United States Patent 9,572,857: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,572,857, titled "Pharmaceutical compositions with enhanced stability," is a significant patent in the field of pharmaceuticals, particularly focusing on stabilized biodegradable polymeric compositions for controlled release delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent describes a stabilized biodegradable polymeric composition designed for the controlled release of peptide agents. This invention is crucial for improving the stability and efficacy of peptide-based drugs, which are often prone to degradation and have limited shelf life[1].
Scope of the Invention
The scope of the invention encompasses several key aspects:
Biodegradable Polymers
The patent focuses on biodegradable polymers, particularly those based on lactic acid and glycolic acid, which are commonly used in controlled release systems. These polymers degrade over time, releasing the peptide agents in a controlled manner[1].
Peptide Agents
The invention is applicable to various peptide agents, including but not limited to leuprolide, which is used in treatments for conditions such as prostate cancer and endometriosis. The stability of these peptides is enhanced through the use of the biodegradable polymeric composition[1].
Controlled Release Mechanism
The controlled release mechanism is a critical aspect of this invention. The biodegradable polymer matrix ensures that the peptide agents are released at a predictable rate, maintaining therapeutic levels over an extended period[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
Claims related to the composition of the biodegradable polymeric matrix, including the types of polymers used, their molecular weight, and the method of preparation[1].
Method Claims
Claims related to the methods of preparing the stabilized biodegradable polymeric compositions and the process of incorporating peptide agents into these compositions[1].
Use Claims
Claims related to the use of these compositions in therapeutic applications, including the treatment of various diseases where peptide agents are beneficial[1].
Key Components and Materials
The patent highlights several key components and materials:
Biodegradable Polymers
Polymers such as poly(lactic-co-glycolic acid) (PLGA) and poly(lactic acid) (PLA) are central to the invention. These polymers have a weight average molecular weight ranging from about 2,000 to about 100,000[2].
Organic Solvents
Organic solvents like ethyl acetate and ethylene glycol are used in the preparation of the polymeric compositions[1].
Peptide Agents
The patent specifies the use of peptide agents such as leuprolide, which is stabilized within the biodegradable polymer matrix[1].
Patent Landscape and Related Patents
The patent landscape surrounding US 9,572,857 includes several related patents and inventions:
Patent Analytics and Claim Coverage
Understanding the patent landscape involves analyzing claim coverage and identifying gaps or opportunities. Tools like Claim Coverage Matrix and ClaimScape® software can help in categorizing patents by claims and scope concepts, ensuring comprehensive coverage of intellectual property[3].
Competing Patents and Litigation
The pharmaceutical industry is highly litigious, with companies often engaging in patent infringement disputes. For example, the case of Biogen International GmbH vs. Mylan Pharmaceuticals Inc. highlights the complexities of patent litigation and the importance of clear written descriptions in patent claims[4].
Industrial Applications and Benefits
The industrial applications of this patent are significant:
Pharmaceutical Industry
The controlled release delivery system enhances the stability and efficacy of peptide-based drugs, making them more reliable and effective in therapeutic applications.
Patient Benefits
Patients benefit from the predictable and sustained release of therapeutic agents, which can improve treatment outcomes and reduce the frequency of dosing.
Regulatory Considerations
The regulatory environment plays a crucial role in the development and approval of pharmaceutical compositions:
FDA Approval Process
The FDA approval process, including the Hatch-Waxman Act, is critical for generic drug manufacturers and patent holders. The automatic thirty-month stay in the FDA-approval process for generic drugs pending litigation is a key regulatory aspect[4].
Future Directions and Opportunities
The patent opens up several future directions and opportunities:
Research and Development
Further research can focus on optimizing the biodegradable polymer matrix and exploring new peptide agents for various therapeutic applications.
Market Expansion
The invention has the potential to expand into new markets, particularly in regions where access to stable and effective peptide-based treatments is limited.
Challenges and Limitations
Despite the advancements, there are challenges and limitations:
Degradation and Stability
Ensuring the stability of the biodegradable polymer matrix and the peptide agents over time remains a significant challenge.
Regulatory Hurdles
Navigating the complex regulatory landscape, including patent litigation and FDA approvals, can be a significant hurdle for companies developing these compositions.
Key Takeaways
- Stabilized Biodegradable Polymers: The patent introduces a stabilized biodegradable polymeric composition for controlled release of peptide agents.
- Enhanced Stability: The invention enhances the stability of peptide agents, making them more effective in therapeutic applications.
- Controlled Release Mechanism: The biodegradable polymer matrix ensures a predictable and sustained release of therapeutic agents.
- Regulatory Considerations: The FDA approval process and patent litigation are critical aspects of the pharmaceutical industry.
- Future Directions: The patent opens up opportunities for further research and market expansion.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 9,572,857?
The main focus is on stabilized biodegradable polymeric compositions for the controlled release of peptide agents.
What types of polymers are used in this invention?
The polymers used include poly(lactic-co-glycolic acid) (PLGA) and poly(lactic acid) (PLA).
How does the controlled release mechanism work?
The biodegradable polymer matrix degrades over time, releasing the peptide agents at a predictable rate.
What are the benefits of this invention for patients?
Patients benefit from the predictable and sustained release of therapeutic agents, improving treatment outcomes and reducing dosing frequency.
What regulatory considerations are important for this patent?
The FDA approval process, including the Hatch-Waxman Act, and patent litigation are crucial regulatory aspects.
Cited Sources
- US9572857B2 - Pharmaceutical compositions with enhanced stability - Google Patents
- US Patent No. 9744207 B2 - Regulations.gov
- Patent Analytics | Intellectual Property Law - SLWIP
- Biogen - United States Court of Appeals for the Federal Circuit - CAFC.USCourts.gov
