United States Patent 9,511,031: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,511,031, titled "Controlled Release Doxycycline," was granted to Mayne Pharma International Pty Ltd. on December 6, 2016. This patent is significant in the pharmaceutical field, particularly for its advancements in controlled release formulations of doxycycline, a broad-spectrum antibiotic.
Background
Tetracyclines and Doxycycline
Tetracyclines, including doxycycline, are widely used antibiotics that interfere with the protein synthesis of Gram-positive and Gram-negative bacteria. Despite their efficacy, traditional formulations of doxycycline can have side effects such as nausea and irritation[1].
Patent Overview
Applicants and Inventors
The patent was filed by Mayne Pharma International Pty Ltd., with inventors Stefan Lukas, Angelo Lepore, and Stuart Mudge. It is a continuation-in-part of a previous application (U.S. application Ser. No. 14/521,998) and claims priority to a provisional application (U.S. Provisional Application No. 62/061,481)[1].
Claims and Scope
Controlled Release Formulations
The patent claims cover pharmaceutical compositions comprising doxycycline with improved controlled release characteristics. These formulations are designed to exhibit a superior dissolution profile, which helps in reducing side effects associated with traditional doxycycline formulations[1].
Key Claims
- The patent includes 30 claims, with a focus on the composition, method of preparation, and the controlled release profile of doxycycline.
- Claim 1 is a broad claim that covers a pharmaceutical composition comprising doxycycline and a controlled release matrix.
- Subsequent claims detail specific aspects such as the type of matrix, the ratio of doxycycline to the matrix, and the method of manufacturing[1].
Technical Field
Classification
The patent is classified under various CPC (Cooperative Patent Classification) categories, including A61K 9/5047, A61K 9/167, and A61K 9/1652. These classifications indicate that the patent pertains to pharmaceutical preparations, specifically those involving tetracyclines and their derivatives[1].
Advantages
Reduced Side Effects
The controlled release formulations described in the patent are designed to minimize side effects such as nausea and irritation, which are common with traditional doxycycline formulations. This is achieved through a superior dissolution profile that ensures a more gradual release of the antibiotic[1].
Improved Efficacy
By providing a controlled release, the formulations can maintain therapeutic levels of doxycycline over an extended period, potentially improving the efficacy of the treatment.
Related Patents and Prior Art
Prior Publications and Patents
The patent references several prior patents and publications, including U.S. Patent Nos. 6,958,161 B2, 7,232,572 B2, and 8,603,506 B2. These references highlight the evolution of controlled release formulations and the specific advancements made in this patent[1].
Patent Eligibility and Legal Considerations
Patent Eligibility
While the patent does not face the same abstract idea challenges as seen in cases like Broadband iTV, Inc. v. Amazon.com, Inc.[2], it is crucial to ensure that the claims are directed to a patent-eligible invention. The controlled release formulations and the specific methods of preparation described in the patent are tangible and practical, aligning with the requirements for patent eligibility.
Economic and Innovation Impact
Patenting Trends
The granting of this patent reflects broader trends in pharmaceutical innovation. According to the USPTO, patents in the pharmaceutical sector are critical indicators of technological advancement and innovation[4].
Market Impact
Controlled release formulations like those described in this patent can significantly impact the market by offering improved patient compliance and reduced side effects. This can lead to better treatment outcomes and increased market share for the patent holder.
Future Implications
Potential for Further Innovation
The advancements in controlled release technology described in this patent can serve as a foundation for further innovation in pharmaceutical formulations. This could lead to the development of new drugs or improved formulations of existing drugs.
Regulatory and Legal Framework
The establishment of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could impact the enforcement and litigation landscape for patents like this one. Such a court could provide a more streamlined and cost-effective way to resolve patent disputes[5].
Key Takeaways
- Controlled Release Formulations: The patent introduces improved controlled release formulations of doxycycline, reducing side effects and enhancing efficacy.
- Patent Scope: The patent includes 30 claims covering composition, preparation methods, and controlled release profiles.
- Technical Field: Classified under CPC categories related to pharmaceutical preparations involving tetracyclines.
- Advantages: Minimized side effects and improved therapeutic efficacy.
- Economic Impact: Reflects broader trends in pharmaceutical innovation and can significantly impact the market.
FAQs
Q: What is the main innovation of United States Patent 9,511,031?
A: The main innovation is the development of controlled release formulations of doxycycline, which reduce side effects and improve therapeutic efficacy.
Q: Who are the inventors of this patent?
A: The inventors are Stefan Lukas, Angelo Lepore, and Stuart Mudge.
Q: What are the key claims of this patent?
A: The patent includes 30 claims, with a focus on the composition, method of preparation, and the controlled release profile of doxycycline.
Q: How does this patent impact the pharmaceutical market?
A: It can improve patient compliance and reduce side effects, leading to better treatment outcomes and potentially increased market share.
Q: What are the potential future implications of this patent?
A: It can serve as a foundation for further innovation in pharmaceutical formulations and may be influenced by future regulatory and legal frameworks such as a small claims patent court.
Sources
- United States Patent 9,511,031 B2 - Controlled Release Doxycycline.
- Broadband iTV, Inc. v. Amazon.com, Inc. - Federal Circuit Court of Appeals.
- Patent Claims Research Dataset - USPTO.
- Invention: U.S. and Comparative Global Trends - National Science Foundation.
- U.S. Patent Small Claims Court - Administrative Conference of the United States.
