United States Patent 10,028,912: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 10,028,912, titled "Method of lyophilizing liposomes," is a significant patent in the field of pharmaceuticals, particularly in the area of drug delivery systems. This patent is owned by Celator Pharmaceuticals Inc. and is part of a broader portfolio of patents related to the drug Vyxeos.
Patent Scope and Claims
General Description
The patent describes a method for lyophilizing liposomes, which are microscopic vesicles composed of a lipid bilayer. Lyophilization, or freeze-drying, is a process used to preserve these liposomes by removing the water content, thereby enhancing their stability and shelf life. The method outlined in this patent is crucial for the formulation and storage of liposomal drugs[2].
Key Claims
- Lyophilization Process: The patent details a specific method for lyophilizing liposomes, including the use of cryoprotectants to prevent damage to the liposomes during the freezing and drying process. Cryoprotectants such as sucrose are mentioned as essential components to maintain the structural integrity of the liposomes[1].
- Composition: The patent specifies the composition of the liposomal formulation, including the therapeutic agents encapsulated within the liposomes. For example, drugs like cytarabine and daunorubicin, used in the treatment of leukemia, are mentioned as potential therapeutic agents[1].
- Phase Transition: The method involves controlling the phase transition of the liposomal formulation during the lyophilization process to ensure that the liposomes remain intact and retain their therapeutic efficacy[1].
Patent Landscape
Related Patents
The patent US10,028,912 is part of a series of patents related to the lyophilization of liposomes. Other patents, such as US10166184 and US10835492, also focus on similar methods and aspects of liposomal drug delivery. These patents collectively protect various facets of the drug formulation, including dosage, mode of administration, and storage conditions[2].
Exclusivities and Patent Protection
The patent is protected until October 2032, and it is one of several patents that contribute to the overall exclusivity of the drug Vyxeos. In addition to patent protection, Vyxeos has been granted exclusivities by the FDA, which further delay the potential launch of generic or bioequivalent versions of the drug[2].
Litigation History
The patent has been subject to various legal proceedings, including challenges to its validity. However, as of the latest information, none of these challenges have resulted in the patent being invalidated. Understanding the litigation history is crucial for estimating the potential early arrival of generic versions of the drug[2].
Importance in Drug Delivery
Therapeutic Agents
The method described in this patent is particularly important for drugs like cytarabine, which is used in treating various forms of leukemia. The stability and efficacy of such drugs are significantly enhanced through the lyophilization process outlined in the patent[4].
Clinical Implications
The ability to lyophilize liposomes effectively ensures that these drug delivery systems can be stored and transported without significant degradation. This is critical for maintaining the therapeutic efficacy of the encapsulated drugs and ensuring consistent patient outcomes.
Technical Aspects
Freezing and Drying
The patent emphasizes the importance of controlled freezing and drying conditions to prevent damage to the liposomes. This includes the use of specific temperatures and the presence of cryoprotectants to protect the liposomal structure during the lyophilization process[1].
Phase Transition Control
Controlling the phase transition of the liposomal formulation is a key aspect of the method. This involves ensuring that the liposomes do not undergo significant structural changes during the freezing and drying process, which could compromise their therapeutic efficacy[1].
Economic and Regulatory Implications
Patent Scope and Quality
The scope and quality of this patent are significant in the broader debate about patent quality. Metrics such as independent claim length and count can be used to measure the scope of the patent, which in turn affects its validity and the potential for litigation[3].
Market Impact
The exclusivity provided by this patent, along with other related patents, has a substantial impact on the market. It delays the entry of generic competitors, allowing the patent holder to maintain market dominance and protect their investment in research and development.
Key Takeaways
- Method of Lyophilization: The patent describes a specific method for lyophilizing liposomes, including the use of cryoprotectants and controlled phase transitions.
- Therapeutic Agents: The method is crucial for stabilizing and preserving therapeutic agents like cytarabine and daunorubicin.
- Patent Protection: The patent is part of a broader portfolio protecting the drug Vyxeos and is set to expire in October 2032.
- Litigation and Exclusivities: The patent has been subject to legal challenges, and Vyxeos has additional exclusivities granted by the FDA.
- Clinical and Economic Impact: The method ensures the stability and efficacy of liposomal drugs, impacting patient outcomes and market dynamics.
FAQs
What is the primary focus of United States Patent 10,028,912?
The primary focus of this patent is a method for lyophilizing liposomes, which involves the use of cryoprotectants and controlled phase transitions to preserve the structural integrity of the liposomes.
Which therapeutic agents are mentioned in the patent?
The patent mentions therapeutic agents such as cytarabine and daunorubicin, which are used in the treatment of various forms of leukemia.
What is the significance of cryoprotectants in the lyophilization process?
Cryoprotectants, such as sucrose, are essential to prevent damage to the liposomes during the freezing and drying process, ensuring that the liposomes retain their therapeutic efficacy.
When is the patent set to expire?
The patent is set to expire in October 2032.
How does the patent impact the market for Vyxeos?
The patent, along with other related patents and FDA-granted exclusivities, delays the entry of generic competitors, allowing Celator Pharmaceuticals Inc. to maintain market dominance for Vyxeos.
What are the potential implications of litigation on the patent?
Litigation challenging the validity of the patent could potentially lead to its early invalidation, allowing generic versions of the drug to enter the market sooner. However, as of the latest information, the patent remains active.
Sources:
- US10028912B2 - Method of lyophilizing liposomes - Google Patents
- Vyxeos patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Cytarabine: Uses, Interactions, Mechanism of Action - DrugBank
