United States Patent 10,940,128: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,940,128, titled "Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same," is a significant patent in the pharmaceutical field. This patent, granted to address specific needs in cancer treatment, involves innovative formulations of melphalan, a chemotherapy drug, using cyclodextrin derivatives. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Melphalan
Melphalan is a chemotherapeutic agent used in the treatment of various cancers, including multiple myeloma, ovarian cancer, and certain types of leukemia. However, its use is often limited by its solubility and stability issues, which can affect its efficacy and safety profile[1].
Scope of the Patent
The patent US10,940,128 focuses on overcoming the solubility and stability challenges associated with melphalan by incorporating cyclodextrin derivatives into its formulation. Cyclodextrins are known for their ability to form inclusion complexes with drugs, enhancing their solubility and stability.
Key Components
- Melphalan: The primary active ingredient, a chemotherapeutic agent.
- Cyclodextrin Derivative: Used to improve the solubility and stability of melphalan.
- Pharmaceutical Composition: The final formulation that includes melphalan, cyclodextrin derivative, and other excipients.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: A pharmaceutical composition comprising melphalan and a cyclodextrin derivative.
- Claim 2: A method of making the pharmaceutical composition.
- Claim 3: A method of using the pharmaceutical composition for treating cancer.
Dependent Claims
- Claims 4-10: Various embodiments of the pharmaceutical composition, including different types of cyclodextrin derivatives and excipients.
- Claims 11-15: Methods of administration, dosing regimens, and specific cancer types treated.
Detailed Analysis of Claims
Pharmaceutical Composition
The patent describes a pharmaceutical composition that includes melphalan and a cyclodextrin derivative. This composition is designed to be injectable, addressing the solubility issues of melphalan. The claims specify the types of cyclodextrin derivatives that can be used, such as hydroxypropyl-β-cyclodextrin or sulfobutyl ether-β-cyclodextrin[1].
Method of Making
The method of making the pharmaceutical composition involves dissolving melphalan in a solvent, adding the cyclodextrin derivative, and then adjusting the pH and osmolality to ensure stability and compatibility for injection.
Method of Use
The method of use claims cover the administration of the pharmaceutical composition for treating various cancers, including multiple myeloma, ovarian cancer, and certain types of leukemia. The claims also specify dosing regimens and treatment protocols.
Patent Landscape
Prior Art
The patent landscape for melphalan formulations is extensive, with numerous prior art references to various formulations aimed at improving its solubility and stability. However, the use of cyclodextrin derivatives in this specific context is a novel approach that distinguishes this patent from prior art[1].
Related Patents
Other patents in the field focus on different solubilizing agents or formulation techniques. For example, some patents use liposomal formulations or other solubilizing agents like polyethylene glycol. The unique combination of melphalan and cyclodextrin derivatives in this patent sets it apart from these related patents.
Global Patent System
The global patent system, facilitated by organizations like the USPTO, EPO, and WIPO, allows for the search and analysis of patent families across different jurisdictions. This patent, being part of a global patent family, would be searchable through databases like PATENTSCOPE and esp@cenet, providing a comprehensive view of its international scope[4].
Impact on the Pharmaceutical Industry
Innovation and Improvement
This patent represents a significant innovation in the formulation of melphalan, offering improved solubility and stability. This can lead to better patient outcomes by ensuring more consistent and effective drug delivery.
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents like US10,940,128 play a crucial role in protecting intellectual property. This patent gives the holder a competitive edge by providing a unique solution to a long-standing problem in cancer treatment.
Legal and Regulatory Considerations
Patent Scope and Quality
The scope of this patent is well-defined, with clear claims that specify the composition, method of making, and method of use. This clarity is important in the context of patent quality debates, where overly broad or unclear claims can lead to litigation and decreased innovation[3].
Small Claims Patent Court
The concept of a small claims patent court, as studied by ACUS, could potentially impact the enforcement and litigation of patents like US10,940,128. Such a court could provide a more streamlined and cost-effective way to resolve patent disputes, which is particularly relevant for smaller entities or individual inventors[5].
Conclusion
The United States Patent 10,940,128 is a significant contribution to the field of pharmaceuticals, particularly in cancer treatment. The use of cyclodextrin derivatives to improve the solubility and stability of melphalan addresses a critical need and offers a novel solution. Understanding the scope, claims, and broader patent landscape of this invention is crucial for both industry professionals and researchers.
Key Takeaways
- Innovative Formulation: The patent introduces a new formulation of melphalan using cyclodextrin derivatives.
- Improved Solubility and Stability: This formulation enhances the solubility and stability of melphalan, making it more effective and safer.
- Clear Claims: The patent has well-defined claims that specify the composition, method of making, and method of use.
- Competitive Edge: The patent provides a competitive advantage in the pharmaceutical industry.
- Global Patent Family: The patent is part of a global patent family, searchable through international databases.
FAQs
Q: What is the main innovation of US Patent 10,940,128?
A: The main innovation is the use of cyclodextrin derivatives to improve the solubility and stability of melphalan.
Q: What types of cancers can be treated with this pharmaceutical composition?
A: The composition can be used to treat cancers such as multiple myeloma, ovarian cancer, and certain types of leukemia.
Q: How does the use of cyclodextrin derivatives benefit the formulation?
A: Cyclodextrin derivatives form inclusion complexes with melphalan, enhancing its solubility and stability.
Q: What is the significance of clear claims in a patent?
A: Clear claims help in defining the scope of the invention, reducing the likelihood of litigation and ensuring better protection of intellectual property.
Q: How can the global patent system help in understanding the scope of this patent?
A: The global patent system allows for the search and analysis of patent families across different jurisdictions, providing a comprehensive view of the patent's international scope.
Sources
- US10940128B2 - Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS
