Analyzing the Scope and Claims of United States Patent 10,835,488
Introduction
United States Patent 10,835,488, titled "Stable Orally Disintegrating Pharmaceutical Compositions," is a patent that describes innovative pharmaceutical formulations and methods for their production. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, granted on October 13, 2020, pertains to stable orally disintegrating tablets containing a proton pump inhibitor (PPI), along with methods for making these tablets and their use in treating subjects[4].
Scope of the Patent
The scope of a patent is defined by its claims, which outline the specific aspects of the invention that are protected.
Claim Structure
The patent includes a series of claims that define the invention's boundaries. These claims can be categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.
- Independent Claims: These claims define the core aspects of the invention, such as the composition of the orally disintegrating tablets, the method of manufacturing, and the therapeutic use.
- Dependent Claims: These claims build upon the independent claims, adding specific details or limitations that further define the invention.
Metrics for Measuring Patent Scope
Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, are often associated with a higher probability of grant and a shorter examination process[3].
Claims Analysis
Independent Claims
The independent claims in US Patent 10,835,488 focus on several key aspects:
- Composition: The claims describe the specific formulation of the orally disintegrating tablets, including the active ingredient (a proton pump inhibitor), excipients, and other components.
- Method of Manufacture: The patent outlines the steps involved in producing these tablets, ensuring their stability and efficacy.
- Therapeutic Use: The claims specify the use of these tablets in treating conditions such as gastroesophageal reflux disease (GERD).
Dependent Claims
Dependent claims in this patent provide additional details, such as:
- Specific Excipients: Claims that specify the types and amounts of excipients used in the formulation.
- Manufacturing Process Variations: Claims that detail variations in the manufacturing process, such as different drying methods or coating techniques.
- Dosage Forms: Claims that describe different dosage forms or strengths of the orally disintegrating tablets.
Patent Landscape
Technological Field
This patent falls under the pharmaceutical and chemical technology areas, which are among the broad categories used by the USPTO and WIPO for classifying patents. The increase in patents within these fields reflects the growing innovation in healthcare and pharmaceuticals[1].
Trends in Pharmaceutical Patents
The pharmaceutical sector has seen significant patent activity in recent years, driven by advancements in drug delivery systems, new therapeutic agents, and improvements in existing medications. Patents like US 10,835,488 contribute to this trend by introducing innovative formulations that enhance patient compliance and treatment efficacy.
Global Comparisons
When comparing patent trends globally, the USPTO data shows that the United States is a leader in pharmaceutical patent filings. The classification of patents into detailed technology areas, as done by WIPO, helps in analyzing trends and focus areas in patenting over time[1].
Inventorship and Ownership
Determining Inventorship
The determination of inventorship is a critical aspect of patent law. For US Patent 10,835,488, the inventors listed must have contributed to the conception and reduction to practice of the invention. Incorrect or incomplete identification of inventors can lead to legal challenges and affect the enforceability of the patent[5].
Ownership
The patent is owned by the entity that has been assigned the rights of ownership. This could be a business, academic institution, or government entity. The ownership structure is crucial for licensing, litigation, and other legal considerations related to the patent.
Legal and Regulatory Aspects
Patent Examination Process
The examination process for this patent would have involved a thorough review of the claims to ensure they meet the criteria of novelty, non-obviousness, and utility. The narrower claims associated with this patent would have likely facilitated a smoother examination process[3].
Enforcement and Litigation
The enforceability of the patent depends on the accuracy of inventorship and the clarity of the claims. Any challenges to the patent would be heard by the Court of Appeals for the Federal Circuit, which has jurisdiction over patent cases in the United States[5].
Key Takeaways
- Patent Scope: Defined by independent and dependent claims, with narrower claims often associated with a higher probability of grant.
- Claims Analysis: Focuses on composition, method of manufacture, and therapeutic use.
- Patent Landscape: Part of the broader pharmaceutical and chemical technology areas, reflecting trends in healthcare innovation.
- Inventorship and Ownership: Critical for legal and regulatory compliance, affecting the enforceability and ownership of the patent.
- Legal and Regulatory Aspects: Involves a thorough examination process and potential litigation challenges.
FAQs
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What is the main subject matter of US Patent 10,835,488?
- The patent pertains to stable orally disintegrating pharmaceutical compositions containing a proton pump inhibitor, along with methods for their production and therapeutic use.
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How are the claims structured in this patent?
- The claims are structured into independent claims that define the core aspects of the invention and dependent claims that further limit and specify these aspects.
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What metrics can be used to measure the scope of a patent?
- Metrics such as independent claim length and independent claim count can be used to measure patent scope.
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Why is accurate inventorship important in patent law?
- Accurate inventorship is crucial for ensuring the enforceability of the patent and avoiding legal challenges related to ownership and inventorship.
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Under which jurisdiction would any challenges to this patent be heard?
- Any challenges to the patent would be heard by the Court of Appeals for the Federal Circuit, which has jurisdiction over patent cases in the United States.
Sources
- Invention: U.S. and Comparative Global Trends - National Science Foundation.
- U.S. Patent and Trademark Office (USPTO) | USAGov - USA.gov.
- Patent Claims and Patent Scope - SSRN.
- Stable orally disintegrating pharmaceutical compositions - Google Patents.
- Determining Inventorship for US Patent Applications - Oregon State University.
