Detailed Analysis of the Scope and Claims of United States Patent 11,072,586
Introduction
United States Patent 11,072,586, titled "Solid state forms of Eltrombopag choline," was issued on July 27, 2021, to Assia Chemical Industries Ltd. This patent is significant in the pharmaceutical industry, particularly in the development and formulation of Eltrombopag choline, a compound used in the treatment of certain blood disorders.
Inventors and Assignees
The patent was invented by a team of researchers including Hariprasad Sharma Vijay, Shafakat Ali Nasir Ali, Ashutosh Vijay Joshi, Parven Kumar Luthra, Anantha Rajmohan Muthusamy, Amit Singh, Rajesh Sadanand Bate, and Sadanand Hardeo Maurya. The assignee of the patent is Assia Chemical Industries Ltd., based in Petach Tikva, Israel[4].
Patent Scope
The scope of this patent encompasses several key aspects:
Solid State Forms
The patent discloses various solid state forms of Eltrombopag choline, including different polymorphs, salts, and solvates. These forms are crucial for improving the bioavailability, stability, and shelf life of the pharmaceutical compound[4].
Preparation Processes
The patent includes detailed processes for the preparation of these solid state forms. These processes involve various techniques such as crystallization, grinding, and drying to achieve the desired polymorphic forms[4].
Pharmaceutical Compositions
The patent also covers pharmaceutical compositions that include these solid state forms of Eltrombopag choline. These compositions are designed to enhance the therapeutic efficacy and stability of the drug[4].
Claims
The claims of the patent are critical in defining the scope of protection granted to the inventors.
Independent Claims
The patent includes independent claims that define the novel aspects of the invention. These claims typically cover the specific solid state forms, their preparation methods, and the pharmaceutical compositions containing these forms[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as specific conditions for preparing the solid state forms, particular characteristics of the forms, and specific uses of the pharmaceutical compositions[4].
Patent Landscape
Related Patents
The patent landscape for Eltrombopag choline includes other related patents that cover different aspects of the compound, such as its synthesis, other solid state forms, and various pharmaceutical applications. These patents may be held by different entities, contributing to a complex intellectual property environment[2].
International Patent Family
The patent is part of an international patent family, with applications filed in multiple jurisdictions. This is evident from the priority claims to international patent applications and provisional patents filed in India and other countries[4].
Examination Process
The examination process for this patent, as with many others, involved narrowing the scope of the claims to ensure clarity and validity. Research indicates that the examination process tends to narrow the scope of patent claims, especially in terms of claim length and count, to avoid overly broad claims[3].
Patent Expiration and Exclusivity
The patent is set to expire on November 5, 2038, which is 20 years from the date of filing. However, the actual expiration date can be adjusted based on various factors, including patent term adjustments and any potential litigation[2].
Technological and Market Impact
Improvements in Bioavailability and Stability
The solid state forms disclosed in this patent can significantly improve the bioavailability and stability of Eltrombopag choline, making it a more effective treatment option. This can lead to better patient outcomes and enhanced market competitiveness for the drug[4].
Competitive Advantage
By securing this patent, Assia Chemical Industries Ltd. gains a competitive advantage in the market for Eltrombopag choline formulations. This exclusivity can help the company to dominate the market segment for this specific drug formulation[2].
Regulatory and Legal Considerations
FDA Approval and Exclusivity
While the patent provides exclusive rights to the inventor, FDA approval and exclusivity periods can also play a crucial role in the market exclusivity of the drug. These periods can run concurrently with the patent term and provide additional protection against generic competition[2].
International Intellectual Property Rights
The global nature of the patent family means that the inventors must comply with intellectual property laws and regulations in multiple jurisdictions. This includes accessing file histories and citation data through services like the Global Dossier[1].
Search and Analysis Tools
USPTO Resources
For conducting a thorough search and analysis of patents like 11,072,586, resources such as the USPTO's Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs) are invaluable. These tools provide access to prior art, file histories, and other critical information necessary for understanding the patent landscape[1].
International Databases
Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), is essential for a comprehensive analysis of the global patent landscape[1].
Key Takeaways
- Solid State Forms: The patent covers various solid state forms of Eltrombopag choline, including polymorphs, salts, and solvates.
- Preparation Processes: Detailed methods for preparing these forms are disclosed.
- Pharmaceutical Compositions: The patent includes pharmaceutical compositions that enhance the drug's efficacy and stability.
- Patent Expiration: The patent is set to expire on November 5, 2038.
- Competitive Advantage: The patent provides a competitive advantage in the market for Eltrombopag choline formulations.
- Regulatory Considerations: Compliance with FDA regulations and international intellectual property laws is crucial.
Frequently Asked Questions (FAQs)
Q: What is the main subject of United States Patent 11,072,586?
A: The main subject is the solid state forms of Eltrombopag choline, including their preparation and pharmaceutical compositions.
Q: Who are the inventors of this patent?
A: The inventors include Hariprasad Sharma Vijay, Shafakat Ali Nasir Ali, Ashutosh Vijay Joshi, and several others.
Q: What is the significance of the solid state forms disclosed in this patent?
A: These forms improve the bioavailability, stability, and shelf life of Eltrombopag choline.
Q: How long is the patent term for this invention?
A: The patent is set to expire on November 5, 2038, which is 20 years from the date of filing.
Q: What tools can be used to conduct a thorough search and analysis of this patent?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and international patent databases like those from EPO, JPO, and WIPO are useful.
Cited Sources
- USPTO - Search for patents https://www.uspto.gov/patents/search
- Drugs.com - Generic Alvaiz Availability https://www.drugs.com/availability/generic-alvaiz.html
- SSRN - Patent Claims and Patent Scope https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Googleapis.com - U.S. Patent 11,072,586 B2 https://patentimages.storage.googleapis.com/d2/02/8b/458f1cd4e1e85f/US11072586.pdf
