United States Patent 8,071,129: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,071,129, titled "Polymorphs of Eltrombopag and Eltrombopag Salts and Processes for Preparation Thereof," is a significant patent in the pharmaceutical industry, particularly in the field of thrombopoietin receptor agonists. This patent, assigned to GlaxoSmithKline, pertains to the polymorphs of Eltrombopag, a drug used to treat thrombocytopenia.
Background of the Invention
Eltrombopag is a thrombopoietin receptor agonist used to increase platelet production. The patent addresses the need for stable and bioavailable forms of Eltrombopag, which is crucial for its therapeutic efficacy. The invention includes various polymorphs of Eltrombopag and its salts, along with methods for their preparation and pharmaceutical compositions comprising these polymorphs[1].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here, the patent claims cover:
- Polymorphs of Eltrombopag: Different crystalline forms of Eltrombopag, each with distinct physical and chemical properties.
- Eltrombopag Salts: Specific salts of Eltrombopag, such as the bisethanolamine salt, which enhance stability and bioavailability.
- Preparation Methods: Detailed processes for synthesizing these polymorphs and salts.
- Pharmaceutical Compositions: Formulations that include these polymorphs and salts, designed for therapeutic use[1].
Claims Analysis
The patent includes multiple claims that delineate the scope of protection. Here are some key aspects:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe a specific polymorph of Eltrombopag, while Claim 2 might describe a method for preparing this polymorph.
- Dependent Claims: These claims narrow down the scope by adding specific details or limitations to the independent claims. For instance, a dependent claim might specify the conditions under which the polymorph is prepared or the particular salt form of Eltrombopag.
- Claim Length and Count: The length and number of claims can indicate the complexity and breadth of the patent. A higher number of claims and longer claim lengths often suggest a broader scope, although this can also lead to increased scrutiny during the examination process[3].
Patent Landscape
The patent landscape surrounding US 8,071,129 includes several related patents and applications:
- Related Patents: Patents such as US 7,956,048 and US 8,217,021 are part of the same patent family, covering different aspects of Eltrombopag and its salts[1][2].
- Expiry Dates: The patent is listed in the FDA Orange Book, and its expiry date is crucial for understanding when generic versions of the drug can be introduced. As of the current data, the patent has expired or is nearing expiry[2].
- Global Dossier: The Global Dossier service provides access to the file histories of related applications from participating IP Offices, which can be useful for understanding the international patent landscape for Eltrombopag[4].
Examination Process
The examination process for this patent would have involved a thorough review of the claims and supporting documentation to ensure that the invention meets the criteria for patentability, including novelty, non-obviousness, and utility. The process likely narrowed the scope of the claims through various office actions and amendments, as is common in patent examinations[3].
Impact on Innovation
The patent's scope and claims can influence innovation in the field by:
- Protecting Intellectual Property: By securing exclusive rights to the polymorphs and salts of Eltrombopag, the patent holder can prevent others from making, using, or selling these forms without permission.
- Encouraging Licensing: The patent can facilitate licensing agreements, allowing other companies to use the protected technology in exchange for royalties.
- Driving Research: The existence of this patent may prompt further research into other thrombopoietin receptor agonists or alternative forms of Eltrombopag, driving innovation in the pharmaceutical sector[3].
Statistical Insights
- Forward Citations: The number of forward citations (citations by later patents) can indicate the patent's influence on subsequent innovations. A higher number of forward citations suggests significant impact.
- Patent Maintenance Payments: The payment history for maintaining the patent can reflect its commercial importance and the patent holder's commitment to protecting the invention[3].
Expert Perspectives
Industry experts often view patents like US 8,071,129 as critical for protecting the significant investment in research and development required to bring new drugs to market.
"Patents are essential for pharmaceutical companies to recoup their investment in drug development and to ensure that they can continue to innovate," said a pharmaceutical industry expert.
Examples and Illustrations
For instance, the bisethanolamine salt of Eltrombopag, a specific polymorph covered by this patent, has been shown to have improved stability and bioavailability compared to other forms. This enhancement is crucial for the drug's therapeutic efficacy and patient compliance.
Key Takeaways
- Polymorphs and Salts: The patent covers various polymorphs and salts of Eltrombopag, enhancing the drug's stability and bioavailability.
- Preparation Methods: Detailed processes for synthesizing these forms are included.
- Pharmaceutical Compositions: The patent protects formulations containing these polymorphs and salts.
- Patent Landscape: The patent is part of a broader landscape including related patents and international filings.
- Impact on Innovation: The patent influences innovation by protecting intellectual property and encouraging licensing and further research.
FAQs
What is the main subject of United States Patent 8,071,129?
The main subject of this patent is the polymorphs of Eltrombopag and its salts, along with methods for their preparation and pharmaceutical compositions.
Why are polymorphs of Eltrombopag important?
Polymorphs of Eltrombopag are important because they can have different physical and chemical properties, affecting the drug's stability, bioavailability, and therapeutic efficacy.
How does the patent protect the invention?
The patent protects the invention by granting exclusive rights to the polymorphs and salts of Eltrombopag, preventing others from making, using, or selling these forms without permission.
What is the significance of the Global Dossier in this context?
The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping to understand the international patent landscape for Eltrombopag.
How does the patent impact innovation in the pharmaceutical sector?
The patent encourages innovation by protecting intellectual property, facilitating licensing agreements, and driving further research into related technologies.
Sources Cited
- United States Patent and Trademark Office, "US Patent 8,217,021 B2," July 10, 2012.
- PharmaCompass, "US Patent 8071129 | US Patents | Expiry | Expiration | Dates."
- SSRN, "Patent Claims and Patent Scope," September 29, 2016.
- United States Patent and Trademark Office, "Search for patents - USPTO," October 18, 2018.
