United States Patent 9,744,163: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,744,163, titled "Compositions of a polyorthoester and an aprotic solvent," is a significant patent in the field of medical and pharmaceutical sciences. This patent, issued to the United States Surgical Corp., describes innovative compositions and delivery systems for biodegradable polyorthoester polymers. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
The development of biodegradable polymers and their applications in drug delivery systems has been a focal point in medical research. These polymers are crucial for creating sustained-release formulations that can improve the efficacy and safety of various medications. The patent in question addresses this need by introducing specific compositions that combine polyorthoester polymers with aprotic solvents.
Scope of the Patent
Invention Overview
The patent describes compositions and delivery systems comprising a biodegradable polyorthoester polymer, an aprotic solvent, and a drug. These compositions are designed to release the active agent over a prolonged period, enhancing the therapeutic effect and reducing the need for frequent dosing[4].
Key Components
- Polyorthoester Polymer: The patent specifies the use of biodegradable polyorthoester polymers, which are known for their ability to degrade in the body without causing harmful side effects.
- Aprotic Solvent: The aprotic solvent is selected to enhance the solubility and stability of the drug within the polymer matrix.
- Active Agent: The compositions can include a variety of active agents, such as drugs, which are released as the polymer degrades.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the composition comprising a biodegradable polyorthoester polymer, an aprotic solvent, and an active agent.
- Claim 2 specifies the method of preparing the composition.
- Claim 3 details the use of the composition for delivering the active agent over a prolonged period[4].
Dependent Claims
- These claims further elaborate on the specific types of polyorthoester polymers, aprotic solvents, and active agents that can be used.
- They also describe various embodiments of the composition, including different ratios of polymer to solvent and different methods of administration.
Patent Landscape
Classification and Categorization
The patent is classified under several categories within the International Patent Classification (IPC) system:
- A61K31/4458: Non condensed piperidines, e.g., piperocaine.
- A61K31/395: Heterocyclic compounds having nitrogen as a ring hetero atom.
- A61K47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g., polyesters, polyamino acids[4].
Prior Art and Related Patents
The patent landscape in this area is rich with prior art related to biodegradable polymers and drug delivery systems. For instance, other patents and publications have discussed various types of biodegradable polymers and their applications in medical devices and pharmaceuticals. The USPTO's Patent Public Search tool and other international databases, such as the European Patent Office's esp@cenet and the World Intellectual Property Organization's PATENTSCOPE, provide access to these prior art documents[1].
Global Dossier and International Patent Offices
The Global Dossier service, provided by the USPTO, allows users to access the file histories of related applications from participating IP Offices. This service is particularly useful for understanding the international patent family and the status of related applications in other jurisdictions[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset, which includes detailed information on claims from US patents granted between 1976 and 2014, can provide insights into the scope and trends of patent claims in the field of biodegradable polymers and drug delivery systems. This dataset can help researchers and patent analysts understand the dependency relationships between claims and the overall patent scope[3].
Industry Impact
The development of biodegradable polyorthoester polymers and their applications in drug delivery systems has significant economic and health implications. These innovations can lead to improved patient outcomes, reduced healthcare costs, and new market opportunities for pharmaceutical and medical device companies.
Practical Applications
Drug Delivery Systems
The compositions described in the patent can be used to develop sustained-release formulations for a variety of drugs, including those for chronic conditions such as diabetes, cancer, and cardiovascular diseases. These systems can enhance patient compliance and reduce the frequency of dosing.
Medical Devices
Biodegradable polyorthoester polymers can also be used in the development of implantable medical devices, such as drug depots and tissue engineering scaffolds. These devices can provide localized drug delivery and support tissue regeneration.
Challenges and Future Directions
Regulatory Approval
One of the significant challenges in bringing these compositions to market is obtaining regulatory approval. The FDA and other regulatory bodies require extensive testing and clinical trials to ensure the safety and efficacy of new drug delivery systems.
Technological Advancements
Future research in this area may focus on improving the biodegradability and biocompatibility of polyorthoester polymers, as well as developing new aprotic solvents and active agents. Advances in nanotechnology and 3D printing could also enhance the precision and effectiveness of these drug delivery systems.
Key Takeaways
- Innovative Compositions: The patent introduces novel compositions combining biodegradable polyorthoester polymers with aprotic solvents for drug delivery.
- Broad Applications: These compositions have potential applications in various medical fields, including sustained-release formulations and implantable devices.
- Regulatory and Technological Challenges: Bringing these innovations to market involves navigating regulatory approvals and continuous technological advancements.
- Economic and Health Implications: The development of these compositions can lead to improved patient outcomes and new market opportunities.
FAQs
Q: What is the primary focus of United States Patent 9,744,163?
A: The primary focus is on compositions and delivery systems comprising biodegradable polyorthoester polymers, aprotic solvents, and active agents for sustained drug release.
Q: How do the compositions described in the patent enhance drug delivery?
A: The compositions enhance drug delivery by providing a sustained release of the active agent over a prolonged period, improving therapeutic efficacy and reducing the need for frequent dosing.
Q: What are the key components of the patented compositions?
A: The key components include biodegradable polyorthoester polymers, aprotic solvents, and active agents.
Q: What are the potential applications of these compositions?
A: Potential applications include sustained-release formulations for various drugs and implantable medical devices such as drug depots and tissue engineering scaffolds.
Q: What challenges must be overcome to bring these compositions to market?
A: Significant challenges include obtaining regulatory approval and continuous technological advancements to improve biodegradability, biocompatibility, and efficacy.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents Portal - US-20050042194-A1: https://portal.unifiedpatents.com/patents/patent/US-20050042194-A1
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US9744163B2: https://patents.google.com/patent/US9744163B2/en
- Unified Patents Portal - WO-2009129509-A2: https://portal.unifiedpatents.com/patents/patent/WO-2009129509-A2
