Detailed Analysis of the Scope and Claims of United States Patent 10,406,160
Introduction
The United States Patent 10,406,160, titled "Sustained Release Small Molecule Drug Formulation," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted on September 10, 2019, pertains to an injectable depot formulation designed for the sustained release of small molecule drugs. This formulation includes a biocompatible polymer and an organic solvent combined to form a viscous gel, which encapsulates the drug, facilitating its gradual release over time[4].
Scope of the Patent
Technical Field
The patent falls within the technical field of pharmaceutical formulations, specifically focusing on sustained release drug delivery systems. This area is crucial for improving the efficacy and compliance of drug treatments by reducing the frequency of administration.
Key Components
- Biocompatible Polymer: The formulation includes a biocompatible polymer, such as PLGA (Poly(lactic-co-glycolic acid)), which is commonly used in drug delivery systems due to its biodegradability and non-toxic nature.
- Organic Solvent: The organic solvent is combined with the biocompatible polymer to create a viscous gel. This gel encapsulates the small molecule drug, allowing for its sustained release.
- Small Molecule Drug: The patent is applicable to a wide range of small molecule drugs, which are typically defined as molecules with a molecular weight of less than 900 Daltons.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: This claim describes the injectable depot formulation comprising a biocompatible polymer, an organic solvent, and a small molecule drug, where the formulation is in the form of a viscous gel.
- Claim 10: This claim specifies the method of preparing the formulation, including the steps of combining the biocompatible polymer and organic solvent, and then adding the small molecule drug.
Dependent Claims
Dependent claims further specify the details of the independent claims, such as:
- Claim 2: This claim details the type of biocompatible polymer used, such as PLGA.
- Claim 11: This claim describes the method of administering the formulation, including the use of a syringe or other injection device.
Patent Landscape
Related Patents
The patent landscape in the area of sustained release drug formulations is extensive. Other patents, such as those related to different types of biodegradable polymers or various methods of drug encapsulation, are relevant. For example, patents like US10406160B2 are part of a larger family of patents focused on drug delivery systems.
Prior Art
The prior art in this field includes numerous patents and publications related to sustained release formulations. The patent in question builds upon this prior art by providing a specific formulation and method that enhances the efficacy and convenience of drug delivery.
Competitors and Similar Technologies
Companies and researchers in the pharmaceutical industry are continually developing new sustained release formulations. Competitors may include other biodegradable polymer-based formulations or alternative drug delivery systems such as nanoparticles or implants.
Legal and Regulatory Considerations
Patent Term and Extensions
The patent term for US10406160B2 is 20 years from the filing date of the application, subject to any adjustments or extensions. However, as seen in cases like In re Cellect, the patent term can be affected by factors such as Patent Term Adjustment (PTA) and obviousness-type double patenting (ODP) analyses[1].
Litigation and Enforcement
The enforcement of this patent would involve ensuring that other entities do not infringe on the claimed invention. This could involve litigation if necessary, and the patent holder would need to demonstrate that the infringing product or method falls within the scope of the claims.
Economic and Practical Implications
Market Impact
The sustained release small molecule drug formulation has significant market potential, particularly in treating chronic conditions where frequent dosing is a challenge. This formulation can improve patient compliance and reduce the overall cost of treatment.
Research and Development
The patent encourages further research and development in the field of drug delivery systems. By providing a specific formulation and method, it sets a benchmark for future innovations and improvements.
Key Takeaways
- Innovative Formulation: The patent introduces a novel injectable depot formulation for sustained release of small molecule drugs.
- Biocompatible Materials: The use of biocompatible polymers like PLGA ensures the safety and efficacy of the formulation.
- Sustained Release: The formulation allows for the gradual release of the drug, improving patient compliance and treatment outcomes.
- Market Potential: The patent has significant market implications, particularly in the treatment of chronic conditions.
- Legal Considerations: The patent term and any extensions or adjustments must be carefully managed to ensure the full protection of the invention.
FAQs
Q: What is the primary component of the sustained release formulation described in US10406160B2?
A: The primary components include a biocompatible polymer, such as PLGA, and an organic solvent combined to form a viscous gel.
Q: How does the formulation improve drug delivery?
A: The formulation allows for the sustained release of the small molecule drug, reducing the need for frequent dosing and improving patient compliance.
Q: What is the significance of using PLGA in the formulation?
A: PLGA is biodegradable and non-toxic, making it an ideal material for drug delivery systems.
Q: How long is the patent term for US10406160B2?
A: The patent term is 20 years from the filing date of the application, subject to any adjustments or extensions.
Q: What are the potential market implications of this patent?
A: The patent has significant market potential, particularly in the treatment of chronic conditions, by improving patient compliance and reducing treatment costs.
Sources
- In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
- U.S. Patent Small Claims Court, Administrative Conference of the United States.
- Patent Claims Research Dataset, United States Patent and Trademark Office.
- US10406160B2 - Sustained release small molecule drug formulation, Google Patents.
