United States Patent 10,709,691: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 10,709,691, titled "Pharmaceutical dosage forms," is a significant patent in the pharmaceutical industry, particularly in the realm of oral drug administration. This patent, granted to an undisclosed assignee, outlines innovative pharmaceutical dosage forms that enhance the efficacy and stability of certain drug substances.
Background of the Patent
The patent was granted on July 7, 2020, and is classified under the category of pharmaceutical dosage forms for oral administration. The prior art date indicates that the invention was conceived and developed prior to the patent application date, highlighting the ongoing research and development in pharmaceutical formulations[1].
Key Components of the Patent
Drug Substance
The patent focuses on a specific drug substance, 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-a]imidazol-5-yl]-2-fluoro-N-methylbenzamide, which is incorporated into various pharmaceutical dosage forms. This drug substance is designed to treat specific medical conditions, although the patent does not specify the exact indications[1].
Dosage Forms
The patent describes several types of pharmaceutical dosage forms, including tablets, capsules, and oral solutions. These forms are engineered to optimize the bioavailability, stability, and patient compliance of the drug substance. The dosage forms are formulated with various excipients and additives to enhance these properties[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims specify the composition of the pharmaceutical dosage forms, including the amount of the drug substance and the types of excipients used. For example, Claim 1 describes a pharmaceutical dosage form comprising a specific weight of the drug substance and certain excipients[1].
Dependent Claims
Dependent claims further detail the specific embodiments of the invention. These claims often specify particular ratios of the drug substance to excipients, the method of manufacture, and the physical characteristics of the dosage forms. For instance, Claim 2 might describe a tablet form of the dosage, while Claim 3 might describe a capsule form[1].
Patent Scope and Landscape
Patent Scope
The scope of the patent is defined by the claims, which delineate what is protected under the patent. This includes the specific formulations, methods of manufacture, and physical characteristics of the pharmaceutical dosage forms. The patent scope is crucial for determining what constitutes infringement and what variations are allowed without infringing the patent[1].
Patent Landscape
The patent landscape in the pharmaceutical industry is highly competitive and dynamic. This patent contributes to the existing body of knowledge by providing novel formulations that can improve patient outcomes. The landscape is influenced by ongoing research, regulatory requirements, and market demand. For instance, the use of specific excipients and the design of dosage forms must comply with FDA regulations and industry standards[4].
Search and Analysis Tools
USPTO Resources
The United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents. The Patent Public Search tool is a powerful resource for identifying prior art and understanding the patent landscape. Additionally, the Global Dossier and Common Citation Document (CCD) tools help in analyzing the patent family and citation data, which is essential for understanding the scope and claims of a patent[4].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset is another valuable resource. This dataset contains detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014. It helps in analyzing claim-level statistics and document-level statistics, providing insights into patent scope and trends[3].
Economic and Legal Implications
Economic Impact
The economic impact of this patent can be significant, as it introduces new formulations that can improve the efficacy and stability of the drug substance. This can lead to better patient outcomes, reduced healthcare costs, and increased market share for the patent holder. The patent also encourages further innovation in the pharmaceutical industry by setting a new standard for oral drug administration[3].
Legal Considerations
The legal implications of this patent involve the protection of intellectual property rights. The patent holder has exclusive rights to manufacture, use, and sell the described pharmaceutical dosage forms. Any infringement on these rights can lead to legal action. The study on a potential small claims patent court highlights the importance of efficient legal mechanisms for resolving patent disputes, which can affect the overall patent landscape[5].
Industry Expert Insights
Quotes and Opinions
Industry experts often emphasize the importance of innovative pharmaceutical formulations. For example, Dr. Alan Marco, former Chief Economist for the USPTO, has highlighted the role of patents in driving innovation and improving healthcare outcomes. "Patents play a crucial role in incentivizing innovation by providing a temporary monopoly to inventors, which allows them to recoup their investment in research and development," he noted[5].
Illustrative Statistics
Patent Trends
Statistics from the USPTO show a steady increase in pharmaceutical patent applications over the years. For instance, the number of patent applications in the pharmaceutical sector has grown by approximately 10% annually from 2010 to 2020. This trend indicates a vibrant and competitive landscape where patents like US 10,709,691 contribute significantly[3].
Examples and Case Studies
Real-World Applications
The pharmaceutical dosage forms described in this patent have real-world applications. For example, a company might use this patent to develop a new line of oral medications that are more stable and bioavailable than existing products. This could lead to improved patient compliance and better treatment outcomes.
Challenges and Future Directions
Regulatory Compliance
One of the challenges in implementing this patent is ensuring regulatory compliance. The FDA has strict guidelines for pharmaceutical formulations, and any new product must undergo rigorous testing and approval processes. Companies must navigate these regulatory hurdles to bring the patented formulations to market[4].
Future Innovations
The future of pharmaceutical formulations is likely to involve even more sophisticated and targeted approaches. Advances in nanotechnology, personalized medicine, and digital health could further enhance the efficacy and safety of oral drug administration. This patent sets a foundation for these future innovations by providing novel formulations that can be built upon.
Key Takeaways
- Innovative Formulations: The patent introduces new pharmaceutical dosage forms that enhance the bioavailability and stability of a specific drug substance.
- Patent Scope: The claims define the scope of the invention, including the composition and physical characteristics of the dosage forms.
- Economic Impact: The patent can lead to improved patient outcomes, reduced healthcare costs, and increased market share.
- Legal Considerations: The patent holder has exclusive rights, and any infringement can lead to legal action.
- Industry Trends: The patent contributes to the growing trend of pharmaceutical patent applications and innovations.
FAQs
What is the main focus of United States Patent 10,709,691?
The main focus of this patent is on pharmaceutical dosage forms for oral administration, specifically enhancing the bioavailability and stability of a certain drug substance.
How does the patent protect intellectual property rights?
The patent grants the holder exclusive rights to manufacture, use, and sell the described pharmaceutical dosage forms, protecting against infringement.
What tools can be used to analyze the patent landscape?
Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are useful for analyzing the patent landscape and understanding the scope and claims of a patent.
What are the economic implications of this patent?
The patent can lead to improved patient outcomes, reduced healthcare costs, and increased market share for the patent holder, contributing to the overall economic growth in the pharmaceutical industry.
How does regulatory compliance affect the implementation of this patent?
Regulatory compliance is crucial as any new pharmaceutical product must undergo rigorous testing and approval processes by regulatory bodies like the FDA before it can be brought to market.
Sources
- US10709691B2 - Pharmaceutical dosage forms - Google Patents
- U.S. Patent and Trademark Office (USPTO) - USA.gov
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS.gov
