United States Patent 9,248,195: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,248,195, titled "Abuse-deterrent pharmaceutical compositions of opioids and other drugs," is a significant development in the field of pharmaceuticals, particularly in the context of opioid abuse prevention. This patent, granted to address the critical issue of drug abuse, introduces innovative formulations designed to deter improper administration of drugs.
Background
Opioid abuse has been a pervasive and devastating issue globally, leading to numerous deaths and health complications. The need for abuse-deterrent formulations has become increasingly urgent. This patent aims to provide a solution by developing pharmaceutical compositions that are resistant to tampering and misuse.
Scope of the Patent
Overview
The patent covers abuse-deterrent pharmaceutical compositions, specifically focusing on opioids and other drugs that are prone to abuse. These compositions are designed to prevent or deter the improper administration of these drugs, such as crushing, grinding, or dissolving them to achieve a rapid release of the active ingredient[1].
Key Components
- Microparticles: The patent involves the use of microparticles that contain the active pharmaceutical ingredient. These microparticles are formulated to release the drug in a controlled manner, preventing rapid release even when the formulation is tampered with[1].
- Carrier Materials: The compositions include carrier materials that help in maintaining the integrity of the microparticles and ensuring the controlled release of the drug[1].
- Degradation Mechanisms: The patent describes degradation mechanisms that prevent the drug from being released quickly, even if the formulation is subjected to various forms of tampering[1].
Claims
Essential Claims
The claims of this patent are crucial as they define the scope of protection for the invention. Here are some key claims:
- Claim 1: This claim describes the abuse-deterrent pharmaceutical composition comprising microparticles containing the active pharmaceutical ingredient, a carrier material, and optionally, a diluting agent or other ingredients to prevent rapid release of the drug[1].
- Claim 2: This claim specifies the method of preparing the composition, including the steps of mixing the active ingredient with the carrier material and forming microparticles[1].
- Claim 3: This claim details the characteristics of the microparticles, such as their size and the controlled release profile[1].
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. For example:
- Claim 4: This claim describes specific types of carrier materials that can be used, such as lactose or methyl cellulose[1].
- Claim 5: This claim outlines the use of additional ingredients to enhance the abuse-deterrent properties of the composition[1].
Patent Landscape
Prior Art
The patent landscape for abuse-deterrent pharmaceutical compositions is complex and involves numerous prior art references. The USPTO conducts a thorough prior art search to ensure that the claimed invention is novel and non-obvious. For this patent, the prior art search would have included existing formulations and methods for preventing drug abuse[5].
Related Patents
There are several related patents and patent applications that address similar issues of drug abuse prevention. These patents often involve different formulations, delivery systems, or mechanisms to deter abuse. Analyzing these related patents helps in understanding the broader patent landscape and identifying potential gaps or opportunities for further innovation[4].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To fully understand the protection offered by this patent, a Claim Coverage Matrix can be used. This matrix categorizes the patents and claims by scope concepts, helping to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist. This tool is particularly useful for managing large numbers of patent claims and ensuring comprehensive coverage[3].
Claim Charts
Interactive claim charts generated by software like ClaimScape® can be used to review the patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking and identifying future design opportunities[3].
Practical Implications
Manufacturing and Formulation
The practical implications of this patent involve the development and manufacturing of abuse-deterrent pharmaceutical compositions. Pharmaceutical companies must adhere to the specified formulations and methods to ensure that their products comply with the patent claims. This includes using the correct microparticles, carrier materials, and other ingredients to achieve the desired controlled release profile[1].
Regulatory Compliance
Compliance with regulatory requirements is crucial. The USPTO and other regulatory bodies will review the patent application and ensure that the claimed invention meets the statutory conditions of being useful, novel, and non-obvious. Any Office Actions or rejections must be addressed to secure the patent grant[5].
Future Directions
Continuous Innovation
The field of abuse-deterrent pharmaceuticals is continuously evolving. Future directions may include the development of new formulations, improved delivery systems, and innovative mechanisms to further deter drug abuse. Patent analytics and claim coverage tools will be essential in navigating this evolving landscape and identifying opportunities for innovation[3].
Global Harmonization
Global harmonization of patent systems, facilitated by tools like the Global Dossier, will play a significant role in ensuring that patent protection is consistent across different jurisdictions. This harmonization helps in streamlining the patent search and examination process, making it easier to manage global patent portfolios[4].
Key Takeaways
- Abuse-Deterrent Formulations: The patent introduces innovative formulations designed to prevent the improper administration of opioids and other drugs.
- Microparticles and Carrier Materials: The use of microparticles and specific carrier materials is crucial for achieving controlled drug release.
- Regulatory Compliance: Ensuring compliance with regulatory requirements is essential for securing and maintaining patent protection.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are vital for managing patent claims and identifying gaps or opportunities.
- Continuous Innovation: The field of abuse-deterrent pharmaceuticals is dynamic, requiring continuous innovation and adaptation to new technologies and regulatory standards.
FAQs
What is the primary purpose of the United States Patent 9,248,195?
The primary purpose of this patent is to develop and protect abuse-deterrent pharmaceutical compositions, particularly for opioids and other drugs prone to abuse.
How do the microparticles in the patent work?
The microparticles contain the active pharmaceutical ingredient and are formulated to release the drug in a controlled manner, preventing rapid release even when the formulation is tampered with.
What are the key components of the abuse-deterrent pharmaceutical compositions?
The key components include microparticles containing the active ingredient, carrier materials, and optionally, diluting agents or other ingredients to prevent rapid drug release.
How does the patent ensure regulatory compliance?
The patent ensures regulatory compliance by adhering to the statutory conditions of being useful, novel, and non-obvious, as reviewed by the USPTO during the patent examination process.
What tools can be used to analyze the patent claims and coverage?
Tools such as Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® can be used to analyze the patent claims and coverage.
Sources
- US Patent and Trademark Office, "Abuse-deterrent pharmaceutical compositions of opioids and other drugs," US Patent 9,248,195 B2.
- U.S. Patent and Trademark Office, "U.S. Patent and Trademark Office (USPTO) | USAGov."
- Schwegman, Lundberg & Woessner, P.A., "Patent Analytics | Intellectual Property Law."
- U.S. Patent and Trademark Office, "Search for patents - USPTO."
- The Maryland People's Law Library, "Patents | The Maryland People's Law Library."
