United States Patent 9,446,057: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,446,057, titled "Controlled Release Doxycycline," was granted on September 20, 2016, to Mayne Pharma International Pty Ltd. This patent revolves around the development of controlled release compositions comprising tetracyclines, with a specific focus on doxycycline. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Doxycycline, a broad-spectrum antibiotic belonging to the tetracycline class, is widely used to treat various bacterial infections. However, traditional formulations often come with side effects such as nausea and irritation. The invention described in US 9,446,057 aims to address these issues by developing controlled release compositions that enhance the dissolution profile and reduce adverse effects[1][4].
Scope of the Patent
The patent scope is defined by the claims, which outline the specific aspects of the invention that are protected. Here, the scope includes:
Controlled Release Compositions
The patent covers controlled release compositions that contain tetracyclines, with doxycycline being a primary embodiment. These compositions are designed to release the active ingredient over a prolonged period, improving the therapeutic efficacy and reducing side effects[1][4].
Dosage Forms
The invention encompasses various dosage forms, including tablets, capsules, and other oral formulations. These dosage forms are engineered to provide a superior dissolution profile, ensuring consistent and sustained release of doxycycline[1].
Manufacturing Process
The patent details the manufacturing process for these controlled release compositions, including the use of specific excipients and the method of formulation. This ensures that the final product meets the desired release characteristics[1].
Claims Analysis
The patent includes 27 claims that define the boundaries of the invention.
Independent Claims
Independent claims are crucial as they stand alone and do not depend on other claims. For US 9,446,057, these claims focus on the composition itself, the dosage forms, and the method of manufacture. For example, Claim 1 describes a controlled release composition comprising doxycycline and specific excipients that provide a sustained release profile[1].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims often specify particular aspects of the composition, such as the ratio of active ingredient to excipients or the specific release characteristics[1].
Patent Landscape
Related Patents and Prior Art
The patent cites several prior art documents, including U.S. patents and applications related to controlled release formulations. For instance, U.S. Patent 6,958,161 B2 and U.S. Patent 7,232,572 B2 are referenced as prior art, indicating the evolution of controlled release technology in the pharmaceutical field[1].
Patent Scope Metrics
Research on patent scope, such as the study by Marco, Alan C., and Sarnoff, Joshua D., highlights the importance of metrics like independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. For US 9,446,057, the claims are structured to be clear and specific, reflecting a narrower scope that is associated with a higher probability of grant and shorter examination process[3].
Economic and Legal Implications
Patent Prosecution Costs
The proposed terminal disclaimer rule by the USPTO, although withdrawn, highlights the complexities and costs associated with patent prosecution. For patents like US 9,446,057, the decision to file a terminal disclaimer or argue against obviousness-type double patenting rejections can significantly impact prosecution costs[5].
Innovation and Competition
The controlled release doxycycline compositions patented in US 9,446,057 represent an innovation that can enhance patient compliance and reduce side effects. This innovation can promote competition in the pharmaceutical industry by offering a differentiated product, thereby driving further research and development in controlled release technologies.
Impact on Pharmaceutical Industry
Patient Benefits
The controlled release formulations described in the patent offer several benefits to patients, including reduced side effects and improved therapeutic efficacy. This can lead to better patient outcomes and increased patient compliance with treatment regimens[1].
Market Competition
The introduction of controlled release doxycycline compositions can alter the market landscape by providing a competitive edge to the patent holder. This can drive other pharmaceutical companies to invest in similar research, leading to a broader range of treatment options for bacterial infections.
Conclusion
The United States Patent 9,446,057 for controlled release doxycycline compositions is a significant development in the pharmaceutical industry. The patent's scope, defined by its claims, protects a specific and innovative approach to drug delivery that enhances patient care. Understanding the patent landscape and the economic and legal implications surrounding this invention is crucial for both patent holders and competitors in the industry.
Key Takeaways
- Controlled Release Technology: The patent focuses on controlled release compositions of doxycycline, improving the dissolution profile and reducing side effects.
- Claims Structure: The patent includes 27 claims, with independent claims defining the composition and dependent claims providing additional details.
- Patent Landscape: The patent is part of a broader landscape of controlled release formulations, with citations to prior art and metrics indicating a narrower scope.
- Economic Implications: The patent prosecution costs and the impact of terminal disclaimers are significant considerations.
- Innovation and Competition: The invention promotes competition and drives further innovation in the pharmaceutical industry.
FAQs
What is the main focus of the United States Patent 9,446,057?
The main focus of the patent is the development of controlled release compositions comprising tetracyclines, specifically doxycycline, to improve the dissolution profile and reduce side effects.
How does the controlled release formulation benefit patients?
The controlled release formulation reduces side effects such as nausea and irritation and improves therapeutic efficacy by providing a sustained release of the active ingredient.
What are the key claims in the patent?
The patent includes 27 claims, with independent claims defining the composition and dosage forms, and dependent claims providing additional details on the manufacturing process and release characteristics.
How does the patent impact the pharmaceutical industry?
The patent introduces a competitive product that can drive other pharmaceutical companies to invest in similar research, leading to a broader range of treatment options for bacterial infections.
What are the economic implications of the patent?
The patent can influence patent prosecution costs, especially in relation to terminal disclaimers and arguments against obviousness-type double patenting rejections.
Sources
- US Patent Office: US9446057B2 - Controlled release doxycycline.
- USPTO: Patent Claims Research Dataset.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: US9446057B2 - Controlled release doxycycline.
- Morgan Lewis: USPTO Withdraws Proposed Terminal Disclaimer Rule.
