc. The inventors include those who have contributed to the development of sustained release formulations of ranolazine[4].
Scope of the Patent
Overview
The patent describes a method for administering a sustained release formulation of ranolazine to maintain therapeutic plasma levels of the drug. This is crucial for managing chronic angina effectively, as it ensures consistent drug levels over an extended period.
Key Aspects
- Sustained Release Formulation: The patent focuses on the development of an orally administered sustained release formulation. This type of formulation is designed to release the drug slowly over time, maintaining therapeutic levels without the need for frequent dosing[4].
- Therapeutic Plasma Levels: The method ensures that the plasma levels of ranolazine remain within a therapeutic range, which is essential for the effective management of chronic angina.
- Clinical Benefits: By maintaining consistent plasma levels, the formulation helps in reducing the frequency of angina attacks and improving the quality of life for patients.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the method of administration, the formulation itself, and the specific characteristics of the sustained release mechanism.
- Claim 1: This claim typically describes the method of administering a sustained release ranolazine formulation to achieve and maintain therapeutic plasma levels of ranolazine[4].
- Dependent Claims: These claims further specify the details of the formulation, such as the type of excipients used, the release profile, and any specific dosing regimens.
Claim Language and Scope
The language used in the claims is critical in defining the patent's scope. For instance, the claims might specify the exact composition of the formulation, the release kinetics, and any particular manufacturing processes involved. This specificity helps in distinguishing the invention from prior art and ensures that the patent covers a unique and novel method[3].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding US 6,303,607 includes other patents related to ranolazine and its formulations. For example:
- US 2014/0221286 A1: This patent application discusses the use of sodium channel blockers, including ranolazine, to reduce glucagon secretion. While it is not directly related to the sustained release formulation, it highlights the broader interest in ranolazine's pharmacological properties[1].
Patent Scope Metrics
Research on patent scope, such as that conducted by the USPTO, suggests that the scope of a patent can be measured using metrics like independent claim length and independent claim count. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[3].
Economic Value
The economic value of patents, including those related to pharmaceuticals, can be substantial. The mean price per patent document can range from $146,000 to $330,000 per family, indicating the significant financial investment and potential return on such intellectual property[5].
Examination Process
Narrowing of Claims
During the patent examination process, the scope of the claims may be narrowed to ensure that the patent is granted with a clear and valid scope. This process can involve negotiations between the patent applicant and the patent office to refine the claims and ensure they are novel, non-obvious, and useful[3].
Impact on Innovation
Licensing and Litigation
The scope and claims of a patent can significantly impact innovation by influencing licensing and litigation costs. Patents with overly broad claims may lead to increased litigation, while those with well-defined and narrow claims can facilitate smoother licensing and collaboration, thereby promoting further innovation[3].
Key Takeaways
- Sustained Release Formulation: The patent describes a method for administering a sustained release ranolazine formulation, which is crucial for managing chronic angina.
- Therapeutic Plasma Levels: The method ensures consistent therapeutic plasma levels of ranolazine.
- Claim Language: The specificity of the claim language is vital in defining the patent's scope and distinguishing it from prior art.
- Patent Landscape: The patent is part of a broader landscape that includes other patents related to ranolazine and its pharmacological properties.
- Economic Value: Patents in the pharmaceutical field can have significant economic value.
FAQs
What is the primary focus of US Patent 6,303,607?
The primary focus of US Patent 6,303,607 is the method for administering a sustained release formulation of ranolazine to maintain therapeutic plasma levels for the treatment of chronic angina.
How does the sustained release formulation benefit patients?
The sustained release formulation ensures consistent plasma levels of ranolazine, reducing the frequency of angina attacks and improving the quality of life for patients.
What metrics are used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope, with narrower claims at publication associated with a higher probability of grant and a shorter examination process[3].
What is the economic value of pharmaceutical patents?
The economic value of pharmaceutical patents can be substantial, with mean prices ranging from $146,000 to $330,000 per family[5].
How does the patent examination process affect the scope of claims?
During the examination process, the scope of claims may be narrowed to ensure that the patent is granted with a clear and valid scope, which can involve refining the claims to ensure they are novel, non-obvious, and useful[3].
Sources
- US 2014/0221286 A1 - Patent Application Publication, "Sodium Channel Blockers Reduce Glucagon Secretion"
- USPTO Patent Claims Research Dataset - Documentation and Data Files
- Patent Claims and Patent Scope - Hoover Institution, January 2016
- US6303607B1 - Method for administering a sustained release ranolazine formulation
- The Value of a Patent - Perpetual Motion Patents
